Documentation of Informed Consent

It’s important to ensure you document informed consent in a manner that is legal and valid. To meet that aim, study teams often assume that documenting consent is as simple as obtaining a subject’s signature on the form. Although a subject’s signature is a vital component in the documentation the process, considering consent documentation more broadly, as a process, as you would any other essential or required study documentation will help ensure success.

Remember, study documentation, including documentation of informed consent, serves as evidence to demonstrate the conduct of the research and your compliance with applicable ethical standards, federal regulations, state law, institutional policy and your study protocol. Therefore, in order for your consent documentation to reflect compliance, you need to consider all of the requirements related to the informed consent process (i.e., not just those related to a signature/date).

Informed consent requirements and corresponding documentation

Listed below is each consent-related requirement, with a description of how compliance with the corresponding requirement is reflected in the study documentation.

Only individuals who have met institutional, Reviewing Institutional Review Board (IRB), and/or study-specific requirements for engaging in the research can obtain consent

Consent documentation, specifically the individual who signs and dates the consent form as the person obtaining consent, should align with applicable requirements for engaging in the research. Typically, this includes: 1) meeting (and maintaining) Human Subject Protection (HSP) training (per OHSP Policy 201 Education Program); and 2) being approved as a member of the study team on the corresponding IRB submission per Reviewing IRB requirements (reference our Identifying Study Team Members on RSRB (IRB) Submissions page for additional information).

If the study team maintains (or is required to maintain) documentation related to delegation of tasks (e.g., via Delegation of Authority log), the individual who signs and dates the consent form as the person obtaining consent should be identified on the log as study personnel and be assigned the task of obtaining informed consent prior to engaging with research subjects.

The subject’s signature and date on the consent form is meant to document their agreement to participate in the research. Any/all checkboxes or initial lines for optional procedures must be completed to further demonstrate the subject’s consent for participating in such procedures. Any checkboxes or initial lines left blank do not confirm consent. The signature and date of the person obtaining consent further affirms (and documents) the subject’s consent. And the signatures/dates should further align with the dates of all study procedures (i.e., the dates of study-specific procedures identified in other types of study documentation should not occur before the date of consent).

The method and timing of documentation of consent should align with the information described in the protocol approved by the Reviewing IRB. E.g., if the protocol indicates that consent will be obtained from the subject in writing, during an in-person visit, then the consent form should be signed in indelible ink by both the subject and the person obtaining consent on the same day (not on different days, nor should consent be obtained over the phone, electronically, via mail, from a legally authorized representation in lieu of the subject, or in any other manner that isn’t consistent with the IRB-approved protocol).

Provide sufficient opportunity for potential subjects to discuss their participation, read the consent form and consider their participation

As above, follow the process outlined in your IRB-approved protocol (this requirement should be reflected in the consent process described in your study protocol, as required by the criteria for IRB approval of research [45CFR46.111; 21CFR56.111]).

Sufficient detail, key information, required elements of consent, and non-usage of exculpatory language

• Provide sufficient detail/information needed for a reasonable person to make a decision about participation
• Begin with a ‘concise & focused’ presentation of key information
• Disclose all applicable/ required elements of consent
• Do not use exculpatory language

Document consent using the current version of the IRB-approved informed consent document (these requirements should be reflected in the approved consent document, as required by the criteria for IRB approval of research [45CFR46.111; 21CFR56.111]). Utilizing outdated versions of IRB-approved documents will not meet these requirements as the information in the form (i.e., elements of consent) will not be consistent with the current version of the study protocol. Similarly, utilizing a version of the form that is not IRB-approved will not meet these requirements as the IRB has not validated that the contents of the document meets the criteria for IRB approval.

If the research is approved with multiple consent forms (e.g., for different phases or cohorts), ensure consent is obtained using the applicable, current version of the IRB-approved consent form. E.g., Enrolling a subject into Cohort 2 using a Cohort 1 consent form will not meet these requirements, as the information in the form will not be applicable to cohort the subject is enrolling in.

As above, only use the IRB-approved version of the consent document to obtain and document consent (this requirement should be reflected in the approved version of consent documents, as required by the criteria for IRB approval of research [45CFR46.111; 21CFR56.111]).

When enrolling non-English speaking subjects, document consent using appropriately translated materials only (reference OHSP Policy 701: Informed Consent and Enrolling Non-English Speaking Subjects for additional information).

As above, follow the process outlined in your IRB-approved protocol (this requirement should be reflected in the consent process described in your study protocol, as required by the criteria for IRB approval of research [45CFR46.111; 21CFR56.111]). Any individuals/roles specifically restricted from participating in the informed consent process (per the approved study protocol), should not engage in the process, nor sign/date the form as the person who obtained consent.

The only individual who can sign and date the consent form as the subject is the subject themselves, unless the IRB-approved protocol provides provisions for enrolling decisionally impaired adults and the subject meets the criteria for enrollment via a Legally Authorized Representative (LAR), as defined by the protocol.

• If a decisionally impaired adult will be enrolled in the research via LAR, the individual who provides permission on the subject’s behalf (and therefore signs/dates the consent form) must be meet the provisions defined in the IRB-approved protocol regarding who may act as a LAR. Assent from the subject should further be documented via signature and date on the consent form, when applicable.
• If a subject was originally enrolled via LAR and the subject regains capacity during the course of the research, consent for continued participation must be documented by the subject via their signature and date on a complete version of the current, IRB-approved consent form. The permission provided by the LAR becomes invalid when a subject regains capacity.
• If an individual enrolls themselves into the research and loses capacity during the course of the research, permission for continued participation must be documented from a LAR as described in the IRB-approved protocol. If provisions for enrollment (or continued participation) are not defined the study protocol, the subject must be withdrawn or the protocol modified.

For minors, only biological/adoptive parents or legal guardians can provide permission (and therefore sign/date the permission form) for subject enrollment. In some cases, permission from both parents is required for enrollment therefore both parents must sign and date the permission form. When written assent is required, only the subject may sign and date the assent form.

The attestation included with the signature/date of the person who obtained consent should include a statement noting that a copy of the signed consent form was provided to the subject; the signature/date of the person who obtained consent affirms this requirement was met.

Additional considerations and best practices

In addition to the requirements identified above, documentation of consent should meet Good Documentation Practices. Specifically, this means:

• Obtaining original signatures in indelible, wet ink (blue or black pen) to document written consent. Do not use signature stamps, pencil, crayons or markers.
• Ensuring the entire form is complete and accurate before leaving the subject’s presence or initiating study procedures, including all dates, checkboxes, initial lines, and any other field that requires any sort of response. Checkboxes are easily overlooked and inaccurate dates are commonly recorded. It may be helpful to remind the subject (and yourself!) of the date just prior to signature. You may also consider utilizing a highlighter or signature stickers/tabs to mark areas that the subject is required to complete.
• When and if an error is made, maintain an audit trail of edits. Corrections to the consent form (or any other study document) should not obscure the original entry; do not white-out, cross out or otherwise redact the original entry. Draw a single link through the error, note the correction, including the revision (as appropriate) and sign (or initial) and date the correction.

Although doing so may not be necessary for all types of research or all subjects, it may be extremely helpful in supporting consent documentation under certain circumstances. Remember, your study documentation serves to demonstrate the conduct of the research and occasionally, the signature and date alone do not sufficiently ‘tell the story’ (or provide enough detail) of an individual’s consent process. For example, consider the following:

• Food and Drug Administration (FDA) regulations for research conducted under an Investigational New Drug (IND) application or Investigational Device Exemption (IDE) specifically state that ‘the case history for each individual shall document that informed consent was obtained prior to participation in the study.’ For FDA-regulated research, as above, the signature and date on a consent form alone may not provide sufficient evidence of meeting this requirement (e.g., when a subject provides consent on the same day that an investigational drug is administered).
• As study designs become more complicated, subjects more vulnerable and/or the risks involved greater, the consent process also often becomes more complicated, involves more people and may be drawn out more over time. Engaging in multiple consent discussions over time, with multiple parties (e.g., multiple study staff, as well as family/friends/caregivers of the subject), will not be demonstrated via a signature on one specific date alone.
• Not all subjects are the same; not all subjects will be ‘textbook’ scenarios (i.e., ideal or predictable cases). Further documentation may be necessary to clarify the consent process when, for example, the consent process strays from what is planned, per the IRB-approved protocol, or good documentation practices are not met.

So, what should the narrative documentation include? It will depend on the circumstance. Some circumstances, as with the first two bullets above (re: FDA-regulated research and complicated study designs), may warrant a more generalized, comprehensive narrative description. This might include, for example, describing what was reviewed, what questions were raised, who was present during consent discussions, over what course of time consent discussions took place, and whether the subject comprehended the information. As well as confirming that the subject agreed to participate in the research, that consent was obtained prior to conducting study procedures, and that a signed copy of the form was provided to the subject. A template for doing so is available via our Templates page.

On the other hand, circumstances that only require simple clarification might warrant a less detailed description. For example, if you didn’t notice that the subject incorrectly dated the form until after they left the visit, you could document the error in narrative form, confirming the consent of date. Or perhaps the subject did not clearly print their name or date (e.g., due to injury or poor penmanship), you could document why the name/date are not legible and provide confirmation of their name and date of consent. A modified version of the template provided above may be used to do so. Alternately, depending on the circumstance, it may be appropriate to document the clarification via Note to File or by simply writing a statement/paragraph directly on the signed consent form (e.g., below the signature block for the person obtaining consent, with an additional date/signature by the individual providing clarification).

In consideration of the fact that approximately 40% of OHSP Quality Improvement Reviews identify findings related to the documentation of consent, it is good practice for study teams to conduct quality checks on completed consent forms (study teams will not be able to correct errors they are unaware of!).

Quality checks should include reviewing forms to ensure all requirements identified on this page are met, as well as Good Documentation Practices. These checks are particularly helpful following the start of new research, after IRB modification/continuing review approval, and while new staff are being on-boarded. Self-audit templates, including a consent form checklist, are available on our Templates page.