Center for Medical Ethics and Health Policy

Completed: Returning Research Results of Pediatric Genomic Research to Participants

Media Component
Genome Law and Policy Research

Project Description

As the whole genome sequencing industry continues to grow, it is imperative that policy challenges arising from the utilization of this technology are identified and addressed in a timely manner. Through a modified Delphi process, a methodology used to iteratively engage a diverse group of stakeholders, this project identifies and prioritizes the unique policy challenges involved in translating WGS into health benefits in the United States. Using a mixed methods approach, such as a landscape analysis of the current and emerging WGS industry and qualitative interviews with industry leaders, the study team is developing an initial list of policy questions to be distributed to key stakeholders who will help refine and prioritize the resulting issues by importance and tractability.

Project Personnel

  • David Kaufman, Ph.D., Co-Principal Investigator
  • Amy McGuire, J.D., Ph.D., Co-Principal Investigator

Supported by: R01HG006460, National Human Genome Research Institute, NIH


Returning Research Results of Pediatric Genomic Research to Participants


Returning genomic research results to participants is rife with ethical issues, especially when the research participants are children. This study explores the legal implications of returning pediatric genomic research results to participants. By using standard legal analytic tools, study investigators are developing criteria to govern the ethical return of incidental findings and results of pediatric genomic research. US laws and international guidelines regarding decision making for and by minors are included in the analysis to provide a foundation for developing these criteria.

Project Personnel

  • Ellen Clayton, J.D., Ph.D., Principal Investigator
  • Amy McGuire, J.D., Ph.D., Co-Investigator
  • Bartha Knoppers, Ph.D., Co-Investigator

Supported by: R21HG006612, National Human Genome Research Institute, NIH


Publications Related to Genome Law and Policy


McGuire AL, Wang MJ, Probst FJ. Identifying consanguinity through routine genomic analysis: Reporting requirements. The Journal of Law, Medicine, and Ethics. 2012; 40 (4): 1040-6.

Clayton EW, McGuire AL. The Legal Risks of Returning Results of Genomics Research. Genetics in Medicine 14(4), 2012:473-477.

McGuire AL, Joffe S, Koenig BA, Biesecker BB, McCullough LB, Blumenthal-Barby JS, Caulfield T, Terry SF, Green RC. Ethics and genomic incidental findings. Science. 2013; 340 (6136): 1047-8.

Green RC, Berg JS, Grody WW, Kalia SS, Korf BR, Martin CL, McGuire AL, Nussbaum RL, O’Daniel JM, Ormond KE, Rehm HL, Watson MS, Williams MC, Biesecker LG. ACMG recommendations for reporting of incidental findings in clinical exome and genome sequencing. Genetics in Medicine. 2013; 15(7): 565-74.


Meet Our Team


The Center for Medical Ethics and Health Policy team is led by Director Amy L. McGuire, J.D., Ph.D.

View faculty and staff listing
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