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Washington State University

HRPP policies & procedures manual

701: Waivers of informed consent

1. Purpose

This policy describes the requirements for waiver of some or all the elements of informed consent procedures and waiver of requirements for obtaining informed consent.

2. Policy

The IRB may approve a consent procedure that does not include, or which alters, some or all of the elements of informed consent or may waive the requirement to obtain informed consent if the IRB finds that the research meets specific criteria.

3. Specific policies

3.1 IRB waives one or more requirements of informed consent

The IRB may approve a consent procedure that does not include or which alters some or all of the elements of informed consent, or waives the requirement to obtain informed consent provided the IRB finds and documents that:

  1. 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:
    • 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
  2. The research could not practicably be carried out without the waiver or alteration, as in prospective emergency research conducted under 21 CFR 50.24, when time may not permit informed consent.
  • Note: The IRB does not approve waiver of the consent process for research that is subject to FDA regulations, except for planned emergency/acute care research as provided under FDA regulations.

Or that:

  1. The research involves no more than minimal risk to the subjects.
  2. The waiver or alteration will not adversely affect the rights and welfare of the subjects.
  3. The research could not practicably be carried out without the waiver or alteration.
  4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
  5. The research is not FDA-regulated.

3.2 Alteration of informed consent process

Some research studies (i.e. medical record review, deception research, or collection of biological specimens) would not be possible if all of the elements of informed consent from subjects were required.

The IRB may consider waiving the requirements for some or all of the informed consent 45 CFR 46.116 (d) elements when the research meets all of the following conditions (the researcher needs to explain for each condition how it applies to his/her research):

  • The research involves no more than minimal risk to the subject;
  • The rights and welfare of subjects will not be adversely affected;
  • The research could not practicably be carried out without the waiver or alteration; and
  • Whenever relevant the subject will be provided with additional pertinent information after they have participated in the study.

The investigator needs to describe which elements of consent will be altered, and /or omitted, and justify the alteration. IRB does not approve alteration of the consent process for research that is subject to FDA regulations, except for planned emergency/acute care research as provided under FDA regulations.

3.3 When obtaining informed consent from a parent is not reasonable

If the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or legally authorized representative permission is not a reasonable requirement to protect the subject (e.g., abused or neglected children), it may waive the consent requirements provided that:

  • The research was designed for conditions or for a subject population for which parental or guardian permission was not a reasonable requirement to protect subjects.
  • An appropriate mechanism for protecting the children who would participate as subjects in the research was substituted.
  • The research was not FDA-regulated.

The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.

The IRB may waive parental permission by determining that:

  1. The research involves no more than minimal risk to the subjects.
  2. The waiver or alteration will not adversely affect the rights and welfare of the subjects.
  3. The research could not practicably be carried out without the waiver or alteration.
  4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation, and
  5. The research is not FDA-regulated.

4. Applicable regulations and guidelines

21 CFR 50.23, 50.24

21 CFR 56.109(c), 56.109(d)

45 CFR 46.116

5. Forms

Addendum 6: Waiver of informed consent process

6. Procedures employed to implement this policy & assignment of responsibility

WhoTask
IRB coordinator, IRB members Review and approve waiver. Document waiver determinations using appropriate checklist(s).
IRB coordinator Review submission to determine if waiver is requested. If so, indicate on the IRB agenda/minutes template that waiver is requested.