Analysis of State Laws
Summary of State Laws
New York, Virginia, California, and (most recently) Maryland impose additional requirements on the conduct of human subjects research beyond those set forth in federal regulations.
Maryland44 and Virginia45 extend the provisions of the Common Rule requiring informed consent from subjects (or a waiver of the requirement to obtain informed consent) and independent ethical review by an IRB or other qualified entity to all human subjects research, regardless of the funding source. In addition, the Maryland law provides for public access to the minutes of IRB meetings, with confidential information redacted if necessary. California mandates that informed consent be obtained from participants in research; however, no independent scientific review is required.
New York state public health statutes include an explicit requirement to obtain informed consent and to review research for studies not otherwise covered by the federal regulations.46 New York’s law on human subject protection exempts from the definition of human research “biological studies exclusively utilizing tissue or fluids after their removal or withdrawal from a human subject in the course of standard medical practice, or for epidemiological investigations.” By explicitly exempting tissue taken exclusively for research purposes, and excess surgical or diagnostic tissue, New York permits the use of tissue samples in research without the attendant requirements for specific informed consent and review of the research.
Many states have enacted some form of a patients’ bill of rights,47 some of which require that written informed consent be obtained to participate in research, or that informed consent be documented.48 Of these, only New York explicitly excludes tissue research from the restrictions of the statute.
