DETERMINING WAIVER OF CONSENT REQUIREMENTS

KEY POINTS

Waiver or Alteration of Regulatory Elements of Informed Consent

• For research that is no more than minimal risk the IRB may approve a request to waive some or all of the required elements of informed consent required under the Common Rule (45 CFR 46) under specific circumstances.  
• To waive in full or to alter informed consent elements, the IRB must determine that:
  • The research involves no more than minimal risk to subjects;
  • The research could not be carried out practicably without the waiver or alteration;
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects; and,
  • Where appropriate, the subjects will be provided with additional information about their participation.  
    • Note: The intent of this waiver criterion is to require debriefing for participants in deception research
  • Under the 2018 Common Rule, there is an additional requirement for the IRB approval of an informed consent waiver request:
    • If the research involves identifiable private information or identifiable biospecimens, this research could not be carried out practicably without using the information/specimen in an identifiable form.
• A full waiver of consent involves a waiver of both the elements and the documentation of consent. This type of waiver is typically used for studies involving the secondary analysis of existing data.
• A Waiver of Consent determination is not required when requesting permission to waive or alter non-regulatory sections of the consent, including additional sections present in the NCI informed consent template, although IRB approval is still needed.  
• The regulatory elements of consent include:
  • Basic Elements 
    • A Statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental
    • A description of any reasonably foreseeable risks or discomforts to the subject
    • A description of any benefits to the subject or to others which may reasonably be expected from the research
    • A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
    • A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
    • For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtained
    • An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject
    • A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled
    • One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
      • A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used  for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility
      • A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
  • Additional Elements as Appropriate
    • A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable
    • Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s or legally authorized representative’s consent
    • Any additional costs to the subject that may result from participation in the research
    • The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject
    • A statement that significant new findings developed during the course of the research that may relate to the subject’s willingness to continue participation will be provided to the subject
    • The approximate number of subjects involved in the study
    • A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit
    • A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions
    • For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen)

Waiver or Alteration of Regulatory Elements Example:  

• The research design is such that participants must be left unaware of the actual purpose of the study because their responses might be biased if they knew in advance what the investigators were actually studying.

Waiver of Documentation of Consent

• For some research projects, the IRB may approve a request to waive the documentation of informed consent. This means that the study team must provide a subject with the required consent information, but the study team is not required to obtain the subject's signature on the informed consent document. 
• To waive documentation of informed consent, the IRB must determine that:
  • The signature on the informed consent document would be the only record linking the subject to the research and the principal risk of harm to the subject would be a breach of confidentiality; or
  • The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context.  For example, minimal risk research that involves surveys/interviews conducted via telephone or online; or
  • Where the participants are members of a cultural group in which signing forms is not a normal/acceptable practice.
• Waiver of Documentation of Consent Examples:  
  • A research study enrolling participants who are members of a distinct cultural group or community who do not normally sign forms.
  • A study of illicit drug use in young adults, where the only record linking the participants to the study is the informed consent.
  • In rare cases, research in emergency settings.