UAB Policy on Waiver, Alterations, and Exceptions to Informed Consent; Waiver of Documentation of Informed Consent - IRB POL036

UAB Policy on Waiver, Alterations, and Exceptions to Informed Consent; Waiver of Documentation of Informed Consent - IRB POL036

Abstract:
This policy describes the exceptions to beginning human subjects research without informed consent. Links to corresponding procedures are included within the document.
Effective Date:
9/24/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     POL036
Effective Date:   3/30/07
Revision Date:  2/17/10, 9/24/2010
Subject:  UAB Policy on Waiver, Alterations, and Exceptions to Informed Consent; Waiver of Documentation of Informed Consent

POLICY STATEMENT

It is UAB policy that no investigator may involve a human being as a subject in research before the investigator has obtained and documented the legally effective informed consent of the subject or the subject’s legally authorized representative unless federal regulations or policies provide for a waiver, alteration, or exception to the informed consent process or waiver of documentation of consent. For investigations subject to FDA jurisdiction, the FDA has made no provision for waiver of informed consent by the IRB. Therefore, research subject to FDA regulation will include an informed consent process unless the research qualified for an FDA exception. The IRB may waive documentation of informed consent in accordance with FDA regulations and this policy. (See also PRO153 Procedure for Approving a Waiver or Alteration of the Consent Process and the Waiver of Consent Documentation; PRO119 Procedure for Waiver to Informed Consent Process in Research Planned for Emergency Settings.)

For research falling under the Department of Defense (DoD) Addendum, see GUI339 Guidance for Department of Defense (DoD) Component Sponsored Research Being Conducted by UAB.

For research falling under the Department of Education 34 CFR 99, see SUP428 FERPA (Family Educational Rights and Privacy Act): Understanding the Privacy of Student Records and GUI345 Family Educational Rights and Privacy Act (FERPA) and Pupil Rights Amendment (PPRA) Guidance.

For non-FDA-regulated research the IRB may waive or alter informed consent requirements only if it finds and documents the criteria listed in 45 CFR 46.116 (c) or (d) are satisfied as well as any other applicable regulations of sponsoring federal agencies and state and local laws and regulations.

The IRB may waive the requirement for the investigator to obtain a signed informed consent document for some or all subjects if it finds that:

  • The only records linking the subject and the research would be the consent document; the principal risk would be potential harm resulting from a breach of confidentiality; and the research is not regulated by the FDA. Each subject will be asked whether (s)he wants documentation linking the subject with the research, and his/her wishes will govern; or
  • The research meets the FDA requirements for emergency research under 21 CFR 50.24 (see POL021 UAB Policy on Use and Investigation with Drugs, Biologics, Devices or Test Articles under FDA Regulations); or
  • The research presents no more than minimal harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

When requesting a waiver of the requirements to obtain written documentation of the consent process, the investigator will submit to the IRB a written statement of the information that will be provided to the participant. The IRB will review this information for inclusion of all required and appropriate additional elements of disclosure.

Approved on October 29, 2010, by:

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

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director