Library Document Details

Procedure for Reviewing and Signing of Independent Investigator Agreements - IRB PRO156

Abstract:
This procedure details the responsibilities of the investigator, OIRB, IRB and the institution for reviewing and signing of independent investigator agreements.
Effective Date:
9/16/2013
Responsible Party:
Contacts:
IRB
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document: PRO156

Effective Date: 11/05/09

Revision Date: 9/16/13

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 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;
  • Drafts, reviews, signs letters on behalf of the IRB to the principal investigator;
  • Issues signed IIA to investigator.

Administrative staff:

  • Distributes amendment materials to IRB in accordance with (see PRO145 Procedure for Timing of document Distribution for IRB Meetings);
  • Notes the determination of the convened IRB review in the minutes;
IRB Responsibilities

IRB

  • Reviews the Project Revision/Amendment Form and IIA(s);
  • Makes a determination regarding approval of the amendment and the IIA(s).

Chair or designee

  • Signs (executes) the IIA.
 

Institutional Responsibilities

Institutional Official:

  • Signs (executes) the IIA; or
  • Delegates the authority to the Chair or designee.

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 on September 25, 2013 by:

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

    Ferdinand Urthaler, MD
    IRB Chair

    Jonathan Miller, MPPA, CIP
    OIRB Director