Part IV of V Series: Recording the Consent Process

03/17/2026

Written by Jamie Saunders, M.S., Research Program Manager, MaineHealth Cancer Care Network NCORP

 Once consent is obtained, the next step is ensuring that there is a record of the informed consent process within the medical record. The consent note should reflect the way consent was obtained.

• In-person with hardcopy signatures
• In-person with electronic signatures
• Remote with hardcopy signatures
• Remote with electronic signatures
• Consent without signatures (verbal consent) for instances where a waiver of consent documentation is in place

In addition, the consent note should include the following:

• How, when, and by whom were the informed consent documents initially provided to the participant
• Participants were given time to review the documents before the consent discussion(s)
• Who was present, including consenter name and credentials, participant name, and any others who were present (either from the study team or any others who were involved)
• When the discussions took place
• How the discussions took place (remote, in-person)
• Study Information and ICF (including version dates)
• A statement that includes what was reviewed, including procedures involved, risks, alternatives, and follow-up
• Statement regarding participant understanding of the research, that participation is voluntary and that they may withdraw at any time
• A statement indicating that the participant had adequate time to review the documents and that all their questions were answered to their satisfaction
• How the participant signed
• How the participant received a completed copy
• A statement that no research activities were performed prior to consent
• If a witness is required, then documentation of the witness should also be included

The following are examples of consent notes. These examples are not exhaustive but are suggestions of ways to record the informed consent process and support that all necessary elements were performed. Consent notes should be saved to the patient’s research folder and in the patient’s medical record.

Please note that with any consent discussion that is conducted remotely, identification of the participant must be verified at the beginning of the consent discussion. This can be done in different ways such as by asking personal questions (such as DOB and name) and/or viewing government issued identification.   A statement that identification was verified should be included as part of the consent note.

Example #1 (without waiver of documentation of consent):

[Insert Name] [emailed, mailed, directly presented] the study ICF & HIPAA authorization to the participant on [Insert Date] so that they had the opportunity to review the written document in advance of the discussion.

[Insert CRC name and credentials], met [in person or remotely] with [Insert participant name] on [Insert Meeting Date(s)] to discuss study protocol entitled [Insert full Study Title]. [Participant identification was verified by confirmed full name and date of birth. Remote consent was used for the discussion to reduce burden on participant.]

[Additionally, [Insert Names of other attendees] were present for the discussion.] 

The study was explained to the participant and all sections of informed consent [Insert Study Number and ICF Version] were discussed including study procedures, risks, alternatives and follow-up.  HIPAA authorization was presented and reviewed with the participant. Participant verbalized an understanding of the study, including their rights as a research participant, the voluntary nature of their participation and that they may withdraw at any time. The participant confirmed that they were given adequate time to consider enrolling in the study and all of their questions were answered to their satisfaction prior to signing consent. 

No research procedures/activities were performed prior to obtaining consent & HIPAA authorization.

Upon the participant verbally consenting to participation, the participant’s signatures on the informed consent & HIPAA authorization were obtained using [in-person signatures, DocuSign, REDCap, etc.].

[Participant was given a hardcopy of the signed ICF form and HIPAA authorization /emailed an electronic copy of the signed ICF and HIPAA authorization for download /mailed a hard copy of the signed ICF form and HIPAA authorization].

A copy (specify hardcopy or certified electronic copy) was retained in the participant’s research folder.  

Does protocol require a witness to be present? If so, note should include documentation of presence of a witness.

Example #2 (with waiver of documentation of consent):

[Insert Name] [emailed, mailed, directly presented] the study ICF form & HIPAA authorization to the participant on [Insert Date] so that they had the opportunity to review the written document in advance of the discussion.

[Insert CRC name and credentials], [met remotely via telephone, videoconference or telehealth or in person] with [Insert participant name] on [Insert Meeting Date] to discuss study protocol entitled [Insert full Study Title]. [Remote consent was used for the discussion to reduce burden on participant.]

[Additionally, [Insert Names of other attendees] were present for the discussion.]

The study was explained to the participant and all sections of informed consent [Insert Study Number and ICF Version] were discussed including study procedures, risks, alternatives and follow-up.  HIPAA authorization was presented and reviewed with the participant. Participant verbalized an understanding of the study, including their rights as a research participant, the voluntary nature of their participation and that they may withdraw at any time. The participant states that they were given adequate time to consider enrolling in the study and all of their questions were answered to their satisfaction. 

[Participant Name] verbally agreed to participate in the study.

No research procedures/activities were performed prior to obtaining consent & HIPAA authorization.

Does protocol require a witness to be present? If so, note should include documentation of presence of a witness.

Missed Parts I, II, or III? You can catch up here:

Part I of IV Part Series: Informed Consent Discussion & Documentation – NRG Oncology

Part II of IV Part Series: Informed Consent Discussion & Documentation Options – NRG Oncology

PSC – Part III of IV Series: Waivers – Documentation & Consent – NRG Oncology