Informed consent is a process that involves a dynamic and continuing exchange of information throughout a study.
Federal human subject research regulations do not reference the term reconsent. However, the regulations do state that, when appropriate, participants will be provided with significant new findings that develop during the research, which may relate to their willingness to continue participation (45 CFR 46.116(c)(5)).
When new information related to the study becomes available, study modifications are proposed, or new risks/alternatives are identified, investigators notify the IRB. The investigator, sponsor, and IRB determine whether reconsent is warranted or if other means of notification are most appropriate. The IRB maintains documentation of significant new findings provided to participants (45 CFR 46.115(a)(7)).
Notification: Provides new information without consent to continue.
Reconsent: Provides new information and documents consent to continue participation.
Potential Reasons for Reconsent or Notification
Notification or reconsent may be required for various reasons, including, but not limited to, cases where:
- the study protocol/procedure has been modified (e.g., increase time commitment or burden);
- new safety or effectiveness information exists;
- new alternative treatment becomes available;
- a pediatric participant reaches adulthood
(18 years old); - original consent or process not properly executed (e.g., participants were consented by individuals not listed on the study personnel list or not HSP trained or using an invalid form);
- potential consent capacity concerns; or
- other changes as required by the IRB or sponsoring agency.
Reconsent Form and Process
If reconsent is needed, the IRB reviews the revised consent form and materials, as well as the proposed methods and process to reconsent participants.
Typically, all active participants must be reconsented with the revised form unless the investigator and IRB agree that the change does not impact current active participants.
A strategy to facilitate the process involves the use of a cover page outlining the changes and describing the potential impact on participants.
Generally, you would use the IRB-approved revised form for enrollment of future participants.
Communication Methods and Process to Inform Participants
The investigator proposes, and the IRB determines the method or combination of methods for providing new information to future, current, and/or past participants (i.e., notification, reconsent, both).
The following is a list of potential communication methods:
- reconsent with revised consent document;
- reconsent with a consent addendum;
- consent cover letter outlining changes;
- notification letter or email;
- phone consent with a waiver of documentation; and
- phone call with a notification script.
Regardless of the method chosen, participants should be provided with the opportunity to discuss the information with the researchers, and the researchers should ensure participants’ understanding of the information and appreciation for the implications.
Consider the following criteria when submitting justification to the IRB about who, what, and how you propose to communicate new information.
| Considerations and Criteria for Determining the Most Appropriate Communication Method/Process | |
|---|---|
| Nature of the information (e.g., protocol change, schedule or procedure change, new risk, new advantageous alternative, minor administrative edits) |
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| Complexity of the information |
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| Stage of the research (e.g., recruitment, treatment, follow-up) |
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| Participant population (e.g., all or select subset) |
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| Degree of documentation (e.g., note to file, phone script, written notification, signed consent addendum, or revised consent) |
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| Urgency of information (e.g., safety information, schedule change) |
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The Secretary’s Advisory Committee for Human Research Protections (SACHRP) provides a table of Additional Information Scenarios and Suggested Options based on the significance of the change and whether the information is time-sensitive, also taking into account the recruitment status of the study.
IRB Application Forms that address New Information
Modification Request: Includes questions to assess whether the change increases risk to study participants, is due to an Unanticipated Problem or Adverse Event (UP/AE), Protocol Violation, and whether it might relate to a participant’s willingness to continue to take part in the research.
If so, the researcher is asked to state how the information will be communicated to participants (i.e., reconsent, letter, etc.).
The UP/AE Forms include questions to assess the need for consent revision and address whether participants should be informed.
Sources:
March 2020 Secretary’s Advisory Committee on Human Research Protections New Information Provided to Previously Enrolled Research Subjects – Attachment A; Cornell Medical College Office of Clinical Trial Administration; University of Kansas Human Research Protection Program, Mayo Clinic Human Research Protection Program, and 2019 AAHRPP Conference Session F3: Revisiting Reconsent: Is it an Urban Legend or a Regulatory Requirement.