Sharing research test results with trial volunteers could boost levels of trust and engagement, making the costs of overcoming barriers a worthwhile investment.
That’s according to a new report from the National Academies of Sciences, Engineering, and Medicine, Returning Individual Research Results to Participants.
It found that while ethical and regulatory barriers to the free-sharing of such information did exist, the benefits of overcoming these outweighed the costs.
“Our hope is that this report will provide a road map toward better, more collaborative and transparent research practices that will benefit participants, investigators, and society more broadly,” said Jeffrey Botkin, Associate Vice President for Research and Professor of Pediatrics at University of Utah, and report lead author.
One of the barriers to the free-sharing of information, the report highlighted, was inconsistent federal regulations.
The Centers for Medicare and Medicaid Services (CMS) prohibits the return of results from laboratories that are not certified under the Clinical Laboratory Improvement Amendments (CLIA). Yet, under the Health Insurance Portability and Accountability Act (HIPAA), results can be requested regardless of where they were generated in certain circumstances.
“There is a long-standing tension in biomedical research arising from a conflict in core values – the desire to respect the interests of research participants by communicating results versus the responsibility to protect participants from uncertain, perhaps poorly validated information,” added Mr. Botkin.
Report authors recommend solving this conflict by moving away from the strict CLIA and HIPAA rules and creating a new process that would enable researchers to decide how and when to share results on a study-by-study basis.
This would include involving advocacy and community groups in the process to ensure volunteers are represented in that decision and utilizing effective communication strategies to minimize the risks of people misinterpreting their own data.
The report explained: “In the consent process, investigators should communicate clearly to research participants whether, under what circumstances, and how investigators will offer and return research results.
“When individual results are communicated to participants, investigators should facilitate understanding of the meaning and limitations of results by, for example, ensuring there is a clear take-away message, explaining the level of uncertainty, and providing mechanisms for the participants to obtain additional information and guidance for follow-up consultation, when appropriate.”
“The justification for returning results becomes stronger as both the potential value of the result to participants and the feasibility of return increase,” the report said.
“To harmonize relevant regulations, regulators and policymakers should revise them in a way that respects the interests of research participants in obtaining individual research results and balances the competing considerations of safety, quality, and burdens on the research enterprise.”
Adoption of the committee’s recommendations will take time, as the necessary expertise, infrastructure, policies and resources are developed, authors pointed out.
But that doesn’t mean it shouldn’t be done.
“Although initial investments will likely be significant, the return on those investments – increased participant trust and engagement with the research enterprise, as well as higher quality standards for research laboratories – will be worthwhile,” the report concluded.
National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. https://doi.org/10.17226/25094.