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Ethical Considerations in Research | Types & Examples

Published on October 18, 2021 by Pritha Bhandari . Revised on June 22, 2023.

Ethical considerations in research are a set of principles that guide your research designs and practices. Scientists and researchers must always adhere to a certain code of conduct when collecting data from people.

The goals of human research often include understanding real-life phenomena, studying effective treatments, investigating behaviors, and improving lives in other ways. What you decide to research and how you conduct that research involve key ethical considerations.

These considerations work to

  • protect the rights of research participants
  • enhance research validity
  • maintain scientific or academic integrity

Table of contents

Why do research ethics matter, getting ethical approval for your study, types of ethical issues, voluntary participation, informed consent, confidentiality, potential for harm, results communication, examples of ethical failures, other interesting articles, frequently asked questions about research ethics.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe for research subjects.

You’ll balance pursuing important research objectives with using ethical research methods and procedures. It’s always necessary to prevent permanent or excessive harm to participants, whether inadvertent or not.

Defying research ethics will also lower the credibility of your research because it’s hard for others to trust your data if your methods are morally questionable.

Even if a research idea is valuable to society, it doesn’t justify violating the human rights or dignity of your study participants.

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ethical issues in research proposal sample

Before you start any study involving data collection with people, you’ll submit your research proposal to an institutional review board (IRB) .

An IRB is a committee that checks whether your research aims and research design are ethically acceptable and follow your institution’s code of conduct. They check that your research materials and procedures are up to code.

If successful, you’ll receive IRB approval, and you can begin collecting data according to the approved procedures. If you want to make any changes to your procedures or materials, you’ll need to submit a modification application to the IRB for approval.

If unsuccessful, you may be asked to re-submit with modifications or your research proposal may receive a rejection. To get IRB approval, it’s important to explicitly note how you’ll tackle each of the ethical issues that may arise in your study.

There are several ethical issues you should always pay attention to in your research design, and these issues can overlap with each other.

You’ll usually outline ways you’ll deal with each issue in your research proposal if you plan to collect data from participants.

Voluntary participation means that all research subjects are free to choose to participate without any pressure or coercion.

All participants are able to withdraw from, or leave, the study at any point without feeling an obligation to continue. Your participants don’t need to provide a reason for leaving the study.

It’s important to make it clear to participants that there are no negative consequences or repercussions to their refusal to participate. After all, they’re taking the time to help you in the research process , so you should respect their decisions without trying to change their minds.

Voluntary participation is an ethical principle protected by international law and many scientific codes of conduct.

Take special care to ensure there’s no pressure on participants when you’re working with vulnerable groups of people who may find it hard to stop the study even when they want to.

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Informed consent refers to a situation in which all potential participants receive and understand all the information they need to decide whether they want to participate. This includes information about the study’s benefits, risks, funding, and institutional approval.

You make sure to provide all potential participants with all the relevant information about

  • what the study is about
  • the risks and benefits of taking part
  • how long the study will take
  • your supervisor’s contact information and the institution’s approval number

Usually, you’ll provide participants with a text for them to read and ask them if they have any questions. If they agree to participate, they can sign or initial the consent form. Note that this may not be sufficient for informed consent when you work with particularly vulnerable groups of people.

If you’re collecting data from people with low literacy, make sure to verbally explain the consent form to them before they agree to participate.

For participants with very limited English proficiency, you should always translate the study materials or work with an interpreter so they have all the information in their first language.

In research with children, you’ll often need informed permission for their participation from their parents or guardians. Although children cannot give informed consent, it’s best to also ask for their assent (agreement) to participate, depending on their age and maturity level.

Anonymity means that you don’t know who the participants are and you can’t link any individual participant to their data.

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, and videos.

In many cases, it may be impossible to truly anonymize data collection . For example, data collected in person or by phone cannot be considered fully anonymous because some personal identifiers (demographic information or phone numbers) are impossible to hide.

You’ll also need to collect some identifying information if you give your participants the option to withdraw their data at a later stage.

Data pseudonymization is an alternative method where you replace identifying information about participants with pseudonymous, or fake, identifiers. The data can still be linked to participants but it’s harder to do so because you separate personal information from the study data.

Confidentiality means that you know who the participants are, but you remove all identifying information from your report.

All participants have a right to privacy, so you should protect their personal data for as long as you store or use it. Even when you can’t collect data anonymously, you should secure confidentiality whenever you can.

Some research designs aren’t conducive to confidentiality, but it’s important to make all attempts and inform participants of the risks involved.

As a researcher, you have to consider all possible sources of harm to participants. Harm can come in many different forms.

  • Psychological harm: Sensitive questions or tasks may trigger negative emotions such as shame or anxiety.
  • Social harm: Participation can involve social risks, public embarrassment, or stigma.
  • Physical harm: Pain or injury can result from the study procedures.
  • Legal harm: Reporting sensitive data could lead to legal risks or a breach of privacy.

It’s best to consider every possible source of harm in your study as well as concrete ways to mitigate them. Involve your supervisor to discuss steps for harm reduction.

Make sure to disclose all possible risks of harm to participants before the study to get informed consent. If there is a risk of harm, prepare to provide participants with resources or counseling or medical services if needed.

Some of these questions may bring up negative emotions, so you inform participants about the sensitive nature of the survey and assure them that their responses will be confidential.

The way you communicate your research results can sometimes involve ethical issues. Good science communication is honest, reliable, and credible. It’s best to make your results as transparent as possible.

Take steps to actively avoid plagiarism and research misconduct wherever possible.

Plagiarism means submitting others’ works as your own. Although it can be unintentional, copying someone else’s work without proper credit amounts to stealing. It’s an ethical problem in research communication because you may benefit by harming other researchers.

Self-plagiarism is when you republish or re-submit parts of your own papers or reports without properly citing your original work.

This is problematic because you may benefit from presenting your ideas as new and original even though they’ve already been published elsewhere in the past. You may also be infringing on your previous publisher’s copyright, violating an ethical code, or wasting time and resources by doing so.

In extreme cases of self-plagiarism, entire datasets or papers are sometimes duplicated. These are major ethical violations because they can skew research findings if taken as original data.

You notice that two published studies have similar characteristics even though they are from different years. Their sample sizes, locations, treatments, and results are highly similar, and the studies share one author in common.

Research misconduct

Research misconduct means making up or falsifying data, manipulating data analyses, or misrepresenting results in research reports. It’s a form of academic fraud.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement about data analyses.

Research misconduct is a serious ethical issue because it can undermine academic integrity and institutional credibility. It leads to a waste of funding and resources that could have been used for alternative research.

Later investigations revealed that they fabricated and manipulated their data to show a nonexistent link between vaccines and autism. Wakefield also neglected to disclose important conflicts of interest, and his medical license was taken away.

This fraudulent work sparked vaccine hesitancy among parents and caregivers. The rate of MMR vaccinations in children fell sharply, and measles outbreaks became more common due to a lack of herd immunity.

Research scandals with ethical failures are littered throughout history, but some took place not that long ago.

Some scientists in positions of power have historically mistreated or even abused research participants to investigate research problems at any cost. These participants were prisoners, under their care, or otherwise trusted them to treat them with dignity.

To demonstrate the importance of research ethics, we’ll briefly review two research studies that violated human rights in modern history.

These experiments were inhumane and resulted in trauma, permanent disabilities, or death in many cases.

After some Nazi doctors were put on trial for their crimes, the Nuremberg Code of research ethics for human experimentation was developed in 1947 to establish a new standard for human experimentation in medical research.

In reality, the actual goal was to study the effects of the disease when left untreated, and the researchers never informed participants about their diagnoses or the research aims.

Although participants experienced severe health problems, including blindness and other complications, the researchers only pretended to provide medical care.

When treatment became possible in 1943, 11 years after the study began, none of the participants were offered it, despite their health conditions and high risk of death.

Ethical failures like these resulted in severe harm to participants, wasted resources, and lower trust in science and scientists. This is why all research institutions have strict ethical guidelines for performing research.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

  • Normal distribution
  • Measures of central tendency
  • Chi square tests
  • Confidence interval
  • Quartiles & Quantiles
  • Cluster sampling
  • Stratified sampling
  • Thematic analysis
  • Cohort study
  • Peer review
  • Ethnography

Research bias

  • Implicit bias
  • Cognitive bias
  • Conformity bias
  • Hawthorne effect
  • Availability heuristic
  • Attrition bias
  • Social desirability bias

Ethical considerations in research are a set of principles that guide your research designs and practices. These principles include voluntary participation, informed consent, anonymity, confidentiality, potential for harm, and results communication.

Scientists and researchers must always adhere to a certain code of conduct when collecting data from others .

These considerations protect the rights of research participants, enhance research validity , and maintain scientific integrity.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe.

Anonymity means you don’t know who the participants are, while confidentiality means you know who they are but remove identifying information from your research report. Both are important ethical considerations .

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, or videos.

You can keep data confidential by using aggregate information in your research report, so that you only refer to groups of participants rather than individuals.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement but a serious ethical failure.

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Addressing ethical issues in your research proposal

This article explores the ethical issues that may arise in your proposed study during your doctoral research degree.

What ethical principles apply when planning and conducting research?

Research ethics are the moral principles that govern how researchers conduct their studies (Wellcome Trust, 2014). As there are elements of uncertainty and risk involved in any study, every researcher has to consider how they can uphold these ethical principles and conduct the research in a way that protects the interests and welfare of participants and other stakeholders (such as organisations).  

You will need to consider the ethical issues that might arise in your proposed study. Consideration of the fundamental ethical principles that underpin all research will help you to identify the key issues and how these could be addressed. As you are probably a practitioner who wants to undertake research within your workplace, consider how your role as an ‘insider’ influences how you will conduct your study. Think about the ethical issues that might arise when you become an insider researcher (for example, relating to trust, confidentiality and anonymity).  

What key ethical principles do you think will be important when planning or conducting your research, particularly as an insider? Principles that come to mind might include autonomy, respect, dignity, privacy, informed consent and confidentiality. You may also have identified principles such as competence, integrity, wellbeing, justice and non-discrimination.  

Key ethical issues that you will address as an insider researcher include:

  • Gaining trust
  • Avoiding coercion when recruiting colleagues or other participants (such as students or service users)
  • Practical challenges relating to ensuring the confidentiality and anonymity of organisations and staff or other participants.

(Heslop et al, 2018)

A fuller discussion of ethical principles is available from the British Psychological Society’s Code of Human Research Ethics (BPS, 2021).

You can also refer to guidance from the British Educational Research Association and the British Association for Applied Linguistics .

Pebbles balance on a stone see-saw

Ethical principles are essential for protecting the interests of research participants, including maximising the benefits and minimising any risks associated with taking part in a study. These principles describe ethical conduct which reflects the integrity of the researcher, promotes the wellbeing of participants and ensures high-quality research is conducted (Health Research Authority, 2022).  

Research ethics is therefore not simply about gaining ethical approval for your study to be conducted. Research ethics relates to your moral conduct as a doctoral researcher and will apply throughout your study from design to dissemination (British Psychological Society, 2021). When you apply to undertake a doctorate, you will need to clearly indicate in your proposal that you understand these ethical principles and are committed to upholding them.  

Where can I find ethical guidance and resources? 

Professional bodies, learned societies, health and social care authorities, academic publications, Research Ethics Committees and research organisations provide a range of ethical guidance and resources. International codes such as the Universal Declaration of Human Rights underpin ethical frameworks (United Nations, 1948).  

You may be aware of key legislation in your own country or the country where you plan to undertake the research, including laws relating to consent, data protection and decision-making capacity, for example, the Data Protection Act, 2018 (UK).  If you want to find out more about becoming an ethical researcher, check out this Open University short course: Becoming an ethical researcher: Introduction and guidance: What is a badged course? - OpenLearn - Open University  

You should be able to justify the research decisions you make. Utilising these resources will guide your ethical judgements when writing your proposal and ultimately when designing and conducting your research study. The Ethical Guidelines for Educational Research (British Educational Research Association, 2018) identifies the key responsibilities you will have when you conduct your research, including the range of stakeholders that you will have responsibilities to, as follows:   

  • to your participants (e.g. to appropriately inform them, facilitate their participation and support them)
  • clients, stakeholders and sponsors
  • the community of educational or health and social care researchers
  • for publication and dissemination
  • your wellbeing and development

The National Institute for Health and Care Research (no date) has emphasised the need to promote equality, diversity and inclusion when undertaking research, particularly to address long-standing social and health inequalities. Research should be informed by the diversity of people’s experiences and insights, so that it will lead to the development of practice that addresses genuine need. A commitment to equality, diversity and inclusion aims to eradicate prejudice and discrimination on the basis of an individual or group of individuals' protected characteristics such as sex (gender), disability, race, sexual orientation, in line with the Equality Act 2010.  

The NIHR has produced guidance for enhancing the inclusion of ‘under-served groups’ when designing a research study (2020). Although the guidance refers to clinical research it is relevant to research more broadly.  

You should consider how you will promote equality and diversity in your planned study, including through aspects such as your research topic or question, the methodology you will use, the participants you plan to recruit and how you will analyse and interpret your data.    

What ethical issues do I need to consider when writing my research proposal?

Camera equipment set up filming a man talking

You might be planning to undertake research in a health, social care, educational or other setting, including observations and interviews. The following prompts should help you to identify key ethical issues that you need to bear in mind when undertaking research in such settings.  

1.     Imagine you are a potential participant. Think about the questions and concerns that you might have:

  • How would you feel if a researcher sat in your space and took notes, completed a checklist, or made an audio or film recording?
  • What harm might a researcher cause by observing or interviewing you and others?
  • What would you want to know about the researcher and ask them about the study before giving consent?
  • When imagining you are the participant, how could the researcher make you feel more comfortable to be observed or interviewed? 

2.     Having considered the perspective of your potential participant, how would you take account of concerns such as privacy, consent, wellbeing and power in your research proposal?  

[Adapted from OpenLearn course: Becoming an ethical researcher, Week 2 Activity 3: Becoming an ethical researcher - OpenLearn - Open University ]  

The ethical issues to be considered will vary depending on your organisational context/role, the types of participants you plan to recruit (for example, children, adults with mental health problems), the research methods you will use, and the types of data you will collect. You will need to decide how to recruit your participants so you do not inappropriately exclude anyone.  Consider what methods may be necessary to facilitate their voice and how you can obtain their consent to taking part or ensure that consent is obtained from someone else as necessary, for example, a parent in the case of a child. 

You should also think about how to avoid imposing an unnecessary burden or costs on your participants. For example, by minimising the length of time they will have to commit to the study and by providing travel or other expenses. Identify the measures that you will take to store your participants’ data safely and maintain their confidentiality and anonymity when you report your findings. You could do this by storing interview and video recordings in a secure server and anonymising their names and those of their organisations using pseudonyms.  

Professional codes such as the Code of Human Research Ethics (BPS, 2021) provide guidance on undertaking research with children. Being an ‘insider’ researching within your own organisation has advantages. However, you should also consider how this might impact on your research, such as power dynamics, consent, potential bias and any conflict of interest between your professional and researcher roles (Sapiro and Matthews, 2020).  

How have other researchers addressed any ethical challenges?

The literature provides researchers’ accounts explaining how they addressed ethical challenges when undertaking studies. For example, Turcotte-Tremblay and McSween-Cadieux (2018) discuss strategies for protecting participants’ confidentiality when disseminating findings locally, such as undertaking fieldwork in multiple sites and providing findings in a generalised form. In addition, professional guidance includes case studies illustrating how ethical issues can be addressed, including when researching online forums (British Sociological Association, no date).

Watch the videos below and consider what insights the postgraduate researcher and supervisor provide  regarding issues such as being an ‘insider researcher’, power relations, avoiding intrusion, maintaining participant anonymity and complying with research ethics and professional standards. How might their experiences inform the design and conduct of your own study?

Postgraduate researcher and supervisor talk about ethical considerations

Your thoughtful consideration of the ethical issues that might arise and how you would address these should enable you to propose an ethically informed study and conduct it in a responsible, fair and sensitive manner. 

British Educational Research Association (2018)  Ethical Guidelines for Educational Research.  Available at:  https://www.bera.ac.uk/publication/ethical-guidelines-for-educational-research-2018  (Accessed: 9 June 2023).

British Psychological Society (2021)  Code of Human Research Ethics . Available at:  https://cms.bps.org.uk/sites/default/files/2022-06/BPS%20Code%20of%20Human%20Research%20Ethics%20%281%29.pdf  (Accessed: 9 June 2023).

British Sociological Association (2016)  Researching online forums . Available at:  https://www.britsoc.co.uk/media/24834/j000208_researching_online_forums_-cs1-_v3.pdf  (Accessed: 9 June 2023).

Health Research Authority (2022)  UK Policy Framework for Health and Social Care Research . Available at:  https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/uk-policy-framework-health-and-social-care-research/#chiefinvestigators  (Accessed: 9 June 2023).

Heslop, C., Burns, S., Lobo, R. (2018) ‘Managing qualitative research as insider-research in small rural communities’,  Rural and Remote Health , 18: pp. 4576.

Equality Act 2010, c. 15.  Available at:   https://www.legislation.gov.uk/ukpga/2010/15/introduction   (Accessed: 9 June 2023).

National Institute for Health and Care Research (no date)  Equality, Diversity and Inclusion (EDI) . Available at:  https://arc-kss.nihr.ac.uk/public-and-community-involvement/pcie-guide/how-to-do-pcie/equality-diversity-and-inclusion-edi  (Accessed: 9 June 2023).

National Institute for Health and Care Research (2020)  Improving inclusion of under-served groups in clinical research: Guidance from INCLUDE project.  Available at:   https://www.nihr.ac.uk/documents/improving-inclusion-of-under-served-groups-in-clinical-research-guidance-from-include-project/25435  (Accessed: 9 June 2023).

Sapiro, B. and Matthews, E. (2020) ‘Both Insider and Outsider. On Conducting Social Work Research in Mental Health Settings’,  Advances in Social Work , 20(3). Available at:  https://doi.org/10.18060/23926

Turcotte-Tremblay, A. and McSween-Cadieux, E. (2018) ‘A reflection on the challenge of protecting confidentiality of participants when disseminating research results locally’,  BMC Medical Ethics,  19(supplement 1), no. 45. Available at:   https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-018-0279-0

United Nations General Assembly (1948)  The Universal Declaration of Human Rights . Resolution A/RES/217/A. Available at:  https://www.un.org/en/about-us/universal-declaration-of-human-rights#:~:text=Drafted%20by%20representatives%20with%20different,all%20peoples%20and%20all%20nations . (Accessed: 9 June 2023).

Wellcome Trust (2014)  Ensuring your research is ethical: A guide for Extended Project Qualification students . Available at:  https://wellcome.org/sites/default/files/wtp057673_0.pdf  (Accessed: 9 June 2023).

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Research Method

Home » Ethical Considerations – Types, Examples and Writing Guide

Ethical Considerations – Types, Examples and Writing Guide

Table of Contents

Ethical Considerations

Ethical Considerations

Ethical considerations in research refer to the principles and guidelines that researchers must follow to ensure that their studies are conducted in an ethical and responsible manner. These considerations are designed to protect the rights, safety, and well-being of research participants, as well as the integrity and credibility of the research itself

Some of the key ethical considerations in research include:

  • Informed consent: Researchers must obtain informed consent from study participants, which means they must inform participants about the study’s purpose, procedures, risks, benefits, and their right to withdraw at any time.
  • Privacy and confidentiality : Researchers must ensure that participants’ privacy and confidentiality are protected. This means that personal information should be kept confidential and not shared without the participant’s consent.
  • Harm reduction : Researchers must ensure that the study does not harm the participants physically or psychologically. They must take steps to minimize the risks associated with the study.
  • Fairness and equity : Researchers must ensure that the study does not discriminate against any particular group or individual. They should treat all participants equally and fairly.
  • Use of deception: Researchers must use deception only if it is necessary to achieve the study’s objectives. They must inform participants of the deception as soon as possible.
  • Use of vulnerable populations : Researchers must be especially cautious when working with vulnerable populations, such as children, pregnant women, prisoners, and individuals with cognitive or intellectual disabilities.
  • Conflict of interest : Researchers must disclose any potential conflicts of interest that may affect the study’s integrity. This includes financial or personal relationships that could influence the study’s results.
  • Data manipulation: Researchers must not manipulate data to support a particular hypothesis or agenda. They should report the results of the study objectively, even if the findings are not consistent with their expectations.
  • Intellectual property: Researchers must respect intellectual property rights and give credit to previous studies and research.
  • Cultural sensitivity : Researchers must be sensitive to the cultural norms and beliefs of the participants. They should avoid imposing their values and beliefs on the participants and should be respectful of their cultural practices.

Types of Ethical Considerations

Types of Ethical Considerations are as follows:

Research Ethics:

This includes ethical principles and guidelines that govern research involving human or animal subjects, ensuring that the research is conducted in an ethical and responsible manner.

Business Ethics :

This refers to ethical principles and standards that guide business practices and decision-making, such as transparency, honesty, fairness, and social responsibility.

Medical Ethics :

This refers to ethical principles and standards that govern the practice of medicine, including the duty to protect patient autonomy, informed consent, confidentiality, and non-maleficence.

Environmental Ethics :

This involves ethical principles and values that guide our interactions with the natural world, including the obligation to protect the environment, minimize harm, and promote sustainability.

Legal Ethics

This involves ethical principles and standards that guide the conduct of legal professionals, including issues such as confidentiality, conflicts of interest, and professional competence.

Social Ethics

This involves ethical principles and values that guide our interactions with other individuals and society as a whole, including issues such as justice, fairness, and human rights.

Information Ethics

This involves ethical principles and values that govern the use and dissemination of information, including issues such as privacy, accuracy, and intellectual property.

Cultural Ethics

This involves ethical principles and values that govern the relationship between different cultures and communities, including issues such as respect for diversity, cultural sensitivity, and inclusivity.

Technological Ethics

This refers to ethical principles and guidelines that govern the development, use, and impact of technology, including issues such as privacy, security, and social responsibility.

Journalism Ethics

This involves ethical principles and standards that guide the practice of journalism, including issues such as accuracy, fairness, and the public interest.

Educational Ethics

This refers to ethical principles and standards that guide the practice of education, including issues such as academic integrity, fairness, and respect for diversity.

Political Ethics

This involves ethical principles and values that guide political decision-making and behavior, including issues such as accountability, transparency, and the protection of civil liberties.

Professional Ethics

This refers to ethical principles and standards that guide the conduct of professionals in various fields, including issues such as honesty, integrity, and competence.

Personal Ethics

This involves ethical principles and values that guide individual behavior and decision-making, including issues such as personal responsibility, honesty, and respect for others.

Global Ethics

This involves ethical principles and values that guide our interactions with other nations and the global community, including issues such as human rights, environmental protection, and social justice.

Applications of Ethical Considerations

Ethical considerations are important in many areas of society, including medicine, business, law, and technology. Here are some specific applications of ethical considerations:

  • Medical research : Ethical considerations are crucial in medical research, particularly when human subjects are involved. Researchers must ensure that their studies are conducted in a way that does not harm participants and that participants give informed consent before participating.
  • Business practices: Ethical considerations are also important in business, where companies must make decisions that are socially responsible and avoid activities that are harmful to society. For example, companies must ensure that their products are safe for consumers and that they do not engage in exploitative labor practices.
  • Environmental protection: Ethical considerations play a crucial role in environmental protection, as companies and governments must weigh the benefits of economic development against the potential harm to the environment. Decisions about land use, resource allocation, and pollution must be made in an ethical manner that takes into account the long-term consequences for the planet and future generations.
  • Technology development : As technology continues to advance rapidly, ethical considerations become increasingly important in areas such as artificial intelligence, robotics, and genetic engineering. Developers must ensure that their creations do not harm humans or the environment and that they are developed in a way that is fair and equitable.
  • Legal system : The legal system relies on ethical considerations to ensure that justice is served and that individuals are treated fairly. Lawyers and judges must abide by ethical standards to maintain the integrity of the legal system and to protect the rights of all individuals involved.

Examples of Ethical Considerations

Here are a few examples of ethical considerations in different contexts:

  • In healthcare : A doctor must ensure that they provide the best possible care to their patients and avoid causing them harm. They must respect the autonomy of their patients, and obtain informed consent before administering any treatment or procedure. They must also ensure that they maintain patient confidentiality and avoid any conflicts of interest.
  • In the workplace: An employer must ensure that they treat their employees fairly and with respect, provide them with a safe working environment, and pay them a fair wage. They must also avoid any discrimination based on race, gender, religion, or any other characteristic protected by law.
  • In the media : Journalists must ensure that they report the news accurately and without bias. They must respect the privacy of individuals and avoid causing harm or distress. They must also be transparent about their sources and avoid any conflicts of interest.
  • In research: Researchers must ensure that they conduct their studies ethically and with integrity. They must obtain informed consent from participants, protect their privacy, and avoid any harm or discomfort. They must also ensure that their findings are reported accurately and without bias.
  • In personal relationships : People must ensure that they treat others with respect and kindness, and avoid causing harm or distress. They must respect the autonomy of others and avoid any actions that would be considered unethical, such as lying or cheating. They must also respect the confidentiality of others and maintain their privacy.

How to Write Ethical Considerations

When writing about research involving human subjects or animals, it is essential to include ethical considerations to ensure that the study is conducted in a manner that is morally responsible and in accordance with professional standards. Here are some steps to help you write ethical considerations:

  • Describe the ethical principles: Start by explaining the ethical principles that will guide the research. These could include principles such as respect for persons, beneficence, and justice.
  • Discuss informed consent : Informed consent is a critical ethical consideration when conducting research. Explain how you will obtain informed consent from participants, including how you will explain the purpose of the study, potential risks and benefits, and how you will protect their privacy.
  • Address confidentiality : Describe how you will protect the confidentiality of the participants’ personal information and data, including any measures you will take to ensure that the data is kept secure and confidential.
  • Consider potential risks and benefits : Describe any potential risks or harms to participants that could result from the study and how you will minimize those risks. Also, discuss the potential benefits of the study, both to the participants and to society.
  • Discuss the use of animals : If the research involves the use of animals, address the ethical considerations related to animal welfare. Explain how you will minimize any potential harm to the animals and ensure that they are treated ethically.
  • Mention the ethical approval : Finally, it’s essential to acknowledge that the research has received ethical approval from the relevant institutional review board or ethics committee. State the name of the committee, the date of approval, and any specific conditions or requirements that were imposed.

When to Write Ethical Considerations

Ethical considerations should be written whenever research involves human subjects or has the potential to impact human beings, animals, or the environment in some way. Ethical considerations are also important when research involves sensitive topics, such as mental health, sexuality, or religion.

In general, ethical considerations should be an integral part of any research project, regardless of the field or subject matter. This means that they should be considered at every stage of the research process, from the initial planning and design phase to data collection, analysis, and dissemination.

Ethical considerations should also be written in accordance with the guidelines and standards set by the relevant regulatory bodies and professional associations. These guidelines may vary depending on the discipline, so it is important to be familiar with the specific requirements of your field.

Purpose of Ethical Considerations

Ethical considerations are an essential aspect of many areas of life, including business, healthcare, research, and social interactions. The primary purposes of ethical considerations are:

  • Protection of human rights: Ethical considerations help ensure that people’s rights are respected and protected. This includes respecting their autonomy, ensuring their privacy is respected, and ensuring that they are not subjected to harm or exploitation.
  • Promoting fairness and justice: Ethical considerations help ensure that people are treated fairly and justly, without discrimination or bias. This includes ensuring that everyone has equal access to resources and opportunities, and that decisions are made based on merit rather than personal biases or prejudices.
  • Promoting honesty and transparency : Ethical considerations help ensure that people are truthful and transparent in their actions and decisions. This includes being open and honest about conflicts of interest, disclosing potential risks, and communicating clearly with others.
  • Maintaining public trust: Ethical considerations help maintain public trust in institutions and individuals. This is important for building and maintaining relationships with customers, patients, colleagues, and other stakeholders.
  • Ensuring responsible conduct: Ethical considerations help ensure that people act responsibly and are accountable for their actions. This includes adhering to professional standards and codes of conduct, following laws and regulations, and avoiding behaviors that could harm others or damage the environment.

Advantages of Ethical Considerations

Here are some of the advantages of ethical considerations:

  • Builds Trust : When individuals or organizations follow ethical considerations, it creates a sense of trust among stakeholders, including customers, clients, and employees. This trust can lead to stronger relationships and long-term loyalty.
  • Reputation and Brand Image : Ethical considerations are often linked to a company’s brand image and reputation. By following ethical practices, a company can establish a positive image and reputation that can enhance its brand value.
  • Avoids Legal Issues: Ethical considerations can help individuals and organizations avoid legal issues and penalties. By adhering to ethical principles, companies can reduce the risk of facing lawsuits, regulatory investigations, and fines.
  • Increases Employee Retention and Motivation: Employees tend to be more satisfied and motivated when they work for an organization that values ethics. Companies that prioritize ethical considerations tend to have higher employee retention rates, leading to lower recruitment costs.
  • Enhances Decision-making: Ethical considerations help individuals and organizations make better decisions. By considering the ethical implications of their actions, decision-makers can evaluate the potential consequences and choose the best course of action.
  • Positive Impact on Society: Ethical considerations have a positive impact on society as a whole. By following ethical practices, companies can contribute to social and environmental causes, leading to a more sustainable and equitable society.

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What Are the Ethical Considerations in Research Design?

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When I began my work on the thesis I was always focused on my research. However, once I began to make my way through research, I realized that research ethics is a core aspect of the research work and the foundation of research design.

Research ethics play a crucial role in ensuring the responsible conduct of research. Here are some key reasons why research ethics matter:

Why Research Ethics Matter

Let us look into some of the major ethical considerations in research design.

Ethical Issues in Research

There are many organizations, like the Committee on Publication Ethics , dedicated to promoting ethics in scientific research. These organizations agree that ethics is not an afterthought or side note to the research study. It is an integral aspect of research that needs to remain at the forefront of our work.

The research design must address specific research questions. Hence, the conclusions of the study must correlate to the questions posed and the results. Also, research ethics demands that the methods used must relate specifically to the research questions.

Voluntary Participation and Consent

An individual should at no point feel any coercion to participate in a study. This includes any type of persuasion or deception in attempting to gain an individual’s trust.

Informed consent states that an individual must give their explicit consent to participate in the study. You can think of consent form as an agreement of trust between the researcher and the participants.

Sampling is the first step in research design . You will need to explain why you want a particular group of participants. You will have to explain why you left out certain people or groups. In addition, if your sample includes children or special needs individuals, you will have additional requirements to address like parental permission.

Confidentiality

The third ethics principle of the Economic and Social Research Council (ESRC) states that: “The confidentiality of the information supplied by research subjects and the anonymity of respondents must be respected.” However, sometimes confidentiality is limited. For example, if a participant is at risk of harm, we must protect them. This might require releasing confidential information.

Risk of Harm

We should do everything in our power to protect study participants. For this, we should focus on the risk to benefit ratio. If possible risks outweigh the benefits, then we should abandon or redesign the study. Risk of harm also requires us to measure the risk to benefit ratio as the study progresses.

Research Methods

We know there are numerous research methods. However, when it comes to ethical considerations, some key questions can help us find the right approach for our studies.

i. Which methods most effectively fit the aims of your research?

ii. What are the strengths and restrictions of a particular method?

iii. Are there potential risks when using a particular research method?

For more guidance, you can refer to the ESRC Framework for Research Ethics .

Ethical issues in research can arise at various stages of the research process and involve different aspects of the study. Here are some common examples of ethical issues in research:

Examples of Ethical Issues in Research

Institutional Review Boards

The importance of ethics in research cannot be understated. Following ethical guidelines will ensure your study’s validity and promote its contribution to scientific study. On a personal level, you will strengthen your research and increase your opportunities to gain funding.

To address the need for ethical considerations, most institutions have their own Institutional Review Board (IRB). An IRB secures the safety of human participants and prevents violation of human rights. It reviews the research aims and methodologies to ensure ethical practices are followed. If a research design does not follow the set ethical guidelines, then the  researcher will have to amend their study.

Applying for Ethical Approval

Applications for ethical approval will differ across institutions. Regardless, they focus on the benefits of your research and the risk to benefit ratio concerning participants. Therefore, you need to effectively address both in order to get ethical clearence.

Participants

It is vital that you make it clear that individuals are provided with sufficient information in order to make an informed decision on their participation. In addition, you need to demonstrate that the ethical issues of consent, risk of harm, and confidentiality are clearly defined.

Benefits of the Study

You need to prove to the panel that your work is essential and will yield results that contribute to the scientific community. For this, you should demonstrate the following:

i. The conduct of research guarantees the quality and integrity of results.

ii. The research will be properly distributed.

iii. The aims of the research are clear and the methodology is appropriate.

Integrity and transparency are vital in the research. Ethics committees expect you to share any actual or potential conflicts of interest that could affect your work. In addition, you have to be honest and transparent throughout the approval process and the research process.

The Dangers of Unethical Practices

There is a reason to  follow ethical guidelines. Without these guidelines, our research will suffer. Moreover, more importantly, people could suffer.

The following are just two examples of infamous cases of unethical research practices that demonstrate the importance of adhering to ethical standards:

  • The Stanford Prison Experiment (1971) aimed to investigate the psychological effects of power using the relationship between prisoners and prison officers. Those assigned the role of “prison officers” embraced measures that exposed “prisoners” to psychological and physical harm. In this case, there was voluntary participation. However, there was disregard for  welfare of the participants.
  • Recently, Chinese scientist He Jiankui announced his work on genetically edited babies . Over 100 Chinese scientists denounced this research, calling it “crazy” and “shocking and unacceptable.” This research shows a troubling attitude of “do first, debate later” and a disregard for the ethical concerns of manipulating the human body Wang Yuedan, a professor of immunology at Peking University, calls this “an ethics disaster for the world” and demands strict punishments for this type of ethics violation.

What are your experiences with research ethics? How have you developed an ethical approach to research design? Please share your thoughts with us in the comments section below.

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Ethical considerations in research: Best practices and examples

ethical issues in research proposal sample

To conduct responsible research, you’ve got to think about ethics. They protect participants’ rights and their well-being - and they ensure your findings are valid and reliable. This isn’t just a box for you to tick. It’s a crucial consideration that can make all the difference to the outcome of your research.

In this article, we'll explore the meaning and importance of research ethics in today's research landscape. You'll learn best practices to conduct ethical and impactful research.

Examples of ethical considerations in research

As a researcher, you're responsible for ethical research alongside your organization. Fulfilling ethical guidelines is critical. Organizations must ensure employees follow best practices to protect participants' rights and well-being.

Keep these things in mind when it comes to ethical considerations in research:

Voluntary participation

Voluntary participation is key. Nobody should feel like they're being forced to participate or pressured into doing anything they don't want to. That means giving people a choice and the ability to opt out at any time, even if they've already agreed to take part in the study.

Informed consent

Informed consent isn't just an ethical consideration. It's a legal requirement as well. Participants must fully understand what they're agreeing to, including potential risks and benefits.

The best way to go about this is by using a consent form. Make sure you include:

  • A brief description of the study and research methods.
  • The potential benefits and risks of participating.
  • The length of the study.
  • Contact information for the researcher and/or sponsor.
  • Reiteration of the participant’s right to withdraw from the research project at any time without penalty.

Anonymity means that participants aren't identifiable in any way. This includes:

  • Email address
  • Photographs
  • Video footage

You need a way to anonymize research data so that it can't be traced back to individual participants. This may involve creating a new digital ID for participants that can’t be linked back to their original identity using numerical codes.

Confidentiality

Information gathered during a study must be kept confidential. Confidentiality helps to protect the privacy of research participants. It also ensures that their information isn't disclosed to unauthorized individuals.

Some ways to ensure confidentiality include:

  • Using a secure server to store data.
  • Removing identifying information from databases that contain sensitive data.
  • Using a third-party company to process and manage research participant data.
  • Not keeping participant records for longer than necessary.
  • Avoiding discussion of research findings in public forums.

Potential for harm

​​The potential for harm is a crucial factor in deciding whether a research study should proceed. It can manifest in various forms, such as:

  • Psychological harm
  • Social harm
  • Physical harm

Conduct an ethical review to identify possible harms. Be prepared to explain how you’ll minimize these harms and what support is available in case they do happen.

Fair payment

One of the most crucial aspects of setting up a research study is deciding on fair compensation for your participants. Underpayment is a common ethical issue that shouldn't be overlooked. Properly rewarding participants' time is critical for boosting engagement and obtaining high-quality data. While Prolific requires a minimum payment of £6.00 / $8.00 per hour, there are other factors you need to consider when deciding on a fair payment.

First, check your institution's reimbursement guidelines to see if they already have a minimum or maximum hourly rate. You can also use the national minimum wage as a reference point.

Next, think about the amount of work you're asking participants to do. The level of effort required for a task, such as producing a video recording versus a short survey, should correspond with the reward offered.

You also need to consider the population you're targeting. To attract research subjects with specific characteristics or high-paying jobs, you may need to offer more as an incentive.

We recommend a minimum payment of £9.00 / $12.00 per hour, but we understand that payment rates can vary depending on a range of factors. Whatever payment you choose should reflect the amount of effort participants are required to put in and be fair to everyone involved.

Ethical research made easy with Prolific

At Prolific, we believe in making ethical research easy and accessible. The findings from the Fairwork Cloudwork report speak for themselves. Prolific was given the top score out of all competitors for minimum standards of fair work.

With over 25,000 researchers in our community, we're leading the way in revolutionizing the research industry. If you're interested in learning more about how we can support your research journey, sign up to get started now.

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Ethics statement examples - ESRC

Introduction.

Proposals submitted to the ESRC must provide a full ethics statement that confirms that proper consideration has been given to any ethics issues raised. All ESRC-funded grants must be approved by at least a light-touch ethics review.

The ESRC does not require a favourable ethics opinion to be secured prior to submission of a research proposal. However, a proposal must state what the applicant considers to be the possible ethics implications throughout the research project lifecycle, what measures will be taken for ongoing consideration of ethics issues, what review will be required for their proposed research and how and when it will be obtained.

Risk and benefit to researchers, participants and others (for example,  potentially stigmatised or marginalised groups) as a result of the research and the potential impact, knowledge exchange, dissemination activity and future re-use of the data should also be considered as part of the ethical statement.

If an ethics review is required at a later stage in the project, this should be discussed and funding arrangements agreed in advance with the ESRC. At a minimum we expect that ethics review will be undertaken prior to the stage in the project that the actual research is carried out.

During peer review, reviewers and assessors will be asked to consider the ethical statement in the proposal. If they disagree with the proposed approach to ethics issues, or the statement does not adequately address these issues, this could lead to the rejection of a proposal, or the award of a conditional grant to ensure the necessary ethical considerations and ethical review are undertaken.

Last updated: 28 January 2022

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Ethical Issues in Research Methods

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This chapter explores only some of the ethical issues related to methodology – issues that have to be borne in mind when selecting the most appropriate research method or methods through which to conduct a study. Some methods are more ethically appropriate to some study topics and target populations rather than others. While reviewers of research proposals often seek to separate method from ethics, the distinction is far from clear. There is, though, a relatively clear distinction between what is likely to be most effective in producing answers to research questions and what is ethical. Some methods distance the researcher too far from their participant study population, others require far too close an engagement. There is no one “best” method for all study populations and all research settings. The choice of method, like the perception of ethical risks, is highly context-dependent. Researchers, reviewers, funders, and subjects should all be in a position to make a judgment call about which method is most appropriate to their needs and risks in the specific research setting.

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Iphofen, R. (2020). Ethical Issues in Research Methods. In: Iphofen, R. (eds) Handbook of Research Ethics and Scientific Integrity. Springer, Cham. https://doi.org/10.1007/978-3-319-76040-7_54-1

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Received : 15 November 2019

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Research-Methodology

Ethical Considerations

Ethical Considerations can be specified as one of the most important parts of the research. Dissertations may even be doomed to failure if this part is missing.

According to Bryman and Bell (2007) [1] the following ten points represent the most important principles related to ethical considerations in dissertations:

  • Research participants should not be subjected to harm in any ways whatsoever.
  • Respect for the dignity of research participants should be prioritised.
  • Full consent should be obtained from the participants prior to the study.
  • The protection of the privacy of research participants has to be ensured.
  • Adequate level of confidentiality of the research data should be ensured.
  • Anonymity of individuals and organisations participating in the research has to be ensured.
  • Any deception or exaggeration about the aims and objectives of the research must be avoided.
  • Affiliations in any forms, sources of funding, as well as any possible conflicts of interests have to be declared.
  • Any type of communication in relation to the research should be done with honesty and transparency.
  • Any type of misleading information, as well as representation of primary data findings in a biased way must be avoided.

In order to address ethical considerations aspect of your dissertation in an effective manner, you will need to expand discussions of each of the following points to at least one paragraph:

1. Voluntary participation of respondents in the research is important. Moreover, participants have rights to withdraw from the study at any stage if they wish to do so.

2. Respondents should participate on the basis of informed consent. The principle of informed consent involves researchers providing sufficient information and assurances about taking part to allow individuals to understand the implications of participation and to reach a fully informed, considered and freely given decision about whether or not to do so, without the exercise of any pressure or coercion. [2]

3. The use of offensive, discriminatory, or other unacceptable language needs to be avoided in the formulation of Questionnaire/Interview/Focus group questions.

4. Privacy and anonymity or respondents is of a paramount importance.

5. Acknowledgement of works of other authors used in any part of the dissertation with the use of Harvard/APA/Vancouver referencing system according to the Dissertation Handbook

6. Maintenance of the highest level of objectivity in discussions and analyses throughout the research

7. Adherence to Data Protection Act (1998) if you are studying in the UK

In studies that do not involve primary data collection, on the other hand, ethical issues are going to be limited to the points d) and e) above.

Most universities have their own Code of Ethical Practice. It is critically important for you to thoroughly adhere to this code in every aspect of your research and declare your adherence in ethical considerations part of your dissertation.

My e-book,  The Ultimate Guide to Writing a Dissertation in Business Studies: a step by step assistance  offers practical assistance to complete a dissertation with minimum or no stress. The e-book covers all stages of writing a dissertation starting from the selection to the research area to submitting the completed version of the work within the deadline. John Dudovskiy

Ethical Considerations in dissertation

[1] Bryman, A. &  Bell, E. (2007) “Business Research Methods”, 2nd edition. Oxford University Press.

[2] Saunders, M., Lewis, P. & Thornhill, A. (2012) “Research Methods for Business Students” 6th edition, Pearson Education Limited.

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Ethics are broadly the set of rules, written and unwritten, that govern our expectations of our own and others’ behaviour.

Effectively, they set out how we expect others to behave, and why. While there is broad agreement on some ethical values (for example, that murder is bad), there is also wide variation on how exactly these values should be interpreted in practice.

Research ethics are the set of ethics that govern how scientific and other research is performed at research institutions such as universities, and how it is disseminated.

This page explains more about research ethics, and how you can ensure that your research is compliant.

What are Research Ethics?

When most people think of research ethics, they think about issues that arise when research involves human or animal subjects.

While these issues are indeed a key part of research ethics, there are also wider issues about standards of conduct. These include the importance of publishing findings in a transparent way, not plagiarising others’ work, and not falsifying work.

The Importance of Research Ethics

Research ethics are important for a number of reasons.

  • They promote the aims of research, such as expanding knowledge.
  • They support the values required for collaborative work, such as mutual respect and fairness. This is essential because scientific research depends on collaboration between researchers and groups.
  • They mean that researchers can be held accountable for their actions. Many researchers are supported by public money, and regulations on conflicts of interest, misconduct, and research involving humans or animals are necessary to ensure that money is spent appropriately.
  • They ensure that the public can trust research. For people to support and fund research, they have to be confident in it.
  • They support important social and moral values, such as the principle of doing no harm to others.

Source: Resnick, D. B. (2015) What is Ethics in Research and Why is it Important?

Codes of Ethics

Government agencies who fund or commission research often publish codes of conduct for researchers, or codes of ethics.

For example, the US National Institutes of Health (NIH) and Food and Drug Administration (FDA) both publish ethical codes. Some ethical codes may have the force of law behind them, while others may simply be advisable.

Be aware that even if you do nothing illegal, doing something unethical may end your research career.

Many or even most ethical codes cover the following areas:

Honesty and Integrity

This means that you need to report your research honestly, and that this applies to your methods (what you did), your data, your results, and whether you have previously published any of it. You should not make up any data, including extrapolating unreasonably from some of your results, or do anything which could be construed as trying to mislead anyone. It is better to undersell than over-exaggerate your findings.

When working with others, you should always keep to any agreements, and act sincerely.

Objectivity

You should aim to avoid bias in any aspect of your research, including design, data analysis, interpretation, and peer review. For example, you should never recommend as a peer reviewer someone you know, or who you have worked with, and you should try to ensure that no groups are inadvertently excluded from your research. This also means that you need to disclose any personal or financial interests that may affect your research.

Carefulness

Take care in carrying out your research to avoid careless mistakes. You should also review your work carefully and critically to ensure that your results are credible. It is also important to keep full records of your research. If you are asked to act as a peer reviewer, you should take the time to do the job effectively and fully.

You should always be prepared to share your data and results, along with any new tools that you have developed, when you publish your findings, as this helps to further knowledge and advance science. You should also be open to criticism and new ideas.

Respect for Intellectual Property

You should never plagiarise, or copy, other people’s work and try to pass it off as your own. You should always ask for permission before using other people’s tools or methods, unpublished data or results. Not doing so is plagiarism. Obviously, you need to respect copyrights and patents, together with other forms of intellectual property, and always acknowledge contributions to your research. If in doubt, acknowledge, to avoid any risk of plagiarism.

Confidentiality

You should respect anything that has been provided in confidence. You should also follow guidelines on protection of sensitive information such as patient records.

Responsible Publication

You should publish to advance to state of research and knowledge, and not just to advance your career. This means, in essence, that you should not publish anything that is not new, or that duplicates someone else’s work.

You should always be aware of laws and regulations that govern your work, and be sure that you conform to them.

Animal Care

If you are using animals in your research, you should always be sure that your experiments are both necessary and well-designed. You should also show respect for the animals you are using, and make sure that they are properly cared for.

Human Subjects Protection

If your research involves people, you should make sure that you reduce any possible harm to the minimum, and maximise the benefits both to participants and other people.

This means, for example, that you should not expose people to more tests than are strictly necessary to fulfil your research aims. You should always respect human rights, including the right to privacy and autonomy. You may need to take particular care with vulnerable groups, which include, but are not limited to, children, older people, and those with learning difficulties.

Source: Resnick, D. B. (2015) What is Ethics in Research and Why is it Important? List adapted from Shamoo A and Resnik D. 2015. Responsible Conduct of Research, 3rd ed. (New York: Oxford University Press).

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The Role of the Ethics Committee

Most universities have an ethics committee. This is required to scrutinise all research proposals, to ensure that they do not raise any ethical issues. This will generally include research for master’s and undergraduate degrees, although undergraduate research may be covered by a broader research proposal from your supervisor.

There is likely to be a standard form to complete for ethical approval, which will cover who will be involved, how you will recruit your participants, and what steps you will take to ensure that they have provided informed consent.

There is an example form on our page Writing a Research Proposal , which also contains more detail about how to go about preparing a proposal.

The ethics committee’s role is to consider that what you are doing is appropriate and proportionate to your research aims.

If a research proposal raises ethical issues, the committee will ask the researcher to look again at the issue, and consider whether they could do it differently.

For example , if you are proposing to carry out a study on a particular disease, and you want to ask all your participants whether they are married and have any children, the committee may want to know why this is relevant. It may be relevant (for example, if you think the disease may be reduced by living in a family), in which case, you will need to justify this.

The committee may also suggest alternative methods that they think are more suitable for the target group, or additional precautions that you should take.

You cannot start your research until you have been granted ethical approval, which will be granted formally, together with an approval number.

When you publish your research, whether as a thesis or in one or more journal articles, you will need to provide details of the ethical approval, including this number.

If you are unsure how to behave in a particular situation…

…and think you may have an ethical dilemma, then you should always seek advice before you act.

If you are a student, your supervisor should be happy to help and advise you. If necessary, they will be able to advise you about who else to ask.

As a researcher, you should consult more senior colleagues around, either at your own institution or others, who should be happy to help you.

After all, it is in everyone’s interests to promote research ethics, and support the integrity and reputation of research.

Continue to: Designing Research Writing a Methodology

See also: Writing a Literature Review Academic Referencing Sources of Information

Ethical consideration of the research proposal and the informed-consent process: An online survey of researchers and ethics committee members in Thailand

Affiliations.

  • 1 a Department of Tropical Hygiene, Faculty of Tropical Medicine , Mahidol University , Bangkok , Thailand.
  • 2 b Office of Research Services, Faculty of Tropical Medicine , Mahidol University , Bangkok , Thailand.
  • PMID: 30987450
  • DOI: 10.1080/08989621.2019.1608190

Researchers designing and conducting studies using human data should consider the values and principles of ethical conduct. Research ethics committees (RECs) typically evaluate the ethical acceptability of research proposals. Sometimes, differences arise between how researchers and RECs interpret ethical principles, and how they decide what constitutes ethical conduct. This study aimed to explore the opinions of these two groups about the importance of core ethical issues in the proposal and in the informed-consent process. An anonymous online questionnaire was distributed to a target population in health-related academic/research institutes across Thailand; 219 researchers and 72 REC members participated. Significantly, more REC members than researchers attributed the highest importance to three core ethical considerations - risk/benefit, vulnerability, and confidentiality/privacy. For the informed-consent process, significant differences were found for communication of risks, decision-making authority for consent, process for approaching study participants, and availability of a contact for study deviations/violations. The different ratings indicate differences in the groups' perspectives on ethical principles, which may affect focal congruence on ethical issues in the proposal. Communication of these findings should help close gaps between REC and researcher perceptions. Further study should investigate how RECs and researchers perceive equivocal ethics terms.

Keywords: Ethical consideration; ethics committee; informed-consent form; informed-consent process; perception.

  • Committee Membership*
  • Ethics Committees, Research*
  • Informed Consent / ethics*
  • Research Design
  • Research Personnel / psychology*
  • Surveys and Questionnaires

Ethical Considerations In Psychology Research

Saul Mcleod, PhD

Editor-in-Chief for Simply Psychology

BSc (Hons) Psychology, MRes, PhD, University of Manchester

Saul Mcleod, Ph.D., is a qualified psychology teacher with over 18 years experience of working in further and higher education. He has been published in peer-reviewed journals, including the Journal of Clinical Psychology.

Learn about our Editorial Process

Olivia Guy-Evans, MSc

Associate Editor for Simply Psychology

BSc (Hons) Psychology, MSc Psychology of Education

Olivia Guy-Evans is a writer and associate editor for Simply Psychology. She has previously worked in healthcare and educational sectors.

On This Page:

Ethics refers to the correct rules of conduct necessary when carrying out research. We have a moral responsibility to protect research participants from harm.

However important the issue under investigation, psychologists must remember that they have a duty to respect the rights and dignity of research participants. This means that they must abide by certain moral principles and rules of conduct.

What are Ethical Guidelines?

In Britain, ethical guidelines for research are published by the British Psychological Society, and in America, by the American Psychological Association. The purpose of these codes of conduct is to protect research participants, the reputation of psychology, and psychologists themselves.

Moral issues rarely yield a simple, unambiguous, right or wrong answer. It is, therefore, often a matter of judgment whether the research is justified or not.

For example, it might be that a study causes psychological or physical discomfort to participants; maybe they suffer pain or perhaps even come to serious harm.

On the other hand, the investigation could lead to discoveries that benefit the participants themselves or even have the potential to increase the sum of human happiness.

Rosenthal and Rosnow (1984) also discuss the potential costs of failing to carry out certain research. Who is to weigh up these costs and benefits? Who is to judge whether the ends justify the means?

Finally, if you are ever in doubt as to whether research is ethical or not, it is worthwhile remembering that if there is a conflict of interest between the participants and the researcher, it is the interests of the subjects that should take priority.

Studies must now undergo an extensive review by an institutional review board (US) or ethics committee (UK) before they are implemented. All UK research requires ethical approval by one or more of the following:

  • Department Ethics Committee (DEC) : for most routine research.
  • Institutional Ethics Committee (IEC) : for non-routine research.
  • External Ethics Committee (EEC) : for research that s externally regulated (e.g., NHS research).

Committees review proposals to assess if the potential benefits of the research are justifiable in light of the possible risk of physical or psychological harm.

These committees may request researchers make changes to the study’s design or procedure or, in extreme cases, deny approval of the study altogether.

The British Psychological Society (BPS) and American Psychological Association (APA) have issued a code of ethics in psychology that provides guidelines for conducting research.  Some of the more important ethical issues are as follows:

Informed Consent

Before the study begins, the researcher must outline to the participants what the research is about and then ask for their consent (i.e., permission) to participate.

An adult (18 years +) capable of being permitted to participate in a study can provide consent. Parents/legal guardians of minors can also provide consent to allow their children to participate in a study.

Whenever possible, investigators should obtain the consent of participants. In practice, this means it is not sufficient to get potential participants to say “Yes.”

They also need to know what it is that they agree to. In other words, the psychologist should, so far as is practicable, explain what is involved in advance and obtain the informed consent of participants.

Informed consent must be informed, voluntary, and rational. Participants must be given relevant details to make an informed decision, including the purpose, procedures, risks, and benefits. Consent must be given voluntarily without undue coercion. And participants must have the capacity to rationally weigh the decision.

Components of informed consent include clearly explaining the risks and expected benefits, addressing potential therapeutic misconceptions about experimental treatments, allowing participants to ask questions, and describing methods to minimize risks like emotional distress.

Investigators should tailor the consent language and process appropriately for the study population. Obtaining meaningful informed consent is an ethical imperative for human subjects research.

The voluntary nature of participation should not be compromised through coercion or undue influence. Inducements should be fair and not excessive/inappropriate.

However, it is not always possible to gain informed consent.  Where the researcher can’t ask the actual participants, a similar group of people can be asked how they would feel about participating.

If they think it would be OK, then it can be assumed that the real participants will also find it acceptable. This is known as presumptive consent.

However, a problem with this method is that there might be a mismatch between how people think they would feel/behave and how they actually feel and behave during a study.

In order for consent to be ‘informed,’ consent forms may need to be accompanied by an information sheet for participants’ setting out information about the proposed study (in lay terms), along with details about the investigators and how they can be contacted.

Special considerations exist when obtaining consent from vulnerable populations with decisional impairments, such as psychiatric patients, intellectually disabled persons, and children/adolescents. Capacity can vary widely so should be assessed individually, but interventions to improve comprehension may help. Legally authorized representatives usually must provide consent for children.

Participants must be given information relating to the following:

  • A statement that participation is voluntary and that refusal to participate will not result in any consequences or any loss of benefits that the person is otherwise entitled to receive.
  • Purpose of the research.
  • All foreseeable risks and discomforts to the participant (if there are any). These include not only physical injury but also possible psychological.
  • Procedures involved in the research.
  • Benefits of the research to society and possibly to the individual human subject.
  • Length of time the subject is expected to participate.
  • Person to contact for answers to questions or in the event of injury or emergency.
  • Subjects” right to confidentiality and the right to withdraw from the study at any time without any consequences.
Debriefing after a study involves informing participants about the purpose, providing an opportunity to ask questions, and addressing any harm from participation. Debriefing serves an educational function and allows researchers to correct misconceptions. It is an ethical imperative.

After the research is over, the participant should be able to discuss the procedure and the findings with the psychologist. They must be given a general idea of what the researcher was investigating and why, and their part in the research should be explained.

Participants must be told if they have been deceived and given reasons why. They must be asked if they have any questions, which should be answered honestly and as fully as possible.

Debriefing should occur as soon as possible and be as full as possible; experimenters should take reasonable steps to ensure that participants understand debriefing.

“The purpose of debriefing is to remove any misconceptions and anxieties that the participants have about the research and to leave them with a sense of dignity, knowledge, and a perception of time not wasted” (Harris, 1998).

The debriefing aims to provide information and help the participant leave the experimental situation in a similar frame of mind as when he/she entered it (Aronson, 1988).

Exceptions may exist if debriefing seriously compromises study validity or causes harm itself, like negative emotions in children. Consultation with an institutional review board guides exceptions.

Debriefing indicates investigators’ commitment to participant welfare. Harms may not be raised in the debriefing itself, so responsibility continues after data collection. Following up demonstrates respect and protects persons in human subjects research.

Protection of Participants

Researchers must ensure that those participating in research will not be caused distress. They must be protected from physical and mental harm. This means you must not embarrass, frighten, offend or harm participants.

Normally, the risk of harm must be no greater than in ordinary life, i.e., participants should not be exposed to risks greater than or additional to those encountered in their normal lifestyles.

The researcher must also ensure that if vulnerable groups are to be used (elderly, disabled, children, etc.), they must receive special care. For example, if studying children, ensure their participation is brief as they get tired easily and have a limited attention span.

Researchers are not always accurately able to predict the risks of taking part in a study, and in some cases, a therapeutic debriefing may be necessary if participants have become disturbed during the research (as happened to some participants in Zimbardo’s prisoners/guards study ).

Deception research involves purposely misleading participants or withholding information that could influence their participation decision. This method is controversial because it limits informed consent and autonomy, but can provide otherwise unobtainable valuable knowledge.

Types of deception include (i) deliberate misleading, e.g. using confederates, staged manipulations in field settings, deceptive instructions; (ii) deception by omission, e.g., failure to disclose full information about the study, or creating ambiguity.

The researcher should avoid deceiving participants about the nature of the research unless there is no alternative – and even then, this would need to be judged acceptable by an independent expert. However, some types of research cannot be carried out without at least some element of deception.

For example, in Milgram’s study of obedience , the participants thought they were giving electric shocks to a learner when they answered a question wrongly. In reality, no shocks were given, and the learners were confederates of Milgram.

This is sometimes necessary to avoid demand characteristics (i.e., the clues in an experiment that lead participants to think they know what the researcher is looking for).

Another common example is when a stooge or confederate of the experimenter is used (this was the case in both the experiments carried out by Asch ).

According to ethics codes, deception must have strong scientific justification, and non-deceptive alternatives should not be feasible. Deception that causes significant harm is prohibited. Investigators should carefully weigh whether deception is necessary and ethical for their research.

However, participants must be deceived as little as possible, and any deception must not cause distress.  Researchers can determine whether participants are likely distressed when deception is disclosed by consulting culturally relevant groups.

Participants should immediately be informed of the deception without compromising the study’s integrity. Reactions to learning of deception can range from understanding to anger. Debriefing should explain the scientific rationale and social benefits to minimize negative reactions.

If the participant is likely to object or be distressed once they discover the true nature of the research at debriefing, then the study is unacceptable.

If you have gained participants’ informed consent by deception, then they will have agreed to take part without actually knowing what they were consenting to.  The true nature of the research should be revealed at the earliest possible opportunity or at least during debriefing.

Some researchers argue that deception can never be justified and object to this practice as it (i) violates an individual’s right to choose to participate; (ii) is a questionable basis on which to build a discipline; and (iii) leads to distrust of psychology in the community.

Confidentiality

Protecting participant confidentiality is an ethical imperative that demonstrates respect, ensures honest participation, and prevents harms like embarrassment or legal issues. Methods like data encryption, coding systems, and secure storage should match the research methodology.

Participants and the data gained from them must be kept anonymous unless they give their full consent.  No names must be used in a lab report .

Researchers must clearly describe to participants the limits of confidentiality and methods to protect privacy. With internet research, threats exist like third-party data access; security measures like encryption should be explained. For non-internet research, other protections should be noted too, like coding systems and restricted data access.

High-profile data breaches have eroded public trust. Methods that minimize identifiable information can further guard confidentiality. For example, researchers can consider whether birthdates are necessary or just ages.

Generally, reducing personal details collected and limiting accessibility safeguards participants. Following strong confidentiality protections demonstrates respect for persons in human subjects research.

What do we do if we discover something that should be disclosed (e.g., a criminal act)? Researchers have no legal obligation to disclose criminal acts and must determine the most important consideration: their duty to the participant vs. their duty to the wider community.

Ultimately, decisions to disclose information must be set in the context of the research aims.

Withdrawal from an Investigation

Participants should be able to leave a study anytime if they feel uncomfortable. They should also be allowed to withdraw their data. They should be told at the start of the study that they have the right to withdraw.

They should not have pressure placed upon them to continue if they do not want to (a guideline flouted in Milgram’s research).

Participants may feel they shouldn’t withdraw as this may ‘spoil’ the study. Many participants are paid or receive course credits; they may worry they won’t get this if they withdraw.

Even at the end of the study, the participant has a final opportunity to withdraw the data they have provided for the research.

Ethical Issues in Psychology & Socially Sensitive Research

There has been an assumption over the years by many psychologists that provided they follow the BPS or APA guidelines when using human participants and that all leave in a similar state of mind to how they turned up, not having been deceived or humiliated, given a debrief, and not having had their confidentiality breached, that there are no ethical concerns with their research.

But consider the following examples:

a) Caughy et al. 1994 found that middle-class children in daycare at an early age generally score less on cognitive tests than children from similar families reared in the home.

Assuming all guidelines were followed, neither the parents nor the children participating would have been unduly affected by this research. Nobody would have been deceived, consent would have been obtained, and no harm would have been caused.

However, consider the wider implications of this study when the results are published, particularly for parents of middle-class infants who are considering placing their young children in daycare or those who recently have!

b)  IQ tests administered to black Americans show that they typically score 15 points below the average white score.

When black Americans are given these tests, they presumably complete them willingly and are not harmed as individuals. However, when published, findings of this sort seek to reinforce racial stereotypes and are used to discriminate against the black population in the job market, etc.

Sieber & Stanley (1988) (the main names for Socially Sensitive Research (SSR) outline 4 groups that may be affected by psychological research: It is the first group of people that we are most concerned with!
  • Members of the social group being studied, such as racial or ethnic group. For example, early research on IQ was used to discriminate against US Blacks.
  • Friends and relatives of those participating in the study, particularly in case studies, where individuals may become famous or infamous. Cases that spring to mind would include Genie’s mother.
  • The research team. There are examples of researchers being intimidated because of the line of research they are in.
  • The institution in which the research is conducted.
salso suggest there are 4 main ethical concerns when conducting SSR:
  • The research question or hypothesis.
  • The treatment of individual participants.
  • The institutional context.
  • How the findings of the research are interpreted and applied.

Ethical Guidelines For Carrying Out SSR

Sieber and Stanley suggest the following ethical guidelines for carrying out SSR. There is some overlap between these and research on human participants in general.

Privacy : This refers to people rather than data. Asking people questions of a personal nature (e.g., about sexuality) could offend.

Confidentiality: This refers to data. Information (e.g., about H.I.V. status) leaked to others may affect the participant’s life.

Sound & valid methodology : This is even more vital when the research topic is socially sensitive. Academics can detect flaws in methods, but the lay public and the media often don’t.

When research findings are publicized, people are likely to consider them fact, and policies may be based on them. Examples are Bowlby’s maternal deprivation studies and intelligence testing.

Deception : Causing the wider public to believe something, which isn’t true by the findings, you report (e.g., that parents are responsible for how their children turn out).

Informed consent : Participants should be made aware of how participating in the research may affect them.

Justice & equitable treatment : Examples of unjust treatment are (i) publicizing an idea, which creates a prejudice against a group, & (ii) withholding a treatment, which you believe is beneficial, from some participants so that you can use them as controls.

Scientific freedom : Science should not be censored, but there should be some monitoring of sensitive research. The researcher should weigh their responsibilities against their rights to do the research.

Ownership of data : When research findings could be used to make social policies, which affect people’s lives, should they be publicly accessible? Sometimes, a party commissions research with their interests in mind (e.g., an industry, an advertising agency, a political party, or the military).

Some people argue that scientists should be compelled to disclose their results so that other scientists can re-analyze them. If this had happened in Burt’s day, there might not have been such widespread belief in the genetic transmission of intelligence. George Miller (Miller’s Magic 7) famously argued that we should give psychology away.

The values of social scientists : Psychologists can be divided into two main groups: those who advocate a humanistic approach (individuals are important and worthy of study, quality of life is important, intuition is useful) and those advocating a scientific approach (rigorous methodology, objective data).

The researcher’s values may conflict with those of the participant/institution. For example, if someone with a scientific approach was evaluating a counseling technique based on a humanistic approach, they would judge it on criteria that those giving & receiving the therapy may not consider important.

Cost/benefit analysis : It is unethical if the costs outweigh the potential/actual benefits. However, it isn’t easy to assess costs & benefits accurately & the participants themselves rarely benefit from research.

Sieber & Stanley advise that researchers should not avoid researching socially sensitive issues. Scientists have a responsibility to society to find useful knowledge.

  • They need to take more care over consent, debriefing, etc. when the issue is sensitive.
  • They should be aware of how their findings may be interpreted & used by others.
  • They should make explicit the assumptions underlying their research so that the public can consider whether they agree with these.
  • They should make the limitations of their research explicit (e.g., ‘the study was only carried out on white middle-class American male students,’ ‘the study is based on questionnaire data, which may be inaccurate,’ etc.
  • They should be careful how they communicate with the media and policymakers.
  • They should be aware of the balance between their obligations to participants and those to society (e.g. if the participant tells them something which they feel they should tell the police/social services).
  • They should be aware of their own values and biases and those of the participants.

Arguments for SSR

  • Psychologists have devised methods to resolve the issues raised.
  • SSR is the most scrutinized research in psychology. Ethical committees reject more SSR than any other form of research.
  • By gaining a better understanding of issues such as gender, race, and sexuality, we are able to gain greater acceptance and reduce prejudice.
  • SSR has been of benefit to society, for example, EWT. This has made us aware that EWT can be flawed and should not be used without corroboration. It has also made us aware that the EWT of children is every bit as reliable as that of adults.
  • Most research is still on white middle-class Americans (about 90% of research is quoted in texts!). SSR is helping to redress the balance and make us more aware of other cultures and outlooks.

Arguments against SSR

  • Flawed research has been used to dictate social policy and put certain groups at a disadvantage.
  • Research has been used to discriminate against groups in society, such as the sterilization of people in the USA between 1910 and 1920 because they were of low intelligence, criminal, or suffered from psychological illness.
  • The guidelines used by psychologists to control SSR lack power and, as a result, are unable to prevent indefensible research from being carried out.

American Psychological Association. (2002). American Psychological Association ethical principles of psychologists and code of conduct. www.apa.org/ethics/code2002.html

Baumrind, D. (1964). Some thoughts on ethics of research: After reading Milgram’s” Behavioral study of obedience.”.  American Psychologist ,  19 (6), 421.

Caughy, M. O. B., DiPietro, J. A., & Strobino, D. M. (1994). Day‐care participation as a protective factor in the cognitive development of low‐income children.  Child development ,  65 (2), 457-471.

Harris, B. (1988). Key words: A history of debriefing in social psychology. In J. Morawski (Ed.), The rise of experimentation in American psychology (pp. 188-212). New York: Oxford University Press.

Rosenthal, R., & Rosnow, R. L. (1984). Applying Hamlet’s question to the ethical conduct of research: A conceptual addendum. American Psychologist, 39(5) , 561.

Sieber, J. E., & Stanley, B. (1988). Ethical and professional dimensions of socially sensitive research.  American psychologist ,  43 (1), 49.

The British Psychological Society. (2010). Code of Human Research Ethics. www.bps.org.uk/sites/default/files/documents/code_of_human_research_ethics.pdf

Further Information

  • MIT Psychology Ethics Lecture Slides

BPS Documents

  • Code of Ethics and Conduct (2018)
  • Good Practice Guidelines for the Conduct of Psychological Research within the NHS
  • Guidelines for Psychologists Working with Animals
  • Guidelines for ethical practice in psychological research online

APA Documents

APA Ethical Principles of Psychologists and Code of Conduct

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Ethical considerations in malaria research proposal review: empirical evidence from 114 proposals submitted to an Ethics Committee in Thailand

Pornpimon adams.

Office of Research Services, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand

Sukanya Prakobtham

Chanthima limphattharacharoen, pitchapa vutikes, srisin khusmith.

Department of Microbiology and Immunology, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand

Krisana Pengsaa

Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand

Polrat Wilairatana

Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand

Jaranit Kaewkungwal

Department of Tropical Hygiene, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand

Malaria research is typically conducted in developing countries in areas of endemic disease. This raises specific ethical issues, including those related to local cultural concepts of health and disease, the educational background of study subjects, and principles of justice at the community and country level. Research Ethics Committees (RECs) are responsible for regulating the ethical conduct of research, but questions have been raised whether RECs facilitate or impede research, and about the quality of REC review itself. This study examines the review process for malaria research proposals submitted to the Ethics Committee of the Faculty of Tropical Medicine at Mahidol University, Thailand.

Proposals for all studies submitted for review from January 2010 to December 2014 were included. Individual REC members’ reviewing forms were evaluated. Ethical issues (e.g., scientific merit, risk–benefit, sample size, or informed-consent) raised in the forms were counted and analysed according to characteristics, including study classification/design, use of specimens, study site, and study population.

All 114 proposals submitted during the study period were analysed, comprising biomedical studies (17 %), drug trials (13 %), laboratory studies (24 %) and epidemiological studies (46 %). They included multi-site (13 %) and international studies (4 %), and those involving minority populations (28 %), children (17 %) and pregnant women (7 %). Drug trials had the highest proportion of questions raised for most ethical issues, while issues concerning privacy and confidentiality tended to be highest for laboratory and epidemiology studies. Clarifications on ethical issues were requested by the ethics committee more for proposals involving new specimen collection. Studies involving stored data and specimens tended to attract more issues around privacy and confidentiality. Proposals involving minority populations were more likely to raise issues than those that did not. Those involving vulnerable populations were more likely to attract concerns related to study rationale and design.

Conclusions

This study stratified ethical issues raised in a broad spectrum of research proposals. The Faculty of Tropical Medicine at Mahidol University is a significant contributor to global malaria research output. The findings shed light on the ethical review process that may be useful for stakeholders, including researchers, RECs and sponsors, conducting malaria research in other endemic settings.

Malaria research is predominantly conducted in developing countries, corresponding to endemic areas of the disease. Over the past few decades, there have been ongoing concerns and arguments on research ethics. These issues are related to the over- or under-protection of human subjects in drug and vaccine clinical trials, as well as non-clinical studies carried out in disease burden areas [ 1 – 6 ]. Concerns raised include the balance between ethics and science, patient risks and benefits, individuals’ educational background and local concepts of health and disease, ethical justice principles at the community and country level, and even arguments around the Hippocratic dictum ‘ primum non nocere’ [ 1 , 2 , 5 ]. Regarding research ethics in developing countries, it is a reasonable notion that regardless of where the research is conducted, not only should the quality be the same, but also that study participants are equally valued and respected [ 7 ]. Despite the generic ethical principles that can be applied to healthcare-related research, there has been debate about the application of such principles in different research settings because socio-cultural and economic contexts vary considerably around the world [ 2 , 7 ].

In attempting to prohibit malpractice of human experiments in the medical community, the “Declaration of Helsinki” was initially adopted in 1964 and has undergone several revisions since. The Declaration introduced the concept of an independent committee; it stated explicitly that the research protocol must be submitted to the concerned research ethics committee for consideration, comment, guidance, and approval before the study begins [ 8 ]. The research ethics committee (REC) must be qualified, independent, and have no conflict of interest when reviewing the research protocol. This evolved into the term “institutional review board” (IRB) used in the US. The IRB concept was established after the U.S. National Research Act (1974), and the Belmont Report (1979), stating its purpose to protect human subjects involved in both clinical and behavioural research [ 9 ]. The IRB Guidebook [ 10 ] was developed by the US Office for Human Research Protections (OHRP) and is one of the resources that ethics committees across the globe adopt for their own operations. It includes issues of IRB administration, regulation and policies, protocol review mechanisms and other ethical principles. Similarly, the European Union Clinical Trials Directive regards the research ethics committee as an independent body with responsibility to protect the rights, safety, and well-being of human subjects involved in a research study [ 11 ]. The terms IRB and REC are often used interchangeably, but arguably have somewhat different meanings; according to the ICH Guideline [ 12 ]: IRB could be a subsection of REC (a review board or a committee, institutional, regional, national, or supranational), but the IRB or REC plays a major role in regulating the ethical conduct of research by reviewing research proposals before the research is carried out. While judging whether the proposal is worthwhile and ethical, part of the committee’s role may also be to provide constructive recommendations to researchers in an attempt to maintain high-quality, ethical research [ 8 , 10 – 12 ].

With its role in ethical review of research proposals, questions have been raised about whether the REC is facilitating or impeding the advancement of scientific research, and there have been comments from researchers regarding the quality of the REC review itself [ 13 ]. Some investigators in international or multicentre studies have complained of substantial inefficiencies in REC review, and have requested that RECs pay more attention to scientific integrity alongside the protection of human subjects involved in the study [ 14 ]. Investigators have also raised concerns that REC review burdens have grown to include studies involving interviews, secondary use of public-use data and similar activities, most of which involve minimal risks [ 9 ]. Criticism has also been raised regarding the REC requirement for paperwork and mechanical monitoring, which may undermine the main goal of the protection of human subjects [ 9 ]. With the emergence of new fields in biomedical research and technology, particularly in genetics and genomics, a range of views exist within and between RECs and the research groups in these evolving fields [ 15 ]. This reflects the complexity and diversity and lack of common ground surrounding many ethical issues related to this type of research [ 15 , 16 ].

In assessing ethical quality in protocol review—particularly the oversight of human subject research—RECs and other stakeholders, including sponsors, regulators and the public, need to have evidence-based information [ 17 , 18 ]. Several proxy indicators of ethical quality assessment have been proposed. Some suggest using measurement parameters and/or quality metrics including objective and subjective quality assessment, which can be used to improve REC review and deliberation processes, and strengthen relationships between the REC and researchers [ 13 , 19 ]. It has been suggested that ethnographic studies on REC meetings and minutes could help identify the critical ethical issues that the REC considers when reviewing proposals, thus determining whether ethical principles have been thoroughly considered [ 14 ].

An analysis of malaria publication data (2010–2014) in the SciVal database, to which Mahidol University subscribes, found that Mahidol University (Thailand) ranked #4 (with 450 papers) for number of research studies. Of these, the Faculty of Tropical Medicine, Mahidol University contributed 87 % (with 391 papers), correlating to a ranking of #6 if counted as an independent institute. To promote the conduct of research at FTM, the Office of Research Services (ORS) provides administrative services to the faculty’s research community. One of its major functions is as the Secretariat to the FTM Ethics Committee (FTM-EC), managing the operations of Ethics Committee meetings. The FTM-EC has been continuously registered with the Federal-wide Assurance (FWA) of the US OHRP since 2002. The FTM-EC comprises one clinical and one non-clinical panel, which convene at monthly meetings.

Given the level of malaria research output and ethics committee activity at the FTM, it is an ideal location to examine the REC review process for malaria research. Therefore, this study attempts to reveal how malaria research studies conducted in Southeast Asia (along the Thai borders) were reviewed by the local REC, the FTM-EC. In particular, the purpose of this study was to identify the ethical considerations for different types of malaria research proposals submitted to the FTM-EC during the period 2010–2014.

Dimensions of ethical consideration

In reviewing research proposals, REC members should base their judgment on international standards of ethical concerns pertaining to moral values including dignity, bodily integrity, autonomy, and privacy. Such ethical concerns are listed in several guidelines for REC review, and although they might be expressed differently in varying circumstances, similar principles are often cited [ 11 , 20 – 24 ]. The World Health Organization (WHO) [ 22 ] states in its standards for ethical review that the approval or disapproval of the protocol should be based on the ethical acceptability of the research while accounting for its social value, scientific validity, and applicable laws. As stated in the guidelines of the Council for International Organizations of Medical Sciences (CIOMS) [ 21 ], all research involving human subjects should be in accordance with the moral weight of the three basic ethical principles: respect for persons, beneficence, and justice. The European guidelines [ 11 ] suggest four main components of a research ethics committee: dignity, bodily integrity, autonomy, and privacy. The European Commission [ 23 ] even suggests that researchers pre-check their proposal to ensure that it follows the principles of human dignity, fair distribution of research benefits and burden, and protection of the values, rights, and interests of the research participants. The UK Health Department [ 24 ] provides guidance in governance arrangements for RECs in reviewing research proposals to act as part of an efficient, accountable, and independent body in protecting the dignity, rights, safety, and well-being of people who take part in research. The US IRB Guideline on basic IRB review [ 25 ] discusses issues of human subject research, in particular for risk–benefit analysis, monitoring and observation, informed consent and additional safeguards, selection of subjects, incentives for participation, and privacy and confidentiality.

Ethics is not about prescribing a specific set of rules or policies, rather it is about providing a framework for evaluating problems and determining an appropriate course of action [ 26 ]. According to the WHO manual for capacity training for RECs [ 26 ], the ethical analysis is to identify a set of governing principles reflecting both internationally accepted norms and locally relevant cultural values, and then apply such principles to evaluate the research. Several frameworks for ethical research conducted in developing countries have been proposed, focusing on collaborative partnerships and sharing responsibilities with researchers, policy-makers and the community [ 2 , 21 , 26 , 27 ]. The framework should be based on the notation set forth in the Declaration of Helsinki so that ethical principles could be effectively identified and applied, particularly in developing countries in regards to each country’s socioeconomic circumstances, laws and regulations, and executive and administrative arrangements [ 21 ]. Proposed basic ethical principles include: (1) considering social value by specifying the beneficiaries of the research, (2) ensuring scientific validity through the scientific design and research objectives, (3) fair study population selection to ensure scientific validity, (4) assessment of the risk–benefit ratio by comparing the net risks of the research project with the potential benefits, (5) ensuring public accountability through independent reviews mandated by laws and regulations, (6) ensuring informed consent while involving the community in establishing recruitment procedures and incentives, and (7) respecting study participants and communities [ 2 , 26 , 27 ].

In particular, ethical issues that should be considered as part of malaria field studies in developing countries have been discussed as lessons learned in a community-based clinical trial of rectal artesunate conducted in a few developing countries [ 28 ]. Issues to consider include the ethical review process, standard of care, incentives and reimbursement, and insurance and indemnity. It has also been suggested that local ethical review should consider the vulnerability of patients with no or poor access to healthcare, specific cultural attitudes, literacy, and both local written and oral languages [ 28 ]. A study on convergent ethical issues in HIV/AIDS, TB, and malaria vaccine trials in Africa revealed that sharing simple and effective consent form templates and procedures across diseases was achievable [ 29 ]. Comprehension testing of subjects prior to and during study participation, to ensure understanding of the important study concepts, has also been proposed [ 28 ]. Moreover, it has been suggested that the REC should also examine the suitability of the investigators and the adequacy of facilities and the methods and documentation to be used in the study [ 11 ].

At the FTM-EC, individual REC members are provided with a review form prior to every convened meeting. The review form outlines certain ethical issues similar to those described above. Each member uses this form as a guide to ethical issues to consider when reading the proposal. They then complete each part that he/she considers relevant and requires explanations from the researchers. The form also has an open-ended component, where the REC can note other ethical considerations. The review form used during the study period (currently the form has been revised) guiding the REC members in reviewing each protocol was composed of 19 check boxes for close-ended items on being a human research subject study: types of study (clinical, epidemiological, social science, or behavioural); reasonable scientific questions/objectives; proper sampling techniques/data collection methods; quality of investigators/facilities; project budget; compensation; justification of the involvement of vulnerable populations; rationale for use of human specimen; adequate toxicological/pharmaceutical information; sufficient provision of information and proper informed consent process and forms; rating on level of risk and benefit of the study; and the overall ethical acceptability of the proposal. The review form also consists of 9 open-ended comment items regarding project summary (to be filled in by two primary reviewers) and other ethical issues (to be filled by all REC members) including major points of concern, levels of risk, comments on the title, proposal content (objectives, research methodology, protection of privacy and confidentiality), participation information sheet, informed consent/assent form, questionnaire/advertisement/case record form, attached document (investigator’s brochure, material transfer, etc.), and other comments/suggestions. For the purpose of this study, the ethical issues were divided into six dimensions, as follows: (1) study rationale and validity; (2) study design; (3) study participants; (4) informed consent process; (5) data collection and analysis; and (6) facility and support. Each dimension thus covers its related ethical considerations in the review form (as presented in the “ Results ” section).

Classification of malaria research studies

Research protocols reviewed by RECs can be categorized according to different schemes [ 22 , 30 , 31 ]. The European Science Foundation [ 31 ] reviews health research classification systems in different countries across continents. The UK Health Research Classification System (HRCS) for classifying and analyzing biomedical and health research funding applies a two-dimensional framework. Codes on health categories are used to classify the type of health or disease being studied, covering 21 categories encompassing all diseases, conditions and areas of health. Research activity codes are used to classify the type of research activity being undertaken (from basic to applied), covering 48 codes of eight subgroups: (1) Underpinning, (2) Aetiology, (3) Prevention, (4) Detection and Diagnosis, (5) Treatment Development, (6) Treatment Evaluation, (7) Disease Management, and (8) Health Services. The Australian and New Zealand research classification scheme has been developed and updated over the years. The three constituent classifications in use are: (1) Type of Activity (ToA)—pure basic research, strategic basic research, applied research and experimental development; (2) Field of Research (FoR)—methodology used in research and development (R&D) fields of the research investigated by institutions and organizations as well as emerging areas of study; and (3) Socio-economic objective (SEO) consisting of discrete economic, social, technological or scientific domains for identifying the principal purposes of R&D.

On the other hand, the WHO [ 22 ] simply classifies different types of research studies to be reviewed by RECs, including, but not limited to, the following: (1) clinical trials, (2) epidemiological research, (3) social science research, (4) research on medical records or other personal information, (5) research on stored samples, (6) health systems research, and (7) implementation research. The US Office for Human Research Protections [ 30 ] categorized research reviewed by IRBs as either biomedical or behavioural studies. Biomedical research covers two types of studies: (1) those designed primarily to generate scientific knowledge about the natural history of the disease and normal or abnormal physiology, and (2) studies designed primarily to evaluate the development of medical products and the efficacy, effectiveness, efficiency and safety of a medical intervention. Behavioural research includes studies of the epidemiology and social science of individual or group behaviour. As part of the biomedical research study, clinical trials, which often originate in the laboratory to develop new therapies or procedures, are tested in animal studies, then subsequently on human subjects [ 32 ]. The US National Institutes of Health (NIH) distinguishes between different types of clinical trials including, for example, natural history studies, prevention, screening, diagnostic, treatment, or quality of life trials [ 32 ]. Biomedical research can be sub-classified as basic/pre-clinical research or clinical research [ 33 ].

Many RECs face challenges in the protocol review of studies in the fields of molecular and genetic or genomic research. Lack of clarity on how researchers should respond to RECs has been reported, particularly concerning issues of informed consent and the use of archived specimens [ 20 , 34 ]. Confusion and debate remains within and across RECs around studies involving the collection and use of non-identifiable stored tissue specimens. There is disharmony among regulatory requirements in different countries and REC bodies within countries, but there is a growing international agreement on the provision and access to research data and bio-specimen collections in order to optimize their long-term value and potential for health discovery and validation [ 35 – 37 ]. The UK Medical Research Council [ 35 ] proposed operational and ethical guidelines for the use of human tissue and biological samples, such that samples of human biological material should be treated as donations, and research involving these should be conducted with respect and transparency. The research study should be planned with respect to the trust of the potential donors with individual, cultural, or religious differences in the meaning and significance attached to samples for use.

With contradictory legal and ethical frameworks across national borders, there has been an attempt to set up an international charter of principles for sharing bio-specimens and data [ 36 ]. The following five principles include major ethical considerations: (1) respect for privacy and autonomy, (2) reciprocity, (3) freedom of scientific enquiry, (4) attribution, and (5) respect for intellectual property. In the US, the Food and Drug Administration has set rules and regulations regarding the use of identifiable and unidentifiable specimens for clinical investigators, sponsors, and RECs. The US Health Insurance Portability and Accountability Act privacy rule has set less restrictive rules for the use of stored specimens and tissue repositories (such as biobanks), when released data have been de-identified [ 20 ]. The UK Medical Research Council [ 35 ] emphasizes custodianship as the responsibility of researchers for safe keeping of samples and control of their use and eventual disposal, defining “anonymized samples or data” where all identifying information is removed, either as linked or unlinked anonymous data and samples; and “coded samples or data” where a code is used in place of identifiers to protect the confidentiality of the individual during routine use. The American Society of Human Genetics distinguishes between retrospective and prospective studies, such that the “retrospective research studies” utilise previously obtained samples collected for a purpose that is different from that of the current proposal and the “prospective research studies” are those in which the collection of the new samples is part of the current study design [ 37 ]. Similarly, four types of sample identification were defined: (1) anonymous, no identifiers and impossible to link with their sources, (2) anonymised, originally with identified information but irreversibly stripped off and are impossible to link to their sources, (3) identifiable, unidentified for the current research purposes, but can be linked to their sources, and (4) identified, with identifiers and are attached and available to the researchers [ 37 ]. In Thailand, however, the use of specimens or medical records, either identifiable or unidentifiable, is considered to be human subject research. Studies involving such material commonly require REC review, either full-board or expedited, and very few receive exemption.

The two panels of the FTM-EC comprise different sets of members. The “clinical panel” reviews clinical research studies involving the application of any clinical interventions in human research subjects, while the “non-clinical panel” reviews other types of biomedical study, including research conducted in clinical settings but where no clinical intervention was applied, epidemiological studies, and studies that use stored specimen or secondary data. Malaria study proposals submitted to the FTM-EC fall into either of the categories and are reviewed by the relevant panel. Because these two broad categories of research might be subject to different constraint levels of ethical consideration, reviewed studies were classified for the purposes of this study in two ways. For classification based on research study design, there are four categories: (1) clinical (drug) trials; (2) biomedical studies; (3) laboratory studies, and (4) epidemiological/social science studies. For classification based on the use and non-use of specimens, there are four categories: (1) new specimen collection; (2) use of archived un-identifiable/un-linked specimens; (3) use of archived/identifiable/linked specimens; and (4) use of medical records and new data collection.

Sources of information and statistical analysis

This study adopts the process of internal audits on quality systems of independent ethics committees in Europe [ 38 ], by conducting documentation reviews. The reviewed documentation included minutes of meetings and agendas, each individual REC member’s reviewing form, and the notifications to researchers informing them of the review outcome for the submitted proposal. This study was conducted by the office managing the submitted proposals and the REC members at the FTM-EC. Information was extracted by personnel authorized to access these documents. To avoid bias, three office employees (non-voting members of the FTM-EC), were assigned to identify the main ethical considerations noted by each REC member on his/her review form, while cross-checking with each other. Ethical considerations raised were counted quantitatively whether the ethical issues (e.g. scientific merit, risk and benefit, sample size, or informed-consent process) were noted/discussed, both in the pre-specified and open-ended items, on each individual REC member’s review form as well as all other documents related to the submitted proposal. It should be noted that for the open-ended items, very little subjective judgment was required by the person extracting the data, because most of the major ethical issues raised by the reviewers could be obviously categorized. All proposals related to malaria research submitted to FTM-EC over a period of 5 years, from January 2010 to December 2014, were reviewed. Analyses of ethical considerations were presented according to study classification, study design and specimen uses; Chi square tests were performed on each ethical issue separately. In addition, analyses were performed according to study location (multi-site, international, approval together with other REC study) and study population (minority or vulnerable population involved). To further investigate the relationship between ethical considerations and different study types, additional statistical analyses were performed using simple crude odds ratios (ORs). Logistic regression was performed for each ethical issue by different type of study separately.

Types of malaria research studies

During the study period, 114 research proposals on different malaria species were submitted to the FTM-EC for review. These comprised 19 (17 %) biomedical studies, 15 (13 %) drug trials, 28 (24 %) laboratory studies and 52 (46 %) epidemiological/social science studies. Drug trials adopted atypical phase classification of the drug development process including 12 studies on investigational new drug ranging from Phase I to Phase III, and 3 Phase IV drug safety studies. No malaria vaccine trial proposals were submitted to the FTM-EC during the study period. Biomedical studies included eight studies comparing different malaria treatments/regimens and/or with different indications in clinical settings, and 11 bioequivalence or pharmacokinetic studies. Laboratory studies covered pure basic science and genetic studies. Epidemiology/social science studies included retrospective study using medical records and social/behavioural research. Approximately one-third of studies required FTM-EC approval together with that of other RECs, within Thailand and/or internationally. Approximately 13 % were multi-site and 4 % were international studies. Most malaria studies were conducted at malaria-endemic areas along the Thai borders; therefore, 28 % involved minority (hill tribe and cross-border) populations. Seventeen percent involved children and 7 % involved pregnant women (Table  1 ).

Table 1

Malaria study proposals submitted to the FTM-EC during the study period

FTM - EC Faculty of Tropical Medicine Ethics Committee and IRB institutional review board

Overall ethical considerations on malaria proposals

Of the 114 proposals, the ethical issues raised by REC members on “study rationale and significance of the study” included 12 % on research questions and 17 % on research objectives. As shown in Fig.  1 , regarding the “study design and methodology” dimension, approximately 30 % were related to study schedule and activities, and 37 % to risk–benefit balance. For the ethical considerations concerning “research study participant”, 52 % were related to inclusion and exclusion criteria, 26 % to sample size, 27 % to recruitment procedures, and 23 % to participant compensation. Higher percentages were shown for the “informed consent process” dimension, with 57 % on the participation information sheet, 50 % on the informed consent form/process, and 24 % on the privacy and confidentiality of the information. Regarding the “data collection and analysis” dimension, approximately 61 % related to the specimen and data collection procedure, 17 % to case record form (CRF) design and use and 13 % to data analysis methods. For “study facility and supporting information”, 4 % were on study site location, 2 % on study budget, and 15 % on supporting documentation (e.g. material transfer agreement, and approval of authorities in the community where the study was taking place).

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Overall ethical considerations on malaria research proposals (n = 114)

Comparisons of ethical considerations by proposal type

When comparing ethical considerations according to study design, almost all ethical issues were statistically significantly different across the four study designs. Proposals for drug trials had higher percentages for most ethical issues, followed by proposals of for biomedical/clinical research then laboratory or basic science research (Table  2 ). Proposals for epidemiology studies had fewer ethical issues raised by the FTM-EC. Interestingly, ethical issues for “privacy and confidentiality” specifically showed an opposite but non-statistically significant trend, being higher for laboratory and epidemiology studies than biomedical studies or drug trials. Other non-statistically significant differences among different study designs were for CRFs, data analysis, study budget and supporting documents.

Table 2

Comparisons of ethical considerations by study design

When comparing ethical considerations by different types of specimen/data collection and use, again almost all ethical issues were statistically significantly different across the four types of study proposal. Proposals involving new specimen collection had higher percentages for most ethical issues, followed by proposals using medical records or collecting new data using CRFs or questionnaires (Table  3 ). The proposals involving the use of stored specimens, either linked (identifiable) or unlinked (un-identifiable) had a smaller percentage of ethical issues raised by the FTM-EC. Again, ethical issues for “privacy and confidentiality” showed an opposite but non-statistically significant trend, with the percentage higher for studies involving stored specimens. Other non-statistically significant differences among different study designs were study rationale, data analysis, and study facility and supporting documents.

Table 3

Comparisons of ethical considerations by type of specimen/data use

CRF case record form

Strength of relationship between ethical considerations and different types of malaria proposals

Regarding study location, proposals that required other REC review had higher ORs compared with proposals that required only FTM-EC review for the following ethical issues: study design and methodology; study participants; the informed consent process; and study facility and supporting documents. For comparisons between international vs. local studies, and between multi- vs. single-site studies, higher ORs were found for the dimension study facility and supporting documents (Table  4 ).

Table 4

Comparisons of ethical considerations by different study characteristics

Italics denotes statistically significant values

CI confidence interval, IRB institutional review board, OR odds ratio

Regarding study populations, proposals involving minority populations had higher ORs than proposals that did not involve such populations, for all ethical issues apart from study rationale and significance. In contrast, proposals involving vulnerable populations had higher ORs than proposals that did not, for study rationale/significance and study design/methodology.

When comparing the four study designs using epidemiology studies as a reference group, higher ORs were reported for biomedical/clinical research for all ethical issues except study facility and supporting documents. For drug trials, higher ORs were reported for all ethical issues except study participants and informed consent process. This was because 100 % of drug trial researchers were asked for clarifications on these two ethical issues. For laboratory studies, higher ORs were reported for three ethical issues: study design and methodology, study participants, and the informed consent process.

When comparing the four types of specimen/data use using proposals with medical records/CRFs as the reference group, higher ORs were reported for studies that collected new specimens for all ethical issues except study rationale, data collection and analysis, and research facility and supporting documents. Interestingly, when comparing proposals for studies using medical records/CRFs with those using identifiable or unidentifiable stored specimens, no statistically significant differences were reported.

The roles and responsibilities of an REC are to ensure protection of the safety, well-being and basic rights of potential participants and participants of a research study. The REC should review the protocol and associated documents and provide opinions on three different ethical considerations, i.e. science, ethics, and data quality [ 33 ]. The classical view of research ethics is governed by four ethical principles: respect for persons, beneficence, justice, and respect for communities [ 39 , 40 ]. Ethical foundations to be considered and addressed include issues on research subjects, the informed consent process, study design concept, risk–benefit ratio, vulnerable group protection and research gatekeepers [ 10 , 41 ]. In this study, the ethical issues raised in malaria research proposals fell within these common principles. Approximately half of the proposals required revision and clarification on the informed consent process and study participant protection; and, for those studies that required specimen collection, the process to obtain the specimen from the study participants. Approximately one-third required information about risk–benefit and study schedule-activities. Less than one-fifth required explanation of the research objectives and a few proposals required clarification or revision of research questions and supporting documents.

Although only approximately 12 % of the proposals in the present study needed elaboration or provision of more robust information about the research questions (study rationale and significance), debate remains whether the FTM-EC has gone beyond its designated roles. The highest percentage of ethical issues raised by the FTM-EC regarding the malaria research proposals in the study related to the specimen and data collection schedule and activities. At times, some investigators have also questioned whether the ethics committee should comment on research methodology. These scientific merit and research procedure issues remain controversial internationally. It has been reported that REC members are pressured to review a wide range of issues in research proposals, needing to provide opinions ranging from research design to patient privacy and budgeting matters [ 9 , 33 ]. Some research investigators believe that these are beyond the scope of research protection [ 9 ]. Others have suggested that researchers should have already thought carefully about the nature of how the study results can be generated and how they are aligned with the aims of the research. Heterogeneity of bioethics ought to be welcomed, but those involved should engage meaningfully and explicitly with questions concerning normative justification and the methodological process and about the coherence of components of their study [ 42 ]. The OHRP also notes that REC members very often ask to what degree it is his/her responsibility to review the underlying science of the proposal [ 43 ]. It has long been argued that “if it is not good science, it is not ethical” and the US federal regulations do not clearly call for REC review of the scientific validity of the research design. However, if the underlying science is inadequate, then it follows that the study is unlikely to yield important knowledge [ 43 ]. To mitigate this controversial ethical consideration made by RECs, the ORHP guideline suggests that if the REC lacks expertise in the scientific matter of the particular proposal, the REC should recognise its limits. Although REC members are not required to be experts in scientific methodology or statistics, they should have certain basic knowledge about study design, and they should consult experts if they have concerns about the research rationale and methodology that seem to pose a significant problem [ 43 ]. At the FTM, besides some FTM-EC members who have been working in malaria research over decades, there is a pool of expertise in malaria research, ranging from molecular to field studies, and several of them have been consulted for advice for any unclear or controversial matter before issuing the letter to investigators or making a final decision on the submitted proposals.

The REC has a responsibility to consider the balance between the risks and benefits of the research proposal. International standards clearly state that the REC must safeguard the rights, safety and well-being of all study participants [ 10 , 33 , 44 ]. Based on the classic ethics principle of beneficence, researchers have an obligation not to harm needlessly and to promote the good of the study participants where possible. Regarding justice, researchers have an obligation to ensure that study procedures for the selection of research subjects are equitable [ 44 ]. It is also agreed that researchers neither exploit the vulnerable nor exclude unreasonably those who could be receive benefit from the study. This means that eligibility criteria listed in the proposal must be clearly justified [ 45 ]. Among all 114 malaria proposals submitted for FTM-EC review, about 28 % involved minority populations along the country borders, and 27 % involved other vulnerable groups (pregnant women, children, the elderly or unconscious patients). Thus, the finding that over one-third of proposals required clarification on the risk–benefit balance is not surprising.

As clearly stated in international standards on ethical review of research protocols [ 12 , 23 – 25 , 46 ], the informed consent process is one of the main ethical considerations that must be observed by RECs. Indeed, it could be said that the informed consent process is a legal, ethical, and regulatory requirement for most research and healthcare transactions [ 20 , 47 ]. The informed consent process is based on the classic ethical principle of respect for persons, such that researchers must ensure that potential study participants make their own decisions whether or not to take part [ 44 ]. It should also be noted that, by signing informed consent documents, the study participants have agreed to a controlled breach of their privacy/confidential information for a specific purpose mentioned in the study protocol, and for use over a specific period of time [ 14 ]. It is thus important that participants are clearly informed about the methods of handling and use of their personal data, the justification for requesting or obtaining their data from different sources, and the duration of data use and storage, while maintaining their right to withdraw their consent at any time [ 14 ]. All guidelines suggest that special attention should be paid to studies involving vulnerable participants who may be unable or have limited capacity to make a decision [ 10 , 21 , 48 , 49 ]. In a study on ethical dilemmas in malaria drug and vaccine trials [ 1 ], it was stated that, in most cases, obtaining informed consent was problematic because the studies were usually conducted with patients or surrogates with limited educational attainment levels in developing countries, and thus were not able to fully understand the study protocol. Potential participants may not understand the science underlying the study and therefore be able to make proper informed decisions. The finding in that study suggests the need for a better consent processes. As suggested elsewhere in the literature, a consent process considered valid or truly informed should have the following characteristics: (1) provision of adequate information, (2) capacity to understand that information, (3) decision making voluntarily, (4) understanding of information provided, and (5) agreement to the proposed treatment or procedure [ 50 ]. It has also been suggested that the informed consent forms are usually too long and complex for a layperson to read and comprehend, but there are various methods to simplify such forms [ 51 ]. Researchers are obliged to ensure that they plan their informed consent process with care, even the complicated aspects of research, by having the information explained simply and comprehensibly to the potential study participants. In the present study, over half the malaria research proposals and all malaria drug trial proposals submitted to FTM-EC required revision of the informed consent process to meet such requirements.

When examining different research designs, it was found that proposals on laboratory-based (usually using archived specimens) and epidemiological studies had fewer ethical issues raised by the FTM-EC than clinical research and drug trials. However, “privacy and confidentiality” showed an opposite, albeit non-statistically significant, trend. This concurs with one of the main ethical considerations in all international guidelines, that possible invasions of privacy of individuals and breaches of confidentiality may arise in biomedical and behavioural/social research [ 22 , 24 , 25 , 27 , 46 ]. As suggested in the guideline on ethics of research related to healthcare in developing countries, one of the RECs’ primary tasks is to review the ethical acceptability of research proposals with special attention to the provisions for protecting the security and confidentiality of data about patients [ 7 ]. From a data protection and privacy issues point of view, all study participants must be informed about not only what they have to do in the research, if they decide to participate, but also what and how the research plans to use the data that they provide [ 46 ]. There were reports of potential improper use or misuse of the collected data; even in case studies showing that what seems to be unlinked information can sometimes be taken for use out of context and lead to a personal data breach [ 46 ]. This could be because study procedures in clinical and drug trial proposals tended to be stated clearly by the study investigators in protecting participants’ personal information, whereas proposals of laboratory (predominantly using stored specimens) and epidemiology studies (predominantly using medical records and CRFs in healthcare settings) were generally not as clear. As suggested in the literature about ethical and legal issues of research using human specimens and clinical data, materials should be provided to the investigator with the minimal clinical information needed for the study and specimens should not be individually identifiable where applicable [ 15 , 16 , 20 ].

The malaria proposals that required additional review by other RECs, whether international or local, appeared to raise more ethical issues regarding study design and methodology, study participants, informed consent processes and study facility and supporting documents. This might be because such proposals are likely to be developed by non-local investigators and thus there might be certain local sensitive issues that were overseen by the proposal developers. As suggested in the literature regarding ethical principles in conducting clinical research in developing countries, investigators should consider the principle of collaboration by developing partnerships with local researchers, policy makers and the community [ 2 ]. It is recommended that the study should respect the community’s values, culture, traditions, and social practices. Even regarding scientific validity, the research team should ensure that the scientific design and methodology has recognized social value for the primary beneficiaries of the research, and is feasible within the social, political, and cultural context, or provides sustainable improvements in the local healthcare and physical infrastructure [ 2 ].

Ethical issues that should be considered, as part of field studies of malaria in developing countries, were also discussed in terms of practical problems that arise in the course of research. These include differing circumstances in developing countries, such as standards of care, incentives and reimbursement, insurance and indemnity [ 28 ]. The local REC should ensure that local context is adequately addressed and convey their knowledge of local factors that affect human subject protection [ 52 ]. The issues raised by the FTM-EC for these international studies confirm the notion that local ethical review should consider the vulnerability of study participants, particularly in remote border areas with no or poor access to healthcare services, alongside cultural beliefs and attitudes, literacy and language [ 25 , 28 ]. As has also been suggested by others, the REC should provide public assurance of such protection by ensuring that investigator(s) are suitable to conduct the study, facilities are adequate, and that the methods and materials and informed consent process are appropriate [ 33 ].

Malaria research studies conducted along the Thai borders generally involved minority populations in endemic areas. These populations are considered vulnerable, with poor/limited educational attainment and cross-border/migrant status. Therefore, it is not surprising to observe that all ethical issues (except study rationale) were raised for such proposals by FTM-EC. The principle of fair selection of study population is important to minimize risks while enhancing other critical principles of collaborative partnership and social value when the research study is taking place in local communities [ 2 ]. Balancing risk–benefit considerations, informed consent processes and having respect for recruited participants and study communities, especially among vulnerable populations, remain the major concerns of all RECs [ 2 , 25 ].

There were more ethical considerations in almost all aspects for drug trials and clinical studies compared with proposals for epidemiological studies. Clinical research studies usually directly involve human subjects, either with preventive, therapeutic, or non-therapeutic procedures. In general, the study procedures in such study designs put human subjects at higher risks, thus there are more ethical concerns. The primary ethical considerations of clinical studies are competent medical treatment and care, alongside an acceptable risk–benefit balance [ 40 , 41 , 44 ]. However, many laboratory research studies use stored specimens, with less invasive procedures, and epidemiology studies usually employ data collection through medical records, CRFs or questionnaires. Ethical issues for the latter, therefore, mainly concern confidentiality and privacy of the study participants [ 25 ]. However, it was found that studies that collect new specimens received more comments on ethical issues. There remains debate among RECs about solutions for issues around sample export, storage, and reuse [ 15 , 16 , 34 ]. However, it is recommended that in order to ensure adequate protection of human research subjects participating in scientific research, RECs bear the responsibility of guaranteeing that participants are provided with sufficient detail to be able to provide informed consent as well as to understand the reality of genetic research as it is practiced [ 53 ].

Limitations of the study

The main limitation of this study is that it is based on information from only one institution, the Faculty of Tropical Medicine, Mahidol University. It may, therefore, not be representative of RECs elsewhere in Thailand or around the world where malaria proposals are submitted. However, the top five institutions publishing malaria research papers during 2010–2014 were the London School of Hygiene and Tropical Medicine (882), the University of Oxford (766), the University of Liverpool (485), Mahidol University (450, including 391 from the FTM), and Johns Hopkins University (409). The proposals under the FTM affiliation were all reviewed by the FTM-EC. This study examined all 114 malaria research proposals submitted to an REC in Thailand during a five-year period. Overall, the FTM makes a considerable contribution to malaria research globally. Identifying the ethical issues considered during the protocol review process at the FTM may inform the planning of future malaria research studies in endemic countries in Southeast Asia and/or beyond.

Regardless of study design and setting, the REC focus is on the science, ethics and quality assurance of each study protocol. Several important ethical issues were identified for protocol approval, ranging from study design to supporting documents. Ethical considerations, particularly for clinical research and drug trials appeared to be mainly focused on the risk–benefit balance, vulnerable participants, and informed consent process, whereas the main considerations for laboratory and epidemiology studies were the confidentiality and privacy of data and use of specimens. As with studies subject to review by any REC, generic ethical principles are applied to malaria research, such that research validity and quality must be maintained while respecting study participants within the social, cultural and economic contexts where the research is conducted. Ethics and bioethics represent large domains of their own in balancing both theoretical and practical aspects of human research study conduct. While stakeholders, including researchers, sponsors and RECs, have to consider the practicability of research conduct within malaria-endemic settings, which are commonly populated with those who are poor and vulnerable, they cannot violate the classic ethical principles of autonomy, beneficence, and justice.

Authors’ contributions

All authors discussed and agreed upon the content, contributed to the development and revision of the draft manuscripts. PA, JK drafted the initial version. PW, SK, KP contributed useful criticism and suggestions. CL, SP, PV extracted unlinked study data from the secured documents of the FTM-EC. All authors read and approved the final manuscript.

Acknowledgements

The authors would like to thank the FTM-EC members in both panels for their kind support for this study.

Compliance with ethical guidelines

Competing interests The authors declare that they have no competing interests.

Abbreviations

Contributor information.

Pornpimon Adams, Email: [email protected] .

Sukanya Prakobtham, Email: [email protected] .

Chanthima Limphattharacharoen, Email: [email protected] .

Pitchapa Vutikes, Email: [email protected] .

Srisin Khusmith, Email: [email protected] .

Krisana Pengsaa, Email: [email protected] .

Polrat Wilairatana, Email: [email protected] .

Jaranit Kaewkungwal, Email: [email protected] .

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Both students and faculty at Lehigh University are encouraged to become involved in the research life of the University.  Departmental honors and capstone courses, as well as a number of campus fellowships and programs, offer opportunities for students to learn the skills of research and present their results.  Frequently, these research projects involve interactions with and/or identifiable data about human beings as participants (or “subjects”).

Some research activities that involve people require approval by the Institutional Review Board (IRB), and others do not. The IRB is a federally mandated committee that reviews human subjects research protocols. Regardless of whether a research project is subject to IRB review, the rights and welfare of any human participants involved in the project must be protected.

The first section of this document provides guidance to students and their faculty mentors on how to incorporate human subjects protections into student research activities. This advice applies to all student research projects, including both those that are subject to IRB review and those that are not because they are chiefly learning activities. The second section of the document discusses what types of projects may be subject to review by Lehigh’s IRB.

What are key features of protecting participants in research?

Excellent human participant protection includes:

• Minimizing the risks of research to participants. • Protecting individuals who are members of a group that may be vulnerable to coercion or undue influence, as it relates to providing informed consent. • Ensuring that research subjects’ participation is informed and voluntary. 

1. Minimizing the risks of research

In all aspects of the research, from recruiting subjects to collecting and storing data to reporting results, risks to research participants must be minimized. 

Students are strongly encouraged to design their projects so that they are “ minimal risk ” research.  As defined in the federal regulations, “minimal risk” means that participants will encounter no harms or discomforts greater than those that are a normal part of their daily lives.   Faculty advisors and research program staff are asked to guide students in developing minimal risk projects.  If, in the opinion of the student or faculty advisor, an intended project might be greater than minimal risk, the student or faculty advisor must seek the advice of the Research Integrity office . 

What risks can arise in or result from research?

• Disclosure of identifiable sensitive information : Recording and storing individual-level identifiable information can pose risks if the data are sensitive, in the sense that disclosure could lead to harm for a research participant.  Some examples of sensitive data include:

  • Information about criminal behavior
  • Information about work-related actions that if known could damage the individual’s employment
  • Information that if widely known could engender stigma or shunning
  • Information beyond the very general about the respondent’s health (which may also be subject to other privacy regulations, e.g. HIPAA)
  • Information about financial or legal aspects of an individual’s life which if publicly known might enable identity theft or fraud
  • Data can be sensitive in one context and not in another (e.g., certain political opinions are risky under politically repressive regimes).

These types of data only present risks if they are identifiable, that is, if linked to names, Social Security numbers, or other identifiable information, or if recorded using audio or video media (with recognizable voices or faces).  To protect research participants, researchers should take steps to minimize the risk of inadvertent disclosure of identifiers and research data.  It is also wise to only gather sensitive information if absolutely necessary for the research.

Good research practices include: using password protection (at a minimum) and encryption (preferred) for computer files and digitized audio or video files; using removable storage devices (thumb or flash drives) that are encrypted and password protected; locking filing cabinets where paper files are stored; and quickly transcribing unprotected, taped interviews and notes on paper so they can then be destroyed.

• Emotional or psychological trauma is a risk when respondents are asked to describe a painful event or a stigmatized identity that they do not usually discuss otherwise.  Personal experiences of war, of refugee flight, of being assaulted, or of serious illness or injury are among the many potentially traumatizing topics of interview.  One risk-minimizing strategy is to interview individuals who already talk publicly or frequently about a past trauma or a stigmatized identity. 

Students with limited experience and training in sensitive interviewing are strongly discouraged from trying to interview research participants about painful topics.  Interviewers who do conduct emotionally sensitive interviews should plan to provide subjects with a list of local counseling resources. Faculty advisors and student investigators should be aware that interviewing participants regarding emotional or psychological trauma, especially when the interviewer is inexperienced and not sufficiently trained, presents greater than minimal risk to the participants. Reminder: if an intended project might be greater than minimal risk, the student or faculty advisor must seek the advice of the Research Integrity office .

• Potential for other types of greater than minimal risks arise if individuals are asked to do anything that they would not normally do in the course of daily life which could jeopardize (i) their physical safety, (ii) their physical health, (iii) their emotional well-being, (iv) their academic standing, (v) their legal standing, (vi) their financial or employment security, or (vii) their reputation in any context. For example, asking individuals for interviews when engaging in such an interview might put them at risk of retribution for “snitching” (e.g., individuals engaged in criminal activity). Other examples include asking participants to engage in unaccustomed physical activity in which they could experience strain or injury; asking them to substantially change their diet over more than a very brief period; asking them to interact socially in unusual ways, to spy on others, or to deceive others; and so forth. Reminder: if an intended project might be greater than minimal risk, the student or faculty advisor must seek the advice of the Research Integrity office .

• Deception : Avoid deceiving research participants unless clearly necessary and no greater than minimal risk; debrief as soon as possible afterwards .  Research that involves actively deceiving participants about research activities presents ethical problems.  A student whose proposed project includes active deception should work with his/her faculty advisor to ensure that the overall level of risk to participants is minimal and that other IRB requirements for use of deception, e.g., an appropriate debriefing process, are included.

2. Protecting individuals who are members of a vulnerable group

“Vulnerable populations” in IRB parlance are categories of individuals whose capacity to give voluntary informed consent is likely to be impaired in some way.  They may not be capable of fully assessing the risks of research participation.  They may feel compelled to participate in research because of their relationship to the researcher or because their freedom is curtailed.  Fully informed consent may not be possible for them because the consequences of their research participation are unpredictable.

Prisoners are vulnerable to coercion and to penalties imposed by the prison system.  Medical research on pregnant women can have unknown consequences for the woman or the fetus.  Accordingly, federal regulations require heightened scrutiny of research involving prisoners and pregnant women.  Research to be conducted with prisoners or with pregnant women as a target group must be submitted for IRB review .  Federally-mandated requirements for such scrutiny will introduce substantial delays in the review process, and could put ultimate approval in jeopardy.  Research on prisoners will also require the approval of prison or jail authorities.  Parolees are an intermediate category almost as vulnerable as prisoners, as they can be re-incarcerated for many activities that are not illegal for non-parolees.  Students are advised to consider a research topic that does not call for interviewing (as a target population) prisoners, parolees, or pregnant women .

Children are vulnerable because their cognitive and decision-making capacities are still developing.  Federal regulations require in almost all cases parental consent (permission) for children to participate in research activities. In many cases, assent from the child will also be required.  Anyone planning research activities with children must be aware of regulations regarding permissible research with children, including obtaining informed parental permission as well as child assent for the research .  In addition, the IRB strongly recommends that undergraduates who plan to interview or interact with children do not include activities or interview questions that could be controversial.  At all times, the interaction must be conducted in a manner that protects the child .

Other vulnerable populations :  Cognitively impaired individuals might not have the intellectual capacity to consent to research participation.  Other groups are vulnerable because any harm that might arise from research would be particularly consequential for them.  For example, undocumented residents whose status was revealed outside the research could be deported, a grave risk.  Residents in homeless shelters, nursing homes and half way houses have limited autonomy with respect to housing and are vulnerable to the authority of house managers.  They, as well as people who have experienced major injury, illness or disability that interferes with the quality of their lives , might be traumatized by unskillful interviewing.

The IRB strongly recommends that an undergraduate student who wishes to study a vulnerable population turn to group spokespeople, group representatives, expert informants, and professionals working with the population if they wish to learn sensitive information about the population .  Members of vulnerable groups – excepting those who are identified as spokespeople – should not be asked sensitive questions, by which we mean questions that could re-traumatize them or that, if responses were revealed outside the research, could put respondents at risk.

3. Ensuring that research subjects’ participation is informed and voluntary

Even when research activities do not require IRB review, they should include an informed consent process that: (a) identifies the researcher; (b) describes what is being requested of the person (i.e., what participation  in the project will require); (c) clarifies that he/she does not have to participate; (d) explains any risks or discomforts of the research; (e) explains any potential benefits to the participant, the community, and/or scientific knowledge; and (f) provides contact information for the researcher(s) and for the Lehigh IRB. (The latter contact information should be omitted if the project has not been reviewed by the IRB.)   The IRB website has several examples of consent documents.

The standard process of informed consent includes a written (signed) document.  However, an oral (unsigned) consent process is acceptable for a minimal-risk project not submitted for IRB review, and may be acceptable for an IRB-reviewed project as well, as long as justification for not seeking signed consent is included in the application.  When oral consent is used, it is good practice for the researcher to give participants a document for their future reference stating what they were told (i.e., including all the consent elements above).

What types of research activities require IRB approval ?

Lehigh’s IRB is required to review all projects that are considered human subjects research under the federal regulatory definition of research: “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” (45 CFR 46.102(d)). 

A “ systematic investigation ” is a study or examination that involves a methodical procedure and plan, is theoretically grounded, specifies a focused and well-defined research problem or question, is informed by the empirical findings of others, is analytically robust, and provides a detailed and complete description of data collection methods. 

“ Generalizable knowledge ” is conclusions, facts, or principles derived from particulars (e.g., individual subjects, medical records) that are applicable to or affect a whole category (members of a class, kind, or group, a field of knowledge, etc.) and enhance scientific or academic understanding. (Note that publication or other dissemination of findings does not in and of itself make the activity human subjects research.) 

The experience of the IRB has been that many student-initiated or class-related research activities do not meet the federal regulatory criteria for IRB jurisdiction. However, the IRB will review any student-initiated or class-related human subjects project if the student or faculty advisor believes, and justifies briefly in the writing to the Research Integrity office, that the research falls under the regulatory jurisdiction of the IRB.

Students planning a project with human participants are encouraged to start by referring to the IRB website for information on What Types of Activities Require IRB Review , and to consult with their faculty advisor or the Research Integrity office to determine if they need IRB approval .  

1. Some research activities may require IRB review, others may not.  Regardless of whether or not the project requires such review, the rights and welfare of the human participants involved in the project must be protected.

2. The IRB strongly recommends that students design minimal-risk research activities.  Most IRB-approved research at Lehigh is minimal risk research, and student-initiated research should, in general, be minimal risk as well.  The standard of minimal risk for research is that it does not expose participants to risks greater than those they are likely to encounter in their daily lives.

3. Special attention should be paid to the potential for risks in research involving certain activities, e.g., disclosure of identifiable sensitive information, interviewing on topics of emotional or psychological trauma, and deception.

4. Students who wish to gather information about a vulnerable population should consider interviewing spokespeople and expert informants instead of members of the vulnerable group.

5. Federal law requires that research projects that involve prisoners or pregnant women must receive heightened review scrutiny.  Federal regulations also require (with a few exceptions) parental consent (permission) for children to participate in research activities.

6. Research should include a process for informed consent, which can be oral (supplemented by a document) rather than signed.  The process should include all the elements of informed consent.

7. Student-initiated or class-related research activities engaged in as part of an educational process usually do not require IRB review, unless the project appears to the student or faculty advisor to fit the regulatory definition of “human subjects research”: “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (45 CFR 46.102(d)).

In all cases, students undertaking research activities are encouraged to first consult with their faculty advisors, using this document, along with Research Design Guidance  and other resources on the IRB website , to develop meaningful and ethical research projects.

This guidance was adapted, with permission, from U.C. Berkley Human Research Protections Program’s “Ethical Issues in Undergraduate Research Activities with Human Participants” guidance .

EU AI Act: first regulation on artificial intelligence

The use of artificial intelligence in the EU will be regulated by the AI Act, the world’s first comprehensive AI law. Find out how it will protect you.

A man faces a computer generated figure with programming language in the background

As part of its digital strategy , the EU wants to regulate artificial intelligence (AI) to ensure better conditions for the development and use of this innovative technology. AI can create many benefits , such as better healthcare; safer and cleaner transport; more efficient manufacturing; and cheaper and more sustainable energy.

In April 2021, the European Commission proposed the first EU regulatory framework for AI. It says that AI systems that can be used in different applications are analysed and classified according to the risk they pose to users. The different risk levels will mean more or less regulation. Once approved, these will be the world’s first rules on AI.

Learn more about what artificial intelligence is and how it is used

What Parliament wants in AI legislation

Parliament’s priority is to make sure that AI systems used in the EU are safe, transparent, traceable, non-discriminatory and environmentally friendly. AI systems should be overseen by people, rather than by automation, to prevent harmful outcomes.

Parliament also wants to establish a technology-neutral, uniform definition for AI that could be applied to future AI systems.

Learn more about Parliament’s work on AI and its vision for AI’s future

AI Act: different rules for different risk levels

The new rules establish obligations for providers and users depending on the level of risk from artificial intelligence. While many AI systems pose minimal risk, they need to be assessed.

Unacceptable risk

Unacceptable risk AI systems are systems considered a threat to people and will be banned. They include:

  • Cognitive behavioural manipulation of people or specific vulnerable groups: for example voice-activated toys that encourage dangerous behaviour in children
  • Social scoring: classifying people based on behaviour, socio-economic status or personal characteristics
  • Biometric identification and categorisation of people
  • Real-time and remote biometric identification systems, such as facial recognition

Some exceptions may be allowed for law enforcement purposes. “Real-time” remote biometric identification systems will be allowed in a limited number of serious cases, while “post” remote biometric identification systems, where identification occurs after a significant delay, will be allowed to prosecute serious crimes and only after court approval.

AI systems that negatively affect safety or fundamental rights will be considered high risk and will be divided into two categories:

1) AI systems that are used in products falling under the EU’s product safety legislation . This includes toys, aviation, cars, medical devices and lifts.

2) AI systems falling into specific areas that will have to be registered in an EU database:

  • Management and operation of critical infrastructure
  • Education and vocational training
  • Employment, worker management and access to self-employment
  • Access to and enjoyment of essential private services and public services and benefits
  • Law enforcement
  • Migration, asylum and border control management
  • Assistance in legal interpretation and application of the law.

All high-risk AI systems will be assessed before being put on the market and also throughout their lifecycle.

General purpose and generative AI

Generative AI, like ChatGPT, would have to comply with transparency requirements:

  • Disclosing that the content was generated by AI
  • Designing the model to prevent it from generating illegal content
  • Publishing summaries of copyrighted data used for training

High-impact general-purpose AI models that might pose systemic risk, such as the more advanced AI model GPT-4, would have to undergo thorough evaluations and any serious incidents would have to be reported to the European Commission.

Limited risk

Limited risk AI systems should comply with minimal transparency requirements that would allow users to make informed decisions. After interacting with the applications, the user can then decide whether they want to continue using it. Users should be made aware when they are interacting with AI. This includes AI systems that generate or manipulate image, audio or video content, for example deepfakes.

On December 9 2023, Parliament reached a provisional agreement with the Council on the AI act . The agreed text will now have to be formally adopted by both Parliament and Council to become EU law. Before all MEPs have their say on the agreement, Parliament’s internal market and civil liberties committees will vote on it.

More on the EU’s digital measures

  • Cryptocurrency dangers and the benefits of EU legislation
  • Fighting cybercrime: new EU cybersecurity laws explained
  • Boosting data sharing in the EU: what are the benefits?
  • EU Digital Markets Act and Digital Services Act
  • Five ways the European Parliament wants to protect online gamers
  • Artificial Intelligence Act

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