Panel issues guidelines for practice on the newly dead
Respect for the person, loved ones should be priority
They are considered one of the most valuable teaching tools for doctors in training, yet they also are the topic of a highly charged ethical debate — the bodies of newly deceased patients.
No model or diagram can duplicate the realism of practicing a medical procedure such as intubation on a human body. But even when agreeing that cadavers are valuable teaching tools that offer training benefits that carry over to the student physicians’ living patients, ethicists say strict limits should be placed on the use of dead people as 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 the newly deceased.
A multidisciplinary expert panel, led by Rebecca Pentz, PhD, professor of hematology and oncology in research ethics at the Winship Cancer Institute at Emory University in Atlanta, agreed unanimously on specific recommendations to balance the potential benefits of research with dignity and respect for the subjects.
Guidelines provide some ethical direction
The term "recently dead" includes cadavers with no heartbeat as well as brain-dead cadavers still on ventilators and other technological supports.
The panel, known as the Consensus Panel on Research with the Recent Dead, comprises 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 November 2005 issue of Nature Medicine are based on the overriding principle of respect for people, which the panel believes should extend to the dead. Therefore, the individual’s goals and wishes are to be honored in 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," explains 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."
For example, fears that wide acceptance of the use of the newly dead for training or research could result in the maintaining of "biomort emporiums," where cadavers would be kept on life-support equipment for days or weeks, would be allayed by adherence to the consensus panel’s recommendation that studies using recently deceased patients be limited to one day, unless there are strong scientific reasons to extend the study.
"The prospect of prolonged storage of ventilated and profused bodies for research is deemed abhorrent to many and risks undermining public support for research with the recently deceased," the guidelines state.
The eight guidelines created by the consensus panel are:
• Review and oversight
Jurisdictions differ on whether research with the newly dead must be reviewed. In the United States, federal regulations define human subjects as living human beings; thus, the requirement that all human research undergo review by an IRB does not extend to research with the deceased. Regardless of regulatory requirements, the panel recommends that research with the dead should proceed only after approval by a properly constituted review board.
Review of proposals for research with the dead should assess the scientific validity and value of the research, and the research should address a significant question, use methods likely to produce valid results, and, to the extent possible, employ procedures similar to those used with living subjects to facilitate subsequent clinical application.
In addition, the degree of invasiveness to the corpse must be minimized and justified in terms of expected scientific benefits. Because such research could be burdensome to families, for example, by delaying funerals or disfiguring corpses, the panel recommends negative consequences should be minimized and any delay or disfigurement justified by a likely yield of scientific knowledge.
• Community involvement
The panel recommends community involvement in review, approval, and oversight of studies involving the dead, with representation from the pool of potential research subjects; from ethnic, minority, and religious groups prominent in the geographic area; and "articulate and interested lay persons."
Investigators who propose research on or educational use for cadavers must justify having chosen this subject population, considering potential risks and benefits to survivors, scientific advantages, the potential for harm to alternative subjects (including animals), and feasibility.
Importantly, the consensus panel rejects the notion that research with the deceased be a last resort, "as the dead may be preferable to living humans or animals as subjects for some research, such as research with potentially painful procedures."
One thing that takes ethical priority over research, the panel emphasizes, is organ procurement. Because organ donation’s benefit to living individuals is immediate, organ donors should be considered ineligible for research unless: the research will not interfere with organ procurement; the individual had consented prior to death to being a research subject in preference to organ donation; or, in the absence of clear directives from the deceased, family members consent to postmortem research in preference to organ donation.
Likewise, legally required autopsy takes precedent over both transplantation and research, the panel notes.
To instill confidence and trust in the use of the deceased in postmortem research, physicians not involved in the training exercise or research should be the ones to determine that death has occurred.
• Research procedures
The guidelines state that procedures on the newly dead must be conducted with respect, but need not be identical to those used with the living. The body should be kept covered to the extent possible, and procedures should be as minimally invasive as possible. If disfigurement is unavoidable, family members should be informed in advance, and the possible disfigurement should be described in the consent document.
Cultural standards should be considered in determining respectful treatment. Likewise, time considerations should be taken into account, with research and training procedures limited to one day unless more time is demanded for valid scientific reasons.
When training or research is conducted in patient facilities such as hospitals or clinics, the research should not compromise the care of living patients. Protocols must establish whether family members will be permitted to visit during a study.
The panel writes that the "bedrock ethical requirement for research on all human subjects, including the recently dead, is to obtain informed consent from competent prospective subjects or their legally authorized representatives." If there is no directive from the deceased and his or her legally authorized surrogates disagree, the panel recommends intervention by the institution’s ethics committee to help resolve the dispute, but discourages proceeding with research with the dead in cases of disagreement.
To avoid any appearance of conflict of interest, the panel suggests that if surviving family members are to be approached about consenting to the use of a deceased person for research or educational purposes, it should be done by physicians who did not participate in caring for the person while he or she was still alive.
Review boards should approve proposals for research with the recently dead only if confidentiality protections are satisfactory. Respect for the dead and their living relatives and friends require that information about them not be openly shared, the panel notes, and all requirements for use of protected health information under the Healthcare Insurance Portability and Accountability Act (HIPAA) be met.
• Resource use and cost
Posthumous whole-body research should not impose extra costs on the subject’s estate, family or surrogates, and there should be no payments or incentives offered for participation.
• Conclusion of research
The return of remains to the family should be observed per the agreement and requests established at the time of consent.
A long-debated subject
Legal, but debated over the last 25 years, the issue of 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 authors for the consensus panel note that there are several reasons for requiring that the bodies of the recently deceased be treated with dignity. First, many people have strong preferences about how they want their bodies disposed of after they die, and an aversion to disrespectful treatment — considered "desecration" by some — is commonly among those feelings.
Honoring those preferences after death is a mark of respect both to the deceased and to surviving loved ones. Respectful treatment of the dead also demonstrates to those still living that their wishes about the disposition of their bodies will be honored and that bodies used for medical study will be respected.
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.
Pentz RD, Cohen CB, Wicclair M, et al. Consensus Panel on Research with the Recently Dead. Ethics guidelines for research with the recently dead. Nature Medicine 2005; 11:1145-1149.
Rebecca Pentz, PhD, professor, hematology and oncology in research ethics, Winship Cancer Institute, Emory University, Atlanta, GA. E-mail: firstname.lastname@example.org.