The Investigator:

• Forwards a copy of the formal signed approval form—“Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption (Common Rule)” OMB No. 0990-0263, (also called Form 310; see http://www.hhs.gov/ohrp/humansubjects/assurance/OF310.rtf)—to appropriate federal funding agency in a timely manner.

The IRB Chair or designee:

• Reviews and signs the approval form;
• Returns signed approval form and applicable attachments to administrative staff for processing and filing.

The OIRB Director:

• 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 3 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)).

The Administrative Staff:

• Maintains records of all assurance and IRB registration updates;
• 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 database and includes it in the protocol file for issuance;
• Issues original signed approval form to investigators;
• Includes copy of signed approval form in the protocol file. 

Institutional Responsibilities

The Institutional Official:

• Executes the assurance document;
• Executes assurance updates.

Approved on March 1, 2010, by:

Richard B. Marchase, PhD
Vice President for Research and Economic Development

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director