At the Research-Clinical Interface
Abstract
Whether individual results of genetic research studies ought to be disclosed to study participants has been debated in recent decades. Previously, the prevailing expert view discouraged the return of individual research results to participants because of the potential lack of analytic validity, questionable clinical validity and medical actionability, and questions about whether it is the role of research to provide participants with their data. With additional knowledge of participant perspectives and shifting views about the benefits of research and respect for participants, current expert consensus is moving toward support of returning such results. Significant ethical controversies remain, and there are many practical questions left to address, including appropriate procedures for returning results and the potential burden to clinicians when patients seek guidance about the clinical implications of research results. In this review, we describe current views regarding the return of genetic research results, including controversies and practical challenges, and consider the application of these issues to research on apolipoprotein L1 (APOL1), a gene recently associated with health disparities in kidney disease. Although this case is unique, it illustrates the complexities involved in returning results and highlights remaining questions.
Document Details
- Document Type
- Pub Defense Publication
- Publication Date
- Feb 10, 2020
- Source ID
- 10.2215/cjn.09670819
Entities
People
- Bessie A. Young
- Ebele M. Umeukeje
- Erika Blacksher
- Kathleen M. West
- Kerri L. Cavanaugh
- Stephanie M. Fullerton
- Wylie Burke
Organizations
- National Center for Advancing Translational Sciences
- National Human Genome Research Institute
- National Institute of Diabetes and Digestive and Kidney Diseases
- National Institutes of Health
- United States Department of Defense
- United States Department of Veterans Affairs
- University of Washington
- Vanderbilt University