HRPP policies & procedures manual

106: Signature and designee authority

1. Purpose

The purpose of this policy is to describe signature authority for IRB actions.

2. Policy

The chairperson, ORA director and specifically designated individuals (for example, the IRB coordinator) are authorized to sign any and all documents in connection with the review and approval of research projects involving the use of humans as subjects, which have been reviewed and approved pursuant to WSU policies and procedures.

3. Specific policies

3.1 Authorization for signatory authority

Authorization to sign documents not described in this policy may be made in writing to the ORA director. 

3.2 Chair designee

The chair may authorize experienced members of the IRB to act as his/her designee.  Authorizations may be made in writing. A designee is an IRB member recognized by the IRB chair, who has a minimum of six (6) months experience on the IRB. An experienced member is one who has demonstrated a consistent and comprehensive pattern of review of assigned protocols as an IRB member and has demonstrated a dedication to the protection of human subjects with his/her actions and comments.

3.3 Results of reviews, actions and decisions

Exempt, expedited, or full-board, initial, or continuing review, as well as amendment approvals, may be signed by the ORA director or the IRB coordinator.

3.4 Conducting IRB business

Any letters, memos, or e-mails between the IRB and/or ORA, and/or members of the faculty or staff of the University that provide information concerning the review of research protocols by the IRB or staff may be signed by an IRB staff member. The IRB staff may correspond with external individuals and agencies on behalf of the ORA director or IRB chair and/or members. The ORA director, IRB chair and IRB staff will adhere to all institutional signature authority policies.

4. Applicable regulations and guidelines

45 CFR 46.103, 46.115

5. Forms


6. Procedures employed to implement this policy & assignment of responsibility

ORA director,
chairperson or
IRB coordinator
Establish signature authority delegation based on nature of documents
being signed.
Sign all documents related to the review and approval of research
projects and correspondence with external agencies.
IRB coordinatorSign routine internal correspondence or actions taken by chairperson if
authorized to do so by the chairperson.