Procedure for Approving a Waiver or Alteration of the Consent Process and the Waiver of Consent Documentation - IRB PRO153

Abstract:
This procedure outlines the responsibilities of the investigator, OIRB and IRB for approving a waiver or alteration of the consent process and the waiver of consent documenation.
Effective Date:
3/1/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     PRO153
Effective Date:   3/30/07
Revision Date:  3/1/10
Subject:  Procedure for Approving a Waiver or Alteration of the Consent Process and the Waiver of Consent Documentation

PROCEDURE

Investigator Responsibilities

When requesting a waiver or alteration of the required elements of the informed consent process, an investigator submits the FOR208 Request for Waiver of Consent form. When requesting a waiver of the requirement to obtain written documentation of the informed consent process, an investigator submits the FOR235 Request for Waiver of Consent Documentation, including a written statement of the information that will be provided to the participant pertaining to the consent process for the research. (For relevant information to disclose to participants see POL013 UAB Policy on Elements of Informed Consent, the Informed Consent Process, and Documentation of Informed Consent; PRO113 Procedure for the Informed Consent Process and Documentation of Informed Consent; GUI304 Statement on Elements and Disclosures for Informed Consent Process.)

IRB Responsibilities

The IRB, or Experienced Reviewer for the Expedited Review Procedure:

  • Reviews research that proposes a waiver or alteration of the consent documentation;
  • Reviews a proposed consent procedure which does not include, or which alters, some or all of the requirements of informed consent process set forth in the federal regulations (45 CFR 46.116 (a) and (b));or
  • Waives the requirement to obtain informed consent provided the IRB finds and documents that:
    • The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (45 CFR 46.116(c));
      • Public benefit or service programs;
      • Procedures for obtaining benefits or services under those programs;
      • Possible changes in or alternatives to those programs or procedures; or
      • Possible changes in methods or levels of payment for benefits or services under those programs;
    • The research could not practicably be carried out without the waiver or alteration; and
    • The research is not subject to FDA regulation.
    • The research is not subject to DoD regulation or the Secretary has not approved a waiver (see GUI339).
  • Reviews and approves a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waive the requirements to obtain informed consent provided the IRB finds and documents that (45 CFR 46.116(d)):
    • The research involves no more than minimal risk to the participants;
    • The waiver or alteration will not adversely affect the rights and welfare of the participants;
    • The research could not practicably be carried out without the waiver or alteration;
    • Whenever appropriate, the participants will be provided with additional pertinent information after participation;
    • The research is not subject to FDA regulation;
    • The research is not subject to DoD regulation or the Secretary has not approved a waiver (see GUI339).
  • Waives Documentation of the Informed Consent Process:
    • After finding that all of the following are true before waiving the requirement for the investigator to obtain a signed informed consent document for some or all of the participants (45 CFR 46.117(c)(1)):
      • The only record linking the participant and the research would be the consent document;
      • The principal risk would be potential harm resulting from a breach of confidentiality; and
      • Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant’s wishes will govern; or
      • A written statement describing the research will be provided to participants (e.g., copy of consent document, study information sheet);
      • The research is not subject to FDA regulations; or
    • After finding all of the following are true (45 CFR 46.117(c)(2)) (21 CFR 56.109(c)(1)):
      • The research presents no more than minimal risk of harm to participants;
      • The research involves no procedures for which written consent is normally required outside of the research context;
    • Reviews a copy of the consent document or written statement of information for inclusion of all required and appropriate additional elements of disclosure;
    • Considers whether to require the investigator to provide subjects with a written statement regarding the research if one has not been submitted by the investigator.

OIRB Responsibilities

Senior Staff:

  • Ensures the IRB discussions and findings address the necessary federal regulation requirements as listed under the IRB responsibilities above;
  • Reviews the minutes of the IRB meeting to confirm the determinations of the IRB waiver have been recorded appropriately.

Administrative Staff:

  • Documents in the minutes that the IRB approved a waiver or alteration of the consent process or approved a waiver of the requirement to document consent;
  • Documents the protocol-specific reasons that the waiver(s) meet the criteria of the applicable federal regulations.

Approved on March 1, 2010, by:

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director