Version
1.2
Date Updated
Tuesday, January 3, 2017
Descripton

Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair

AAHRPP REF #: 118

AAHRPP Elements: II.1.B., II.2.C., II.2.E.


POLICY


  1. The UIC IRBs are composed according to the DHSS and FDA regulations (45 CFR 46.107 and 21 CFR 56.107).  
    1. Each IRB has at least five members with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution.
    2. Each IRB includes one or more members who are knowledgeable about and experienced in working with the vulnerable categories of participants, such as children, prisoners, pregnant women, or handicapped or mentally disable persons, involved in research regularly reviewed by the Board.  
    3. Each IRB includes at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.
    4. Each IRB includes at least one 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.
    5. Each IRB includes at least one member representing the perspective of research participants.
    6. Non-scientist and non-affiliated members are designated to represent the perspective of research participants for each board. The non-scientist, non-affiliated member representing the perspective of research participants may be the same or different individuals.
    7. When the convened IRB reviews research involving prisoners, a prisoner representative is present.
    8. When the IRB reviews research that involves categories of participants vulnerable to coercion or undue influence (e.g., children, impaired capacity to consent, mentally disabled, educationally or economically compromised, pregnant women, neonates, fetuses), one or more members or ad hoc consultants who are knowledgeable about or experienced in working with such participants are present.
  2. The ethical criteria at 45 CFR 46.107 and 21 CFR 56.107 guide the selection of members.
    1. The IRB is sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human participants.
    2. To assist in fulfilling its role, the IRB includes persons knowledgeable about the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice.
    3. Every nondiscriminatory effort is made to ensure that no IRB consists entirely of men or entirely of women, including the institution’s consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.     
    4. No IRB may have a member participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. The member with the conflicting issue is recused from the meeting during this time.
  3. Additional Requirement for CHAIRb:  UIC IRB #7, Chicago Area IRB (CHAIRb), has been charged with reviewing human subjects research under the scope of the Chicago Area Patient Centered Outcomes Research Network (CAPriCORN).  In addition to the requirements outlined in this policy, the following requirements are in place for CHAIRb:
    1.  Each institution participating in CAPriCORN research assigns a full member and, when desired, an alternate member to CHAIRb;
    2. Each participating VA assigns a minimum of two voting members to CHAIRb;
    3. CHAIRb follows VHA Handbook1200.05 and VA regulations 38 CFR 16 when VA research is being conducted.
    4. Additional criteria and IRB composition are described in the CHAIRb policy CHAIRb Operations SOP.
  4. The membership includes not only voting members but alternates.  The alternates are designated as replacements for specific members with comparable qualifications.  Alternates replace designated voting members who are unable to attend the meeting or are recused due to a conflict and the alternate provides necessary expertise.  When an alternate replaces a regular member, the alternate is provided the same material that the regular member received or would have received.  Alternates adhere to the same conflict of interest and confidentiality standards as members.
  5. An IRB panel may, at its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.
  6. Voting members as indicated on the IRB roster provided to OHRP who are present at the meeting either in person or via tele- or videoconference for the discussion of the protocol and do not have a conflict of interest are eligible to vote.  This includes both the Chair and Vice Chairs.  Voting members may be replaced by their designated alternate when they are unable to attend or vote.  When the voting member and their alternate both attend the meeting, only one may participate in the voting for a given study.