Introduction
State laws regulating the conduct of research using human tissue specimens and associated data exist in nearly every one of the fifty states. States have enacted laws that restrict the uses and disclosures of medical information, the conduct of genetic tests, and the use of genetic information, and that impose additional requirements for review of research and informed consent when human beings are involved as subjects of research. State statutes often overlap with the federal rules governing the conduct of human subjects research, but the scope, definitions, and standards of protection differ among the states.
This report presents an overview of the state laws that affect the uses of tissue and associated data in research. It includes a chart showing the requirements for the conduct of tissue research state by state and a table compiling state statutes, and addresses the following questions when tissue specimens and data are obtained:
- How do state laws protecting the confidentiality of medical information and individual privacy affect the use of tissue samples and associated data?
- How do state laws on human subject protection affect the uses of tissue samples and data for research?
- How do state statutes that define and regulate the conduct of “genetic tests” or the acquisition of “genetic information” affect the conduct of research on tissue samples and associated data?
The Resources Development Branch of the Cancer Diagnosis Program at the National Cancer Institute has prepared this survey and analysis to serve as a guide to researchers interested in the state legal and regulatory requirements for research and to examine the potential consequences of a system that incorporates divergent (and sometimes not well known) standards. The survey reflects the status of state laws as of November 2004. It is not intended as legal advice, but as an outline of the legal and regulatory requirements for tissue research. For further information on specific state law requirements, please consult an attorney.
