Author(s): Thomas H. Murray, Ph.D.
Consent for Archived Tissue Specimens
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.
- What considerations do we need to bear in mind when deciding whether it is permissible to use such tissue?
- What factors might incline people towards approving of research on their archived tissue?
- Towards disapproving such research? Under what circumstances should we contact people to get their renewed, explicit consent to use their archived tissue?
- Does it matter whether that tissue was originally obtained for clinical purposes rather than for a specific research project (other than the one now being proposed)?
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Potentially Objectionable Research
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.
- How can we show respect for people's preferences not to aid such research?
- Can we find criteria or principles for determining when a proposed study might be objectionable?
- What mechanisms could we use to decide how to prevent tissues from being used in research when the sources of those tissues are likely to object? (Remember, the issue here is not scientific freedom, but whether and how to take into account and protect the ethical sensibilities of the sources of human biological materials.)
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How Anonymous are "Anonymized" Samples?
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.
- What circumstances would make it difficult to render a sample anonymous?
- What policies could be created that would enhance the likelihood that an "unlinked sample" would be truly anonymous?
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Linking Tissues with Medical and Genealogical Records
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.
- How should we balance the concerns for confidentiality, privacy and the possibility of discrimination with the desire to do the best science possible?
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It is quite common these days for biomedical scientists to be alert to potential commercial applications of their research.
- What ethical rights or interests do the sources of human biological materials have in their commercial development?
- Under what circumstances, if any, should a tissue donor share in the profits from a successful product developed from their tissues? If scientists foresee the possibility that research utilizing tissues might have commercial potential, should that be expressly mentioned in the informed consent to use the tissue?