Anticipate and Plan for Collateral Findings Before Study Implementation

Investigators should prospectively consider the potential for collateral findings in pragmatic clinical trials during study design and work with their partnering healthcare institutions to understand processes for managing any collateral findings that might arise.

IRBs can support research teams in prospective consideration of potential collateral findings in pragmatic trials by ensuring that investigators have a management plan at the time of study review. However, IRB members should be aware that, because many pragmatic trials are conducted with waivers or alterations of informed consent, individuals may not have previously had the opportunity to consider their preferences for receiving additional information related to their health. As a result, informed consent will likely have limited value as a solution for decision making regarding disclosure of collateral findings in pragmatic trials.

Prepare Clinicians to Discuss Collateral Findings With Patients

Frontline clinicians in the healthcare systems in which pragmatic trials are embedded will play a key role in the disclosure and management of collateral findings. Healthcare systems should prepare clinicians accordingly. Relevant components include preparing to discuss with patients the rationale for pragmatic trials (and for conducting at least some pragmatic trials without prospective informed consent), responding to negative reactions from patients regarding disclosure, and directing patients to appropriate resources within their institution for management and follow-up.

Use Multiple Modes to Communicate About Collateral Findings to Patients

When communicating information about collateral findings in pragmatic trials to patients, healthcare systems should consider using multiple channels, from electronic notifications through patient portals to phone calls or in-person visits. Using multiple approaches recognizes the heterogeneity of patients’ informational preferences, as well as differences in their access to relevant communication modes.