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U.S. National Institutes of Health
Last Updated: 03/05/10

Conclusion

While few states specifically address research uses of tissue samples, numerous laws that regulate medical information, genetic testing, and the conduct of human subjects research affect the ability of researchers to collect, store, access, distribute, or analyze tissue samples and associated data. A review reveals that most of these laws focus on protecting individual privacy and confidentiality to minimize risks of harm. Some potential risks to subjects whose specimens and data are used in research could result from releases of private medical information. These risks might include loss of insurance or loss of employment. Other risks that have been identified are not necessarily related to inappropriate releases of information, such as loss of dignity or autonomy, or infringement on privacy.

The laws in various states differ widely in scope, definitions used, and applications for research. The rules also differ depending on whether the source is public health statutes, insurance statutes, privacy laws, or laws protecting research subjects. As a result, the application of many statutes to research uses of tissue and data is unclear, with vague and conflicting definitions leading to variable interpretations and implementation.

Statutes that permit uses of tissue and data for research may state that “anonymous” research is allowed, without defining “anonymous.” Other statutes may intend to allow research uses of data where confidentiality is “protected” or “ensured” without providing an explanation of the standard. Various states define the terms “genetic test” and “genetic information” differently, affecting their scope and the type of scientific activity covered. As a result, some scientific research activity could be limited, depending on a state’s definitions of “genetic test” or “genetic information,” even when the legislative intent seems to be regulation of the conduct of clinical genetic tests. For example, research that studies certain hereditary characteristics (such as hair color, eye color, etc.) could be defined broadly as “genetic” research and become subject to additional restrictions, even though the research is unlikely to create increased risk to subjects.

The difficulty in applying the limits on uses of medical information or genetic information to research on tissue samples and data is further complicated when the provisions of one state law diverge from those of another. If interpreting the rules for research in any single state is difficult, adhering to the rules when multiple state statutes apply is exponentially more complicated. This may present challenges for multi-site collaborative research involving the collection, distribution, and use of specimens and data if these sites are located in different states.

Research depends on a timely and smooth flow of scientific information. Research depends equally on the trust of the public that participates in and supports the conduct of research. Maintaining that trust requires protecting research subjects from risks by ensuring the integrity and confidentiality of information and individual privacy, dignity, and autonomy. Since state laws are designed to incorporate a balance of societal and individual interests, adopting clear standards and definitions is critical to supporting valuable scientific research that is reliant on a smooth flow of data, while ensuring adequate protections for the rights of individuals.