1. University of North Carolina at Greensboro Protecting Research Participants

2. What is Research? l Research is an organized way to gather information that is useful for as many people as possible in the future.

3. What is a Research Participant? l l Anybody we gather information about

4. The Belmont Report l l Respect l l voluntary consent l l protect those who cannot make decisions l l Benefits Outweigh Harms l l maximize benefits & minimize risk of harm l l Justice l l the burdens and benefits of research should be distributed fairly

5. “I don’t know what they used us for.” Survivor of Tuskegee Syphilis Study, 1932-72 The Belmont Report

6. Applying Guidelines PrincipleApplications Respect for Persons Informed consent Privacy (Confidentiality and Anonymity) Benefits/Harms Protecting participants from harm Assessment of risks and benefits Justice Choosing participants

7. Applying the Principles in Your Role l Honesty l Informed Consent l Confidentiality

8. Rights of the Research Participants l Right to accurate and complete information about the study l Right to informed consent l Right to refuse l Right to privacy

9. Elements of Informed Consent l Your full name l Who is conducting the study l Purpose/content of the study l Approximate length of the study l Risks and benefits of participating (if any) l Participation is voluntary l Can stop participating at any time l Responses are confidential

10. INFORMED CONSENT “GETTING PERMISSION FROM RESEARCH PARTICIPANTS” l l Consent is a PROCESS... l l Researcher tells all important information l l Participant has chance to ask questions l l Researcher answers questions l l Participant signs a consent form agreeing to participate

11. UNDERSTANDING CONSENT l l Clearly written l l Everyday words l l Plan for participants who cannot read

12. Institutional Review Board (IRB) l l An IRB is a committee that reviews proposed research studies to ensure that participants are protected from unfair treatment and risks that could be caused by the research l l Every research project involving human participants must gain the approval of at least one IRB; sometimes more than one

13. Functions of the IRB l Ensure that research participants are treated ethically at all times (principles of the Belmont report) l Ensure that researchers are adequately gaining informed consent from every research participant l Monitor projects to ensure adherence to protocol l Provide a contact point for participants if they are concerned about their rights l Handle reports of violations of participants’ rights or adverse outcomes of the research

14. Special Populations l Children and Minors l Prisoners l Pregnant women and fetuses l Cognitively impaired persons l Students/employees

15. Confidentiality l We are dependent upon the goodwill of the participants in order to carry out a valid study l This requires their trust l Cornerstone of trust is knowing that we will keep the information they provide confidential

16. Confidential vs. Anonymous l Anonymous means the research participant’s identity is not known, even to the interviewer. l Confidential means we have identifying information about the research participant (in some cases, only a phone number and/or first name) but we will not reveal that information to anyone.

17. Confidential Means… l Names will not be associated with responses when results are reported l Information research participants give you must not be shared with anyone else—not even other interviewers l Do not tell research participants what other participants have said, even if they ask you what other people think l Information about a research participant and/or his data can not be left in an unsecured place.

18. Confidentiality is Serious l You must sign a Confidentiality Statement before calling or speaking with any research participants l Violation of the terms of the Statement is grounds for immediate dismissal.

19. The Only Exceptions  If you have reason to believe a research participant is in a situation so dangerous that they are a threat to themselves or others, alert your supervisor immediately.  Suspected child abuse must be reported to the authorities per North Carolina law

20. Privacy l l All personal information remains confidential (private) l l Behaviors l l Lab tests l l Questionnaire results l l Age, phone numbers, etc

21. If Research Participants have Questions… l For questions about the study, what the data will be used for, etc.: principal investigator or study staff l For questions or concerns about rights as a research participant: director of the UNCG Office of Research Compliance (Provided on Study Info Sheet)

22. Summary l Research involving people l Helps make better programs or treatments l Only done with permission of participants l Rules to make it as safe as possible l Must be approved by an IRB

23. Acknowledgements l l Slides adapted from work by l l Daniel K. Nelson Director, Office of Human Research Ethics Associate Professor of Social Medicine and Pediatrics, UNC School of Medicine l l Teresa Edwards Assistant Director for Survey Research and Development H W Odum Inst Research Social Sciences, UNC