The Flexibility Of Reconsent In Clinical Trials

By Linda Reuter, Sr. IRB Director at BRANY

Reconsent is often misunderstood as a burdensome, formal process requiring full documentation and participant signatures. However, federal regulations do not mandate reconsent as a standardized event; rather, they require that participants be informed of significant new findings that could influence their continued participation. Here we take a closer look at common misconceptions and see how reconsent can be a flexible, ethics-driven communication practice grounded in respect for participant autonomy. Learn when reconsent is necessary—such as in cases of increased risk, protocol changes, or newly available treatment alternatives—and distinguish these from minor updates that can be conveyed informally.

Reconsent strategies should be tailored to the significance of the information and participant impact, not dictated by rigid procedural norms. Through examples and practical strategies—like using short addendums, conditional reconsent, and technology-enabled communication—research teams can meet ethical obligations without undue administrative burden. Ultimately the best approach a participant-centered one, where informed consent is an ongoing process and reconsent serves as a tool to maintain trust, transparency, and autonomy in clinical research. By promoting collaboration among sites, sponsors, and IRBs, reconsent can become both efficient and meaningful.