title: Ethics and regulation in organ procurement research.
abstract: This article explores the role of ethics and regulation in human research conducted by organ procurement agencies; basic ethical principles for human research are outlined. Organ procurement agencies are not required to observe federal regulations; however, voluntary adherence will ensure that procurement research is conducted according to current standards of ethical practice. Although most organ procurement research will qualify for exempt status, this determination should be made by an institutional review board. Even if studies qualify for exempt status, there is a moral presumption that informed consent should be sought, unless certain narrow conditions for waiver of consent are satisfied. Finally, when future research utilizing organ procurement records is anticipated, procurement coordinators should provide sufficiently detailed information to families about such plans to permit their advance informed consent to research activities.
authors.affiliation: University of Tennessee Health Science Center, Memphis, Tenn., USA.
authors.forename: Terrence F
authors.initials: TF
authors.lastname: Ackerman
authors.forename: Rebecca P
authors.initials: RP
authors.lastname: Winsett
mesh_terms: D017041:Ethics Committees / Q000458:organization & administration; D032984:Ethics, Research; D005161:Facility Regulation and Control / Q000941:ethics* / Q000458:organization & administration*; D005190:Family; D019983:Guideline Adherence / Q000331:legislation & jurisprudence; D006805:Human Experimentation / Q000941:ethics* / Q000331:legislation & jurisprudence / Q000592:standards; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D010344:Patient Advocacy / Q000941:ethics / Q000331:legislation & jurisprudence; D017410:Practice Guidelines as Topic; D028662:Principle-Based Ethics; D009927:Tissue and Organ Procurement / Q000941:ethics* / Q000458:organization & administration*; D014481:United States