title: A Framework for Conducting Deceased Donor Research in the United States.
abstract: There are a number of regulatory barriers both perceived and real that have hampered widespread clinical research in the field of donation and transplantation. This article sets forth a framework clarifying the existing legal requirements and their application to the conduct of research on deceased donors and donor organs within the United States. Recommendations are focused on resolving some of the ambiguity surrounding deceased donor authorization for research, Health Insurance Portability and Accountability Act requirements and the role of institutional review board oversight. The successful conduct of clinical research in the field of donation and transplantation requires an understanding of these regulatory nuances as well as identification of important ethical principles to consider. Facilitation of these concepts will ultimately provide support for innovative research designed to increase the availability of organs for transplantation. Further work identifying the optimal infrastructure for overview of clinical research in the field should be given priority.
authors.affiliation: 1 New England Organ Bank, Waltham, MA. 2 Verrill Dana LLP, Boston, MA. 3 Center for Transplant Outcomes & Quality Improvement, Transplant Institute, Beth Israel Deaconess Medical Center, Boston, MA. 4 Harvard Medical School, Boston, MA.
authors.forename: Alexandra K
authors.initials: AK
authors.lastname: Glazier
authors.forename: Kate Gallin
authors.initials: KG
authors.lastname: Heffernan
authors.forename: James R
authors.initials: JR
authors.lastname: Rodrigue
mesh_terms: D000533:Altruism; D035843:Biomedical Research / Q000331:legislation & jurisprudence*; D037921:Gift Giving; D033161:Government Regulation; D020408:Health Insurance Portability and Accountability Act; D006291:Health Policy / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent; D016377:Organ Transplantation / Q000331:legislation & jurisprudence*; D011050:Policy Making; D036302:Therapeutic Human Experimentation / Q000331:legislation & jurisprudence*; D014019:Tissue Donors / Q000331:legislation & jurisprudence*; D009927:Tissue and Organ Procurement / Q000331:legislation & jurisprudence*; D014481:United States