By Natalie Ram
A full version of this article, published in the Fall 2009 issue of the Harvard Journal of Law & Technology, is available here.
Today, more than 300 million tissue samples from more than 178 million individuals are stored in the United States, and this number has been growing by more than 20 million samples every year. Through genetic analysis, researchers hope to identify disease-related and other genes and to measure the frequency of such genes’ occurrence across large populations. This kind of research requires population-wide bio-repositories of samples available for study.
Yet, individuals providing tissue for research may hesitate to do so if they fear that their interests will not be respected. Tissue providers may have concerns that their cells and genetic material — materials with which they may strongly self-identify — will be used for research they find morally repugnant or about which they were not informed. Unanticipated disclosure of genetic information may negatively impact the ability of unwitting tissue providers and their close genetic relatives to obtain insurance coverage or appropriate medical treatment. Tissue providers may also have strong interests concerning the commercialization of their cells and genetic material, especially if they are not permitted to share in the profits. And tissue providers have a further interest in the progress of science and medicine.
Researchers and society both also have strong interests in how tissue is used. Scientific research using human cells can be (and has been) immensely beneficial. Inappropriate or onerous restrictions on human tissue research may negatively impact the progress of science and medicine—a concern about a tragedy of the anticommons clearly articulated by several courts that have presided over disputes about the ownership and control of human tissues used in research. Moreover, permitting tissue providers to commercialize their cells may divert tissue from worthwhile research, diminish the necessary incentives for research funders to invest in research and development, or undermine societal dignitary interests.
Failing to mediate tensions between tissue providers, researchers, and society may cause individuals to avoid research participation. The solution is not, however, to compel such participation by dispensing with consent altogether and generally conscripting tissue left over from, for example, blood draws or biopsies. Indeed, doing so might cause individuals concerned about the future use of their genetic material to forego routine medical care in order to prevent their cells from being so conscripted. Rather, the interests of tissue providers, of researchers, and of broader society each demand respect and protection. (more…)