Procedure for Request for Documentation Regarding Use of Established Human Cell Lines Not Requiring IRB Review - PRO157

Procedure for Request for Documentation Regarding Use of Established Human Cell Lines Not Requiring IRB Review - PRO157

Abstract:
This procedure describes how investigators may request documentation from the OIRB that the research involving the use of human cell lines in vitro or in research animals does/did not require IRB review and approval.
Effective Date:
5/9/2011
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     PRO157
Effective Date:        5/9/11
Revision Date:          
Subject:                   Procedure for Request for Documentation Regarding Use of Established Human Cell Lines Not Requiring IRB Review

This procedure describes how investigators may request documentation from the OIRB that the research involving the use of human cell lines in vitro or in research animals does/did not require IRB review and approval.  Documentation may be required by the funding agency or journal.  This procedure is applicable only for research using already derived and established human cells lines from which the identity of the donor(s) cannot readily be ascertained by the investigator.  In such cases, the research is not considered human subjects research and is not governed by the HHS or FDA human subject protection regulations appearing at 45 CFR Part 46 and 21 CFR Parts 50 and 56.

Investigator Responsibilities

  • Submits one copy of the completed FOR239 "Application for Request for Documentation Regarding Use of Established Human Cell Lines Not Requiring IRB Review”;
  • Responds to all requests for more information from the OIRB.

OIRB Responsibilities

Clerical staff:

  • Documents receipt of FOR239;
  • Enters information into the database;
  • Forwards application to senior staff member.

Senior staff:

  • Reviews FOR239 to determine whether the activity is research involving human subjects;
  • Takes one of the following actions: 
    • Determines the activity is or is not research involving human subjects (Uses UAB IRB reviewers guide for determination (See GUI328);
    • Requests more information;
    • Refers to the IRB Chair or designee for a determination.
  • Documents the determination of Not Human Subjects Research;
  • Notifies investigator in writing of approval, requests for revision, and deferrals;
  • Scans all applicable materials and files determination in the IRB records.

IRB Responsibilities

Chair or designee:

  • Assists senior staff in determination of Not Human Subjects Research designation upon request of senior staff.

Approved on May 9, 2011 by:  

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director