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 issued guidance on July 25, 2017 to align the FDA’s policy on waiving informed consent requirements for minimal-risk research in certain circumstances. 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; or
If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

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.