Human Subjects Research and the IRB

1. Human Subjects Research and the IRB

2. Course Objectives • Review the basic ethical principles of research involving human subjects • Review the basic regulatory framework for human subjects research • Understand the differences in exempt, expedited and full board review

3. Belmont Principles • Respect for Persons • Beneficence • Justice

4. Respect for Persons • Treat individuals as autonomous agents • Do not use people as a means to an end • Allow people to choose for themselves • Give extra protection to those with limited autonomy

5. Beneficence • Acts of kindness or charity that go beyond duty • Obligations derived from beneficence • Do no harm • Prevent harm • Prevent evil • Promote good

6. Justice • Treat people fairly • Fair sharing of burdens and benefits of research • Distinguish procedural justice from distributive justice

7. Responsibilities of IRB • Safeguard rights & welfare of human subjects • Ensure subjects are adequately informed • Ensure voluntary participation • Ensure risk/benefit ratio is acceptable • Suspend & reportstudies that violate regulations

8. Responsibilities of Investigator • Obtain prospective IRB approval • Adverse events & protocol violations must be reported to IRB • Investigator can be held liable if willfully violates scope of research or does not obtain prospective IRB approval

9. Obtain Mentor • If the PI is a student/trainee, a Mentor is required. • Mentor must be full time Faculty. • This person is listed on the IRB Application as a Mentor.

10. Educational Mandate • CITI / Univ. of Miami Tutorial – Required • To register: • http://www.musc.edu/citi

11. Definition of Research • Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge • 45 CFR 46.102(d)

12. Definition of Human Subject • Living individual • About whom an investigator obtains • Data through intervention or interaction with the individual OR • Identifiable private information • 45 CFR 46.102(f)

13. Types of IRB Review • Exempt, Expedited and Full Board • Type of review depends on level of risks to subjects and federal regulations. Risk due to breach of confidentiality is always considered.

14. Minimal Risk • A risk is minimal when the probability and magnitude of harm or discomfort anticipated in the research is no greater than that ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests

15. Exempt Research Activities • Less than minimal risk to subjects • Does not mean exempt from IRB review • Requires determination from IRB Chair or his/her designee • Examples • Retrospective chart review—data collection with no identifiers • Surveys, questionnaires if the information is recorded without identifiers

16. Expedited • Minimal risk to subjects • Does not mean “review light” or “Fast Approval” • Review by Chair or designee • Examples • Studies involving venipuncture only- volume of collection is limited. • Prospective non-invasive collection of data/specimens (i.e., hair, nail clippings, saliva, etc.) • Retrospective chart review in which identifiers must be documented

17. Full Board • Greater than minimal risk to subjects • Investigational drugs/devices • Sensitive issues (i.e., substance abuse, domestic violence) • Protected Populations (i.e. children, cognitively impaired, pregnant women, fetuses, neonates, etc.) • Reviewed by Full Board at a convened meeting

18. IRB PROCESS(New Study) • PLAN AHEAD TO AVOID DELAYS • Determine which IRB to submit to • Will depend on Dept and Sponsor • Off Site Research • Consider ancillary committees (i.e. VA R&D, PRC, GCRC) • Review meeting dates & deadlines on IRB web site • IRB I & IRB II meet once a month • IRB III meets twice a month • Decide the type of study • Exempt (review categories) • Expedited (review categories) • Full Board

19. IRB PROCESS (Cont) • Electronic application • Current System- ERMA http://erma.musc.edu/ • New System- eIRB http://hssc.scra.org/HSSCSTAGING • Determine items to submit with application. For example: • Protocol (Use template on IRB website) http://research.musc.edu/ori/index.html • Informed Consent (use guide on IRB website) or Consent Waiver • HIPAA Authorization / HIPAA Waiver • Advertisements (include the word “research;” cannot be coercive, need contact information, etc.) • Drug / Device Information Sheet if applicable • Surveys and questionnaires • Budget / IIT

20. IRB FORMS PAGEhttp://research.musc.edu/ori/irb/forms.html

21. PI Statement of Assurance • Signatures may only be obtained after submission of electronic application to the IRB • Signatures needed: • PI • Mentor (If PI is a Student/Trainee) • Department Chair • Associate Provost for Research (If research is Non-Sponsored or internally sponsored)

22. INFORMED CONSENT • 3 Key Elements: • Informed • Understood • Voluntary • MUSC Standard Consent Guide:http://research.musc.edu/ori/irb/Guidecon.html

23. HIPAA • Protected Health information is defined as individually identifiable health information transmitted or maintained in any form (electronic, paper, or oral communication) that relates to the past, present or future physical or mental health or conditions of an individual. • HIPAA contains 18 identifiers (name, SSN, MRN, etc)

24. HIPAA cont. • HIPAA Authorization Form • The subject has signed a written Authorization containing all the elements specified in the Privacy Rule that will be used in the study. • HIPAA Waiver of Authorization Form • Used when it is impracticable to obtain written authorization from research participants.

25. IRB PROCESS (Cont) • IRB checks for completeness • Exempt applications are reviewed by IRB Chair or his/her designee • Expedited and Full Board applications are reviewed by IRB Administrator and Primary Reviewers • Comments/questions sent to PI (via electronic database) • PI provides response (via electronic database – upload revised documents)

26. IRB PROCESS (Cont) • Once the IRB is satisfied, approval is granted • Exempt & Expedited - IRB Chair (or the Chair’s designee) gives approval • Full Board – the board can approve, table or disapprove • Sponsored research requires release from ORSP verifying successful contract completion.

27. Amendments • Change in Personnel • Protocol Change • Consent Change • Change in Recruitment Process • Advertisements

28. Full Board Amendments • Changes to approved studies that are greater than minimal risk will be reviewed by the Full Board at a convened meeting and must be submitted in accordance with deadlines. • Increased risk • Increased dose range or increased number of subjects • Adding minors or other protected populations • Changes to an IND/IDE study other than administrative in nature. • If changes are not tracked on informed consents and/or protocols, they will be returned to the PI without review.

29. Continuing Reviews • Regulations require review no less than once a year or at intervals appropriate to the level of risk as determined by the Board. • Allow IRB to continue to assess the risk/benefit ratio of the study • Due one month prior to expiration; reminder sent two months prior to expiration • If a study is not renewed by the IRB, it will expire and be out of compliance. Enrollment will be suspended and/or research will be stopped. Once expired, re-instatement will require full board review and approval. • Status of study, enrollment numbers, problems or complications

30. AUDITS • Self Audit Checklist: http://academicdepartments.musc.edu/uco/documents/Audit%20Checklist%20MUSC%20and%20VA.doc • The University Compliance Office will initiate audits based on the following criteria: • Priority 1: For-Cause-Audit: HR Study where allegations of human subjects’ violations have been lodged against a Principal Investigator. • Priority 2: Administrative Audit: HR study where the IRB chair has identified a potential administrative problem with study documentation. • Priority 3: Random Audit: HR study selected by chance using a random number generator. Each study has an equal likelihood of selection. This is the most common type of audit.

31. Where to Find Assistance • The IRB • Research Support Services • http://research.musc.edu/researchresourses.html • SUCCESS Center • Provides assistance with research navigation and development

32. IRB KEY CONTACTS • IRB Main Number- 792-4148 • IRB Program Manager • Stacey Goretzka, CIP – 792-6527 (goretzka@musc.edu) • IRB I • Linda Bunch, CIP- IRB I-Administrator 792-2525 (cooperld@musc.edu) • Katherine Duncan- IRB I- Coordinator 792-4843 (duncank@musc.edu) • IRB II • Lisa Johnson, MBA-IRB II- Administrator 792-4144 (johnsli@musc.edu) • Alanna Herman-IRB II-Coordinator 792-6710 (hermana@musc.edu) • IRB III • Jackie Shedrow, CIP-IRB III Administrator 792-3071 (shedrow@musc.edu) • Yashmin Karten, PhD, MBA-IRB III Administrator 792-6521 (karteny@musc.edu) • Kenneth Thomas-IRB III Coordinator 792-9128 (thomaskn@musc.edu) • Cheryl Green-IRB III Coordinator 792-3093 (greench@musc.edu) • EXPEDITED and EXEMPT STUDIES • Summer Young, JD, MPH Administrator 792-6534 (youngsn@musc.edu)

33. Questions?