1. Ethical Issues in Human Subject Research
Developed by Dr. Gina Wong-Wylie for GCAP 691: Methods of Inquiry

2. Introduction
In the world of research and ethics, there is much to be aware of in order to ensure the safe protection and respectful consideration of human participants.
This brief presentation outlines basics to consider in designing ethically sensitive research.
Shaughnessy, Zechmeister, and Zechmeister’s (2006) textbook: Research Methods in Psychology was used as a guide in developing this presentation.

3. Researcher: Professional Competence and Integrity
Carry out the research in a competent manner.
Report results accurately.
Manage research resources honestly.
Fairly acknowledge, in scientific communications, the individuals who have contributed their ideas, time, and effort.
Consider the consequences to society of any research endeavor.
Speak out publicly on societal concerns related to a scientist’s knowledge and expertise.
From Diener and Crandall (1978)

4. Consult… Consult… Consult
Ethical decisions are best made after consultation with others, including peers, those more experienced, and those with expert knowledge.
Failure to conduct ethical research undermines the scientific process, impedes advancement of knowledge, and erodes public respect. It may also have legal and financial implications.

5. Outline of Presentation on Research Ethics
1. Determining Risk
* Minimal Risk Research
2. Recruitment
3. Informed Consent
4. Risks and Benefits
5. Right to Refuse Participation and Withdraw
6. Storage, Retention, and Data Disposition
7. Privacy, Confidentiality, and Anonymity
8. Debriefing

6. 1. Determining Risk
Potential for physical injury, social injury (public embarrassment), and mental or emotional stress
Risk evaluated by participants’ everyday activities, physical and mental health, and capabilities
Must consider specific population or individuals who are likely to participate in study
Connects to protecting confidentiality of participants’ responses
Researcher: protect participants from emotional or mental stress>>

7. Risk in Psychological Research
If the study you are developing has the potential to bring up past issues (e.g., a study of females’ first sexual experience), your research protocol should include a counselling resource sheet to provide to participants. The researcher should also be aware of, or have access to, appropriate referrals (medical, psychological, etc.).
Although there is inherent intersection and overlap in roles of researcher and counsellor, one CANNOT assume both roles in the same context. This is a conflict of interest and a breach of ethics. So, even though you have experience counselling women who have been sexually abused, you cannot begin counselling your research participant. However, you certainly can and should use your working alliance skills to be sensitive to the issue and provide adequate referral.

8. Minimal Risk Research
A study is described as involving minimal risk when the procedures or activities in the study are similar to or no greater than those experienced by participants in everyday life.
To protect from social risks, data should be anonymous or, if that is not possible, the confidentiality of data should be maintained.
No research involving more than minimal risk should be carried out until alternative methods have been explored.

9. 2. Recruitment
Letters of support from authorized representatives of any educational institutions, employers, health facilities, First Nations reserves, and so on, at which researcher proposes to conduct research.
“Support” means permission to access the site, to recruit participants, and to conduct research.
A copy of each recruitment instrument: a script or an informed consent letter should be included in a research ethics proposal.

10. 3. Informed Consent
Informed consent is a person’s explicitly expressed willingness to participate in a research project based on a clear understanding of the nature of the research, of the consequences of not participating, and of all factors that might be expected to influence that person’s willingness to participate.
Informed consent ordinarily requires that the participant (1) has capacity to consent; (2) has been provided with information concerning participation in the activity that reasonably might affect her or his willingness to participate, including limits of confidentiality and monetary or other costs or reimbursements; (3) is aware of the voluntariness of participation and has freely and without undue influence expressed consent; and (4) has had the opportunity to ask questions and receive answers regarding the activities.

11. Informed Consent
Researchers should inform prospective participants about:
the purpose of the research, expected duration, and procedures
their right to decline participation and to withdraw from the research once participation has begun
the foreseeable consequences of declining or withdrawing
reasonably foreseeable factors that may be expected to influence their willingness to participate such as potential risks, discomfort, or adverse effects
any prospective research benefits
limits of confidentiality
incentives for participation
whom to contact with questions about the research and research participants’ rights

12. 4. Risks and Benefits
Research ethics proposals should include a description of any potential adverse effects, including physical, psychological, social, economic, and spiritual risks. Include how adverse effects will be dealt with. Also outline benefits for participants, for the development or knowledge, or for change in practice.
Even if no obvious risks are involved, the phrase “There are no known risks to participation in this research,” included in the ethics proposal, demonstrates to members of a Research Ethics Board that the researcher has thought things through.

13. 5. Right to Refuse Participation and Withdraw
The right to refuse participation and to withdraw at any time during data collection period, without prejudice or judgment, or consequences, must be made explicit in documentation. Participant must also have the right to refuse to answer questions.
If the participant withdraws during the research, all data collected from that individual should be destroyed unless otherwise indicated by the participant.

14. 6. Storage, Retention, and Data Disposition
Details on how and where data in various formats will be stored, who will have access to the data, when it will be destroyed, and how it will be destroyed should be documented in a research ethics proposal.
Generally, retention of data for a minimum of five years is suggested (Athabasca University, Research ethics board).

15. 7. Privacy, Confidentiality, and Anonymity
To protect from social consequences, data collection should keep participants’ responses anonymous by asking participants not to use their names or any identifying information.
When this is not possible, the researcher should keep participants’ responses confidential by removing any identifying information from the data during the research.
Identify the steps that will be taken to respect the privacy of participants and to protect confidential data. Indicate how raw data will be stored. Indicate whether raw data will be disposed of, and if so, describe when and how. Will any agencies or individuals have access to the data, or the report, now or in the future (e.g., employer, service provider)?

16. Privacy, Confidentiality, and Anonymity
Information letters should include the following statement: “All information will be held confidential, except when legislation or professional code of conduct requires that it be reported.”

17. 8. Debriefing
Researchers are ethically obligated to seek ways to benefit participants even after the research is completed. One of the best ways to accomplish this goal is by providing participants with a thorough debriefing.
It is important when planning and conducting research to consider how the experience may affect participants after the research is completed and to seek ways in which the participant can benefit.
Will participants receive a copy of the research report or be made aware of how and where to access the report?

18. Tips:
From a general research ethics perspective, you might also find it useful to visit the online Introduction to the TCPS Tutorial, available at
Your future project supervisor might also find this resource helpful!

19. References
Shaughnessy, J. J., Zechmeister, E. B., & Zechmeidter, J. S. (2006). Research methods in psychology. New York: McGraw-Hill.
Diener, E., & Crandall, R. (1978). Ethics in social and behavioral research. Chicago: University of Chicago Press.