Review and Signing of Independent Investigator Agreements- PRO156   

procedure
 

Investigator Responsibilities

• 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

Administrative staff:

• Documents receipt of the submission containing an IIA.
• Assigns the application to a member of the reviewing staff.
• Uploads a copy of the IIA in the Master File for IIAs.
• Distributes the submission materials for review at a convened IRB meeting or by the expedited review procedures;
  • Documents the determination in the IRB meeting minutes for convened review or directly in the electronic research administration (ERA) system for expedited review.

Reviewing Staff:

• Reviews submission and IIA.
• Requests additional information as necessary to complete above review.
• Forwards the submission for expedited review, and concurrently forwards the IIA to the appropriate signatory official;
• If necessary, refers to the convened IRB for review;
  • Refers submissions for entry into ERA system;
  • Reviews modification prior to meeting; and
  • Takes notes on IRB determination along with administrative staff.
• Drafts, reviews, and issues approval letter on behalf of the IRB to the principal investigator.
• Issues signed IIA to investigator.
• Uploads IIA and approval form in the protocol record in the electronic database.

IRB Responsibilities
 

IRB Chair or designee

• Reviews the submission and IIA(s);
• Makes a determination regarding approval of the submission and the IIA(s).

Institutional Responsibilities

• Institutional Official or designee signs (executes) the IIA.

NOTE: For this procedure the designee for signature authority for the IO will be the Assistant Vice President for Research Regulatory Oversight