Informed consent to tissue donation: policies and practice

• Published in: Cell and tissue banking 2009-08, Vol.10 (3), p.235-240
• Main Authors: Siegel, Andrew, Anderson, Martha W., Schmidt, Tracy C., Youngner, Stuart J.
• Format: Article
• Language: English
• Subjects: Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Biological and medical sciences; Biomedical and Life Sciences; Biomedicine; Blood & organ donations; Bone marrow, stem cells transplantation. Graft versus host reaction; Cell Biology; Humans; Informed consent; Informed Consent - ethics; Informed Consent - statistics & numerical data; Life Sciences; Medical sciences; Miscellaneous; Public health. Hygiene; Public health. Hygiene-occupational medicine; Public Policy; Skin & tissue grafts; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Tissue and Organ Procurement - ethics; Tissue Banks - ethics; Tissue Banks - statistics & numerical data; Tissue Donors - ethics; Tissue Donors - statistics & numerical data; Tissue Transplantation - ethics; Transfusions. Complications. Transfusion reactions. Cell and gene therapy; Transplant Surgery; Transplants & implants; United States
• ISSN: 1389-9333; 1573-6814
• DOI: 10.1007/s10561-008-9115-y

Nearly 10 years ago, the tissue industry’s informed consent practices with donor families in the United States were criticized. In response, the industry, along with the Inspector General of the Department of Health and Human Services, suggested elements to be included in the informed consent process. This study examines which of these elements were present in the informed consent documents of 45 (78%) of the nation’s 58 Organ Procurement Organizations (OPOs). Some elements, such as involvement of for-profit companies, were present in almost all. Others, such as labeling tissue as a gift from donor families, never were. The authors conclude that the time is ripe for reexamination of the informed consent process with an eye to meaningful consent that promotes the benefits of tissue transplantation and at the same time protects the rights and interests of donor families; can be realistically implemented; and, maintains the trust of the American public.