A viewpoint article published in JAMA explored the ethical underpinnings of returning research data to study participants. In an era of larger-scale studies and increased data digitization, the question of which information is appropriate to disclose has become a focal point in medical ethics.
Charlene A. Wong, MD, MSHP, of the Department of Pediatrics at the Duke University School of Medicine and the Duke-Margolis Center for Health Policy in Durham, North Carolina, and colleagues highlighted both the ethical and practical concerns of data-sharing — all patients have a right to access their medical data but delivering large and complex files to study participants may be impractical. The proper timing for returning results also remains unclear; many participants may be accustomed to receiving clinical results in a matter of days, but any turnaround to quickly return data may place undue strain on research sites. Additionally, some data may not be accessible to people without a medical background; it may be appropriate for investigators to “tailor” the results such that they may be understood by recipients.
Dr Wong and colleagues also emphasized the necessity of context in data return. “Anxiety-provoking” results should be delivered with enough information to allow full understanding from the participant. Dr Wong recommended “engaging” clinicians in data return from the start of the process to prevent any decontextualized results and to mitigate potential worry.
The impact and appropriateness of sharing study data is animated by the “what, when, and how”: research sites must choose carefully which data is appropriate to disclose, then construct a timeline and method for disclosure. In the era of high accessibility, research personnel are themselves responsible for constructing an appropriate relationship between participants and study data.
Wong CA, Hernandez AF, Califf RM. Return of research results to study participants [published online June 21, 2018]. JAMA. doi:10.1001/jama.2018.7898