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

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 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

Administrative Staff:

• Receives and documents receipt of FOR239 in the electronic system.
• Assigns application to reviewing staff for review.

Reviewing Staff

• Reviews FOR239 to determine whether the activity is research involving human subjects.
• Takes one of the following actions:
  • Requests more information; or
  • Refers to the IRB Chair or designee for a determination.
• Documents the determination of Not Human Subjects Research.
• Notifies investigator of requests for revision, or determination.

IRB Responsibilities

Chair or designee:

• Determines whether the activity is Not Human Subjects Research (Uses UAB IRB reviewers guide for determination (See GUI328)).