Waiver or Alteration of the Consent Process and the Waiver of Consent Documentation- PRO153   

Procedure
 

Investigator Responsibilities

When requesting a waiver or alteration of the required elements of the informed consent process, an investigator completes the Waiver or Alteration of the Informed Consent Process section of FOR200 IRB application eForm. When requesting a waiver of the requirement to obtain written documentation of the informed consent process, an investigator completes the Request for Waiver of Consent Documentation section of the IRB application eForm, including a written statement or script 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:

• 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 (b) and (c));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(e));
    • 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;

The research is not subject to FDA regulation (or is consistent with the July 2017 guidance title, IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More than Minimal Risk to Human Subjects; and

• 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(f)):
  • 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;
  • If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
  • 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)):
    • 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;
    • Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant’s wishes will govern;
    • 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;
    • 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;

OR

• If the subjects legally authorized representatives are members of a distinct cultural group or community in which signing consent forms ins not the norm, that 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.

• 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

Reviewing Staff:

• Reviews the minutes of the IRB meeting to confirm the determinations of the IRB waiver have been recorded appropriately.
• Ensures that waivers are documented appropriately in the electronic research administration system, when issuing documentation of expedited approvals.

Administrative Staff:

• Ensures the IRB discussions and findings address the necessary federal regulation requirements as listed under the IRB responsibilities above;
• Documents the protocol-specific reasons that the waiver(s) meet the criteria of the applicable federal regulations.
• Documents in the minutes for convened review protocols that the IRB approved a waiver or alteration of the consent process or approved a waiver of the requirement to document consent.