Assurance of Compliance with Department of Health and Human Services Policy on Protection of Human Subjects- PRO107   

Procedure

Investigator Responsibilities

Investigator:

• Forwards a copy of the approval form to the appropriate federal funding agency in a timely manner.

IRB Responsibilities

IRB and/or IRB Chair or designee:

• Determines all approval criteria are met prior to the issuance of the approval form.

OIRB Responsibilities

Director or designee:

• Serves as the the Human Subjects Protections Administrator;
• Prepares and maintains the Federalwide Assurance and all updates (e.g., membership changes, relationships with other IRBs) as required by the Assurance (see http://www.hhs.gov/ohrp/assurances/assurances_index.html#domestic):
  • Submits membership changes to OHRP after discussion and review by the Institutional Official (IO) and the IRB Chair;
  • Submits assurance updates to OHRP after discussion and review by the IO and the IRB Chair whenever changes to the assurance are required or every 5 years to prevent expiration (see http://www.hhs.gov/ohrp/humansubjects/assurance/renwfwa.htm);
  • Registers UAB’s on-campus IRBs with OHRP and submits membership changes to OHRP as required (see HHS - Registration of an Institutional Review Board (IRB) or Independent Ethics Committee (IEC)).
  • Maintains records of all assurance and IRB registration updates.

Administrative Staff:

• Updates the IRB web site with the current assurance information, including expiration dates, and maintains accurate and up-to-date IRB membership lists.
• Generates approval form from the IRB electronic system to sends to the investigators.
• Stores the approval form and applicable attachment in the electronic record.

Institutional Responsibilities

Institutional Official:

• Executes the assurance document and any updates.