The Role of the IRB Chair

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 institutions 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 institutions 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 institutions 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 institutions 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 studys continuing review expires, we (my
  IRB) do not send out a letter to the investigator
  notifying the investigator that the studys
  continuing review (CR) has expired. However, we
  do have an SOP in the investigators 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 doesnt 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 RD Committee a copy of our
  approved minutes approximately two (2) minutes
  after our IRB meetings. No cover letter is
  submitted with the RD 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 INVESTIGATORS 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