Re-Consent
Informed consent is an information exchange process that takes place between a potential subject and the study team, which begins when the subject first learns about the research and continues throughout the course of the study. As ongoing research evolves, it may be necessary at some point to re-consent previously enrolled subjects in order to maintain compliance with the requirements of informed consent (reference OHSP Policy 701: Informed Consent).
While the notion of re-consent broadly encompasses the process by which an enrolled subject is provided new or additional information and/or provides consent for continued participation, approaches for doing so are largely dependent on the circumstance.
Re-consent for new information or modification
In accordance with the Belmont Report and federal regulations, re-consent is required anytime new information/findings, modifications or any other research event has the potential to impact a subject’s willingness to continue study participation. More specifically, this includes, but is not limited to, when:
- Substantive changes are made to the study objectives, procedures, payment or the confidentiality of the data (including HIPAA authorization);
- New information regarding potential risks and anticipated benefits emerges (e.g., the likelihood of a potential risk occurring or the magnitude of a potential risk increases);
- New alternative procedures or courses of treatment become available;
- Consent was originally obtained in a non-compliant manner (e.g., the incorrect version of the document was used); or
- The Reviewing Institutional Review Board (IRB) or study sponsor determines that re-consent is required.
Thoughtfully planning for re-consent when any of the circumstances identified above arise is critical. Just as study teams are responsible for complying with the initial consent process defined in their study protocol, they are responsible for complying with any given plans for re-consent. And the more thought put into a plan, ensuring the plan is commensurate with the circumstance, the more likely the study team will be able to maintain compliance.
questions to consider
Study teams should first consider:
Do all subjects, including those who have completed participation, need to be notified or only a subset of subjects, based on the nature of the information and/or the research? For example, if the research involves an investigational product or treatment, who needs to be informed–subjects actively receiving the product/treatment, subjects who are no longer receiving the product/treatment, or both? Alternately, if multiple cohorts exist (e.g., interventional vs. non-interventional arms), do both cohorts need to be notified or does only one require notification?
Is the information relatively benign and simple to explain/understand? Or is the information safety-related or complicated and likely to require further discussion?
Is it urgent? Does it need to be communicated within a specific time frame? Or can it be communicated at the time of the next study visit?
determining method for re-consent
Based upon the needs established above, the study team can then determine an appropriate method for re-consenting subjects, which may include:
A consent addendum is type of consent form that only includes a description of the new information or revisions being made to the research (unlike a ‘full’ consent that includes all required elements of consent). Consent addendums are an effective method for providing new or revised information to subjects in a clear and concise manner as it is less dense than a full consent form. As with original consent, re-consent is documented via signature and date on the current, watermarked version of the IRB-approved consent addendum, with a copy of the signed addendum provided to the subject and the original maintained by the study team.
As with original consent, re-consent in this manner is documented via signature and date on the ‘full’ current, watermarked, IRB-approved consent form, with a copy of the signed consent form provided to the subject and the original maintained by the study team. NOTE: If checkbox options are included, all checkbox options must be completed at the time of re-consent. Study teams must be careful to note whether the subject’s current agreement to participate in optional procedures aligns with their original agreement. Once a subject re-consents, their agreement as documented on the current (as opposed to the original) consent form must be adhered to. E.g., if a subject originally agreed to have their leftover blood sample stored for future use and at, the time of re-consent, decides that they do not want their sample to be stored, all stored samples must be destroyed and no future samples can be stored.
Special consideration must be given to whether documentation of re-consent is required with this method. In some cases, notification via the information letter may be sufficient. Note, however, that study teams should maintain documentation of who was sent the information letter and when as a means of documenting compliance with the plan for re-consent. On the other hand, if documentation of the subject’s agreement to continue participation is required, a full consent or consent addendum should be utilized and mailed to the subject in order to appropriately document subject re-consent. In this manner, a second copy of the consent document/addendum and instructions for returning a signed copy must be provided with a cover letter.
In this manner, study teams must document in their study file all re-consent discussions, including the date of the discussion, the information discussed, and affirmation of the subject’s willingness to continue. Consideration should also be given as to whether providing written information (e.g., via information letter) is also warranted.
Examples of appropriate methods, given common scenarios, are provided below. Note that, in some cases, you may consider utilizing more than one method (e.g., a circumstance that requires notification to all subjects may involve providing subjects still actively participating an information letter at their next study visit, as well as, phoning and subsequently mailing the information letter to subjects who have already completed participation).
Once an appropriate plan has been decided, study teams will need to submit their proposed process of re-consent with the modification (or report of new information) to the Reviewing IRB and they will ultimately determine whether the proposed plan is appropriate.
Re-consent for changes in subject status
One of the most basic ethical requirements related to informed consent is respecting an individual’s autonomy, as described in the Belmont Report. In practice, this means that consent can only be obtained from someone appropriately able to provide it. When/if an individual’s ability to provide voluntary, informed consent is jeopardized, additional protections need to be put into place in order protect those individuals. In terms of re-consent, this means that anytime a subject’s (or potential subject’s) level of vulnerability changes, re-consent may be required. Minimally, this includes:
- A minor, who was originally enrolled via parental permission and assent (if applicable), reaches the age of majority (in New York State, this is age 18);
- A decisionally-impaired adult, originally enrolled via an authorized representative, regains capacity; and
- An adult, who originally provided consent for themselves to participate in the research, loses capacity during the course of participation.
Study teams that will knowingly encounter these circumstances based on the nature of the research and the population under study, should plan for provisions for re-consent under these circumstances at the time of protocol development. Generally, it is expected that documentation of re-consent for such circumstances will be documented via signature and date on the ‘full’ current, watermarked, IRB-approved consent form, with a copy of the signed consent form provided to the subject and the original maintained by the study team. Reference OHSP Policy 601: Research Involving Children and OHSP Policy 604: Research Involving Adults with Decisional Impairment for additional information.
Re-consent vs. re-affirmation
Depending on the nature of the research, study participation could be as short as 10 minutes or as long as 10 years. Irrespective of the circumstances of re-consent identified above, it is important to remember that the longer a subject participates, the more important it is to keep in mind that the consent process is meant to be ongoing. This can be accomplished by reminding subjects prior to visits what procedure will take place and/or the risks related to a given procedure prior to conduct, continually asking if they have questions or concerns, and periodically re-affirming their willingness to continue participating in the research. While not necessarily required, it is good practice to document these conversations in your study records.
Note however, it’s important to understand the difference between informally re-affirming consent, which is good practice, and formal re-consent, which is required as determined by the Reviewing IRB. Beyond the scenarios described above (i.e., new information/modification and change is subject status), unless specified in the study protocol or a department/study-specific standard operating procedure, it is not generally required that formal re-consent be obtained at every study visit and/or at specified intervals over the course of participation (e.g., every 2 years). Rather, it is expected that informed consent process be ongoing via continued dialogue with enrolled subjects and periodic re-affirmation of consent.
Case examples
This new information presents a potential safety issue that subjects should be informed about in a timely manner. One appropriate method for re-consent would be to contact subjects via telephone to discuss the newly identified risk with them (documenting this conversation in the study record) and then follow-up with a mailed consent addendum describing the new potential risk for subjects to review. Further review of the addendum and documentation of re-consent would then be obtained at the next study visit.
NOTE: The benefit of using a consent addendum in this scenario is that the formatting will help pinpoint the new information that needs to be disclosed to the subject. When a small number of revisions (or revision to only a few elements of consent) are made to a consent form and a full version of the consent form is utilized to re-consent the subject, the new information can get ‘lost’ among other details. When/if a full version of the consent form is utilized to re-consent subjects when only a few revisions have been made to the research, effort should be made to emphasize the revised portions of the document when discussing the changes with the subject (e.g., highlighting or specifically pointing out revisions).
Given the number of changes, it may be more appropriate to utilize the full version of the revised consent to re-consent subjects, though a consent addendum may also be permissible.
Although providing payment to existing subjects (when it previously was not) is unlikely to change subjects’ willingness to continue participating, payment is still an element of consent that requires disclosure to the subject. As such, mailing an information letter or providing the information verbally may be sufficient, over requiring re-consent via full consent or consent addendum.
Re-consent must be obtained using the full version of the current, watermarked, IRB-approved consent form.