State Regulation of Tissue Research

State laws affecting the use of tissue and associated data in scientific research are found in a variety of sources, including medical records laws, privacy and health privacy laws, genetic testing/genetic information laws, and laws on human subject protection. State laws may require researchers to obtain prior written informed consent from individuals for specific research uses of tissue or data, to notify individuals prior to the conduct of a “genetic test,” to limit the length of time permitted for retention of tissue samples when genetic information is obtained, or to remove identifiers prior to release of patient information.

Most states require that “medical” or “health” information, or information collected in the course of clinical care (which often includes tissue specimens and associated data), be kept confidential. Many states that otherwise restrict the disclosure of medical or health information permit disclosure for research purposes when protections for the subjects exist (e.g., anonymization of the record, approval by an IRB, explicit consent of the individual, etc.). Those state laws that permit the disclosure of medical or health information for research purposes generally specify that one or more of the following conditions must be met: (1) IRB review and approval of the research, (2) conduct of research according to federal regulations for the protection of human subjects, or (3) use of “anonymous” information that does not identify the research subject.

Some states impose supplemental restrictions on genetic testing and the collection of genetic information, usually in the context of clinical genetic tests, in order to prohibit “genetic discrimination” in the provision of insurance and employment. A few states extend the duties of the federal regulations to privately sponsored research, or to research not otherwise covered by federal regulations, while others impose supplemental requirements on the process of obtaining informed consent.

The laws are often inconsistent from state to state and even differ within the states depending on the source. Regulations differ with regard to the scope of protection and the types of limits imposed on uses of and access to tissue specimens and associated data. Since much scientific research involves collaboration across state lines, researchers who study human tissue should be aware of their rights and duties under their states’ laws with respect to the control and use of tissue specimens for research. The differences in the requirements of various states, and the difficulty in comparing the conditions required for the conduct of research in different states, have led to uncertainty about the actions required by researchers to comply with state laws when human tissue is used in research. As noted by the National Bioethics Advisory Commission, with respect to the use of information in medical records, “the variability of state law protections has been cited as a problem in and of itself.”¹⁴