A team of researchers from the NIH Collaboratory and the Johns Hopkins Berman Institute of Bioethics recently completed a multi-method investigation of the ethical and regulatory implications of “collateral findings” in pragmatic clinical trials. Lessons from the project—the Management of Trial Incidental Findings Study (MOTIFS)—were published online ahead of print in the journal Healthcare.
Collateral findings in pragmatic clinical trials are findings, whether discovered intentionally or unintentionally, that do not address the trial’s research question(s) but may have implications for the health of patients included in the trial. For example, when collecting data from electronic health records for a pragmatic trial, researchers might detect the use of contraindicated medications in some patients. It is uncertain how to manage these findings, including how best to notify patients of them.
The results of MOTIFS make clear that existing ethics guidance from other clinical research settings cannot easily be adapted to the challenges of collateral findings in pragmatic clinical trials. Moreover, the challenges are complex and do not lend themselves to a one-size-fits-all solution.
The authors offer advice for researchers, institutions, ethics oversight bodies, and funders involved in the design, conduct, and analysis of pragmatic clinical trials, and they recommend important areas for future research.
This work was supported within the NIH Collaboratory by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director. Supplemental funding for this work was provided by the National Center for Complementary and Integrative Health.