Key ethical issues that arise in doing research with human biological materials; including consent, commercialization, and disclosure.
Author(s): Thomas H. Murray, Ph.D.
Until very recently, and in many places today, most human biological materials destined to be archived were obtained for clinical purposes, e.g., through a biopsy to determine whether any pathological changes had taken place. While the clinical procedure itself may have been accompanied by fully informed consent, consent for the subsequent use of that tissue for research is like to have been peremptory. Patients about to undergo surgery are probably not focused on possible research projects using their tissue many years later.
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When the National Bioethics Advisory Commission (NBAC) prepared its report on human biological materials, it found strong and widespread public support for biomedical research, including research on archived tissues. Three sorts of reservations also emerged: concerns about discrimination, privacy, and inappropriate commercialization (to be discussed below), and concerns about uses of tissue that their donors would find ethically objectionable. An example of such potentially objectionable research might be a study meant to show the genetic inferiority of a particular racial or ethnic group. It is easy to imagine that many individuals-- including non-members as well as members of the groups under study-- would be offended by such research and would not want their tissues used in it.
With electronic databases and the Internet, people's identity can sometimes be deduced from seemingly small and unconnected bits of data. For a given sample of tissue, knowing the age and birth date, gender, diagnosis, the date and location at which a given specimen was taken, and a few additional details might, under certain circumstances, allow someone familiar with such databases to ascertain the identity of the tissue source. Merely stripping a specimen of some of its identifying detail such as the person's name of Social Security number might not be sufficient to make the research sample genuinely anonymous.
The scientific value of human biological materials is often enhanced-- sometimes vastly-- when it is accompanied by the clinical and demographic information found in medical records, and by genealogical information. This is exactly the strategy being employed by deCode, a company working in Iceland that is creating electronic medical records, gathering tissue samples, and utilizing that nation's extensive genealogical knowledge for genetic research. DeCode and its backers are betting that putting those three sorts of information together-- tissues, medical records, and genealogical data-- will spur research and lead to profitable new products and services. However one feels about deCode, there is no dispute that scientific questions often are answered more swiftly and surely when clinical and other data can be integrated with what is learned from tissue samples.
It is quite common these days for biomedical scientists to be alert to potential commercial applications of their research.