Waivers of Consent
This page contains guidance for investigators on the regulatory criteria for waivers of informed consent, alterations of informed consent, and waivers of documentation of informed consent.
Waiver or Alteration of Informed Consent (45 CFR 46.116(f))
While the regulatory criteria for waivers and alterations of consent are generally the same, they reflect different processes.
Permits adjustments to the informed consent process. The most common application is the use of deception, misinformation, withholding of pertinent information, or disclosing at a later time.
There is no informed consent discussion and no informed consent documentation.
Regulatory Criteria for a Waiver or Alteration of Informed Consent
If requesting a waiver or alteration of informed consent, it is the responsibility of the investigator to justify (provide rationale) how each criterion are met. For research studies in which participants are prospectively enrolled, it’s generally assumed that participants are available and prospective consent is feasible. If requesting a waiver in this type of situation, the IRB requires thorough rationale for a waiver.
The research involves no more than minimal risk to subjects
Research procedures for which a waiver is requested must meet the regulatory definition of minimal risk, meaning: the “probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” If this criterion is not met, the waiver cannot be granted by the IRB.
The research could not be carried out practicably without the waiver or alteration
It is not a question as to whether it is possible to obtain consent from the subject or their LAR, but whether the study itself would be feasible to conduct without a waiver or alteration. Informed consent should never be waived for convenience, nor waived solely for reasons of cost or speed, if doing so dilutes the protection of subjects’ rights and welfare. The IRB may consider any of the following in relation to this criterion: a) Scientific validity would be compromised if consent was required; b) Ethical concerns would be raised if consent were required; c) There is a scientifically and ethically justifiable rationale why the research could not be conducted with a population from whom consent can be obtained.
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;
It must be explained why the study itself would be infeasible to conduct without using identifiable information / biospecimens.
The waiver or alteration will not adversely affect the rights and welfare of the subjects
The IRB may consider any of the following in relation to this criterion: a) Consider other Federal, state, or local laws that safeguard rights; b) Whether the subject population, in general, would consider that their rights were violated if they knew of the waiver/alteration; and c) Whether the subject population, in general, would consider that the waiver/ alteration has the potential to cause adverse consequences for their welfare or general well-being.
Where appropriate, the subjects or legally authorized representative will be provided with additional information about their participation.
The intent of this criterion is to require debriefing for participants in research that involves deception, misinformation, etc. The IRB may consider whether: A subject is included in research that exposes them to situations or conditions to provoke a response for research purposes, and the situation would not have ordinarily occurred; or Information is obtained during the course of the research that directly impacts on the safety or welfare of the subject.
HIPAA Regulated Research with a Waiver of Informed Consent
If the research involves PHI, then the investigator must also request a waiver of Written Authorization. Click below to access the HIPAA Waiver submission form.
Waivers for FDA Regulated Clinical Investigations
While FDA regulations do not permit a waiver or alteration of consent for FDA-regulated clinical investigations, apart from the exception from Informed Consent (EFIC) for Emergency Research, FDA guidance allows IRBs to waive or alter the informed consent requirements using the Common Rule criteria.
Waiver of Documentation of Informed Consent (45 CFR 46.117)
There are three criteria for a waiver of documentation of consent within the regulations. An IRB may waive the requirement for the investigator to obtain a signed informed consent form for participants. The IRB may still require the investigator to provide participants or legally authorized representatives (LAR) with a written statement regarding the research.
45 CFR 46.117(c)(1)(i)
“The only record linking the participant and the research would be the informed consent form AND the principal risk would be potential harm resulting from a breach of confidentiality. Each participant (or LAR) will be asked whether the participant wants documentation linking the participant with the research, and the participant’s wishes will govern.” This criterion may be applicable to research on sensitive or stigmatizing topics such as HIV, domestic violence, illegal activities, etc.
45 CFR 46.117(c)(1)(ii)
“The research presents no more than minimal risk of harm to participants AND involves no procedures for which written consent is normally required outside of the research context.” This criterion is often applicable to minimal risk survey, interview, and focus group research.
45 CFR 46.117(c)(1)(iii)
“The participants or LARs are members of a distinct cultural group or community in which signing forms is not the norm, the research presents no more than minimal risk of harm to participants, AND there is an appropriate alternative mechanism for documenting informed consent.” This criterion may be applicable to minimal risk research with indigenous populations or international research.