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Washington State University

HRPP policies & procedures manual

200: Composition of the board

1. Purpose

The purpose of this policy is to describe requirements for the composition of the IRBs responsible for reviewing research conducted at, or by agents of WSU.

2. Policy

The IRB will have sufficient expertise among its members to be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law and standards of professional conduct and practice. In addition to the members listed below, the ORA director and IRB coordinator will serve as an ex-officio voting member of the board.

The IRB shall consist of at least five regular voting members. Qualified persons from multiple professions and of both sexes shall be considered for membership. IRB membership shall not consist entirely of men or of women.

WSU will make every effort to have a diverse membership appointed to the IRBs, within the scope of available expertise needed to conduct its functions.

3. Specific policies

3.1 Membership selection criteria

The IRB members shall be sufficiently qualified, through experience and expertise, for reviewing research proposals in terms of regulations, applicable law and standards of professional conduct and practice, and institutional commitments. Therefore, the IRB shall include persons knowledgeable in these areas.

The membership shall be diverse, so selection shall include consideration of race, gender, cultural background, clinical experience, healthcare experience, and sensitivity to such issues as community attitudes, to assess the research submitted for review.

There shall be at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. There shall be one member who has no other affiliation with this institution, either self or family member. For FDA-regulated research, there shall be at least one member who is a licensed physician.

3.2 Regular and alternate members

Regular members

The backgrounds of the members shall be varied in order to promote complete and adequate reviews of the types of research activities commonly reviewed by the IRB. Regular members must include:

  • Nonaffiliated member(s):  The IRB will include at least one member from the community. This member will not be affiliated with WSU, other than IRB membership. Nonaffiliated is defined as: The member has no employment or other relationship with the organization and is not otherwise affiliated with the institution or part of the immediate family of a person who is affiliated with the institution. The nonaffiliated member(s), who can be either a scientific or nonscientific reviewer, should be knowledgeable about the local community and be willing to discuss issues and research from that perspective. Consideration should be given to recruiting individuals who speak for the communities from which WSU draws its research subjects. The nonaffiliated member(s) should not be vulnerable to influence by the professionals on the IRB, and his/her services should be fully utilized.
  • Scientific member(s):  Scientific members are expected to contribute to the evaluation of a study on its scientific and statistical merits and standards of practice. These members should also be able to advise the IRB if additional expertise in a scientific area is required to assess if a protocol adequately protects the rights and welfare of subjects.
  • Nonscientific member(s): The intent of the requirement for diversity of discipline is to include members whose main concerns are not in scientific areas. Non-scientific members are individuals whose education, work, or interests are not primarily in medical or social-behavioral scientific areas.
  • Representatives of special groups of subjects:  When certain types of research are reviewed, members or consultants who are knowledgeable about the concerns of certain groups may be required. When the IRB reviews research involving prisoners, a member who can represent this group, either an ex-prisoner or an individual with specialized knowledge about this group, must be included on the IRB.
    • Clergy: Every effort will be made to include at least one clergy member (non-WSU) or an individual with expertise in ethical practices.
    • Expertise: Every effort will be made to ensure that at least two of the following fields of expertise will be represented on the IRB: sociology, psychology, and anthropology.
    • Location: Every effort will be made to include representation from the regional WSU campuses.
    • Physicians: Every effort will be made to include one or more physicians on the IRB.
Chairpersons

The IRB chairperson should be a highly respected individual from within the WSU community, fully capable of managing the IRB and matters brought before it with fairness and impartiality. The chair must be an experienced member of the IRB, and can be either a scientific member or nonscientific member. The chair is elected from the membership of the IRB. The chair is considered a regular member of the IRB with all applicable responsibilities of voting and motions.

Alternates

Alternate IRB members replace regular IRB members who are unable to attend convened meetings. Alternate members have qualifications comparable to the applicable regular member and may be alternates for more than one IRB member. Alternates are not required to attend each meeting, but are encouraged to attend. Alternates will only vote when officially substituting for a designated regular member. Alternates may be asked to attend a meeting when their expertise is needed and/or when they are needed to establish a quorum. Alternates will receive all materials for meetings and general updates so they are able to actively participate in meetings.   

3.3 Consultants

Each protocol will be reviewed by the ORA director, chair and coordinator (during the pre-IRB meeting) prior to the meeting to determine if a consultant is needed to provide an expertise review. If the need for a consultant is identified, the ORA director in consultation with the chair will contact an appropriate expert (consultant) and arrange for his/her assistance. The consultant will be given the same materials as the primary and secondary and tertiary reviewers per section 3.4.

The consultant may attend the IRB meeting in person or by teleconference. The consultant may participate in the deliberations and make recommendations, but may not vote. If the consultant is unable to attend the IRB meeting, a written report will be requested and all members will receive a copy prior to the IRB meeting. The consultant’s report will become part of the meeting minutes.

If the consultant does not provide a written report, key information from the consultant’s verbal report to the IRB will be recorded in the minutes.

3.4 IRB roster

An IRB roster of regular and alternate members will be maintained for each IRB. The IRB members will be queried at the time of IRB appointment and approximately each year to evaluate any changes.

Any change to the IRB roster will be reported to the ORA director.

The IRB roster will contain, but not be limited to:

      • Name of IRB member
      • Earned degrees
      • Scientific/nonscientific status
      • Representative capacity (e.g. children, prisoners, Native American, pregnant women)
      • Experience and credentials
      • Affiliation status
      • Relationship of the member to the organization
      • Membership status
      • List of members for whom the alternate member can substitute

4. Applicable regulations and guidelines

45 CFR 46.107

21 CFR 56.107

FDA Information Sheets, FAQ section II, questions 14, 15

5. Forms

None

6. Procedures employed to implement this policy & assignment of responsibility

WhoTask
Institutional official (IO), ORA director,
chairperson
Ensure the overall diversity of the IRB membership (gender, race,
ethnicity, community affiliation and professional experience) through
non-discriminatory selection methods.
ORA director, IRB
coordinator
Review all incoming protocols to determine if consultants are needed.
Contact consultants and follows up as needed.
ORA directorReport changes of IRB membership to the IO.
IRB coordinatorMaintain a file on all members, to include their curriculum vita,
education, letters of appointment, and other evidence of professional
ability.
Maintain a roster of all regular and alternate members.
Ensure consultants have all study materials.