ELEMENT II.1.A.

ELEMENT II.1.A.: The IRB or EC membership permits appropriate representation at the meeting for the types of research under review, and this is reflected on the IRB or EC roster. The IRB or EC has one or more unaffiliated members; one or more members who represent the general perspective of participants; one or more members who do not have scientific expertise; one or more members who have scientific or scholarly expertise; and, when the IRB or EC regularly reviews research that involves vulnerable participants, one or more members who are knowledgeable about or experienced in working with such participants.

Laws, regulations, codes, and guidance usually define the requirements of the IRB or EC membership roster. The information in this roster should be used to provide for effective review of research and management of the IRB or EC. For example, if the IRB or EC directs protocols to primary reviewers with scientific or scholarly expertise (professional competence), the information in the IRB or EC roster should be sufficient to implement this function. The IRB or EC roster should include at least one member who represents the perspective of research participants, such as a former or current research participant or a research participant advocate.

At least one individual whose primary interest is scientific, and at least one individual whose primary interest is non-scientific and at least one non-affiliated member should attend meetings. IRB or EC minutes should demonstrate that IRB or EC meetings were convened with members appropriately representing regulatory or legal requirements and the general perspective of participants.

When the IRB or EC reviews research that involves categories of participants vulnerable to coercion or undue influence, if there is not at least one person who is knowledgeable about or experienced in working with such participants present at the meeting, the IRB or EC should defer review until such expertise can be obtained through membership or consultation.

Regulatory and guidance references

DHHS: 45 CFR 46.103(b)(3), 45 CFR 46.108(b), OHRP Step-by-Step Instructions on Registering an Institutional Review Board (IRB) or Independent EC (IEC)
FDA: 21 CFR 56.108(c), 21 CFR 56.115(a)(5), FDA Information Sheets: Frequently Asked Questions: IRB Membership, FDA Information Sheets: Frequently Asked Questions: IRB Procedures
ICH-GCP: 3.2.1, 3.2.3, 3.2.4
VA: 38 CFR 16.103(b)(3), 38 CFR 16.108(b), VHA Directive 1058.01, VHA Handbook 1200.05,7, 12
AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)
AAHRPP Tip Sheet: Review of Research involving Prisoners and the Role of the Prisoner Representative
AAHRPP Tip Sheet: The IRB or EC Member Roster

Required written materials

Essential requirements:
1. IRB or EC rosters include:
  1. Names.
  2. Earned degrees.
  3. Representative capacities.
  4. Scientific/nonscientific status.
  5. Affiliation status (whether the IRB or EC member or an immediate family member of the IRB or EC member is affiliated with the organization).
  6. Indications of experience sufficient to describe each IRB or EC member’s chief anticipated contributions.
  7. Employment or other relationship between each IRB or EC member and the organization.
  8. Alternate members.
  9. The primary members or class of primary members for whom each alternate member can substitute.
2. According to IRB or EC rosters:
  1. Each IRB or EC has at least five members with varying backgrounds to promote complete and adequate review of research commonly conducted by the organization.
  2. No IRB or EC has members who are all males or all females.
  3. No IRB or EC has members who represent a single profession.
  4. Each IRB or EC has at least one member whose primary concerns are in scientific areas.
  5. Each IRB or EC has at least one member whose primary concerns are in nonscientific areas.
  6. Each IRB or EC has at least one member who is not otherwise affiliated with the organization and who is not part of the immediate family of a person who is affiliated with the organization.
  7. Each IRB or EC has at least one member who represents the perspective of research participants.
When following VA requirements:
1. Each IRB must include at least one voting member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.
  1. Members whose training, background, and occupation are within a behavioral or biomedical research discipline should be considered a scientist.
  2. Members whose training, background, and occupation are outside of a behavioral or biomedical research discipline should be considered a nonscientist.
2. Each IRB must include at least one voting member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. Retired VA employees who are receiving VA retirement benefits are considered affiliated for purposes of VA IRB membership. Veterans who receive their care at the facility, but have never been employed by VA, would not be considered affiliated.
3. IRBs should consider including a Veteran or Veteran's representative.
4. Research not requiring continuing review by an IRB is still overseen by the IRB and R&D Committee. Reportable events, such as unanticipated problems involving risks to participants or others, must be reported as required by the IRB. Any changes in the IRB-approved research must be reported to the IRB and may not be implemented prior to review and approval by the IRB (may be expedited) except when necessary to eliminate apparent immediate hazards to the participant.
5. For VA facilities:
  1. VA medical facilities must maintain, or have readily available access to, accurate up-to-date rosters for all IRBs designated on a VA medical facility’s FWA. A membership roster for all IRB(s) required by VHA Directive 1058.03 to be designated on the VA medical facility’s FWA must be submitted to ORO FWA staff at the time of the IRB’s designation as an IRB of Record on the FWA.
  2. The Privacy Officer (PO) and the Information System Security Officer (ISSO) serve in an advisory capacity to the facility’s IRB as either non-voting members or as consultants.
  3. VA facility research office staff including, but not limited to, the Associate Chief of Staff/R&D (ACOS/R&D), the Administrative Officer (AO) for R&D, and IRB administrative staff may not serve as voting members of the facility’s IRB. They may serve as ex officio, non-voting members or attendees; however, they and the IRB must be sensitive to any potential, actual, apparent, or perceived conflicts of interest and appropriately manage such conflicts.
  4. Research Compliance Officers (RCOs) may act as consultants to the facility’s IRB, but may not serve as members of the IRB. RCOs may attend IRB meetings when requested by the IRB or as specified by the IRB’s SOPs. RCOs must be aware of and manage any potential, actual, apparent, or perceived conflicts of interest that arise because of their role.
  5. Facility Directors, their administrative staff, Chief of Staff (COS), other facility senior administrators such as Associate or Assistant Directors or Chief Nurse, and VA-affiliated nonprofit research and education corporation (NPC) Administrative Staff may observe IRB meetings, but may not serve as members of the facility’s IRB.
  6. If alternate members are appointed to the facility’s IRB, the IRB's written procedures must describe the appointment and function of alternate members, and the IRB membership roster must identify by name the primary member(s) for whom each alternate member may substitute.
  7. The alternate members must have similar member qualification(s) of the primary member they replace.
  8. The organizational official appoints VA voting members to an IRB in writing. Appointment procedures for ex officio, non-voting members are made according to local SOPs and any other applicable VA requirements. Voting members of VA IRBs and VA representatives to external IRB(s) of Record and the VA Central IRB are appointed for a period of up to three years. They may be re-appointed to new terms of up to three years without a break in service at the end of each term.
  9. The Chair, Co-Chair(s), and Vice Chair(s) of an internal VA IRB (e.g., an IRB that is managed by the VA Facility or by a VA Program Office such as the VHA Central Office IRB) must be paid VA employees (i.e., not holding a without compensation (WOC) or interagency personnel agreement (IPA) appointment at VA).
  10. There may be one IRB Chair, Co-chairs, or a Chair and Vice Chair(s). Each may serve as a voting member of the IRB pursuant to IRB SOPs.
  11. The Chair and, when applicable, Co-chair(s) or Vice Chair(s), are appointed by the organizational official for a term of up to three years, and may be re-appointed indefinitely.

Common types of materials that may be used to meet the element

IRB or EC roster

Outcomes

The IRB or EC roster contains all the required categories and information.

Proceed To: ELEMENT II.1.B.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT II.1.A.