State regulations are just as important as FDA rules
Lawyers say don’t ignore state requirements
By Jeffrey N. Gibbs,
Noelle C. Sitthikul
Hyman, Phelps & McNamara, PC
Pharmaceutical companies conducting clinical trials in the United States tend to focus their regulatory attention solely on the requirements imposed by the FDA. This can be a mistake. Focusing on FDA regulations to the exclusion of state regulatory requirements may put the sponsor at risk. A large and increasing number of state requirements apply to clinical trials.
For example, while the FDA imposes the consent and, potentially, subject assent requirements, some states have adopted their own statutes regulating informed consent in clinical trials. For studies involving young children, some of the consent issues are fairly straightforward. In order for a child to be enrolled in the study, permission to participate must come from an adult — a parent or guardian. However, determining whether an adult has the authority to provide valid permission — which is not always a simple task — is governed by state law.
Determining applicable state law is also important when the study population involves older children. In many states, the age of consent is 18, but that is not the case universally. The age of consent is 16 in Kansas, Rhode Island, and South Carolina; but in Nebraska and Alabama, it is 19. Further complicating the issue is that the scope of the conduct to which a minor may consent differs among states. In addition, some states have emancipation laws, providing that an emancipated individual who has not yet reached the statutory age of consent is deemed to be an adult and thus capable of giving consent.
Participation by adults who lack the capacity to consent presents additional informed consent issues. As is the case for children, the determination of whether an adult has the capacity to consent is based largely on state law. And if the potential subject lacks the ability to consent for him or herself, state law determines who has the authority to authorize participation for the subject. Again, there is substantial variation among the states on this issue.
Another area where state laws loom large involves the issue of patient privacy. HIPAA contains requirements for protecting the confidentiality of patient identifiable medical information. In addition, many states have adopted their own privacy laws. If a state law is contrary to a provision in HIPAA, and the state law is more stringent, the state law prevails. If a state law and HIPAA are not contrary, a sponsor may have to comply with both laws. Many states have, in fact, adopted privacy laws that apply to clinical studies.
Genetic screening is another area where state law plays a significant role in clinical studies. Sponsors need to be certain that the informed consent form covers any genetic testing conducted on the subject’s tissues in conjunction with the pharmaceutical clinical trial. Many states that have laws regarding genetic testing require written consent for performing tests or releasing results, and some states specifically prescribe the elements of that consent. A consent form that meets FDA requirements may not satisfy state requirements. For example, Missouri requires patients be fully informed of the risks and benefits of releasing the information, and the identity of those to whom it will be released.
Moreover, sponsors need to be aware that genetic screening is an evolving area and state regulations are subject to change. As challenges are raised, state courts or legislatures may impose new requirements.
Sometimes, sponsors will want to test subject specimens for HIV. Sponsors and researchers should consider carefully the state requirements applicable to obtaining participants’ HIV status in clinical research studies. Requesting and obtaining an HIV test result triggers a number of state laws. The vast majority of states require informed consent before an HIV test can be performed. Several states also strictly define what constitutes informed consent for an HIV test. For example, Colorado, Delaware, Iowa, Maryland, and New York require the ordering physician to inform the patient of the causes and symptoms of AIDS and provide information about the behavior that can lead to HIV infection. Once an HIV test has been administered, states require that a positive result be reported to the state health department. In addition, some states require the ordering physicians to provide face-to-face counseling about the meaning of the test. Physicians may also be required to help HIV-positive patients contact individuals who may be infected. Sponsors should not assume that they are exempt from these state laws just because the testing occurs during a clinical study.
Payments to investigators may present yet other state law issues. Although FDA requires that certain types of payments be disclosed, the agency does not restrict sponsor-investigator financial arrangements. Nor does it require disclosure of their arrangement to subjects. Nevertheless, payment could raise state law questions, including whether the subjects were adequately advised of any conflicts of interest. State law will decide the adequacy of disclosure.
Given that the focus has always been on the FDA, a natural question is whether these state law issues are of any practical concern to researchers. The answer is yes. Although many pharmaceutical studies are unlikely to implicate unique state requirements, this is not uniformly the case. Many studies have the potential to raise issues relating to conformance with state-established informed consent requirements. Furthermore, violations of state law can carry a variety of potential penalties. A plaintiff in a product liability suit also can use noncompliance with state informed consent or clinical study requirements.
In conducting pharmaceutical clinical trials in the United States, investigators need to be conscious of myriad regulatory requirements. Determining the applicable legal requirements and adhering to them would be much simpler if all that was needed was FDA compliance. While FDA regulations are, by far, the most important, they are certainly not the only regulatory requirements relating to research-related issues. The failure to be aware of state requirements can create legal problems.