Waivers

Waiver of the Requirement to Obtain a Signed Informed Consent (45 CFR46.117) - Regulatory Requirements

Following expedited or full-board review, the IRB may waive the requirement to obtain a signed consent form for some or all subjects if it finds any of the following:

  • The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. In this case, each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern. Note: This waiver provision is not applicable to research governed by FDA regulations, and the IRB will not approve such alterations or waivers for FDA regulated research.
  • The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. In cases where documentation requirements are waived. Note: This waiver provision can be utilized for FDA regulated research as set forth in 21 CFR 56.109.
  • 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 there is an appropriate alternative mechanism for documenting that informed consent was obtained (45 CFR 46.117(c)(1)(iii).
  • In cases in which the documentation requirement is waived, the IRB may require the study team to provide subjects with a written statement regarding the research (45 CFR 46.117 (c)(2).

Waiver (or Alteration) of Consent in Research Involving Public Benefit and Service Programs Conducted by or Subject to the Approval of State or Local Law Officials

Regulations at 45 CFR 46116(e)(3) permit an IRB to approve a consent procedure that eliminates or alters the required elements of informed consent, or to waive the requirement to obtain informed consent. In order to approve such a waiver or alteration, the IRB must find and document that:

  1. The activity constitutes a research or demonstration project that 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; (a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs; and
  2. The research could not practicably be carried out without the waiver or alteration.

General Waiver or Alteration of Consent

The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent. In addition, the IRB may waive the requirement to obtain informed consent if it finds and documents that the research activity meets the criteria for waiver of consent as addressed under 45 CFR 46.116(d) as follows:

  • The research involves no more than minimal risk to the subjects;
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  • The research could not practicably be carried out without the waiver or alteration; and
  • For research that involves using identifiable private information or identifiable biospecimens, that the research could not practicably be carried out without using such information or biospecimens in an identifiable format.
  • Whenever appropriate, the subjects will be provided with additional pertinent information after participation

Waiver of Consent For Minimal Risk FDA Regulated Research

FDA issued guidance in July 2017 permitting IRBs to waive or alter the informed consent requirement for minimal risk investigations in which obtaining informed consent is not practicable. The IRB will consider the following criteria for FDA regulated research when determining whether a waiver or alteration is appropriate:

  • The clinical investigation involves no more than minimal risk (as defined in 21 CFR 50.3(k) or 56.102(i)) to the subjects;
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  • The clinical investigation could not practicably be carried out without the waiver or alteration; and
  • Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Research Involving Deception

Deception research involves social science research in which the subject is not told, or is misled, about the true purpose of the research. Where deception is involved, the IRB needs to be satisfied that the deception is necessary and that, when appropriate, the subjects will be debriefed. If the debriefing itself would cause an unreasonable risk of harm without some type of benefit, the IRB may consider it to be inappropriate.

Deception can only be permitted where the IRB documents that an alteration of informed consent requirements is justified under the criteria at 45 CFR 46.116(f). In making the determinations to approve the use of deception under an alteration of informed consent, the IRB will consider each criterion, and document specifically how the proposed research satisfies that criterion. Note: the regulations make no provision for the use of deception in research that poses greater than minimal risk to subjects.

Screening, Recruiting, or Determining Eligibility (45 CFR 116(g)

An IRB may approve a research proposal in which an investigator will obtain information or biospecimens for purposes of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject or the subject’s legally authorized representative, if either of the following conditions is met:

  • The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
  • The investigator will obtain identifiable information or identifiable biospecimens by accessing records or stored identifiable biospecimens.

Exception from Informed Consent for Planned Emergency Research

The IRB may approve a research study without requiring that informed consent of all research subjects be obtained if it finds and documents that the research activity meets the criteria for an exception to the requirement to obtain informed consent for emergency research as addressed under planned emergency research regulations found at 21 CFR 50.24.  See Chapter 16.

Waiver of Parental Permission for Abused or Neglected Children

The IRB may also waive the requirement for parental permission if it determines that the research study is designated for conditions or for a subject population (e.g., neglected or abused children) for which parental or guardian permission is not a reasonable requirement to protect the subjects (see Chapter 14 and also refer to 45 CFR 46.408).

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