Spotlight on Compliance: Maryland legislation could be model for other states
July 1, 2002 4 minutes read
Maryland legislation could be model for other states
IRB oversight is result of new research legislation
By J. Mark Waxman, JD
General Counsel
CareGroup Healthcare System
Boston
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As a result of widely publicized adverse outcomes and liability claims arising out of human subjects research, legislatures are beginning to address a variety of issues on a state-by-state basis. One such law is Maryland House Bill 917 "Human Subject Research — Institutional Review Boards," which was recently enacted. The new state law will require that even nonfederally funded research must meet federal guidelines with regard to protecting human subjects.
The background to this legislation is found in the recently decided appellate court decision in Grimes v. Kennedy-Kreiger Institute, 2001 WL 924532 (Md.2001). In that case, the appellate court held that, under Maryland law, a special relationship existed between a researcher and a subject, and that the informed consent documents formed a contractual arrangement, the breach of which could lead to liability and damages.
A further holding was that the court would look to the federal regulations governing human research as a guidance for assessing tort liability standards. In this context, the court specifically held that the duty of informed consent created by the federal regulations (see 45 C.F.R. §46.116) translates into a duty of care arising out of the unique relationship that is researcher-subject, as opposed to doctor-patient. (Of interest as well, the court went on to hold that the Nuremberg Code might provide a standard for negligence actions as well). In reaching its conclusions, the court also expressed concern with respect to the approval process by the IRB involved in the clinical trials under review. Finally, the court held that for nontherapeutic research involving more than minimal risk, a parent cannot consent for his or her children.
Likely stemming from the appellate court’s decision, the Maryland legislation is remarkably simple in concept but sweeping in scope. The legislation requires that:
1. Human subjects research must be conducted in accordance with the federal regulations on the protection of human subjects, notwithstanding any limitation on applicability that may be in the federal regulations. This means that nonfederally funded research will be required to meet the federal requirements for human subject protection. This inherently means that the IRB process is required, as well as the mandated substantial analysis and continuing review follow-up that is necessary for federally funded research.
2. IRB final minutes of meetings should be made publicly available, except for "confidential or privileged" information. Presumably, privileged information relates to statutorily established privileges under Maryland law, such as attorney-client privileged information. Thus communications with counsel during the course of the meeting would be excluded. The statute, however, does not define the scope of the ability to exclude confidential information. Presumably, any applicable HIPAA (Health Insurance Portability and Accountability Act)-related restrictions would ultimately apply. An open question is whether information that has been agreed through contractual provisions by parties to a sponsored research to be contractual agreement would also meet this test.
The potential impact of this portion of the statute is hard to estimate. Perhaps easiest to envision is that public access to IRB minutes is likely to be problematic and raise a variety of issues. First, the fact that minutes will be available to, among others, the press means that they will need to be read very carefully with an eye toward legal exposure and public discussion of the issues being discussed.
Unfortunately, this will likely require legal review of the minutes to ensure both that the minutes reflect that the IRB in fact met the legal requirements with respect to the conduct of its business, and at the same time, the IRB is not exposing itself to unnecessary liability.
3. The attorney general’s (AG) office is specifically authorized to seek "appropriate injunctive or other relief" to protect against violations of the federal regulations. There are two limitations to this authority. The AG is limited in exercising the authority granted in that claims may not be pursued if they would duplicate an investigation, compliance, or enforcement action undertaken by the federal government. Second, if the federal agency, such as the Food and Drug Administration, has actually determined that an investigation is not warranted, the AG also may not proceed.
The Maryland law will take effect Oct. 1, 2002. Given the ease of adopting similar provisions, and the publicity related to the Kennedy-Krieger decision, it is likely that this legislation may serve as a model for other states. It also has the advantage of not requiring new processes most institutions do not already have in place.
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