Individual Research Results Should Be Shared With Participants More Often, Says New Report

A new report from the National Academies of Sciences, Engineering, and Medicine says that when researchers test human biospecimens, investigators and their institutions should routinely consider returning individual research results to the participant, depending on the characteristics of the research, the nature of the results, and the interests of participants. 

Suzanne Bakken, PhD, Alumni Professor of Nursing and Professor of Biomedical Informatics at Columbia University School of Nursing, is a member of the committee that authored the report. Columbia Nursing’s expertise in health literacy – including the use of information visualizations to present results to Latino research participants – helped to inform the new decision-making guidelines.

These recommendations, which support returning individual research results when analyzed in a laboratory with a quality management system (QMS), provide best practices guidance for sharing results “in a health literate, culturally appropriate, and actionable manner,” says Dr. Bakken.

“I was honored to participate in this important consensus committee and to share the strategies we developed through our Columbia Nursing projects on returning results to research participants, particularly Latinos,” she adds.

While participants generally want access to their individual research results, researchers have not, historically, returned them. This tendency, however, is changing says Dr. Bakken, because of the cultural shift to greater transparency and open science and in initiatives such as the National Institute of Health’s (NIH) “All of Us Research Program,” whose goal is to collect clinical, lifestyle, and genomic data on at least a million Americans to generate a rich resource of research data, and includes plans return data to the participants.

The new report notes that the regulatory environment to date has been inconsistent about returning laboratory results collected for research.

For example, the Centers for Medicare & Medicaid Services (CMS) prohibits the return of results from laboratories that are not certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), but in some circumstances the Health Insurance Portability and Accountability Act of 1996 (HIPAA) may require the return of results requested by a participant, regardless of whether they were generated in a CLIA-certified laboratory. 

CLIA requirements ensure the quality and integrity of data, accurate reconstruction of test validation and test performance, and the comparability of test results regardless of performance location. Currently, there is no accepted QMS for research laboratories that could serve as an alternative to CLIA certification.  

Among its recommendations, the report offers a process-oriented approach to returning individual research results that bridges the interests of research participants who want access to their results, with the responsibility to protect them from uncertain or poorly validated information.

The full report, entitled “Returning Individual Research Results to Participants: Guidance for a New Research Paradigm,” was sponsored by the National Institutes of Health, U.S. Food and Drug Administration, and the Centers for Medicare & Medicaid Services.