The Flexibility of Reconsent in Clinical Trials
When an IRB determination letter indicates that reconsent is required, it can feel like a rigid mandate that adds to the workload of teams already operating with limited time and resources.
Reconsent can feel like a disruption if you see it as a complete, formal consent process all over again: revising documents, reviewing changes in detail with participants, collecting new signatures, and meticulously documenting each step.
However, that view does not capture the whole picture. Reconsent is not always a formal, signature-based event. In fact, the term “reconsent” does not appear in the federal regulations. The regulations simply require that participants be informed of any significant new findings that could affect their willingness to stay in the study. How that information is shared is left to professional judgment and should be grounded in the principle of respect for persons.
By reframing your perspective on reconsent, you can fulfill your ethical obligations while minimizing unnecessary burdens and strengthening the partnership between participants and the study team.
When Is Reconsent Required?
IRBs use a guiding question to evaluate whether reconsent is warranted: Would a reasonable person want to know this information to make an informed decision about continued participation? If the answer is yes, then the change likely meets the threshold for reconsent.
Common Scenarios That May Trigger Full Reconsent
While not every change requires a formal reconsent process, certain types of updates—especially those that affect risk, burden, or available alternatives—warrant clear communication. Below are a few situations where reconsent may be appropriate.
- Significant Protocol Amendments
If a study protocol changes in a way that adds a meaningful burden or inconvenience, participants should be allowed to reassess their participation. For example, if monthly study visits are changed to weekly visits, that increased time commitment and logistical complexity could be enough for someone to reconsider.
- New Safety Data
If the study team identifies new risks, such as adverse events observed in participants enrolled at their site or at other participating sites, the consent form may need to be updated. Participants need to know if previously unknown side effects are now associated with the study drug or device, especially if these risks are serious or more common than initially anticipated.
- New Treatment Alternatives
If a new standard of care becomes available (e.g., an FDA-approved treatment for the condition under study), participants may wish to reevaluate their participation. This is especially relevant for people who enrolled because they had no other treatment options at the time.
In all of these cases, the emphasis is not on checking regulatory boxes or collecting signatures; it is about respecting participants’ autonomy by ensuring they remain fully informed and aware of their rights.
What About Less Significant Changes?
Some updates, while still necessary to communicate, may not warrant restarting the formal consent process:
- Minor logistical changes (e.g., using a new lab or collecting an additional tube of blood).
- Updated contact information for study staff or reporting adverse events.
- Small procedural adjustments that do not significantly alter participant burden.
These types of updates can be communicated through letters provided to participants, during the next study visit, or with a verbal explanation followed by documentation in the participant’s study record. IRBs often allow and even encourage these alternative approaches when appropriate.
Common Misconceptions About Reconsent
Reconsent is often misunderstood, and much of this confusion stems from how it is communicated by IRBs and interpreted by sites, sponsors, investigators, and clinical coordinators. These misconceptions can create unnecessary hurdles or cause teams to overlook better, more effective ways to keep participants informed. Clarifying what reconsent really involves can help reduce burdens and support a more thoughtful, participant-centered approach.
Myth #1 Reconsent Is Always Burdensome or Logistically Complex
One common misconception is that whenever an IRB requires reconsent, it automatically implies a complete, formal process. This perception is often fueled by the way some IRBs issue decisions: a simple “reconsent required—yes or no” box checked on an approval letter, with no further context.
This approach can make it seem like reconsent is an all-or-nothing requirement when, in fact, IRBs have the flexibility to be more lenient. The reality is that providing new information to participants does not always require a formal reconsent process. In many cases, IRBs can—and should—clarify the range of communication options available, from a verbal explanation at the next visit to a brief information sheet or letter.
Myth #2 Reconsent Must Mirror the Original Consent Form
Another misconception is that reconsent must replicate the original consent process exactly, often necessitating a complete rewrite of the consent form and new participant signatures. Sometimes, this idea originates not from the IRB but from sponsors, legal teams, or compliance departments that require documented signatures for every update, regardless of its scale or impact.
A strictly legalistic mindset can lead to overly long consent forms or a focus on formality over meaningful communication. However, reconsent does not always require re-signing the full consent document. Depending on the nature of the update, a short addendum, an informational letter, or another streamlined approach may be more appropriate while remaining fully compliant with regulatory requirements.
Myth #3 The IRB’s Reconsent Process Is Inflexible
Not all IRBs take advantage of the flexibility available to them, and when they do not, it reinforces the idea that reconsent is rigid and procedural. However, IRBs can tailor the way new information is delivered to participants based on the nature and significance of the change.
Consider whether to share new information with participants and how to do so in a manner that is both respectful of their needs and practical for the study teams. In many situations, a complete reconsent process with a new signature is not required. What truly matters is whether the communication method allows participants to continue making informed decisions about their involvement.
Strategies for Making Reconsent More Flexible
Reconsent does not have to follow a rigid, one-size-fits-all approach. When investigators, clinical coordinators, sites, sponsors, and IRBs collaborate and communicate proactively, reconsent can respect participants and reduce unnecessary burdens. Here are four strategies that promote flexibility without compromising compliance or participant rights.
Encourage Sites to Propose a Participant Communication Plan
When sites submit protocol amendments, they should also include a proposed plan for communicating any new or relevant information to participants. Too often, IRBs receive amendments with no accompanying strategy, just the updated protocol. This puts the IRB in a position to make assumptions about participant communication and issue blanket requirements, such as revising the consent form, issuing an addendum, or instructing the site to reconsent everyone.
Instead, if sites proactively say: “Here are the changes, and here is how we plan to inform participants,” it allows the IRB to make a more informed, collaborative decision. In some cases, the site may propose that reconsent is not necessary, but that they will contact participants, provide a verbal explanation, and document the interaction in the study record. This approach gives IRBs more confidence in the site’s process and can often streamline the requirements.
Leverage Short Reconsent Addendums When Appropriate
Not every change requires a revised consent form. When the majority of the original consent remains valid, especially in longer-term follow-up situations, an addendum may be the most appropriate and efficient way to share updates.
For example, suppose the original consent covered multiple study visits that have already occurred, and the new information does not invalidate anything previously agreed to. In that case, use a concise addendum to communicate that update.
Addendums are most effective when they supplement the original consent, rather than contradict or override it. If the new information renders parts of the original consent no longer accurate, a revised consent form may be necessary to avoid confusion.
Use Staggered or Conditional Reconsent Based on Participant Impact
Reconsent does not always need to apply to every participant across the board. IRBs can, and often do, apply conditional reconsent based on who is affected by the changes. For example, if new safety information emerges related to an investigational infusion, only participants who are about to receive the infusion or are in early follow-up may need to be reconsented. Those who completed that phase a year ago may not be impacted.
Similarly, if the new information is urgent but does not require immediate formal reconsent, the IRB may allow for a staged approach, such as providing the information quickly via phone, email, or letter and following up with formal documentation later. This ensures timely communication without delaying the message for the sake of a signature.
Sites should also be empowered to triage reconsent efforts based on where participants are in the study and how significantly the new information affects their ongoing involvement. Flexibility and logic should guide these decisions.
Employ Technology to Track and Document Reconsent
Technology plays a key role in making reconsent more efficient and less burdensome, particularly for studies where participants are not coming in regularly to see the research team. eConsent platforms can facilitate the secure delivery of updated information and remote signatures, enabling participants to reconsent without requiring physical presence.
Even when a formal signature is not required, digital communication tools (such as secure emails, apps, or patient portals) can help sites share updates quickly and consistently. Sites can follow up with a phone call to ensure understanding and document verbal agreement in the study record.
Importantly, sites should always document how information was shared, even if a signed form is not involved. A participant’s signature does not necessarily indicate that they fully understood or absorbed the content presented. Therefore, a well-documented discussion—including participant questions, clarifications, or concerns—can often be a more reliable indicator of informed decision-making than a signature alone.
Reconsent: An Ongoing Commitment to Participant Autonomy
Consent is not a one-time event; it is a process that should be maintained throughout the study. After all, keeping participants informed is part of respecting their autonomy and maintaining their trust.
Reconsent is one way to accomplish this. By moving away from the misconception that reconsent must always be a formal, signature-heavy process, you can reduce administrative burden while preserving participant autonomy.
Whether through a formal reconsent, a brief addendum, or a verbal explanation accompanied by proper documentation, the ultimate goal remains the same: to ensure that participants stay informed and empowered to make decisions about their continued involvement in the research.
About the Author:
Linda Reuter is the Sr. IRB Director at BRANY. Her responsibilities include supervising the IRB staff and maintaining compliance with the IRB Standard Operating Procedures as well as applicable regulations. This includes supervising pre and post IRB meeting activities, expedited reviews, continuing reviews, protocol monitoring, continuing education, development of short and long term strategic goals for the organization, maintaining AAHRPP accreditation standards, policy maintenance and development, and training and mentoring of IRB staff.
Ms. Reuter began her career in IRB Administration at North Shore University Hospital Manhasset, currently part of Northwell Health. She held various positions within the Health System’s IRB program over a 20-year period. Linda formed IRB Consulting, LLC in 2012, providing IRB administrative services, training and education, audit services, and general consulting to numerous IRB programs, including BRANY and HRP Consulting Group, as well as several local institutions.
Ms. Reuter graduated with honors from SUNY Stony Brook with a M.S. in Health Sciences. She holds a B.S. in Biology from SUNY Stony Brook, and an advanced certificate in Health Care Management. She published work related to her Master’s thesis on Lyme disease in the Journal of Immunology, is a contributing author for a book on How to Work With and Within IRBs and has been a certified IRB professional since 2001.
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