Recently, more consumers have become interested in whole body donation to entities that make body parts, organs, and tissue available for research, bio-product development, and demonstration of new devices. A crucial element of this donation process is the informed consent of the family, which should, at an absolute minimum, include a voluntary decision based on full disclosure of the facts. To facilitate a fully informed decision, Funeral Consumers Alliance offers the following background and informed consent recommendations for consideration.
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Background: According to a 2001 report from the Department of Health and Human Services, most of the American public believes that all body, organ, and tissue donation is done with the humanitarian aim of helping the living and the critically injured. However, with respect to whole body tissue donation, most specimens are used in medical research, for demonstration purposes by pharmaceutical companies and device manufacturers, in other educational activities, and in the manufacture of therapeutic and cosmetic products.
Because of the recent proliferation in the use of such tissue for both therapeutic and cosmetic purposes, the financial incentives and profits have risen dramatically. While the Uniform Anatomical Gift Act (UAGA) prohibits the sale of body parts for transplantation or therapy, the Act does not define what constitutes “reasonable payment” for procuring, processing and distributing tissue. This provision leaves a loophole allowing some tissue banks, procurement organizations, and for-profit companies to exchange large sums of money for processed skin, bones, tendons, heart valves and other body parts. They do so by referring to the transaction as the collection of “fees,” rather than as an outright sale.
Current biomedical technology has created far more uses for donated tissues and body parts than mere organ transplantation. Donated tissue can be processed and formed into products far different from the tissue’s original form. Consequently, some biomedical companies are making large profits on products derived from donated tissue, a practice that seems to subvert the intent of the Act. In addition, the sale of body parts for medical research was not addressed in the Act.
There is also no mandated system by which to allocate donated tissue and body parts to those in the greatest need. Another report from the Department of Health and Human Services in 2001 found many burn centers had difficulty obtaining skin for grafting when it was needed. By contrast, newspaper and television investigations found many cosmetic or elective surgery clinics were able to obtain skin quickly and easily.
The public considers donation an altruistic act that benefits those most in need. But in a May 19, 2003, Boston Herald article, the chairman of the Health Law Department of Boston University’s School of Public Health said, “The market for body parts has become very lavish—skin, brain, heart valves are not just used for research but are part of a for-profit industry now. People need to be informed of this.”
What constitutes “valuable consideration” and “reasonable payment” for the removal, processing, disposal, preservation, quality control, storage, transportation or implantation of donated tissue and body parts is not regulated and is determined by the individual procurement organization.
Informed consent recommendations: (These recommendations may not be exhaustive. Additional elements of fully informed consent may emerge from further discussion among the stake-holders.)
1. There is no requirement that donated tissue be allocated in order of medical priority. Such a system might allocate tissue in the following order: a) to those in danger of dying if they do not receive imminent treatment, b) to those in need of reconstructive surgery to correct such conditions as congenital birth defects or damage from disease (such as cancer) or injury, c) to organizations doing medical research, d) to entities providing educational services with donated tissue and body parts, and finally e) to those who want purely cosmetic surgery unrelated to a medical condition. However, at present, there is no regulated order of priority for donated bodies to be used for these or other purposes.
2. There is no requirement for disclosure to the family of the identification of specific organs and/or tissues (including cells) that are being requested for donation, nor for providing subsequent information about the use of specific gifts recovered. A
donor family should receive such information from the procurement organization.
3. Donor families should receive an explanation from the procurement organization about how the retrieved organs/tissues may be used, including, but not limited to, use for transplantation, therapy, medical research, or educational purposes.
4. Donor families should receive from the procurement organization a description of the recovery process, including how tissue is recovered, processed, stored, and distributed; the duration of storage; and the possibility that the tissue may not be used.
5. Donor families should be told by the procurement organization what medical information will be needed, including laboratory tests and a medical/social history that may be needed to determine the medical suitability of the donor, including whether blood samples or other biological material from the donor will be tested for certain transmissible diseases and suitability for donation.
6. Donor families should be told by the procurement organization what costs, if any, directly related to the evaluation, recovery, preservation, and placement of the organs, body parts, and tissues will be charged to the family, and what costs will be paid to third parties who assist the procurement organization in the body acquisition process.
7. Donor families should be told by the procurement organization what impact the donation process may have on the return of the donor’s cremated remains to the family. In most cases, not all cremated remains will be returned to the donor family. The procurement organization should explain exactly what is done with cremated remains or body parts, including tissue, that are not returned to the donor family.
8. Families must be informed what tissue can be used or modified in various ways for transplantation in a life-saving capacity, transplantation in a life-enhancing capacity, and medical research or education, including a non-technical explanation of the use and modification process.
9. Families must be told that they have the right to limit or restrict the use of the tissue from the donor body.
10. A completed consent form must be reviewed with the family before final consent, and a copy provided to the family. Other written material explaining tissue donation should be offered to the family.
11. Families must be given the option of receiving acknowledgment of their gifts. This acknowledgment should include disposition and any recipient information available at that time, while protecting the anonymity of both the donor and any human recipient. If a recipient is a research program or the purpose is educational, the family should be told the name of the organization, the program, the specific body parts provided, and the location of the organizational recipient.
12. To obtain additional information about the gift, the donor family should be provided with contact information (including phone number and address) for the recovery agency.
NOTE: This article was written by Gere Fulton and Lamar Hankins as part of their work as Co-Chairs of the Legal Committee of the Funeral Consumers Alliance.