The default in the US regulations is that the consent document is signed by the research participant. However, the regulations also contain flexibility to approve a waiver of the documentation of consent, in essence, while there is a consent process and information is communicated to the potential subject, the person does not have to sign a consent document. Note that a waiver of documentation of consent is different than a waiver or alteration of consent.

Waiver of Documentation of Consent

Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Policy Number: 18
Effective Date: 10/8/2021

Policy

The default in the US regulations is that the consent document is signed by the research participant. However, the regulations also contain flexibility to approve a waiver of the documentation of consent, in essence, while there is a consent process and information is communicated to the potential subject, the person does not have to sign a consent document. Note that a waiver of documentation of consent is different than a waiver or alteration of consent (See, CSS IRB SOP # 15 Waiver or Alteration of Consent (Waiver Request Form Reviewer Checklist).) In a waiver of documentation there is still a consent process, but written documentation is not required.

Purpose

The College of St. Scholastica (CSS) IRB requires that potential participants, or the parents of children who are participants, are presented (either verbally or in writing) with the same information required in a written consent document, but documentation of the process (signing of the consent form) has been waived by the IRB.  This process is often used in minimal risk research involving the administration of online or mailed surveys, telephone interviews, or when anonymous sensitive information is collected, and the PI does not want any written documentation that links the participant to the research study.

Waiver of Documentation of Informed Consent – 45 CFR § 46.117(c).

The DHHS regulations allow for a waiver documentation of consent under three different conditions. An IRB may approve a consent procedure which does not include the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds:

1. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern.

This condition is used in greater than minimal risk research when the knowledge of the subject’s participation in the research may place the subject at risk of harm. The consent document is provided to the subject to read, but the IRB can waive the requirement for a signature, thus protecting the identity of the subject. The subject is asked whether he or she would allow documentation linking them to the research, so each subject can evaluate their situation. The subject’s wishes are always followed. An example is a research project where political dissidents in a dictatorship are interviewed about their views. If their names were to get out it could lead to harm by the government. Note that the harms may be physical or may be other types of harms like termination of employment, loss of insurability, etc. This type of waiver is not allowed for research subject to the FDA regulations. The term “legally authorized representative” clarifies that a waiver of documentation of consent of a legally authorized representative can be granted.

2. That 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.

In this second condition, virtually any research project that is minimal risk can be granted a waiver of documentation. An example could be a survey where a signature is not required, and the submission of a completed survey indicates consent to participate. The researcher may still maintain identifiable information about the subjects. The regulations also stipulate that in cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research. This type of waiver is allowed by the FDA regulations(21CFR 56.109(c)(1))

Note that a waiver of documentation of consent for minimal risk research can only be granted if the research does not involve any procedures for which written consent is normally required outside of the research context. OHRP has not officially opined on this criterion, but provides examples such as renting a car, riding a horse, using a ski facility or medical procedures such as blood draws or MRIs, all of which require written consent outside of the research context. This determination is a gray area which is usually left up to the IRB to determine.  The IRB may waive the requirement for documentation of consent for parental permission if the protocol meets the criteria for a waiver. The IRB could also waive the requirement for documentation of child assent. However, a waiver of documentation of parental permission may not be granted if federal or state law requires “written” parental permission (e.g. the Protection of Pupil Rights Amendment). The IRB must be aware of the relevant laws where the research is being conducted.

3. If the subjects or legally authorized representatives are members of a distinct cultural group orcommunity in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

This condition allows the IRB to grant a waiver of documentation of consent for people in a culture that does not accept or use a signature to indicate their agreement to participate, providing there is some mechanism for a person to indicate their agreement which can be recorded by the researchers. To use this criterion the study must be minimal risk. This will allow the IRB to approve waivers of documentation of consent for a variety of mechanisms for indicating consent (e.g. handshake), other than signatures. The IRB should document the evidence on which they make their decision.

Procedure

Investigator Responsibilities

1. The Investigator will assess the proposed research to determine if it meets regulatory requirementsfor a waiver of the documentation of informed consent.
2. The PI will make an initial request to waive the requirements for obtaining documentation of informedconsent through the IRB application within IRBNet.

IRB Responsibilities

1. The IRB Chair, designee, or full board will consider the request for a waiver of documentation ofconsent and the Investigator’s justification verifying and documenting the regulatory conditions that are applicable to the proposed research activity.
   1. If the IRB Reviewer(s) agree with the Investigator’s justification for a waiver of the documentation of the consent process by approving the proposed research procedure, this is documentation the IRB agrees with the Investigator’s justifications. The IRB should document the evidence on which they make their decision.
   2. In cases in which the documentation requirement is waived, the IRB may require the investigator to provide participants a written statement regarding the research.  When the IRB considers waiving the requirement to obtain documentation of the consent process, the IRB should review a description of the information that will be provided to participants.
   3. If the IRB Reviewer(s) do not agree with the Investigator’s justification or if they do not agree that waiver of documentation of the consent process is allowable and appropriate, the IRB will request revisions to the protocol to require documentation of informed consent to be sought in its entirety.
2. When amendments are made to a currently approved research study which may impact the consentprocedures, an approved waiver of documentation of informed consent is reassessed by the IRB Chairperson or his or her designee, and a determination is made as to whether the conditions for the waiver have been altered, necessitating a removal of the waiver. If this occurs, the IRB will also determine whether currently enrolled participants must be re-consented.

Resources

IRB EasyEd. Waiver of Documentation of Consent.  Volume 1 Number 3 and Addendum.  © 2017 Apex Ethical

FDA regulations – Documentation of Informed Consent Exception - (21CFR 56.109(c)(1))

George Mason University https://rdia.gmu.edu/wp-content/uploads/SOP_2-2-2_Waivers-of-informed-consent_revised-1.pdf

This is a new policy per the 2018 Common Rule Requirements.