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To contribute your point of view on any issue, please contact the ASIP Public Affairs Working Group through Jennifer Dreyfus at jdreyfus@asip.org. Thank you!

 

 

ASIP Public Affairs

1998 ASIP Concern regarding Domenici Proposal

Critical Issues Regarding Senator Domenici's Proposed Genetic Privacy and Nondiscrimination
Act S. 422 and Other Attempts to Regulate Genetic Testing


The American Society for Investigative Pathology is concerned that well-intentioned efforts to regulate genetic testing may add unneeded safeguards of individual privacy at the expense of societal benefits, particularly regarding tissue samples collected with general informed consent for medical purposes.

Confidentiality: Currently, S. 422 treats the confidentiality of genetic information differently from other medical information. We believe that much medical information is equally sensitive, and that all medical information deserves adequate privacy protection. However, not all such information, whether it is termed genetic or medical, is stigmatizing, and much information needs to be readily accessible for appropriate medical treatment.

Definitions: In S. 422, the term genetic, which was formerly applied to inheritable conditions, has been inappropriately extended by using the term DNA [e.g., Sec. 3(6)(A)]. Tests involving DNA apply to many non-inherited disorders, including cancer diagnosis, identification of infectious agents, etc. Conversely, many medical studies develop genetic information without using molecular methods.

Informed Consent: The collection and storage of information and tissues is essential to investigations that seek to relate cause with outcome. Because questions may be posed and techniques for study become available many years after the original collection, it would be difficult or impossible to comply with the requirement that the donor be informed of all possible uses [Sec. 301(a)(4)].

Sample Destruction: Good medical practice and legal statutes require preservation of tissues for the benefit of the individual patient. Retrieval allows confirmation of previous tests or the application of newly available new diagnostic tests. Society benefits when excess tissue is available for studies of cause and effect (e.g., the pathology of unusual tumors led to recognition of cancer-causing effects of DES and of vinyl chloride; the DNA properties of the flu virus in the 1917 epidemic could aid in vaccine development in a future pandemic).

Conclusion: Society has benefited enormously from research conducted on archival human tissues. Because of ambiguities and an overly broad scope, some of the language in S. 422 has the potential to jeopardize this important source of knowledge about human disease. The solution is to have broad scientific input and deliberate, dispassionate formulation of a national policy.