1.19 IRB Signature Authority

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for granting signature authority for Office of Regulatory Affairs (ORA) and IRB 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 Institutional Official (IO), 2) IRB authorization agreements after review and approval by 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 Analysts 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 Analysts have the authority to sign: 1) IRB review letters, 2) IRB approval letters, and 3) other IRB correspondence as necessary. In exercising this authority, the IRB Analysts 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. IRB Associates have the authority to sign routine ORA correspondence, but not correspondence on behalf of the IRB (such as IRB review letters).

DOCUMENT HISTORY:

 Written: 12/28/2015 (Approved: 12/28/2015) - original author not recorded

 Revised: 1/2/2018 - revision not documented

 Revised: 10/7/2022 – clarified that Exec Chair can sign authorization agreements after review and approval by the IO; stylistic changes; correct typos; rename Office Assistant as IRB Associate. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/14/2022