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1997 ASIP Newletter: Human Tissues in Research; Richard Lynch
HUMAN TISSUES IN RESEARCH:
A Pathology Perspective
Several times during 1996, the Newsletter of the American Society of Investigative Pathology (ASIP) reported on initiatives by federal and state governments, professional societies and advocacy groups that were focused on genetic testing, informed consent, confidentiality of genetic information and research with human tissues, including archival tissues. The goal of all these efforts was to ensure that the individual rights of human research subjects were protected: that their participation in the research was voluntary, their decision to participate was an informed decision, and that the privacy of their genetic information was protected. While in strong agreement with the purposes of these initiatives, it was the opinion of many pathologists as they learned the details, that some of the language in the proposed legislation and policy recommendations had the potential to impede important research conducted with human tissues. Furthermore, because of the moving and imprecise boundary that separates research from cutting-edge molecular diagnostics, pathologists believed that the proposals also had the potential to interfere with patient care. In January 1996, representatives of most of the academic and clinical pathology societies presented their concerns at an invitational conference convened jointly by the Association of American Medical Colleges (AAMC) and the National Center for Human Genome Research at NIH. Subsequently, a statement of principles and position was prepared and circulated that represented the consensus of pathology organizations in the United States. This statement is available elsewhere in the Publlic Affairs section of the ASIP Home Page (Combined Pathology Statement)Â http://asip.uthscsa.edu/PUBAFF_ED/tissue.html.
Now is a critical time in the development of a national policy that regulates the use of human tissues in what is defined as genetic research because time is running out. In July 1996, President Clinton appointed a National Bioethics Advisory Commission (NBAC) charged to develop recommendations to protect human research subjects and manage the use of genetic information. NBAC's Genetics Subcommittee had their first meeting on December 13 and established as its first priority the development of recommendations on the use of archival human tissue samples in genetic research. We are rapidly approaching having a national policy regulating the use of human tissues in genetic research, but formulated with little input from the broad scientific community. Information about NBAC and transcripts of their meetings are available on the web at:Â http://www.bioethics.gov/.
Since the initial NIH/ CDC Workshop in 1994, the "tissue issue" agenda has been driven primarily by ethicists, lawyers, social workers, human geneticists, and advocacy groups that represent specific genetic diseases. So far, their discussions and recommendations have emphasized a regulatory approach, which would have the effect of restricting human tissue research that generates genetic information, and would impose a bureaucratic barrier of regulations for the acquisition and management of genetic information. Surprisingly, all these efforts to develop regulatory policy aimed at protecting human research subjects misses the real point of all the concern about genetic research.
The critical issue in protecting human research subjects is not genetic information per se, or the methods that generate genetic information -- it is the misuse of genetic information that is the real threat to an individual's rights. Because information about a subject's genetic composition could potentially be used by employers, insurers or others to discriminate against that person or members of their family, it is the issue of genetic discrimination that needs to be addressed.
There is no question that the issues being addressed by the various initiatives are extremely important, and that there is a pressing need for regulations that will protect the welfare, privacy and individual rights of human research subjects by ensuring that genetic information developed in research will never be disclosed in a way that identifies, or permits the identification of, an individual research subject. In ensuring those protections it is vital that we also protect the enormous societal benefits that come from research on human tissues, including the irreplaceable national resource of archival tissues in departments of pathology throughout the country. A policy that protects the individual rights and privacy of research subjects while simultaneously safeguarding the societal benefits that come from research best serves everyone. However, if those societal benefits are to be preserved, the scientific community needs to speak on their behalf. The hour is getting late, so if the scientific community is to be heard it needs to act effectively and right away. The message that needs to be conveyed is that without input from the scientific community, regulations and p policy, or their interpretation by institutions, have a real potential to create unintended consequences that poorly serve the public interest.Â
Please make your views known to NIH Director Harold Varmus, to Harold Shapiro, Chair of NBAC (and President of Princeton), to your congressional representatives, and to The White House.
Richard G. Lynch
Chair, ASIP Public Affairs Committee