MSU HRPP Manual Section 6-4-D
Informed Consent: Waiver of Documentation of Informed Consent
Revised Common Rule (2018 Requirements
“(1) An IRB may waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects if it finds any of the following:
(i) That the only record linking the subject and the research would be the informed consent form 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;
(ii) 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; or
(iii) If the subjects or legally authorized representatives are members of a distinct cultural group or community 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.
(2) In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research.” 45 CFR 46.117(c)(2018 Requirements)
Pre-2018 Common Rule
“(c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:
(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 will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
(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 cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.” 45 CFR 46.117(Pre-2018 Requirements)
U.S. Food and Drug Administration
“(c) An IRB shall require documentation of informed consent in accordance with §50.27 of this chapter, except as follows:
(1) The IRB may, for some or all subjects, waive the requirement that the subject, or the subject’s legally authorized representative, sign a written consent form if it finds 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 the research context; or
(2) The IRB may, for some or all subjects, find that the requirements in § 50.24 of this chapter for an exception from informed consent for emergency research are met.
(d) In cases where the documentation requirement is waived under paragraph (c) (1) of this section, the IRB may require the investigator to provide subjects with a written statement regarding the research.” 21 CFR 56.109
The IRB may waive the documentation requirement by determining that the regulatory criteria for a waiver of documentation are met. The applicable criteria must be met for the IRB to grant a waiver of documentation. When the documentation requirement is waived, the IRB may require that the investigator provide subjects with a written statement regarding the research. The IRB may require language in the written document (e.g., online research, mail surveys) such as “By completing this survey, you indicate your voluntary agreement to participate.”
Researchers may propose a consent process that involves obtaining oral consent from subjects (e.g., telephone surveys, situations in which written consent is deemed culturally disrespectful or inappropriate). To approve oral consent, the IRB must find the criteria for a waiver of documentation are met. The IRB must review the language that will be used in obtaining oral informed consent. Researchers proposing to obtain informed consent orally must include a script of the oral consent language and content with their IRB application. Oral informed consent must include all the elements of informed consent unless an alteration of consent is approved and should be given to subjects in writing. See HRPP Manual 6-4-B “Waiver or Alteration of Informed Consent” for alteration of informed consent criteria. Investigators should keep a log documenting the oral consent process throughout the duration of the study and maintain such records in accordance with HRPP Manual 4-7 “Recordkeeping.”
Investigators requesting a waiver of documentation must submit the information that will be provided to the subject or legally authorized representative (e.g. oral script, written document). It is the investigator’s responsibility to inform and educate the IRB about any special cultural situations.
Review and Documentation
Review and approval of waiver of documentation follows the procedures as required by the level of review. See HRPP Manual 8-2 “Expedited Review Procedure” and/or HRPP Manual 8-3 “Full Board Review Procedure” for policies and procedures on review and documentation required to waive documentation of consent.
Applicability of the Revised Common Rule (2018 Requirements)
See HRPP Manual Section 4-11 “Applicability of the Revised Common Rule (2018 Requirements),” for a description of whether the Revised Common Rule (2018 Requirements) or the Pre-2018 Common Rule Requirements apply.
This policy and procedure supersedes those previously drafted.
Approved By: Vice President of Research and Graduate Studies, 7-19-2011. Revision 1 approved by Assistant VP Regulatory Affairs on 12-9-2015. Revision 2 approved by Senior VP for Research and Innovation on 1-18-2019.