Responsible Conduct of Research: I nstitutional R eview B oard

1. Responsible Conduct of Research: Institutional Review Board Office of Regulatory Research Compliance

2. Objectives: • To provide an overview of the Office of Regulatory Research Compliance and the role of institutional review committees; • To describe role and function of the Institutional Review Board and the human subjects protection program; • To discuss the IRB review process and the responsible conduct of research involving human participants.

3. ABOUT THE OFFICE OF REGULATORY RESEARCH COMPLIANCE

4. About The Office of Regulatory Research Compliance (ORRC) Location: The Office of Regulatory Research Compliance (ORRC) 1840 Seventh Street, NW HURB-1, Suite 309 Washington, DC 20001 202-865-8597(O) 202-232-5286 (Fax)

5. Regulatory Committee Chairs

6. Function of the ORRC • ORRC supports HU in promoting ethical conduct of research and educating faculty and students about human subjects protections, responsible conduct of research, animal care regulations, and bio-safety. • ORRC has oversight of all research approved by an institutional review committee to ensure regulatory compliance and the protection of all human and animal participants involved in research.

7. Objectives: • To provide an overview of the Office of Regulatory Research Compliance and the role of institutional review committees; • To describe the role and function of the Institutional Review Board (IRB) and the human subjects protections program; • To discuss the IRB review process and the responsible conduct of research involving human subjects.

8. SPECIAL NOTE! NO HUMAN SUBJECTS RESEARCH, ANIMAL RESEARCH, OR RESEARCH INVOLVING BIOAGENTS AND RADIATION CAN BEGIN UNTIL IT HAS RECEIVED APPROVAL BY AN INSTITUTIONAL REVIEW COMMITTEE.

9. ETHICAL FOUNDATION OF HUMAN RESEARCH PROTECTION • Belmont Report • Ethical Principles

10. ETHICAL PRINCIPLES The “Belmont Report,” formally known as the Ethical Principles and Guidelines for the Protection of Human Subjects of Research, was written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

11. ETHICAL PRINCIPLES The Belmont Report identified the following three fundamental ethical principles that must be carefully considered to ensure the ethical practice of research involving human participants:

12. Respect for Persons

13. Justice

14. Beneficence

15. REGULATORY FOUNDATION OF HUMAN RESEARCH PROTECTION • History • Regulations • Policies • HIPAA

16. Significant recent events in research experimentation since the Hippocratic Oath. History

17. History (cont.) * Recent findings on Guatemala and Henrietta Lacks.

18. What regulations govern human subjects research? • Department of Health and Human Services (DHHS) • Food and Drug Administration (FDA) • Sponsors • Howard University Policies

19. What regulations govern human subjects research? (cont.) All research involving human subjects must adhere to DHHS regulation 45 CFR 46, also known as the COMMON RULE, unless the requirement is waived by the IRB.

20. 45 CFR 46: The Common Rule • The Common Rule is a federal policy regarding Human Subjects Protection. The main elements include: • requirements for assuring compliance by research institutions; • requirements for researchers’ obtaining and documenting informed consent; • requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and recordkeeping. • Revisions under consideration affecting informed consent, security and data collection. http://www.hhs.gov/news/press/2011pres/07/20110722a.html

21. What is HIPAA? • The Health Insurance Portability and Accountability Act, commonly known as HIPAA, is another piece of legislation that impacts the conduct of human subjects research. • Establishes national standards for the protection of private health information know as Protected Health Information (PHI). • PHI is defined as any individually identifiable health information that is created or maintained by a Covered Entity (CE) department.

22. HIPAA applies when:

23. ROLE OF THE IRB

24. Basic IRB Member Responsibilities • Conduct Protocol Review • Applying Discipline Expertise and Regulatory Knowledge • Attend Meetings • Review Allegations of Noncompliance • Maintain Confidentiality

25. IRB REVIEW PROCESS • Types of Protocol Submission • Types of Protocol Review • Criteria for Approval • Criteria for Exemption; Expedited Review; • Full Board Review • Points to Consider

26. (4-6 weeks) (2 weeks) (2-3 weeks)

27. Types of Protocol Submission Examples of protocol submission: • Initial Review • Continuation Review • Revisions/Modifications/Amendments • Unanticipated Problems/Adverse Events • Alleged or Reported Noncompliance • Closures

28. Mechanisms of IRB Review:

29. What criteria must be met for research to be approved?

30. Criteria for Exemption = 6:*Only the IRB can make the official determination that your project is exempt based upon 45 CRF 46.101

31. Criteria for Expedited Review • Expedited reviewers must determine the following: • Do the research activities meet the definition of “minimal risk” and do they fit within the federally mandated expedited categories? • Do the research activities meet the eight federal criteria for IRB approval? • “Minimal risk” is defined as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves from those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests.” EXPEDITED REVIEW DOES NOT MEAN PUT A RUSH ON MY REVIEW BECAUSE A GRANT DEADLINE IS COMING UP!!!

34. Criteria for Full Board Review • Research that does meet the criteria for exempt or expedited review must be submitted to the IRB for a review at a convened meeting at which a quorum of the members are present. • Medical IRB meets twice a month and the Nonmedical IRB meets at least once a month. • Research involving “greater than minimal risk” must go before the Full Review process.

35. TYPICAL REVIEW TIMELINES EXEMPT EXPEDITED FULL BOARD REVIEW TYPE RISK ASSESSMENT LOW OR LESS MINIMAL MORE THAN MINIMAL MINIMAL APPROVAL TIMELINE* 2 Weeks* 2-3 Weeks* CONVENED FULL BOARD Review 4-6Weeks* *APPLICATIONS THAT REQUIRE REVISIONS MAY TAKE LONGER.

37. Exempt Review: 2 weeks Expedited Review: 2-3 weeks Full Board Review: 4-6 weeks Most proposals submitted require some form of revision. Submission of additional information will add time to your review and approval. Points to consider: How long?

38. Online CITI Training Module https://www.citiprogram.org

39. IRB CHECKLIST  Form B-1 (always required)  Request for Expedited Review. Typed letter on letterhead signed by the PI.  Request for Exemption (Form D-1). Note: One or both, depending on nature of the research  Conflict of Interest Forms for all Investigators  Certificate of completion of education in the protection of human research participants (required)  Informed consent document(s)  Signed copy of The Principal Investigator’s Assurance Form  Any recruitment notices or advertisements  Any survey instruments, psychological tests (other than standard, commercially available instruments), interview forms, or scripts to be used in the research  Investigator’s qualifications (CV, biographical sketch)  Formal research protocol, if available.  Grant application, if applicable.  SUBMIT ONE APPLICATION. TWO ADDITIONAL COPIES ARE NO LONGER REQUIRED!

40. FORMS Applications forms are available online at: http://www.howard.edu/orrc

42. Questions and Answers

43. The Office of Regulatory Research Compliance Location: The Office of Regulatory Research Compliance (ORRC) 1840 Seventh Street, NW HURB-1, Suite 309 Washington, DC 20001 202-865-8597 (Office) Yonette F. Thomas, PhD Associate Vice President for Research Compliance