Procedure for Scientific/Scholarly Review of Protocols - IRB PRO138

Abstract:
This procedure outlines the responsibilities for the investigator, OIRB and IRB for scientific / scholarly review of protocols.
Effective Date:
4/20/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     PRO138
Effective Date:   3/30/07
Revision Date:  4/20/10
Subject:  Procedure for Scientific/Scholarly Review of Protocols

PROCEDURE

Investigator Responsibilities

An Investigator:

  • Completes and submits appropriate IRB Human Subjects Protocol (HSP) application forms and applicable materials for convened, expedited, or exempt review or Not Human Subjects Research designation;
  • Includes a clear, scientifically sound description of the hypothesis and procedures in the HSP;
  • Provides enough documentation to demonstrate the methodology and procedures are consistent with generally accepted scientific principles in the discipline;
  • Provides an adequate research design that contributes to the advancement of knowledge about corrections, if being conducted within the Bureau of Prisons (see GUI341);
  • Submits gene therapy panel or vaccine panel reviews, if applicable;
  • Submits departmental approval.

The Department Chair (or designee):

  • Completes departmental scientific review and approval (e.g., Protocol Oversight Review Form or departmental equivalent) for submission by the investigator.

OIRB Responsibilities

Administrative support staff:

  • Assigns protocols to Primary Review Teams for convened IRB review in chronological order received.

Senior staff:

  • Reviews all initial protocol submissions for Protocol Oversight Review Form or departmental equivalent.

IRB Responsibilities

Scientific members(s) of the Primary Review Teams (see PRO144 Procedure for Formation and Assignment of IRB Member Primary Review Teams):

  • Review each assigned protocol for scientific merit and scholarly validity with accompanying materials (see GUI308 checklist for new submissions for review by the convened IRB).

Other scientific member(s) assigned to the convened meeting:

  • Review the Human Subjects Protocol (HSP) and informed consent documents and may request delivery of a copy of the accompanying materials prior to the meeting or examine them at any time in the OIRB prior to the meeting.

If the scientific member of a Primary Review Team cannot adequately evaluate the scientific and scholarly validity of an assigned protocol:

  • (S)He may acquire sufficient knowledge to perform a scientific assessment through study of the relevant literature, discussions with colleagues, and contact with the principal investigator provided that the materials received for review are kept confidential; or
  • Notifies the Chair prior to the time the protocol is scheduled for presentation to the IRB or at the IRB meeting.
  • If notified before the meeting, the Chair decides whether to review the protocol, assign the protocol to another Primary Review Team, invite a consultant (see POL014 policy on, PRO114 procedure for IRB use of consultants) to assist in the review or invite the PI to be present during the discussion of the protocol.
  • If notified at the meeting, the IRB decides whether to review the protocol at the meeting, reassign it to another member for review at a later date, or invite a consultant to assist in the review.
  • For expedited review, protocol is reviewed for scientific merit and scholarly validity and if unable to assess, refers to the IRB Chair (or designee) for review or determination on consultant review.

Approved on April 20, 2010, by:

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director