A central tenet of American law is that what is one persons property cannot lawfully be possessed by another unless agreement is mutual, through gifting, barter, or sale. So how should the disposition of samples of blood, bone, tissue, hair or microscopic cells be handled? Do they remain the rightful property of the original donor? Who can, and should, profit from any use of the encoded genetic and proteomic information? If biologic samples are gifts given freely, do they remain so in perpetuity, or is there an effective expiration date? And who ultimately decides their fate?
Such questions are assuming greater urgency as researchers cull more biologic samples and the technologies that analyze them become faster and more capable. Institutions are likewise advancing preservation proficiencies, creating enormous biological repositories containing genetic information collected from millions of individuals. According to figures compiled by University of Arizona professor of philosophy Allen Buchanan, close to 300 million biologic samples are currently stored in the United States, within state public health departments, blood banks, pathology archives, and various researchers laboratories.
Even so, Buchanan reported, most people do not know that these samples were taken, "that they are kept after screening is done, or that they could be used for an indefinite number of purposes in the future, including a complete characterization of the individuals genome," he wrote in "An Ethical Framework for Biological Samples Policy," a paper prepared for the now-defunct National Bioethics Advisory Commission (NBAC), which examined the topic in August 1999.
Cancer patients in particular are faced with giving multiple blood samples and having biopsies and exploratory surgeries that generate large amounts of individual genetic information that can be stored for months, years, or even decades. Nevertheless, in its 1999 paper, NBAC argued for explicit, detailed consent from patients "even in cases where such [future sample] uses are at the time unknown." The debate over stored samples continues, said Commission authors, because of the "uncertain nature of past consents ... Those who agree to provide their DNA, cells, tissues or organs for research purposes [must] not be put at risk."
But adequate systems to safeguard privacy while facilitating reasonable study are not yet in place, at least not on any systematic basis. By August 2001, NBAC, in a separate study, had concluded that there was as yet no "unified response" to the problem of stored biologic samples. Although federal regulations exist that, with some modification, could be adjusted to offer better protections while not impeding research efforts, interpretations of those regulations "vary unpredictably" across different government agencies, NBAC noted.
In the private sector, safeguards can be non-existent. "In an information age, poor management of research using medical records, human tissue, or personal-interview data could lead to employment and insurance discrimination, social stigmatization, or even criminal prosecution," concluded the NBAC members.
Given samplings robust pace, anyone whose cells are collected at a doctors office for any purpose is a prospective donor. The potential health benefits for the individual and for society alike from sample analysis appear vast and will likely affect the treatment and outcomes of a host of diseases. Nevertheless, harm could also come at some future time, in ways not yet foreseen, if genetic material is preserved indefinitely without the proper controls.
Such a prospect worries Robert M. Sade, M.D., director of the Institute of Human Values in Healthcare at the Medical University of South Carolina, and author of a July Archives of Internal Medicine editorial that examines the hazards of perpetual preservation absent ongoing review or consent.
"There are groups of subjects who might not want their genetic information to remain in a computer database for unknown future uses," Sade said. "Even if that information has been anonymized, it could be misused in the future as it has in the past." In particular, Sade pointed to the Nazi exploitation of a detailed German population census, a kind of 1930s-era database used to identify and then imprison those of Jewish descent, and coordinate subsequent concentration camp deportations.
He said he is also troubled by the research communitys use of the word "sources" when referring to contributors of biologic samples. The linguistic distinction is important, Sade asserted, because "subject" is a word that refers to human beings with "certain rights as moral agents." "Sources" of biologic samples, on the other hand, could be obtained from plants, animals, even soil.
"People who contribute biological samples are research subjects. There are broad rules that cover how subjects are treated," Sade said. "Subjects are people, who have feelings and preferences about how parts of their bodies are used. People are individual, with ultimate responsibility for their own bodies."
But adequate safeguards can be devised, especially where privacy is concerned, said Ezekiel Emanuel, M.D., Ph.D., chief of the Department of Clinical Bioethics at the National Institutes of Healths Warren G. Magnuson Clinical Cancer Center. Moreover, the overall societal benefit from biologic sampling is so compelling that consent must not be an absolute. "Consent is a means to an end, not an end in itself," Emanuel said. "The important thing is ultimately respecting people. The question is how we should do that. For most people that means using their tissue."
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Of the 504 respondents, a majority65.8%said they would want to give consent for any personally identified biologic sample used in clinical research. If all identifiers were removed, those who would still require consent dropped to only 27.3%. The vast majority88.8%would want to be notified of the results from clinical studies involving their samples, even if the studies are inconclusive. Most of those responding to the survey, concluded Emanuel and Wendler, "want to control whether their samples are used for research purposes, are not concerned with the particular disease that will be studied, and want to receive results of uncertain clinical significance."
For now, at least, patients appear ready and willing to allow researchers routine and easy access to their samples. In an article published in the Journal of the National Cancer Institute in May, authors Thomas Malone, Paul J. Catalano, Peter J. ODwyer, and Bruce Giantonio reported that, among the 5,411 patients enrolled in 40 different clinical trials conducted by the Eastern Cooperative Oncology Group from February 1998 to October 2000, the vast majority of patientsmore than 90%readily assented when they were allowed to designate the level of research to be performed on donated samples.
The authors believe that patient willingness to provide samples bodes well for those who hope to store samples for future use, although the authors noted that "it will be important to know consent rates from noncancer patients, which could provide a broader picture of patients willingness to allow their samples to be used for future research. Our findings may serve as a baseline for future analyses as the consent process for the storage and use of biologic specimens continues to evolve."
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