regulatory criteria for approval.

The full review of research must be substantive and meaningful with a recorded vote for, against, abstentions, and recusals from each study. The minutes of IRB meetings should document with sufficient detail the deliberations, actions, and votes for each protocol undergoing review by the convened IRB, in addition to a written summary of the discussion of issues related to each application and their resolution.

Review by the full Board at a convened meeting is warranted in circumstances such as the following: the research protocol involves more than minimal risk of harm to subjects, which can include physical, emotional, social, psychological, or financial risks; a certificate of confidentiality is requested; the research involves recruitment of vulnerable populations; and/or a conflict of interest or potential conflict of interest exists.

OSP staff will be responsible for determining if the review of a protocol requires coordination with other University committees or consideration of additional federal regulations and requirements other than those contained in 45 CFR § 46. For example, the agency funding a project may have additional requirements that will have an impact on the review process. OSP staff will provide guidance to the IRB in cases where coordination is needed or where there are additional requirements.

The IRB Chair in consultation with the HRPP specialist assigns a primary and secondary reviewer for each protocol in advance of each full Board meeting. All members, including the IRB Chair, may serve as a primary or secondary reviewer. In selecting the primary reviewer, consideration is given to the individual's knowledge of the subject area embodied in the proposal. The primary and secondary reviewers conduct an in-depth review of all items required for IRB submission of a new application, including informed consent/assent documents and all supplemental materials.

The primary and secondary reviewers are encouraged to contact the IRB Chair and OSP staff in advance of the Board meeting to request any additional information or clarification. OSP staff may contact researchers to obtain any necessary additional information before the meeting. The primary reviewer will lead discussion of the project they were selected to review. The OSP staff member serving as the HRPP specialist will provide a checklist to primary and secondary reviewers to ensure that all criteria for approval of research have been fulfilled. The completed checklist will be returned to OSP staff so it can become part of the complete project file.

If none of the IRB member has adequate knowledge or experience to review a given protocol, a consultant with appropriate expertise and experience may be engaged to assist with conducting the review. Consultants may include ad hoc scientific consultants, with expertise in the relevant area of research, or cultural consultants, with specialized