Human Subjects Protections, Concepts, and Procedures

1. Human Subjects Protections, Concepts, and Procedures Tom Lombardo, Ph.D., Director, Research Integrity & Compliance & Jennifer Caldwell, Ph.D. Research Compliance Specialist March 2013 100 Barr Hall, 662-915-7482 irb@olemiss.edu IRB 101 Office of Research and Sponsored Programs

2. What is the IRB and why do I need to know about it? • IRB = Institutional Review Board • It is University policy AND State & Federal law that “All human research… must be reviewed and approved before the research begins.” Office of Research and Sponsored Programs

3. Why do we need regulations? • Willowbrook (1950s) • San Antonio Birth Control Study (1970) • Tuskegee Syphilis Study (1932-1972)

4. “But this doesn’t apply to me: I’m just doing a survey” • University of VA – all human subject research shut down – because of a survey study. • Parent of research participant sued UVA over a survey on medical problems of family members [violation of his rights] • $3M cost to fix everything Office of Research and Sponsored Programs

5. What counts as “research?” “A systematic investigation designed to develop or contribute to generalizable knowledge.” • Includes pilot studies • Excludes assessments of quality control and teaching, DM polls, etc. Office of Research and Sponsored Programs

6. Who is a “research subject?” ‘A living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual OR identifiable, private information’ (human data or tissue) Excludes de-identified secondary data sets Office of Research and Sponsored Programs

7. Belmont Report-1976 3 Basic Ethical Principles • Respect for Persons • Tell subjects who, what, why • Get Consent – signed or implicit • Beneficence • Maximize benefits and minimize harms or risks • Justice • “Spread” the risks/benefits – justify excluding any group (whites, females, etc.)

8. IRB: Gatekeeper of the Belmont Principles “Investigators should not have sole responsibility for determining whether research involving human subjects fulfills ethical standards. Others who are independent of the research must share this responsibility” National Commission on Institutional Review Boards, 1978 Office of Research and Sponsored Programs

9. Primary Goals of the IRB • IRB is a resource to assist researchers’ compliance with Federal Regulations. (not a paperwork police force) • IRB’s success is measured by the degree to which researchers’ habits are driven by ethical principles, not by meeting regulations. Office of Research and Sponsored Programs

10. INFORMED CONSENT • Decision-Making Competence • Consent / Assent • Disclose information • What would a reasonable person want to know before agreeing to participate? • Comprehension: 6th grade reading level Office of Research and Sponsored Programs

11. What are the Elements of Consent? • This is a Research Study. • It’s Purpose is… • It will take you [30] minutes • In the study, you will… • Study Risks and benefits are… • Researcher and IRB Contact info • Your Participation is voluntary; you can quit any time • Could be signed consent, information sheet, oral Office of Research and Sponsored Programs

12. Levels of IRB Review • Exempt (Administrative) • Form: Screening / Abbreviated Application • Review: IRB Research Compliance Specialist • Education: Brief UM Online reading/quiz • Expedited (Designated) • Form: Full Application • Review: IRB Chair or Board Member(s) • Education: Full CITI online courses • Full Board Review • Convened Meeting of Board Office of Research and Sponsored Programs

13. Training • Ensure that all personnel who will be involved in your study have completed whatever training they need! Information on training can be found on our website at: research.olemiss.edu/irb/education • IRB will not even read your application until you complete the required level of training for your project! Office of Research and Sponsored Programs

14. Exempt Research • Most survey research with adults • Anonymous or innocuous • Research on educational practices – adults or children • Existing data or records that cannot be tied to Ss • Does not require signed consent forms Office of Research and Sponsored Programs

15. Expedited Research Research activities that • Present no more than minimal risk to Ss and • Involve only specific procedures listed in the federal regulations “A risk is minimal where the probability & magnitude of harm or discomfort anticipated …. are not greater …. than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” Office of Research and Sponsored Programs

16. Full Board Review • Examples: • Child studies with manipulations • DXA • > Moderate exercise • Deception • Treatment studies • Some survey studies (e.g., bullying) • Monthly meeting dates posted on website • Submissions must be received 2 weeks in advance Office of Research and Sponsored Programs

17. SURVEYS • Include all elements of consent • For online surveys: add a ‘Click here if you agree’ button • Must allow Ss to omit items • Cannot penalize for failure to complete • Qualtrics: • research.olemiss.edu/resources/surveys Office of Research and Sponsored Programs

18. Tips to Save Time • Most recent form: • Get all forms directly from the website at research.olemiss.edu/irb/protocol • Make sure to include ALL needed attachments • Appendices • Survey or Interview Questions • Permission letters from off-campus locations • Information sheet or consent form • Recruitment email, flyer, or script • Double check that you have thoroughly answered each question on the application! Office of Research and Sponsored Programs