Library Document Details

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

Abstract:
This procedure lists the responsibilities delegated to the Investigator, OIRB and IRB for ensuring that the university complies with DHHS policy on the protection of Human Subjects.
Effective Date:
3/1/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     PRO107
Effective Date:   3/30/07
Revision Date:  3/1/10
Subject:  Procedure for Assurance of Compliance with Department of Health and Human Services Policy on Protection of Human Subjects

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.

IRB Responsibilities

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.

OIRB Responsibilities

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