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• Ethical Considerations in Research | Types & Examples

Ethical Considerations in Research | Types & Examples

Published on October 18, 2021 by Pritha Bhandari . Revised on May 9, 2024.

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.

Prevent plagiarism. Run a free check.

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 .

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?

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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• Knowledge Base
• Methodology
• Ethical Considerations in Research | Types & Examples

Ethical Considerations in Research | Types & Examples

Published on 7 May 2022 by Pritha Bhandari . Revised on 6 July 2024.

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 behaviours, 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 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, 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 aims 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.

Prevent plagiarism, run a free check.

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.

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.

• 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 anonymise 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 pseudonymisation 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, counselling, 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 scientific 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.

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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Dissertations 4: methodology: ethics.

• Introduction & Philosophy
• Methodology

Research Ethics

In the research context, ethics can be defined as "the standards of behaviour that guide your conduct in relation to the rights of those who become the subject of your work, or are affected by it" (Saunders, Lewis and Thornhill 2015, p239).  

The University itself is guided by the fundamental principle that research involving humans and /or animals and/or the environment should involve no more than minimal risk of harm to physical and psychological wellbeing.  

Thus, ethics relates to many aspects of your research, including the conduct towards: 

The participants  of your primary research (experiments, interviews etc). You will need to explain that participation is voluntary, and they have the right to withdraw at any time. You will need the participants' informed consent. You will need to avoid harming the participants, physically as well as mentally. You will need to respect the participants’ privacy and offer the right to anonymity. You will need to manage their personal data confidentially, also according to legislation such as the Data Protection Act 2018. You will need to be truthful and accurate when using the information provided by the participants.  

The authors you have used as secondary sources. You will need to acknowledge their work and avoid plagiarism by doing the proper citing and referencing. 

The readers of your research. You will need to exercise the utmost integrity, honesty, accuracy and objectivity in the writing of your work.   

The researcher . You will need to ensure that the research will be safe for you to undertake. 

Your research may entail some risk, but risk has to be analysed and minimised through risk  assessment. Depending on the type of your research, your research proposal may need to  be approved by an Ethics Committee, which will assess your research proposal in light of the  elements mentioned above. Again, you are advised to use a research methods book for further guidance.  

Research Ethics Online Course

Introduction to Research Ethics: Working with People  

Find out how to conduct ethical research when working with people by studying this online course for university students. Course developed by the University of Leeds. 

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• Volume 36, Issue 7
• Research ethics in dissertations: ethical issues and complexity of reasoning
• Article Text
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• S Kjellström 1 ,
• S N Ross 2 , 3 ,
• B Fridlund 4
• 1 Institute of Gerontology, School of Health Sciences, Jönköping University, Jönköping, Sweden
• 2 Antioch University Midwest, Yellow Springs, Ohio, USA
• 3 ARINA, Inc., Cincinnati, Ohio, USA
• 4 Department of Nursing, School of Health Sciences, Jönköping University, Jönköping, Sweden
• Correspondence to Sofia Kjellström, Institute of Gerontology, School of Health Sciences, Jönköping University, PO Box 1026, SE-551 11 Jönköping, Sweden; sofia.kjellstrom{at}hhj.hj.se

Background Conducting ethically sound research is a fundamental principle of scientific inquiry. Recent research has indicated that ethical concerns are insufficiently dealt with in dissertations.

Purpose To examine which research ethical topics were addressed and how these were presented in terms of complexity of reasoning in Swedish nurses' dissertations.

Methods Analyses of ethical content and complexity of ethical reasoning were performed on 64 Swedish nurses' PhD dissertations dated 2007.

Results A total of seven ethical topics were identified: ethical approval (94% of the dissertations), information and informed consent (86%), confidentiality (67%), ethical aspects of methods (61%), use of ethical principles and regulations (39%), rationale for the study (20%) and fair participant selection (14%). Four of those of topics were most frequently addressed: the majority of dissertations (72%) included 3–5 issues. While many ethical concerns, by their nature, involve systematic concepts or metasystematic principles, ethical reasoning scored predominantly at lesser levels of complexity: abstract (6% of the dissertations), formal (84%) and systematic (10%).

Conclusions Research ethics are inadequately covered in most dissertations by nurses in Sweden. Important ethical concerns are missing, and the complexity of reasoning on ethical principles, motives and implications is insufficient. This is partly due to traditions and norms that discount ethical concerns but is probably also a reflection of the ability of PhD students and supervisors to handle complexity in general. It is suggested that the importance of ethical considerations should be emphasised in graduate and post-graduate studies and that individuals with capacity to deal with systematic and metasystematic concepts are recruited to senior research positions.

• Research ethics
• human development
• dissertation
• graduate education
• applied and professional ethics
• scientific research

https://doi.org/10.1136/jme.2009.034561

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Competing interests None.

Provenance and peer review Not commissioned; externally peer reviewed.

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What is it?

Research ethics are a set of principles that govern how you conduct your research, to make sure that moral guidelines are followed.  Readers usually expect to see ethics in a research proposal, or mentioned in your writing, even if there doesn't appear to be any problematic ethical issues to be addressed. 

Why do I need to do it?

When someone embarks on a piece of research there is a chance of doing harm, even if harm isn't intended. Setting ethical guidelines ensures there are set standards for conducting research to ensure the research will not harm people physically or emotionally. 

How do I do it?

If you are studying on a taught programme (undergraduate or taught postgraduate) then your module or programme leader will let you know what steps you need to take to make sure your research meets the necessary ethical standards.

If you are a postgraduate research student then your supervisory team will be able to give you guidance on submitting a research ethics application.

The books below provide useful background information.

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Ethical Issues in Research

• Living reference work entry
• First Online: 05 March 2021
• Cite this living reference work entry

• Juwel Rana 2 , 3 , 4 ,
• Segufta Dilshad 2 &
• Md. Ali Ahsan 5  

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The most important human endeavor is the striving for morality in our actions. Our inner balance and even our very existence depend on it. Only morality in our actions can give beauty and dignity to life – Albert Einstein.

Ethics ; Methodology ; Mixed-method research ; Observation ; Qualitative research ; Quantitative research ; Research ; Research design ; Research ethics

Ethics is a set of standards, a code, or value system, worked out from human reason and experience, by which free human actions are determined as ultimately right or wrong, good, or evil. If acting agrees with these standards, it is ethical, otherwise unethical.

Scientific research refers to a persistent exercise towards producing new knowledge to unveil a new stream of ideas in academia for humankind.

Research ethics refer to some of the genres that researchers follow to protect the rights in developing research strategies and building a trusted relationship between the...

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Bulmer M (1982) Social Research Ethics: An Examination of the Merits of Covert Participant Observation. Holmes & Meier Publishers

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Butler I (2002) A Code of Ethics for Social Work and Social Care Research. Br J Soc Work [Internet]. 32(2):239–48. Available from: https://doi.org/10.1093/bjsw/32.2.239

Fisher CB, Anushko AE (2008) The SAGE Handbook of Social Research Methods [Internet]. London: SAGE Publications Ltd; p. 95–109. Available from: https://methods.sagepub.com/book/the-sage-handbook-of-socialresearch-methods

Hill J, Wright LT (2001) A qualitative research agenda for small to medium-sized enterprises. Mark Intell Plan 19(6):432–443

Homan R (1991) The ethics of social research. Addison-Wesley Longman Limited

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Principles of research ethics [Internet]. Lund Research Ltd. 2012 [cited 2020 Dec 15]. Available from: https://dissertation.laerd.com/principles-of-research-ethics.php

Robley LR (1995) The ethics of qualitative nursing research. J Prof Nurs 11(1):45–48

Wiles R, Charles V, Crow G, Heath S (2006) Researching researchers: lessons for research ethics. Qual Res. 6(3):283–99

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Department of Public Health, School of Health and Life Sciences, North South University, Dhaka, Bangladesh

Juwel Rana & Segufta Dilshad

Department of Biostatistics and Epidemiology, School of Health and Health Sciences, University of Massachusetts Amherst, Amherst, MA, USA

Department of Research and Innovation, South Asia Institute for Social Transformation (SAIST), Dhaka, Bangladesh

Space and Environment Research Center (SERC), Rajshahi, Bangladesh

Md. Ali Ahsan

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Correspondence to Juwel Rana .

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Florida Atlantic University, Boca Raton, FL, USA

Ali Farazmand

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Rana, J., Dilshad, S., Ahsan, M.A. (2021). Ethical Issues in Research. In: Farazmand, A. (eds) Global Encyclopedia of Public Administration, Public Policy, and Governance. Springer, Cham. https://doi.org/10.1007/978-3-319-31816-5_462-1

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DOI : https://doi.org/10.1007/978-3-319-31816-5_462-1

Received : 01 February 2021

Accepted : 14 February 2021

Published : 05 March 2021

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4 Chapter 4 Ethics and Research Methodology

• Published: December 2009
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This chapter describes ethical issues in social research including discussion of the NASW Code of Ethics, Institutional Review Board (IRB) processes, and requirements for the protection of human subjects. In addition, quantitative research methods; qualitative research methods; mixed-methods research designs; experimental, quasi-experimental, explanatory, exploratory, and descriptive research; program evaluation; and the relative merits of disparate models of research are also presented. The requirements of rigor in both quantitative and qualitative studies and evaluating the degree of fit between research strategies and problems under investigation are also discussed.

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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

[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.

Ethical considerations in research: Best practices and examples

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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What Are the Ethical Considerations in Research Design?

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:

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:

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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• Indian J Anaesth
• v.60(9); 2016 Sep

Legal and ethical issues in research

Camille yip.

1 Department of Women's Anaesthesia, KK Women's and Children's Hospital, Bukit Timah, Singapore

Nian-Lin Reena Han

2 Division of Clinical Support Services, KK Women's and Children's Hospital, Bukit Timah, Singapore

Ban Leong Sng

3 Anesthesiology and Perioperative Sciences Academic Clinical Program, Duke-NUS Medical School, Singapore

Legal and ethical issues form an important component of modern research, related to the subject and researcher. This article seeks to briefly review the various international guidelines and regulations that exist on issues related to informed consent, confidentiality, providing incentives and various forms of research misconduct. Relevant original publications (The Declaration of Helsinki, Belmont Report, Council for International Organisations of Medical Sciences/World Health Organisation International Guidelines for Biomedical Research Involving Human Subjects, World Association of Medical Editors Recommendations on Publication Ethics Policies, International Committee of Medical Journal Editors, CoSE White Paper, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use-Good Clinical Practice) form the literature that are relevant to the ethical and legal aspects of conducting research that researchers should abide by when conducting translational and clinical research. Researchers should note the major international guidelines and regional differences in legislation. Hence, specific ethical advice should be sought at local Ethics Review Committees.

INTRODUCTION

The ethical and legal issues relating to the conduct of clinical research involving human participants had raised the concerns of policy makers, lawyers, scientists and clinicians for many years. The Declaration of Helsinki established ethical principles applied to clinical research involving human participants. The purpose of a clinical research is to systematically collect and analyse data from which conclusions are drawn, that may be generalisable, so as to improve the clinical practice and benefit patients in future. Therefore, it is important to be familiar with Good Clinical Practice (GCP), an international quality standard that is provided by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH),[ 1 ] or the local version, GCP of the Central Drugs Standard Control Organization (India's equivalent of US Food and Drug Administration)[ 2 ] and local regulatory policy to ensure that the research is conducted both ethically and legally. In this article, we will briefly review the legal and ethical issues pertaining to recruitment of human subjects, basic principles of informed consent and precautions to be taken during data and clinical research publications. Some of the core principles of GCP in research include defining responsibilities of sponsors, investigators, consent process monitoring and auditing procedures and protection of human subjects.[ 3 ]

ISSUES RELATED TO THE RESEARCH PARTICIPANTS

The main role of human participants in research is to serve as sources of data. Researchers have a duty to ‘protect the life, health, dignity, integrity, right to self-determination, privacy and confidentiality of personal information of research subjects’.[ 4 ] The Belmont Report also provides an analytical framework for evaluating research using three ethical principles:[ 5 ]

• Respect for persons – the requirement to acknowledge autonomy and protect those with diminished autonomy
• Beneficence – first do no harm, maximise possible benefits and minimise possible harms
• Justice – on individual and societal level.

Mistreatment of research subjects is considered research misconduct (no ethical review approval, failure to follow approved protocol, absent or inadequate informed consent, exposure of subjects to physical or psychological harm, exposure of subjects to harm due to unacceptable research practices or failure to maintain confidentiality).[ 6 ] There is also scientific misconduct involving fraud and deception.

Consent, possibility of causing harm

Based on ICH definition, ‘informed consent is a process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate’. As for a standard (therapeutic) intervention that carries certain risks, informed consent – that is voluntary, given freely and adequately informed – must be sought from participants. However, due to the research-centred, rather than patient-centred primary purpose, additional relevant information must be provided in clinical trials or research studies in informed consent form. The essential components of informed consent are listed in Table 1 [Adapted from ICH Harmonised Tripartite Guideline, Guideline for Good Clinical Practice E6(R1)].[ 1 ] This information should be delivered in the language and method that individual potential subjects can understand,[ 4 ] commonly in the form of a printed Participant Information Sheet. Informed consent is documented by means of written, signed and dated informed consent form.[ 1 ] The potential subjects must be informed of the right to refuse to participate or withdraw consent to participate at any time without reprisal and without affecting the patient–physician relationship. There are also general principles regarding risk assessment, scientific requirements, research protocols and registration, function of ethics committees, use of placebo, post-trial provisions and research publication.[ 4 ]

Essential components of an informed consent

Special populations

Informed consent may be sought from a legally authorised representative if a potential research subject is incapable of giving informed consent[ 4 ] (children, intellectual impairment). The involvement of such populations must fulfil the requirement that they stand to benefit from the research outcome.[ 4 ] The ‘legally authorised representative’ may be a spouse, close relative, parent, power of attorney or legally appointed guardian. The hierarchy of priority of the representative may be different between different countries and different regions within the same country; hence, local guidelines should be consulted.

Special case: Emergency research

Emergency research studies occur where potential subjects are incapacitated and unable to give informed consent (acute head trauma, cardiac arrest). The Council for International Organisations of Medical Sciences/World Health Organisation guidelines and Declaration of Helsinki make exceptions to the requirement for informed consent in these situations.[ 4 , 7 ] There are minor variations in laws governing the extent to which the exceptions apply.[ 8 ]

Reasonable efforts should have been made to find a legal authority to consent. If there is not enough time, an ‘exception to informed consent’ may allow the subject to be enrolled with prior approval of an ethical committee.[ 7 ] Researchers must obtain deferred informed consent as soon as possible from the subject (when regains capacity), or their legally authorised representative, for continued participation.[ 4 , 7 ]

Collecting patient information and sensitive personal information, confidentiality maintenance

The Health Insurance Portability and Accountability Act has requirements for informed consent disclosure and standards for electronic exchange, privacy and information security. In the UK, generic legislation is found in the Data Protection Act.[ 9 ]

The International Committee of Medical Journal Editors (ICMJE) recommendations suggest that authors must ensure that non-essential identifying information (names, initials, hospital record numbers) are omitted during data collection and storage wherever possible. Where identifying information is essential for scientific purposes (clinical photographs), written informed consent must be obtained and the patient must be shown the manuscript before publication. Subjects should also be informed if any potential identifiable material might be available through media access.

Providing incentives

Cash or other benefits ‘in-kind’ (financial, medical, educational, community benefits) should be made known to subjects when obtaining informed consent without emphasising too much on it.[ 7 ] Benefits may serve as appreciation or compensation for time and effort but should not result in the inducement to participation.[ 10 ] The amount and nature of remuneration should be compared to norms, cultural traditions and are subjected to the Ethical Committee Review.[ 7 ]

ISSUES RELATED TO THE RESEARCHER

Legal issues pertaining to regulatory bodies.

Various regulatory bodies have been constituted to uphold the safety of subjects involved in research. It is imperative to obtain approval from the appropriate regulatory authorities before proceeding to any research. The constitution and the types of these bodies vary nation-wise. The researchers are expected to be aware of these authorities and the list of various bodies pertinent to India are listed in the article “Research methodology II” of this issue.

Avoiding bias, inappropriate research methodology, incorrect reporting and inappropriate use of information

Good, well-designed studies advance medical science development. Poorly conducted studies violate the principle of justice, as there are time and resources wastage for research sponsors, researchers and subjects, and undermine the societal trust on scientific enquiry.[ 11 ] The Guidelines for GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials.[ 1 ]

Fraud in research and publication

De novo data invention (fabrication) and manipulation of data (falsification)[ 6 ] constitute serious scientific misconduct. The true prevalence of scientific fraud is difficult to measure (2%–14%).[ 12 ]

Plagiarism and its checking

Plagiarism is the use of others' published and unpublished ideas or intellectual property without attribution or permission and presenting them as new and original rather than derived from an existing source.[ 13 ] Tools such as similarity check[ 14 ] are available to aid researchers detect similarities between manuscripts, and such checks should be done before submission.[ 15 ]

Overlapping publications

Duplicate publications violate international copyright laws and waste valuable resources.[ 16 , 17 ] Such publications can distort evidence-based medicine by double-counting of data when inadvertently included in meta-analyses.[ 16 ] This practice could artificially enlarge one's scientific work, distorting apparent productivity and may give an undue advantage when competing for research funding or career advancement.[ 17 ] Examples of these practices include:

Duplicate publication, redundant publication

Publication of a paper that overlaps substantially with one already published, without reference to the previous publication.[ 11 ]

Salami publication

Slicing of data from a single research process into different pieces creating individual manuscripts from each piece to artificially increase the publication volume.[ 16 ]

Such misconduct may lead to retraction of articles. Transparent disclosure is important when submitting papers to journals to declare if the manuscript or related material has been published or submitted elsewhere, so that the editor can decide how to handle the submission or to seek further clarification. Further information on acceptable secondary publication can be found in the ICMJE ‘Recommendations for the Conduct, Reporting, Editing, and Publishing of Scholarly Work in Medical Journals’.

Usually, sponsors and authors are required to sign over certain publication rights to the journal through copyright transfer or a licensing agreement; thereafter, authors should obtain written permission from the journal/publisher if they wish to reuse the published material elsewhere.[ 6 ]

Authorship and its various associations

The ICMJE recommendation lists four criteria of authorship:

• Substantial contributions to the conception of design of the work, or the acquisition, analysis or interpretation of data for the work
• Drafting the work or revising it critically for important intellectual content
• Final approval of the version to be published
• Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Authors and researchers have an ethical obligation to ensure the accuracy, publication and dissemination of the result of research,[ 4 ] as well as disclosing to publishers relevant corrections, retractions and errata, to protect scientific integrity of published evidence. Every research study involving human subjects must be registered in a publicly accessible database (e.g., ANZCTR [Australia and NZ], ClinicalTrials.gov [US and non-US], CTRI [India]) and the results made publicly available.[ 4 ] Sponsors of clinical trials must allow all study investigators and manuscript authors access to the full study data set and the right to use all study data for publication.[ 5 ] Source documents (containing trial data) and clinical study report (results and interpretation of trial) form part of the essential documentation that must be retained for a length of time prescribed by the applicable local legislation.[ 1 ] The ICMJE is currently proposing a requirement of authors to share with others de-identified individual patient data underlying the results presented in articles published in member journals.[ 18 ]

Those who have contributed to the work but do not meet all four criteria should be acknowledged; some of these activities include provision of administrative support, writing assistance and proofreading. They should have their written permission sought for their names to be published and disclose any potential conflicts of interest.[ 6 ] The Council of Scientific Editors has identified several inappropriate types of authorship, such as guest authorship, honorary or gift authorship and ghost authorship.[ 6 ] Various interventions should be put in place to prevent such fraudulent practices in research.[ 19 ] The list of essential documents for the conduct of a clinical trial is included in other articles of the same issue.

The recent increase in research activities has led to concerns regarding ethical and legal issues. Various guidelines have been formulated by organisations and authorities, which serve as a guide to promote integrity, compliance and ethical standards in the conduct of research. Fraud in research undermines the quality of establishing evidence-based medicine, and interventions should be put in place to prevent such practices. A general overview of ethical and legal principles will enable research to be conducted in accordance with the best practices.

Financial support and sponsorship

Conflicts of interest.

There are no conflicts of interest.

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• Research Ethics
• Data Analysis

Research ethics

When completing an undergraduate or master's level dissertation, there are a number of ethical requirements that must be taken into account. Some of these are formal requirements, such as the submission of an Ethics Proposal and/or the use of an Ethics Consent Form . However, at the undergraduate and master?s level, it is more likely that these ethical requirements simply have to be built into the way that you design and conduct your dissertation research. It is also important to understand what these ethical requirements are in order to write the Research Ethics section of your Research Strategy chapter (usually Chapter Three: Research Strategy ), as well as ensure that issues of research ethics are properly taken into account and do not slow you down.

When considering the research ethics in your dissertation, you need to think about: (a) the five basic ethical principles you need to take into account; and (b) how research ethics are influenced by your chosen research strategy . In addition, we set out some of the components that you will need to consider when writing an Ethics Consent Form .

• Principles of research ethics
• Research strategy and research ethics
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Dissertation Ethics in a Nutshell

Writing a dissertation for dummies.

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Social science studies (including your dissertation), are about individuals, communities and societies. Even though you’re not carrying out a case study, questionnaire or interview when doing your research for your dissertation, you’re bound to be looking at an issue that involves people – and before starting off you need to sort out any ethical matters connected with your research.

You have to make sure that the interests and rights of anyone affected by your work are safeguarded and you must ensure that you keep to the following:

Obeying the legislation on human rights and data protection

Maintaining good quality research (data collection, storage analysis, dissemination of information)

Gaining the informed consent of your subjects

Thinking through the consequences of your work

Most undergraduate dissertations are fairly straightforward because the sample group you’re researching is usually fairly small and the context is known to the supervisor and the student. This scenario (of knowing your subjects and there being minimal risk and concern) is recommended because it makes the whole process manageable and more feasible in the timescale that you’re given for your dissertation.

If your research causes you to fall into any of the following categories, you need to ask your supervisor for advice on what you should do:

Your study involves vulnerable participants and/or those unable to give informed consent (such as children or people with learning difficulties or disabilities).

Some of your subjects may be feeling under pressure to take part (friends, colleagues, family members).

Your research means discussing issues that may upset people or cause stress, such as health matters, personal experiences or something the person knows to be illegal such as drug use.

Your study involves communicating with a ‘gatekeeper’ in order for you to have access to the subjects (for example, you need to obtain the agreement of the teacher and the parents to access the children in her class).

Your participants may be taking part without their knowledge (for example, carrying out observation of children in a playground).

You may be at risk when carrying out observations or interviews.

Dissertation ethics: Check your compliance with university regulations

Universities have specific regulations about getting ethical clearance for any part of a study that may breach ethical guidelines. You’re going to have to comply with particular permissions if you’re carrying out observations or interviews.

Your university may ask you to complete a form to get ethical clearance for your research. This is the norm for higher level studies and research projects but less common for undergraduate dissertations. If you do need to fill in a form addressing ethical concerns, the questions you’re likely to be asked are:

Aim of study.

Background (naming some of the literature and other studies in a similar area).

Research methodologies and methods.

Potential problems for subjects (such as discussing sensitive issues).

Potential problems for the researcher (such as travel following interviews carried out in the evening).

Methods of recruiting subjects (including declaration of inducements – that is, whether or not you paid them).

Evidence of having informed consent.

Data protection (including the security of your data storage and anonymity of subjects).

Look through the list and have an answer in mind for each question in case ethical concerns and obligations come up during supervision.

Dissertation ethics: Know what’s appropriate

A group of first year undergraduate students were interested in looking at teenagers’ views about how sexual content is used to boost sales of magazines. The students put together an interview schedule for a focus group but didn’t run the questions by a tutor first. Using university headed notepaper so that the questions looked official the students presented the group of 13- and 14-year-olds with the questions.

The first question asked: ‘Have you had sex?’ and the questions moved onto others including ‘Do you think that all your friends are sexually active?’ and ‘How does it feel to be the only one in your group of friends who’s still a virgin?’ Clearly these questions wouldn’t have been approved by the tutor, but the students were genuinely surprised when the university staff expressed their shock.

Dissertation ethics: Gain informed consent

You must have the consent of people taking part in your research. In most cases you’re required to have written consent and your course tutor or department may well have a standard form for you to use. Consent forms are designed to comply with Government requirements, which exist to protect vulnerable people from any poor research practices. One example of this is the Criminal Records Bureau (CRB) check that you’re going to need if your research involves children.

Your responsibility to your subjects doesn’t end once you’ve collected the data. It’s up to you to be frank and honest when interpreting your subjects’ words and actions. You’re not allowed to twist words or alter what people have said or done.

Dissertation ethics: Respect other people’s ideas and views

When you’re doing interviews and carrying out questionnaires it’s important to keep your thoughts to yourself. Hiding your feelings can be hard, but if you disagree violently with someone you can end up stopping the person from expressing his views for fear of ‘getting something wrong’.

Don’t be a robot though – you can express mild surprise if someone says something really strange (you may find some subjects are after a reaction so you sometimes need to oblige), but try not to let other people’s views faze you. After all, you’re asking for the person’s opinion, so you need to let him express his opinion without feeling stupid.

Strike the right balance between modesty and arrogance. Don’t be so self-deprecating that people think that your research is a waste of time: ‘Oh, it’s just a little project, it’s not that interesting, it’s not a big deal’. Also avoid sounding self-important as this is equally off-putting: ‘Yes, I’m dealing with some really vital issues here – I want to expose the problems and find a solution to these continual low standards.’

Dissertation ethics: Keep your subjects’ anonymity

When you’re writing about the people in your research project you need to disguise the person’s real identity, making sure that the person can’t be identified and traced. Some of your subjects may say that you don’t need to hide their identity, but although that can seem like a good idea at the time, you don't yet know where you research is going to take you and you may later regret choosing that option.

A parent, (not just the institution where the child is living, studying, or staying), must agree on behalf of a child.

Speak to your dissertation tutor about the legal aspects of your work. Generally a ‘child’ is 16 years old or under, but if someone is 17 and still studying in school, for example, you need to follow different guidelines than if you were asking your college peers who are over 18, or a 17-year-old with a full-time job.

The onus is on you to check the legality of what want to pursue. Consult your tutor if in doubt.

Changing the names of your research subjects when you’re writing about them is a good idea, but you need to do this with care and make it clear that you’ve changed the person’s names to preserve their privacy by simply saying: ‘In this dissertation, the names of subjects have been changed to preserve their anonymity’.

Give some thought to what the alternative names are going to be. Changing ‘Kelly’ to ‘Kerry’ or ‘Ian’ to ‘Iain’ isn’t going to do a good job of hiding anything much, and also be sure that you don’t change genders by mistake.

Although it can be a good idea to find a name that reflects the cultural background of your research subjects, if this is relevant to the study – take care here that you don’t slip into stereotype.

Researchers often refer to their subjects as ‘Child X’ or ‘Mrs Y’ and this does the job perfectly well. Some readers are not keen on dissertations that use this method because it seems very impersonal and makes for a jerky read.

Plus, if the examiner is marking a large number of dissertations that use the same convention, like other examiners, she may tend to forget which ‘Child A’ is which because there’s no personality linked to a person labelled by an initial letter of the alphabet (except for ‘Mr T’ of course).

Your rule of thumb is to use recognisable names that aren’t too outlandish and that are distinct from one another (don’t call your three subjects ‘Emily’, ‘Emma’ and ‘Emmie’ for example). Remember to be consistent throughout your dissertation.

Keep the real and ‘code’ names of your subjects in your dissertation notebook so that you don’t get confused.

Also remember to hide the names of schools, hospitals, specific departments or organisations you’ve been allowed to review where there are any potentially sensitive issues. Don't try to anonymise organisations such as governments or government departments, even if you’re being critical.

In your appendices and additional material you have to make sure that you anonymise any letter headings, delete logos from policy documents and change names or delete them from personal reports. It’s a fairly common error in dissertations to find that students give away their subjects’ identities in the additional material – probably because students leave dealing with the appendices and additional material until the last moment.

When you’ve finished writing up your dissertation, do a Word ‘Find’ search through the text, looking for the real names of your subjects in case you’ve slipped up somewhere.

Dissertation ethics: Acknowledge the people who help you

Your acknowledgements are more about courtesy than being a fixed requirement in your dissertation, but it’s good manners to acknowledge people who’ve helped you by being subjects in your research, or by making it easy for you find your subjects.

For example, if you’ve interviewed budget holders about how they forecast their annual spend and your gatekeeper contact at the department was a research officer or someone in human resources, be sure to thank your contact as well as the subjects you interviewed.

You can make your acknowledgements without revealing the person’s identity. Use the person’s job title and if they evenutally see a copy of your dissertation they’re going to know who they are and recognise and appreciate your gratitude. All you need to say is: ‘With sincere thanks to all those people who helped me by giving up their valuable time and sharing their considered views’.

About This Article

This article is from the book:.

• Writing a Dissertation For Dummies ,

About the book author:

Dr Carrie Winstanley is a Principal Lecturer in Education at Roehampton University, London, where she works with both undergraduate and postgraduate students. Carrie was recently named one of the Top 50 university teachers in the UK by the Higher Education Academy, for which she was awarded a national teaching fellowship.

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Ethical Issues in Treating Substance Use Disorders: Counselor Perspectives

Affiliations.

• 1 Department of Psychiatry and Behavioral Sciences, University of California, San Francisco, CA, USA.
• 2 Mood and Anxiety Disorders Program, University of Illinois at Chicago, Chicago, IL, USA.
• 3 Psychiatry and Human Behaviors, Charles R. Drew University of Medicine and Science, Los Angeles, CA, USA.
• 4 Department of Medicine, Center for AIDS Prevention Studies, University of California, San Francisco, CA, USA.
• PMID: 39215391
• DOI: 10.1080/02791072.2024.2394765

Ethical issues arise frequently in the treatment of substance use disorders (SUD). Counselors need guidance to navigate ethical dilemmas but receive limited training in resolving ethical issues. To narrow the gap between the ethical dilemmas counselors face and their training, this qualitative study assessed ethical issues that counselors encounter, how they resolve them, and desired training. We conducted qualitative individual interviews with 20 front-line counselors working in two SUD treatment programs, presenting brief vignettes that depicted the ethics code of the national organization representing SUD counselors. The interviews asked open-ended questions about how counselors dealt with issues and their ideas for future ethics training. All participants had encountered ethical dilemmas. Areas of concern included confidentiality and privacy, mandatory reporting, fairness/equity, client-counselor boundaries, tensions between workplace and client welfare, and meeting clients' complex needs. Ways participants resolved ethical issues included consultations, using direct approaches to resolve ethical dilemmas, and commitment to providing client-centered care. Useful training in the workplace was sparse. Participants expressed needs for ongoing support to resolve workplace ethical dilemmas. Although the importance of ethical issues is widely acknowledged in treating SUD, this study underscores the need for ongoing and interactive training and supervision about ethical issues.

Keywords: Substance use disorder treatment; counselor training; ethical issues; qualitative research.

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