ELEMENT II.3.G.

ELEMENT II.3.G.: The IRB or EC has and follows written policies and procedures for approving waivers or alterations of the consent process and waivers of consent documentation.

Waiver or alteration of the consent process

In certain situations, the IRB or EC may waive or alter the consent process in accordance with laws, regulations, codes, and guidance.

When an IRB or EC waives the requirement to obtain consent, it waives the entire requirement for consent, both the attributes of the consent process and the elements of disclosure. When an IRB or EC alters the consent process, consent is still obtained, but the consent process or elements of disclosure differ from what is generally required. When the IRB or EC approves a waiver or alteration of the consent process, records should document why the IRB or EC judged that each criterion was met for the specific protocol being reviewed.

IRBs or ECs sometimes use the terms “passive consent,” “deferred consent,” or “implied consent” to describe consent processes that do not follow one or more requirements for the consent process. Each of these cases represents a waiver or alteration in the consent process. Research that proposes these consent procedures cannot be approved unless the IRB or EC approves a waiver or alteration of the consent process.

Waiver of consent documentation

In certain situations, the IRB or EC may waive the requirement to document the consent process. When the IRB or EC approves a waiver of the requirement to document the consent process, records should document the protocol-specific reasons justifying the waiver. An IRB or EC might require that a written statement describing the research be provided to participants, such as a copy of a consent document that might be used if the participant requests written documentation of the consent process.

Regulatory and guidance references

DHHS: 45 CFR 46.116(c), 45 CFR 46.116(d), 45 CFR 46.117(c), OHRP Guidance on Informed Consent Legally Effective and Prospectively Obtained
DOD: Instruction 3216.02 9. (2.1.1), 10 USC 980(a,b)
DOE: 10 CFR 745, DOE Order 443.1C (November 2019)
ED: 343 CFR 99
FDA: 21 CFR 50.22, 21 CFR 56.109(c)(1), 21 CFR 56.109(d), IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects (July 2017)
VA: 38 CFR 16.116(c), 38 CFR 16.116(d), 38 CFR 16.117(c), VHA Directive 1200.05(3)(17)
AAHRPP Tip Sheet: State and Local Law
AAHRPP Tip Sheet: Sufficient Information to Determine Whether the Criteria for Approval are Met

Required written materials

Essential requirements:
1. Policies and procedures describe the process for waivers and alternations of the consent process and documentation of consent:
  1. Policies and procedures allow the IRB or EC to waive or alter the consent process by determining that the criteria for waivers or alterations are met.
  2. Policies and procedures allow the IRB or EC to waive parental permission by determining that the criteria for waivers or alterations are met.
  3. Policies and procedures allow the IRB or EC to waive the requirement for written documentation of the consent process by determining that the criteria for waivers are met.
  4. Policies and procedures have the IRB or EC document its findings justifying the waiver or alteration.
When following DHHS regulations:
1. Policies and procedures allow the IRB or EC to waive or alter the consent process by determining that the regulatory criteria for waivers or alterations of the consent process are met. (See Table II.3.G.1.)
2. Written materials allow the IRB or EC to waive the requirement to document the consent process by determining that the regulatory criteria for waivers are met. (See Table II.3.G.1.)
  1. When the IRB or EC considers waiving the requirement to obtain written documentation of the consent process, policies and procedures have the IRB or EC review a written description of the information that will be provided to participants.
  2. When granting waivers of the requirement to obtain written documentation of the consent process, policies and procedures have the IRB or EC consider requiring the researcher to provide participants with a written statement regarding the research.
3. If the participants or LARs are members of a distinct cultural group or community in which signing forms is not the norm, documentation of consent may be waived if the research presents no more than minimal risk of harm to the participants, and provided there is an appropriate alternative mechanism for documenting consent was obtained.
4. If a broad consent procedure is used:
  1. An IRB may not omit or alter any of the required elements of disclosure, and when appropriate, any of the additional elements of disclosure.
  2. If a study requests broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens, and refused to consent, an IRB or EC cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens.
When following DoD requirements:
1. If non-exempt research is supported by DoD-appropriated funds and involves experimental subjects as defined in DODI 3216.02, consent must be obtained in advance, in accordance with 10 USC 980.
  1. An IRB may waive or alter some elements of informed consent for research involving human beings as experimental subjects, so long as it preserves the informed consent of the participant (i.e., the consent indicates that participation in the research is voluntary and the participant/representative is informed of research risks).
  2. The DOHRP may waive the requirements for prospective consent for research involving human beings as “experimental subjects” when all of the following are met:
  3. Waivers of consent are prohibited for DoD classified research.
When following DOE requirements:
1. Informed consent may only be waived for classified research if the work meets one of the categories of the minimal risk human participant research addressed at 10 CFR Part 745.104.
When following ED requirements:
1. Policies and procedures include a process to comply with the Family Educational Rights and Privacy Act (FERPA). This process may occur outside the IRB or EC.
2. FERPA applies when researchers obtain student records or personal education information from an education program as defined as any program principally engaged in the provision of education, including, but not limited to, early childhood education, elementary and secondary education, postsecondary education, special education, job training, career and technical education, and adult education.
3. The organization has in policies and procedures, a process to grant exceptions to parental or student consent to release student records for research. This responsibility may be delegated to the IRB or EC, another individual, or component of the organization (e.g., a FERPA committee).
4. An educational agency or institution may disclose personally identifiable information from an education record of a student without consent if the disclosure is part of an agreement between organizations or researchers conducting studies for, or on behalf of, educational agencies or institutions to:
  1. Develop, validate, or administer predictive tests.
  2. Administer student aid programs.
  3. Improve instruction.
5. A school district or postsecondary institution that uses this exception is required to enter into a written agreement with the organization or researcher conducting the research that specifies:
  1. The determination of the exception.
  2. The purpose, scope, and duration of the study.
  3. The information to be disclosed.
  4. That information from education records may only be used to meet the purposes of the study stated in the written agreement and must contain the current requirements in U.S. Department of Education regulations on redisclosure and destruction of information.
  5. That the study will be conducted in a manner that does not permit personal identification of parents and students by anyone other than representatives of the organization with legitimate interests.
  6. That the organization is required to destroy or return all personally identifiable information when no longer needed for the purposes of the study.
  7. The time period during which the organization must either destroy or return the information.
6. Education records may be released without consent under FERPA if all personally identifiable information has been removed including:
  1. Student’s name and other direct personal identifiers, such as the student’s social security number or student number.
  2. Indirect identifiers, such as the name of the student’s parent or other family members; the student’s or family’s address, and personal characteristics or other information that would make the student’s identity easily traceable; and date and place of birth and mother’s maiden name.
  3. Biometric records, including one or more measurable biological or behavioral characteristics that can be used for automated recognition of an individual, including fingerprints, retina and iris patterns, voiceprints, DNA sequence, facial characteristics, and handwriting.
  4. Other information that, alone or in combination, is linked or linkable to a specific student that would allow a reasonable person in the school community, who does not have personal knowledge of the relevant circumstances, to identify the student with reasonable certainty.
When following FDA regulations:
1. Policies and procedures allow the IRB or EC to waive or alter the consent process by determining that the regulatory criteria for waivers or alterations of the consent process are met. (See Table II.3.G.2.)
2. Policies and procedures allow the IRB or EC to waive the requirement to document the consent process by determining that the regulatory criteria for waivers are met. (See Table II.3.G.2.)
  1. When the IRB or EC considers waiving the requirement to obtain written documentation of the consent process, policies and procedures have the IRB or EC review a written description of the information that will be provided to participants.
  2. When granting waivers of the requirement to obtain written documentation of the consent process, policies and procedures have the IRB or EC consider requiring the researcher to provide participants with a written statement regarding the research.
When following VA requirements:
1. Policies and procedures require the IRB to document the reason when it waives the requirement to obtain written documentation of the consent process.
2. An informed consent to take a photograph, video and/or audio recording cannot be waived by the IRB.

Outcomes

IRB or EC members waive the requirement to document the consent process according to criteria for waivers.

Proceed To: STANDARD II-4

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

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ELEMENT II.3.G.