OBJECTIVE:

To describe the responsibilities of the members of the IRB, including Primary and Secondary Reviewers.

DESCRIPTION:

The following persons have direct responsibilities on behalf of the VCU IRB, including those described below:

A.   The Responsibilities of Primary Reviewers include:

At Full Board Reviews…

·         conducting a full review of all materials related to the assigned protocol,

·         contacting the Panel Coordinator and/or Chairperson if additional expertise/consultation may be necessary,

·         conducting informal queries of the Principal Investigator and/or other experts in order to provide a thorough review,

·         preparing for and leading the discussion of the protocol, the complete grant application (as applicable), and whether the research meets the criteria for IRB approval,

·         coordinating review comments/questions with the secondary reviewer, if appropriate, and;

·         presenting specific recommendations for panel action, including changes and/or questions in written form (where appropriate) to the Panel Coordinator.

Exempt and Expedited Reviews…

·         conducting a full review of all materials related to the assigned protocol,

·         conducting informal queries of the Principal Investigator and/or other experts in order to provide a thorough review,

·         presenting clear and concise requirements/recommendations for changes and/or questions in written form (by email or otherwise) to the Panel Coordinator.

·         determining whether the rsearch meets the criteria for IRB approval (of exempt/expedited research)

B.   Secondary Reviewers:

At Full Board Reviews…

·         conducting a full review of all materials related to the assigned protocol,

·         contacting the Panel Coordinator and/or Chairperson if additional expertise/consultation may be necessary,

·         conducting informal queries of the Principal Investigator and/or other experts in order to provide a thorough review,

·         preparing for and leading the discussion of the informed consent document or alternative document/request and recruitment procedures,

·         discussing pertinent review comments/questions with the primary reviewer, if appropriate, and;

·         presenting specific recommendations for panel action, including changes and/or questions in written form (where appropriate) to the Panel Coordinator. [NOTE:  Secondary reviewers are asked to record any scripted (specific) changes requested/required directly on his/her copy of the documents and provide the marked copy to the Panel Coordinator following the final vote.]

Exempt and Expedited Reviews:

·         Not Applicable

C.   All IRB Members:

Responsibilities of all IRB members include the following:

·         completing all required VCU human subject protections training and seek additional training where necessary to maintain an effective understanding of human subjects regulations,

·         serving as primary or secondary reviewer when requested by the Chairperson/Coordinator,

·         conducting a review of all materials in the agenda packet in enough depth to be familiar with the protocol and prepared to participate in discussion of the protocol

·         participating in appropriate discussions, and motioning and/or voting to approve, disapprove, require modifications, or table each submission during the IRB meetings.

·         providing prior notice of intention to resign from the IRB, if necessary, the ORSP Director, to the Panel Chairperson, the Senior Chairperson, Chairperson of their department (if applicable), or the Associate Vice President for Research,

·         providing prior notice of unavailability to attend the IRB Panel meeting to the Chairperson and IRB Panel Coordinator AND CONTACTING assigned alternate to ensure coverage at the meeting (provide packet to alternate, as appropriate).

RESPONSIBILITY:

It is the responsibility of each panel member (reviewer) to ensure that the obligations described above are met.

REFERENCES:

None listed.