Procedure for Not Human Subjects Research Designation - IRB PRO117

Procedure for Not Human Subjects Research Designation - IRB PRO117

Abstract:
This procedure describes how human materials or data not involving human subjects may be classified as Not Human Subjects Research.
Effective Date:
11/2/2009
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     PRO117
Effective Date:   3/30/07
Revision Date:  11/2/09
Subject:  Procedure for Not Human Subjects Research Designation

PROCEDURE

This procedure describes how human materials or data not involving human subjects under the definition of 45 CFR Part 46 and 21 CRF Part 56 may receive a designation of "Not Human Subjects Research." Use of the Not Human Subjects Research designation is applicable to research activities that involve cadaver materials, use of outdated blood products (from the Red Cross or other blood banks), commercially available cell lines, or coded private information (OHRP, Guidance on Research Involving Coded Private Information or Biological Specimens) unless the sponsoring agency determines otherwise.

Investigator Responsibilities

The Investigator:

  • Submits one copy of the following materials to the OIRB:
    • Completed FOR202 Application for Not Human Subjects Research Designation, including the faculty advisor/course instructor signature if the investigator is a student;
    • Grant or funding application, if applicable;
    • Investigator Agreement;
    • Written policies and procedures for repository.
  • Responds to all requests for more information from the OIRB.
  • Submits any changes to the protocol during the course of the research by resubmitting the Application for Not Human Subjects Research Designation. The investigator may not initiate any changes prior to OIRB review and approval.

OIRB Responsibilities

Clerical staff:

  • Documents receipt of Application for Not Human Subjects Research Designation;
  • Enters information into the database;
  • Forwards application to senior staff member.

Senior staff:

  • Reviews application to determine whether the activities are research and whether activities that are research involve human subjects;
  • Uses UAB IRB reviewers guide for determination (See GUI328);
  • Requests additional information as necessary to complete above review;
  • Takes one of the following actions:
    • Determines the activity is or is not research involving human subjects;
    • Requests more information;
    • Refers to the IRB chair or designee for a determination.
  • Documents the determination of Not Human Subjects Research, completes, signs, and dates worksheet;
  • Notifies investigator in writing of approvals, requests for revisions, and deferrals.
  • Scans all application materials and files determinations 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 November 2, 2009, by:

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director