Version
1.3
Date Updated
Wednesday, October 15, 2008
Descripton

Approved by:  Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#:  130
AAHRPP Elements:  II.2.C, II.2.D, II.2.D.2., II.2.E.


POLICY


  1. In accordance with federal regulations, initial and continuing reviews of research must be conducted by the IRB at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas (i.e., a quorum), except where expedited review is allowed under HHS regulations at 45 CFR 46.110.
  2. The IRB Chair may expand the required member representation for quorum on a protocol-specific basis secondary to the scope of the research being reviewed or involvement of vulnerable groups in the study.  The presence of an unaffiliated member and member representing the perspective of the participant at the meeting is highly desirable but not mandatory per UIC policy. Refer to UIC HSPP Policy IRB Composition and Membership.
  3. Review of amendments (i.e., proposed changes to previously approved research) must be conducted by the IRB at convened meetings, except when  changes are minor (refer to UIC OPRS Policy Amendments to Previously Approved Research).  
  4. The UIC IRBs use a primary reviewer system with two reviewers having scientific expertise and research experience relevant to the study assigned as primary reviewers. For initial reviews, a nonscientific reviewer is also generally assigned.  The review by this individual focuses on the viewpoint of research participant, acceptability of the consent process and understandability of the consent document.  For Continuing Reviews and Amendments, two primary reviewers are assigned.   
  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. Convened meetings of the IRB require a majority of IRB members and at least one member whose primary concerns are in a non-scientific area.
  7. The expiration date listed in the electronic database and approval letter to the investigator represents the last date on which research activities may occur. All research activities must stop at 11:59 PM on that date unless re-approval by the IRB has occurred, or a protocol exception granted.
  8. The effective approval date for calculating the approval period following initial review is the date when conditions for IRB approval are met. At subsequent continuing reviews, the IRB has adopted the fixed anniversary date approach.