The Role of the IRB Chair in NCQA Accreditation IRB Chair Training April 9, 2004 Karen Jeans, MSN, CCRA

1. The Role of the IRB Chair in NCQA Accreditation IRB Chair Training April 9, 2004 Karen Jeans, MSN, CCRA

2. Objectives • Identify the direct impact of your actions as an IRB Chair on the NCQA Accreditation survey process. • Identify the indirect impact of your actions as an IRB Chair on the NCQA Accreditation survey process.

3. Brief History of ACE! Training Workshops • Series of four (4) workshops • Focus • Teach the basics of preparing VA Human Research Protection Programs (HRPP) for the on-site and off-site survey processes in NCQA Standards Version 2.1 • Teach basic human protection principles described in 21 CFR; 38 CFR; 45 CFR; VHA Handbook 1200.5; and M-2, Part VII, Chapter 6

4. Who were the target audience of the initial ACE! Training Workshops? • The individual(s) responsible for oversight of the institution’s human research protection program. • The individual(s) responsible for preparing the NCQA application packet. • The individual(s) responsible for preparing the documented processes, reports, and IRB documentation for the NCQA survey.

5. Where does the IRB Chair fit in the NCQA Accreditation process? • The IRB Chair has a direct or indirect role in each of the three areas: • Oversight of the institution’s HRPP • NCQA Application Packet • Documented Process, Reports, and IRB Documentation

6. What is the difference in terms of evaluating individual IRB Chair actions? Driven by the NCQA Category: 1. For VA IRBs - larger direct IRB Chair role 2. For Affiliate IRBs – larger indirect IRB chair role

7. Total Points Summary – NCQA Standards Version 2.1

8. IRB Chair Roles – Direct and Indirect • Categories • Institutional Responsibilities (INR) • Institutional Review Board (IRB) • Consideration of Risks and Benefits (CRB) • Informed Consent (ICS)

9. IRB Chair Roles – Evaluation of Institutional Responsibilities Category (INR) • DIRECT • Interview • Statements in IRB minutes or budget requests • INDIRECT • Statements about your specific duties • Implementation of the VA institution’s HRPP • Addressing research-related complaints • Handling conflicts of interest • Research Protocol Approval Dates • Your qualifications and experience as an IRB Chair

10. IRB Chair Roles – Evaluation of Institutional Responsibilities Category (INR) • DIRECT • Interview • VA IRB Chairpersons only • Explain, confirm, and clarify • No points • Statements in IRB minutes, budget requests, MOU • Systematic Budgeting for HRPP • Formal IRB Agreement

11. IRB Chair Roles – Evaluation of Institutional Responsibilities Category (INR) • INDIRECT • Statements about your specific duties • Implementation of the VA institution’s HRPP • Addressing research-related complaints • Handling conflicts of interest • Research Protocol Approval Dates • Your qualifications and experience as an IRB Chair

12. Question For NCQA evaluation, can an IRB Chair be the designated individual who is responsible for ensuring that the institutional human research protection program is operational? Reference to NCQA Standards Version 2.1: Category INR, Element 1B: Responsible Committee or Individual

13. IRB Chair Roles: Institutional Review Board (IRB) Category • Direct • Interview • Indirect • Majority of points in this category involve evaluation of documented processes and reports

14. IRB Chair Roles: Institutional Review Board (IRB) Category • Direct • Interview • Minutes • Letters to investigators reporting IRB decisions • Indirect • Majority of points in this category involve evaluation of documented processes and reports

15. IRB Chair Roles: Institutional Review Board (IRB) Category • Indirect • Roster: If VA IRB, must have VA appointment • Documented processes: • Individuals with special expertise • Materials for IRB review • Assigning reviewers • Continuing Review • Expedited Review • Exempt

16. Question How does NCQA evaluate VA appointment for IRB Chairs with a VA IRB? Reference to NCQA Standards Version 2.1: Category IRB, Element 1A: Factor 8 IRB Membership

17. Question When a study’s continuing review expires, we (my IRB) do not send out a letter to the investigator notifying the investigator that the study’s continuing review (CR) has expired. However, we do have an SOP in the investigator’s handbook that states the study is automatically suspended to enrollment once CR has expired. Is this sufficient? Reference to NCQA Standards Version 2.1: Category IRB, Element 3D: Timely Continuing Review

18. Question During the on-site NCQA survey visit, a sample of expedited review actions will be evaluated. Will the NCQA surveyors be evaluating the actions of the IRB Chair for the appropriate regulatory requirements in the use of expedited procedures? Reference to NCQA Standards Version 2.1: Category IRB, Element 4B: Conduct of Expedited Review

19. Question If an IRB doesn’t allow any projects to be classified as exempt, does the IRB have to have a documented process describing the procedures for determining exempt status? Reference to NCQA Standards Version 2.1: Category IRB, Element 4C: Documented Process - Exempt

20. Question My IRB gives the R&D Committee a copy of our approved minutes approximately two (2) minutes after our IRB meetings. No cover letter is submitted with the R&D Committee. Will this meet the standard? Reference to NCQA Standards Version 2.1: Category IRB, Element 5B: Reporting IRB Decisions

21. IRB Chair Roles: Consideration of Risks and Benefits (CRB) Category • Direct • Interview • File Review • Majority of points in this category involve evaluation of IRB file review • Indirect • Documented processes describing how the IRB evaluates risks and benefits

22. IRB Chair Roles: Consideration of Risks and Benefits (CRB) Category • Direct • Interview • Correlation of policy with practice • File Review • Vulnerable Subjects • Risks • Continuing Review Interval Determination • Majority of points in this category involve evaluation of IRB file review • Indirect • Documented processes describing how the IRB evaluates risks and benefits, recruitment practices, and privacy and confidentiality

23. Question During meetings, the IRB Chair asks the convened membership what is the recommended continuing review interval. The SOP (documented process) states that the continuing review interval is based on numerous factors, including the degree of risk determination. Is this sufficient? Reference to NCQA Standards Version 2.1: Category CRB, Element 2F: Documentation of Continuing Review Interval

24. Question MY IRB IS RESPONSIBLE FOR DOCUMENTING ITS REVIEW OF AMENDED OR UPDATED INVESTIGATOR’S BROCHURES AFFECTING A RESEARCH STUDY DURING THE CONTINUING REVIEW EVALUATION DOES MY IRB ALSO HAVE TO DOCUMENT ITS REVIEW OF AMENDED OR UPDATED INFORMATION ON APPROVED DRUGS OR DEVICES USED IN A RESEARCH STUDY DURING THE CONTINUING REVIEW EVALUATION? Reference to NCQA Standards Version 2.1: Category CRB, Element 4B: Continual Evaluation of Risks and Benefits

25. IRB Chair Roles: Informed Consent (ICS) Category • Direct • Interview • File Review • Majority of points in this category involve evaluation of IRB file review • Indirect • Documented processes describing how the IRB waives the requirements to obtain informed consent, document informed consent, waives or alters elements of informed consent, and uses “short form.”

26. IRB Chair Roles: Informed Consent (ICS) Category • 16 Basic Elements Listed in NCQA Category ICS, Element 1A: Approved Consent Forms – Basic Elements • 6 Additional Elements Listed in NCQA Category ICS, Element 1B: Additional Elements • 3 Elements Listed in NCQA Category ICS, Element 1C: Payment and Exculpatory Language

27. Summary IRB Chair “High Impact” actions on evaluation of the NCQA Accreditation Standards Version 2.1 • Anything with your name on it involving an IRB action or process • Determination and documentation of Expedited and Exempt Actions • Knowledge of IRB process determinations, IRB files, and reviewer tools a. File Review Process of the On-Site Survey b. Interview Process of the On-Site Survey