Procedure for Identification and Communication of Human Subjects Research to UAB-Affiliated Performance Sites - IRB PRO152

Abstract:
This procedure outlines the responsibilities of the investigator, OIRB and IRB for identification and communication of human subjects research to UAB-affiliated performance sites.
Effective Date:
1/25/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     PRO152
Effective Date:   3/30/07
Revision Date:  1/25/10
Subject:  Procedure for Identification and Communication of Human Subjects Research to UAB-Affiliated Performance Sites

PROCEDURE

Investigator Responsibilities

The Investigator:

  • Includes a list of all UAB-affiliated performance sites in the Human Subjects Protocol (HSP) for review by the IRB;
  • Notifies performance sites of intent to perform research;
  • Provides written documentation of site’s willingness to serve as a performance site and/or IRB approval;
  • Submits modifications to the HSP adding and removing performance sites as they occur;
  • Informs and trains, as necessary, all performance site personnel who are involved in the research regarding research procedures;
  • Provides IRB approval to performance sites, as requested.

OIRB Responsibilities

The Senior Staff:

  • Reviews IRB submission and funding application to identify and ascertain concordance in all documents pertaining to performance sites;
  • Documents performance sites on protocol review checklist;
  • Verifies that investigator has submitted appropriate documentation for performance sites (for some studies performed with the Jefferson County Department of Health, the investigator may have to provide IRB approval and/or documentation of site’s willingness to serve as a performance site);
  • Requests appropriate documentation from investigator regarding performance site, if not included with the protocol submission materials;
  • Makes notation of additional performance site(s) in IRB database, as necessary.

The Administrative Staff: 

  • Examines HSP for performance site listings;
  • Enters other performance sites into IRB database;
  • Provides requested reports to UAB-affiliated performance sites;
  • Sends IRB protocol approval to investigator.

The Clerical Staff:

  • Enters in IRB database other performance sites as instructed by administrative and/or senior staff.

IRB Responsibilities

The Primary Reviewer, or experienced reviewer for expedited review procedure review:

  • Reviews IRB submission and funding application to identify and ascertain concordance in all documents pertaining to performance sites;
  • Verifies that investigator has submitted appropriate documentation for performance sites.

Approved on March 1, 2010, by:

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director