December 2005

The Code of Federal Regulations requires that Institutional Review Boards review proposed research with regard to applicable law 45 CFR 46.107(a). Abiding by Federal laws, regulations, and guidelines however is not enough. State laws must also be adhered to and each state has its own statutes, regulations, and case law that may impose stricter or additional requirements on research than those imposed by federal regulations. The issues affected by state law can include the following:

• Age of consent;
• Capacity to consent/legally authorized representatives and who can serve in that capacity;
• Child assent;
• Genetic research;
• Confidentiality of medical records;
• HIV/STD reporting requirements; and
• Laws governing referral fees, recruitment methods, clinical research, investigational drugs, vulnerable patients, medical practice and delegation of authority to perform procedures

One way in which federal laws and state laws interact is that federal laws defer to state law in determining the age of consent for participation in research. For example, in the state of Arizona, the age in which an individual may consent to participate in research is 18 years of age or older.

State laws can also govern who can make health care decisions. In the state of Arizona, a hierarchy not only includes family members but siblings, and close friends.

Another Arizona state law that can affect research is the use of tissue that comes as a result of a spontaneous abortion. These tissues can be used for research purposes whereas tissue from a terminated pregnancy cannot be used for research purposes.

State laws which require certain activities and conditions are also important. In the state of Arizona child and elder abuse are reportable activities. However, in a research study it is not required that the researcher report such activities if they are not among those individuals required to report abuse such as physicians, nurses, counselors, social workers, etc. Additionally, under Arizona state law, the status of a person infected with a Sexually Transmitted Disease must be reported by a health care provider to the local health department (within 5 business days of the diagnosis/treatment).

Federal regulations require that researchers conduct research in compliance with applicable state law. State law can affect researchers in a number of ways and in a variety of situations. Although the above-mentioned areas can affect research conducted in the state of Arizona, there are numerous other instances in which state laws can impose additional restrictions. Understanding how and when to apply state law is an ongoing challenge to the research community.

*Kaltman, S., & Isidor, J. (2002). State Law. In R. J. Amdur and E. A. Bankert (Eds.), Institutional Review Board Management and Function (pp. 339-341). Sudbury, MA: Jones and Bartlett.