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Media Contact: Vincent Joseph Dollard 17 November 2005    
  (404) 727-3366   Print  | Email ]

Consensus Panel Develops Ethical Guidelines for Recently-Dead Research Subjects
For the first time, a consensus set of ethical guidelines has been published to give individual medical institutions -- and the medical community at large -- a foundation on which to launch debate or consider studies with a growing research population: the recently dead.

Convened by Rebecca Pentz, Ph.D., professor of Hematology and Oncology in Research Ethics at the Winship Cancer Institute at Emory University and lead author of the study, a multidisciplinary expert panel agreed unanimously on specific recommendations that balance the potential benefits of the research with the dignity and respect for the subjects. The term, "recently dead," includes cadavers with no heart beat as well as brain-dead cadavers who are still on ventilators and other technological supports.

The panel, known as the Consensus Panel on Research with the Recent Dead, is comprised of 15 ethicists, clinicians, researchers, patient and religious advocates from around the United States. After developing the initial set of recommendations, the panel will review or raise new issues as appropriate.

According to Pentz, the guidelines published in the Nov. 5, 2005 issue of "Nature Medicine," are based on the principle of respect for persons, which the panel believes should extend to the dead. Therefore, the individual's goals and wishes are to be honored by the research in which they participate.

"With the panel, we hoped to create dialogue among the institutions who currently review research with the recently dead as well as answer and anticipate questions from individual researchers and Institutional Review Boards (IRBs) at research institutions that are considering programs," said Pentz. "We want the guidelines to give the research centers a confidence to properly address and assure patients and families that they and/or their loved ones will be treated with respect and dignity, and that their participation in the research will be not only completely voluntary, but highly valued."

Legal but debated over the last 25 years, research on dead individuals has emerged in recent years with two major institutions publishing data from research programs with the recently dead, and with each institution developing separate ethical standards.

Such research, which today is considered a rare practice due in part to ethical considerations, is expected to increase in the coming decade as new technologies such as nanodevices and targeted therapies evolve and require sophisticated research methods. In addition, researchers report that "fresh" tissue is critical in the study of human degenerative diseases such as cancer, Alzheimer's disease and multiple sclerosis.

The University of Texas M. D. Anderson Cancer Center in Houston and the University of Pittsburgh have research programs under way for the recently dead, and have ethical guidelines for their individual programs in place. Representatives from both institutions participated in the consensus panel.

M. D. Anderson is working to develop the first molecular map of the human vasculature in part by gathering data from biopsies of organs administered with a library of peptides or phages that home into specific areas of the body.

Wadih Arap, M.D., professor of medicine and cancer biology at M. D. Anderson, and his colleagues are using the data to learn more about delivering targeted therapies to intended organs.

Members of the consensus panel also included representatives from the Kennedy Institute of Ethics, Georgetown University; University of Pittsburgh Center for Bioethics and Health Law; West Virginia University; University of Pittsburgh School of Medicine; Case Western Reserve University Center for Biomedical Ethics; University of Virginia School of Nursing; Memorial Sloan-Kettering Cancer Center; University of Colorado Heath Sciences Center; Children's Oncology Group; Center for Ethics, Emory University; School of Medicine, Emory University; Wellesley College.

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