HRPP Document: PRO156

Effective Date: 11/05/09

Revision Date: —

Subject: Procedure for Reviewing and Signing of Independent Investigator Agreements (IIA)

PROCEDURE

Investigator Responsibilities

The Investigator:

• Submits one copy of the following materials to the OIRB:
  • Completed Project Revision/Amendment Form;
  • Signed Independent Investigator Agreement (IIA).
• Responds to all requests for more information from the OIRB.
• Submits any changes to the IIA during the course of the research to the IRB for review and approval. The investigator may not initiate any changes prior to OIRB review and approval.

OIRB Responsibilities

Clerical staff:

• Documents receipt of the Project Revision/Amendment Form and IIA;
• Enters information into the database;
• Forwards application to senior staff member;
• Files e-mail from IO giving signature authority to Chair or designee;
• Files IIA and approval form in the IRB protocol file;
• Files a copy of the IIA in the Master File for IIAs;

Senior staff:

• Reviews Project Revision/Amendment Form and IIA;
• Requests additional information as necessary to complete above review;
• Refers to the convened IRB for review:
• Refers submissions for entry into IRB database;
• Reviews modification prior to meeting;
• Takes notes on IRB determination along with technical writer;
• Documents the IO has given signature authority to sign and date the IIA;
• Prints e-mail from IO giving signature authority to Chair or designee;
• Drafts, reviews, signs letters on behalf of the IRB to the principal investigator;
• Issues signed IIA to Investigator.

Administrative staff:

• Notifies the IO of the IRB determination and sends the IIA for signature; or
• Notifies the IO by e-mail of the IRB’s determination and requests signature authority for the IIA(s).

Institutional Responsibilities

Institutional Official:

• Signs (executes) the IIA; or
• Responds to the e-mail of the IRB’s determination and request for designee to sign the IIA(s).

Note: For this procedure the designees for signature authority for the IO will be the IRB Chair, Vice-Chair, or Director, Office of the IRB.

Approved November 5, 2009, by:

Richard B. Marchase, PhD
Vice President for Research and Economic Development

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director