May 13, 2022: Ethics and Collateral Findings in Pragmatic Clinical Trials: Implications of a Multi-Method Exploration

Speaker

Jeremy Sugarman, MD, MPH, MA
Deputy Director for Medicine
Harvey M. Meyerhoff Professor of Bioethics and Medicine
Berman Institute of Bioethics
Johns Hopkins University

Stephanie Morain, PhD, MPH
Assistant Professor
Berman Institute of Bioethics
Johns Hopkins University

Juli Bollinger, MS
Research Scientist
Berman Institute of Bioethics
Johns Hopkins University

Kevin P. Weinfurt, PhD
Professor and Vice Chair of Research
Department of Population Health Sciences
Duke University School of Medicine

Keywords

PragmaticClinicalTrials; Ethics

Key Points

There are many ethical complexities for pragmatic clinical trials, including consent, gatekeepers/relationship to patients, privacy, scale and incidental and secondary findings that may have implications for health, but were not generated to address the PCT’s primary research questions.

MOTIFS: Management of Trial Incidental Findings study aimed to asses gaps in current guidance for managing incidental findings that are relevant to PCTs by holding stakeholder interviews and focus groups.

In interviews with health care provider stakeholders, MOTIFS investigators learned that PCT-CFs are not on peoples’ radar, but there is a shared belief anticipation/planning is critical. A lack of shared language and not having clear “ownership” further complicates communicating about PCT-CFs.

Focus groups were held with patient participants from cities in three different geographic areas of the U.S. Participants had mixed reactions to learning about possible incidental findings, preferences for who and how the findings were communicated varied, but the timeline for delivery of the finding was important. Communication should include clear action steps and not have unneeded details, and a multi-modal approach of communicating was preferred.

Policy recommendations include PCT-CFs should anticipate and plan for incidental findings before study implementation; clincians should be prepared to discuss PCT-CFs with patients and for subsequent management; multiple modes of communication with patients is preferred.

Discussion Themes

– For at least some patients, the value of the information went beyond actionability–they wanted the information, even if not of immediate clinical relevance, as it could influence their future decisions about where/from whom to seek care.

– The study did not factor for race and ethnicity. Even with the large sample size, the experiment was a complex multifactorial design, and so adding new variables implies a multiplicative increase in study size.

– Incidental findings can be introduced as a possibility in the consent process of PCT-CFs when there is a full IC process.

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