Not Human Subjects Research Designation- PRO117   

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 (please note that research using decedent information may not be human subjects research, but any PHI may still be protected by the Privacy Rule), use of outdated blood products (from the Red Cross or other blood banks), or coded private information (OHRP, Guidance on Research Involving Coded Private Information or Biological Specimens) unless the sponsoring agency determines otherwise.

Investigator Responsibilities

• Submits 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 or appropriate information that can be used to access these applications in the electronic research administration system, if applicable;
  • Investigator Agreement;
  • Written policies and procedures for any bank or repository from which data or materials are sourced.
  • Other information or documentation that may be pertinent to the requested determination
• 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

Administrative staff:

• Receives the application for Not Human Subjects Research Designation.
• Assigns application to reviewer.
• Assures that the reviewer worksheet is saved in protocol record.

Reviewing staff:

• Reviews application to determine whether the activities are research and whether activities that are research involve human subjects.
• Uses UAB IRB reviewers guide to make determination (See GUI328).
• Requests additional information as necessary to complete review.
• Takes one of the following actions:
  • Determines the activity is or is not research involving human subjects; or
  • Requests more information.
• Documents the determination of Not Human Subjects Research.
• Notifies investigator of the designation or requests for revisions.