Informed Consent Guidance Now Available

October 17 2023

Written by: Donna White RN, BSN, OCN, and Megan Park, Research Coordinator III, Cleveland Clinic and Mary Jo Antonelli, MBA, MHA, Director of Quality Assurance and Operational Support, NRG Oncology

In this post COVID-19 pandemic world, many are asking about the use of remote consenting for clinical trial participation. In the March 23, 2020, memorandum from NCI an initial allowance for “Alternative Procedures for Informed Consent for Trials” was provided. Stating that the NCI CIRB supported a ‘remote’ informed consent process as COVID-19 control measures.

This allowance continued through the health crisis and as of April 17, 2023, the CIRB SOPs, Section 2.3.8, added requirements for Remote Consent, eSignature and eConsent beyond health crisis.

An excerpt of the SOP is provided here, but the full scope of SOP should be reviewed locally to ensure your institution is in compliance with the requirements for remote consent. It is important to understand that remote consent, eSignature and eConsent processes are required to be submitted on the CIRB Study Specific Worksheets or the Signatory Institution Worksheet before implementation as noted below.

The NCI CIRB SOPs can be found here: Key points taken from Section 2.3.8, Remote consent, eSignature, and eConsent are as follows: Remote consent is permitted for all studies unless stated otherwise in the protocol or determined by the CIRB to be not permissible during a convened meeting or via expedited review procedures. Remote consent, eSignature and eConsent plans are reviewed by the CIRB as part of a research study. The use of remote consent, eSignature and eConsent in situations other than a public health emergency requires the site to submit the information on Study Specific Worksheets (SSW) or the Signatory Institution Worksheet (SIW) before using. Remote consent may occur via telephone, conference call, video conferencing, telemedicine, or other methods.

The use of remote consent is dictated by local institutional policy. The local institution provides the details, including state law and institutional policy, regarding the conduct and limitations of remote consent as part of the CIRB Local Context review.

The CIRB SOPs also addresses Legally Authorized Representatives as part of the consent/remote consent process and the inclusion of a witness and instructs sites to follow FDA and OHRP requirements.

Institutions conducting NCI NCTN research are required to follow the CIRB SOPs, unless a study is outside the purview of the CIRB as per protocol.

Additionally, in August of this year the Food and Drug Administration (FDA) released a guidance document for obtaining and documenting informed consent for participants on a clinical trial titled “Informed consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors. The guidance document was prepared with the intent to assist those “involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent” (1). The guidance suggests that it does not need to be followed exclusively and that one is able to use other source as long as “it satisfies the requirements of the applicable statutes and regulations”. Additionally, the wording such as the word “should”, used in the guidance document are recommendations (suggestions) and not necessarily requirements. (1)

This guidance document was developed by the Office of Clinical Policy (OCLiP), in coordination with the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Drug Evaluation and Research (CDER). (2) Upon review of the document it is a very thorough explanation of all aspects of the informed consent process. The document reminds us that “The informed consent process is an ongoing exchange of information throughout a subject’s participation in a clinical trial and does not end after the consent form is signed.” (2).

Under the section Documentation of Informed Consent while not providing exact guidance for remote consenting, there is some guidance regarding Alternative Methods of Obtaining Informed Consent.

“Methods other than a face-to-face consent discussion may be acceptable if those methods allow for an adequate exchange of information and documentation, and a method to ensure that the signer of the consent form is the person who plans to enroll as a subject in the clinical investigation or is the LAR (Legally Authorized Representative) of the subject. For example, the consent form may be sent to the subject or the subject’s LAR by facsimile or e-mail, and the consent discussion may then be conducted by telephone/videoconference when the subject or subject’s LAR can access the consent form during the discussion. After the consent discussion, the subject or the subject’s LAR can manually or electronically sign and date the consent form and return the document to the clinical investigator through a secure electronic method, such as by scanning the consent form and returning it through a secure e-mail account, or by posting it to a secure internet address. Alternatively, the subject may bring the signed and dated consent form to their next visit to the clinical site or mail it to the clinical investigator.” (2) “In situations in which the signed document cannot be retrieved for filing in the study records (e.g., because the subject is in strict isolation due to a highly transmissible infectious disease), and electronic consent is not available, it is acceptable to retain for the study records a photographic image of the signed consent form along with an attestation by the person entering the photograph into the study records that states how the photograph was obtained and that it is a photograph of the informed consent form signed by the subject.” (2)

It is important to remember to inform and obtain approval from the Institutional Review Board of the plans for obtaining and documenting the informed consent process being used at your site.

All research personnel may find the “Frequently asked Questions” section the most helpful, which gives guidance on frequently asked questions from research personnel regarding the FDA’s regulations for the protection of human subjects.

If it’s your first time enrolling a non-English speaking participant, you will find this section to be very helpful. The section goes over the considerations for enrolling a non-English participant, gives guidance on which processes should be followed when it is expected that subjects who do not understand English is enrolled and lastly, discusses what processes should be followed when the enrollment of subjects who do not understand English is not expected.

If you have ever wondered who can legally serve as a participant’s LAR (Legal Authorized Representative) and exactly what is the LAR’s role, then this is a good section to review. This section goes into detail what a LAR is and what they are allowed to do for the research participant. There are many additional items found within the guidance document including suggestions and recommendations of compliance for IRBs, investigators, and sponsors. It will be an invaluable reference for years to come for those new to research as well as those seasoned research personnel.

Comments regarding this document are now being accepted and may be submitted either publicly or confidentially. Please visit https://www.regulations.govto review the instructions for each.

The guidance document is available at:

  • Lauren K. Roth, Associate Commissioner for Policy. Federal Register/Vol.88, No.157/Wednesday, August 16, 2023/Notices
  • Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors.

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