Providing research participants with findings from completed cancer-related clinical trials

Not quite as simple as it sounds


Providing Research Participants with Findings from Completed Cancer-Related Clinical Trials

We appreciate the challenging difficulties that Dr. Markman describes in his recent commentary1 on returning research results to participants. He recommends that investigators routinely provide results to participants only if therapeutic relevance is identified. He proposes a detailed written consent process at enrollment regarding the right to receive eventual results. These strategies present several concerns.

Study participants have a right to be offered research results based in the principle of respect for persons.2 Potential future therapeutic benefit creates a powerful mandate for offering results. Subjects are increasingly vocal in expressing a right to see the information they helped to generate. Such an offer demonstrates respect, diminishes a perception of exploitation, and may allow for planning for a poor expected outcome (irrespective of whether there is a “future action to favorably influence the subsequent course”). Restricting results to those with perceived therapeutic benefit is not respectful of the participant's autonomous decision making.

Conversely, mandating the provision of research results with potentially therapeutic implications does not allow participants to choose whether to receive such information. Participants may have valid reasons for not wanting research results, even if such results are apparently relevant to health.

The provision of detailed information concerning the eventual offer of results in the upfront consent lacks a sense of immediacy, may be forgotten, and unnecessarily increases complexity. An informed discussion should optimally occur closer to when the offer is made to share results. This should include the potential risks and benefits, and the reliability and validity of the conclusions, whether provided in an individualized manner or as a summary.

Further study in this complex area is urgently needed. Patients have indicated that they expect to be offered results, even if negative.3 Patients will need to be our teachers and partners as we learn to do this with sensitivity and respect. That should be a challenge, not a barrier.

Conrad V. Fernandez MD*, Susan Shurin MD†, Eric Kodish MD‡, * Department of Pediatrics, Department of Bioethics, IWK Heath Centre and Dalhousie University, Halifax, Nova Scotia, Canada, † National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, ‡ Department of Bioethics, Cleveland Clinic Foundation, Cleveland, Ohio.