National Panel Issues Guidelines on Controversial Issue of Returning Results to Study Participants

Jul 18, 2018 9:45 AM

Author: Soumya Yandamuri

Have you ever given a blood sample for a research study and a few months later wondered, “what happened to that study?” Finding the answer to that question can be surprisingly difficult, raising a number of questions.

When do research participants have a right to obtain their results? What are the risks and benefits of providing an individual with this information? Sometimes sticky issues arise such as when participants take part in a genetic study on one condition but are found to have to have a genetic marker that signals they are at risk for another condition altogether. Even if researchers who led the study felt it was important to provide the participant with this information, many laboratories aren’t certified to do so.

Conflict in Core Values

University of Utah bioethicist and pediatrics professor Jeffrey Botkin, MD, MPH, says, “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.” Indeed, regulations reflect these controversies.

In the last five years, United States agencies governing patient information have promoted transparency. For example, research participants now have the right to request their information. However according to the Clinical Laboratory Improvement Amendment (CLIA) passed in 1988,  laboratories that don’t meet stringent certification requirements cannot disseminate results to patients. The goal was to ensure that results from laboratories with unverified quality don’t get into the hands of the public. Yet CLIA certification is not appropriate for all laboratories.

A Path Forward

Given the lack of clarity and cohesion of existing practices, a committee of the National Academies of Sciences, Engineering, and Medicine, chaired by Botkin, developed a report defining a new paradigm for returning research results to study participants. In its release on July 10th, 2018, the report provides guidelines for stakeholders including researchers, institutions, funding agencies, and policy makers.

Several recommendations are designed to make returning results easier and to ensure that the results themselves are more reliable. For example, the report urges the largest funder of biomedical research in the U.S., the National Institutes of Health (NIH), to coordinate development of a new quality management system for labs that are not CLIA certified and to provide additional resources and support for researchers who would like to release research results. Furthermore, it provides directions on how researchers can decide whether and how to return results.

Building Trust

An interesting aspect are provisions aimed at taking research participants’ perspectives into account. In order to understand their needs and wants, the report asks researchers to solicit advice from advocacy groups and community advisory boards. Furthermore, it recommends that researchers convey results in a manner that minimizes misunderstandings. The report reminds researchers to contextualize the results, describe the meaning of the findings, and highlight the limitations of the study.

The ultimate goal is to increase trust in scientific and medical research. “Our hope is that this report will provide a road map toward better and more collaborative and transparent research practices that will benefit participants, investigators, and society more broadly,” says Botkin.

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