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NEUROCRITICAL CARE ETHICS Misconceptions and Uncertainties in Deceased Organ Donor Medical Research By Michael Rubin, MD, MA Conduct of human subject research pursuant When one offers a gift for organ donation, they may also be to the Common Rule has trained researchers consenting for the participation in medical research. Guidelines to not only know about the underlying have been proposed, but your medical center may have not principles and declarations guiding medical participated in such research and, therefore, may not have research, but it may also inculcate an developed guidelines on how they would recommend you proceed. expectation that if the local institutional review board does not regulate a particular Even if your state allows for a first person consent for donation aspect of research, then regulations do not as well as medical research for the purposes of improving the apply. This misconception is evident after a organ donation process, it is prudent to consider if such activities review on the conduct of research on those should be at least assented to by surrogates. Transparency is often who have been declared dead by neurologic criteria. the most effective tool to support trust with decision makers, even if it might mean that some will chose to not participate in Deceased donor research is necessary to maximize the likelihood research. If surrogates become aware of the research indirectly, of successful organ recovery and placement, however, ambiguity they may develop doubt in the organ donation process, which has in its regulation may lead to researchers balking at performing historically been a source of decreased consent for donation. such work. Consequently, hospitals and academic centers should develop policies to encourage compliant and ethical practices in Many questions remain in this field of ethics. Must research on this important field of research. deceased donors be performed with the intent to create knowledge that will improve the organ donation process, or can it be used Contemporary research ethics and federal regulations are designed to generate data for high risk interventions related to disease to protect the wellbeing of living human research subjects. It treatments? For example, if animal studies are insufficient, can allows subjects to make a proper risk-benefit calculation after deceased subjects be exposed to chemotherapeutic agents to test being informed how the opportunity for research is different than their physiologic impact? interventions offered as part of accepted clinical practice. While our usual care is performed with the intent of providing a greater Might this lead to a perception (or a reality) that certain groups benefit than risk, that ratio is unknown in research. Clinical trials receive less aggressive therapeutic interventions so that the may very well injure the subject. deceased can be entered in a deceased subject research trial? What might happen if the dead donor rule is overturned and the laws Research on those declared dead, however, do not fit into this guiding neurologic determination of death are altered? If such rubric. How can the dead be harmed – they are, after all, dead. subjects could not be declared dead, then would they be subject to Certainly, there are aspects of humanity that we must continue the Common Rule? to respect after death: human dignity and personal privacy as well as respect for religious practices in preparation for burial. As much as researchers and clinicians may feel overregulated, Additionally, if it was a person’s intent to offer an anatomical gift policy and mandatory compliance training do provide a certain after their demise, then we might harm them if we interfere with degree of security. In as much as there is a limited supply of life that intent. saving organs, transplantation deserves a serious research effort to maximize its likelihood of success. Consequently, bioethics and Recently, I embarked on preparing a research project involving research centers ought to provide guidance so such work can be subjects declared dead by neurologic criteria and was at a loss of performed in an ethical manner. where to begin. The project aims to increase efficiency in organ donor management while tracking the error rate to see if the new process adds unexpected risk. The IRB and site review officer were helpful – they offered written confirmation that what I was doing was not human subject research. So, am I free to do as I may? Is there nobody looking over my shoulder to confirm that I am a respectable researcher and deserve my academic appointment? No, and yes, but not in the same way an IRB would for living human subject research. Researchers are used to federal regulatory requirements leading to mandatory education and directed processes (i.e., template informed consent forms and HIPAA authorizations). Without such guidance, researchers may not know that they are subject to regulation in this circumstance. First, HIPAA privacy laws apply after death, for a period of fifty years. Second, the use of a body for medical research may be covered by your state’s version of the Uniform Anatomical Gift Act. Please consult your institution’s compliance and legal affairs division for more information. 17


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