Informed consent process for patient participation in rare disease registries linked to biorepositories.

a Office of Rare Diseases Research, National Institutes of Health, Bethesda, MD, United States b Office of the Clinical Director, National Human Genome Research Institute, Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD, United States c Department of Health and Human Services, Office for Human Research Protections, Rockville, MD, United States d Combined NeuroScience Institutional Review Board, National Institute of Health, Bethesda, MD, United States e Office of Biorepositories and Biospecimen Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, United States f Case Western University, Cleveland, OH, United States g University of Rochester School of Medicine and Dentistry, Rochester, NY, United States h Patient Crossroads, Innolyst, Inc., San Mateo, CA, United States i University of Maryland School of Law, College Park, MD, United States