Waivers

Waiver of the Requirement to Obtain a Signed Informed Consent

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 that either:

  1. 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 (i.e., see 45 CFR 46.117 (c) (2); 21 CFR 56.109 (c) (1)) or
  2. the only record linking the subject and the research would be the informed consent document and the principal risk would be potential harm resulting from a breach of confidentiality (i.e., see 45 CFR 46.117 (c) (1))
    • Subject to granting a waiver of the requirement to obtain a signed informed consent based on this criterion, the IRB will require the principal investigator to ask each subject whether s/he wants documentation linking him/her to the research, and the subject’s wishes will govern.

The IRB will not waive the requirement to document informed consent based on criterion #2 if the research study is subject to the FDA regulations (21 CFR Parts 50, 56) governing human subject protections.

Upon granting a waiver of the requirement for obtaining a signed informed consent, the IRB reviews and approves the information that will be provided to potential subjects to obtain their verbal consent for study participation, and the procedure(s) that will be used by the investigators to document obtaining verbal consent.

IRB Documentation of Concurrence

Documentation of concurrence that a request for waiver to obtain written informed consent meets with the applicable regulatory requirements (45 CFR 46.117 (c), 21 CFR 56.109 (c)) is required of the IRB reviewer(s). The IRB reviewer utilizes the "Waiver to Obtain a Signed Consent" form found on the OSIRIS website. For full board protocols, the Full Board Research Review Coordinator documents that the applicable criteria have been met in the minutes. For expedited reviews, the Exempt/Expedite Research Review Coordinator documents that the applicable criteria have been met via electronic notification to the Vice Chair.

Waiver (or Alteration) of Informed Consent
 

Regulatory Requirements

The IRB requires that informed consent be sought from each prospective subject or the subject’s legally authorized representative prior to participation in research activities, with the following exceptions.

  1. The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or
  2. The IRB may waive the requirement to obtain informed consent if it finds and documents that the research activity meets the criteria for a 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
    • Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
  3. The IRB may also waive the requirement to obtain informed consent if it finds and documents that the research activity meets the criteria for a waiver of consent as addressed under 45 CFR 46.116 (c) This IRB does not typically receive requests of this type. If investigators wish to request this waiver, they should contact the IRB for further guidance.

The IRB does not waive the requirement to obtain informed consent if the research study is subject to the FDA regulations (21 CFR Parts 50, 56) governing human subject protections except for planned emergency research 21 CFR 50.24 see Chapter 16.

IRB Documentation of Concurrence

Documentation of concurrence that a request for waiver of informed consent meets with the applicable regulatory requirements (45 CFR 46.116)  is required of the IRB reviewer(s). The IRB reviewer utilizes the "Waiver of Informed Consent" form found on the OSIRIS website. For full board protocols, the Full Board Research Review Coordinator documents that the applicable criteria have been met in the minutes. For expedited reviews, the Exempt/Expedite Research Review Coordinator documents that the applicable criteria have been met via electronic notification to the Vice Chair.

Waiver of Consent for Planned Emergency Research

The IRB (subsequent to full-board review) 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 Consent for Abused or Neglected Children

The IRB may waive the requirement for parental consent 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).