1.19 IRB Signature Authority

1.0 Purpose

The purpose of this policy and procedure is to describe Organization’s requirements for granting signature authority for ORA correspondence.

2.0 Policy

It is the Organization’s policy that the IRB Executive Chair, the IRB Chairs and Vice-Chairs and qualified IRB staff will have appropriate signature authority on behalf of the ORA and the IRB.

3.0 Procedures

The following individuals have signature authority as indicated below:

3.1. IRB Executive Chair has the authority to sign: 1) HRPP policies in conjunction with the IO, 2) IRB authorization agreements on behalf of the IO, 3) IRB review letters, 4) IRB approval letters, and 5) all other IRB correspondence as necessary.

3.2. IRB Chairs and Vice-Chairs have the authority to sign: 1) IRB review letters, 2) IRB approval letters, and 3) all other IRB correspondence as necessary.

3.3. IRB Expedited Reviewers (including IRB Administrators who are also voting IRB members) have the authority to sign: 1) IRB expedited review letters, and 2) other related IRB correspondence as necessary.

3.4. IRB Administrators have the authority to sign: 1) IRB review letters, 2) IRB approval letters, and 2) other IRB correspondence as necessary. In exercising this authority, the IRB Administrators will consult the IRB Executive Chair, chairs and vice-chairs or other IRB members as necessary and may refer IRB review letters or other correspondence to the IRB Executive Chair for signature.

3.5. Office Assistants have the authority to sign routine ORA correspondence, but not correspondence on behalf of the IRB (such as IRB review letters).

ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED JANUARY 2, 2018

 INITIAL DECEMBER 28, 2015