Procedure for Policy Development and Communication for the Human Research Protection Program - IRB PRO110

Abstract:
This procedure lists the responsibilities delegated to the investigators, OIRB and IRB to ensure proper maintenance, development and use of IRB policies.
Effective Date:
10/24/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     PRO110
Effective Date:   3/30/07
Revision Date:  11/2/09, 3/1/10, 10/24/10
Subject:  Procedure for Policy Development and Communication for the Human Research Protection Program

PROCEDURE

Investigator Responsibilities

The Investigator:

  • Reviews UAB Human Research Protection Program policies and procedures posted on the IRB web site as part of biennial training;
  • Checks web site periodically in response to notifications of policy and procedure changes and revisions;
  • Asks for advice from the Office of the IRB or IRB when questions arise.

OIRB Responsibilities

The Senior Staff:

  • Routinely reviews the OHRP and FDA web sites for issuance of new regulations, guidance, and communications from these agencies;
  • Attends staff meetings and IRB meetings to assess need for new or revised policies;
  • Arranges for or provides educational sessions to IRB members and staff on current policies and procedures;
  • Provides regular input to the IRB Chair and OIRB Director on the need for policy review and development;
  • Relies on IRB policies and procedures when reviewing human research proposals.

The Administrative Staff:

  • Relies on IRB policies and procedures when reviewing human research proposals;
  • Consults with senior staff for guidance on applying policies and procedures;
  • Refers any policy that is outdated or no longer applicable to senior staff;
  • Posts and maintains policies and procedures on UAB’s Policy and Procedure Library website (http://sppublic.ad.uab.edu/policies/Pages/default.aspx) including newly developed and recently revised policies and procedures;
  • Posts general information and summaries of the changes to the policies and procedures as well as the link to the Policy and Procedure Library on the IRB’s website.
  • Sends email to all investigators and research personnel listed on active or pending protocols, Deans and Department heads including Senior Administrators when new or updated policies are developed and posted;
  • Copies the email to the Office of Grants and Contracts Administration (OGCA) for distribution to the Research Administration Listserve maintained by OGCA.
  • Emails notifying UAB personnel will include in the subject line – IRB Policy and Procedure Information.
  • Maintains and keeps abreast of IRB policies and procedures.

The OIRB Director:

  • Brings the need for policy and procedure review or development to the attention of the Institutional Official;
  • Ensures all policies and procedures are posted on UAB Policies and Procedures Library website http://sppublic.ad.uab.edu/policies/Pages/default.aspx with a link to the Library on the IRB website;
  • Ensures notification on newly developed and recently revised policies and procedures is posted in the UAB eReporter.

IRB Responsibilities

The IRB Member:

  • Keeps abreast of IRB policies and procedures;
  • Provides input on the need for policy review and development.

The IRB Chair:

  • Brings the need for new and revised policies and procedures to the attention of the Institutional Official.

Institutional Responsibilities

The Institutional Official:

  • Meets at least quarterly with the IRB Chair and OIRB Director, to address the need for updating policies and procedures;
  • Ensures all policies and procedures are reviewed and updated every 5 years;
  • Appoints or authorizes individuals to develop new policies and procedures;
  • Approves all policies and procedures not requiring approval by the President under UAB Policy on Policy Development and Communication for the Human Research Protections Program (see POL010).

Approved on October 29, 2010 by:

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director