The Regulation of MR Neuroimaging Research: Disentangling the Gordian Knot

I. INTRODUCTION In a typical magnetic resonance imaging ("MRI") study of the brain, subjects are screened for contraindications1 before being placed in the bore of a large machine, the MRI scanner, which contains a powerful magnet. The scanner produces cross-sectional images of brain tissue as the subjects undergo a series of brief electromagnetic pulses, perceptible only as noise and vibration. If the protocol involves functional MRI ("fMRI"), a popular research technique for obtaining indirect measurements of brain activity, equipment might be used to present stimuli (sounds or pictures) during the scan, but generally the study involves no invasive procedures, no physical discomfort, and no ionizing radiation.2 Upon completion of the scan, MRI data is transferred to an investigator's computer for further analysis, often in combination with behavioral test results and clinical information obtained from subjects or their medical records. This procedure sounds benign, and usually is. But an MRI scanner is a powerful medical device, capable of causing serious injury or death if operated carelessly.3 MRI scanning of the brain ("MR neuroimaging") also carries psychological risk, in that it may occasionally reveal information about unsuspected brain abnormalities (e.g., tumors or aneurysms) that could have serious health implications. Moreover, identification as a participant in neuroimaging studies of cognitive impairment, such as research involving Alzheimer's disease or dementia, could, in theory, place a subject at risk for discrimination in insurance or employment.4 These various risks are far from unregulated: A potentially bewildering array of federal requirements exists to protect the safety, well-being, and privacy of those who participate in research, including MRI studies. Yet each such regulation is limited in scope; the protections each affords vary, depending upon factors such as the nature of site where the scan is performed, the source of funding for the research, and the purpose of the study. Further, existing protections for human research subjects are insufficient in some respects and inefficiently duplicative in others. As a result, the subjects of MR neuroimaging research may enjoy redundant protection from certain harms, such as breaches of privacy, yet they may lack adequate protection from others, such as physical injury. In this Article I summarize how human MRI studies are regulated at the federal level, using the complexity and limitations of these various regulatory schemes to illustrate a broader concern that existing, nonintegrated systems of research oversight may serve subjects poorly and impede essential research, including the many studies needed to support the innovative applications of MR neuroimaging technology discussed elsewhere in this Symposium Issue of the Journal.5 II. THE REGULATION OF HUMAN SUBJECTS RESEARCH INVOLVING MRI Like the Gordian knot of Greco-Roman mythology,6 the regulation of a study involving human subjects and either a drug or medical device (e.g., an MRI scanner) can appear an impenetrable tangle of additive requirements, each imposed by separate federal agencies or entities. To illustrate, the MRI study described in Section I, above, might be subject to one or more of the following regulations:7 1. Regulations of the U.S. Food and Drug Administration ("FDA") applicable to investigational medical devices8; 2. FDA regulations requiring informed consent and Institutional Review Board ("IRB") review in clinical investigations of regulated products;9 3. Regulations of the U.S. Department of Health and Human Services ("DHHS"), known in part as the "Common Rule," that govern human subjects research conducted or funded by DHHS;10 4. DHHS regulations, known as the HIPAA Privacy Rule and the HIPAA Security Rule, enforced by the DHHS Office for Civil Rights and the Centers for Medicare and Medicaid, respectively, that implement requirements of the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") pertaining to health information (with provisions governing the use of identifiable health information in research);11 and 5. …