Obstacles to research in forensic psychiatry.

From 1987 until 1996, the Human Investigation Committee of the Whiting Forensic Institute (WFI), the maximum-security hospital of the State of Connecticut, reviewed and approved 52 research protocols. Most (45/52 or 87%) were implemented, resulting in the completion of five master’s theses, three doctoral dissertations, and more than 36 publications in peer-reviewed journals, including the American Journal of Psychiatry and the Journal of Consulting and Clinical Psychology. Between 1997 and the present, one research protocol has been approved and is about to be conducted. While the reasons for this dramatic discrepancy are multiple and defy easy categorization, it appears that the decrease in approved protocols is not attributable to personnel changes, as favorable working conditions have resulted in low professional staff turnover. However, one factor may be the challenge that researchers face to obtain Institutional Review Board (IRB) approval in recent years, a phenomenon certainly not unique to forensic research or to Connecticut. As was the case in many other states, several public psychiatric hospitals were closed in Connecticut during the nineties. In 1997, the WFI was merged with Connecticut Valley Hospital. In the wake of the statewide reorganization of public mental health services, regional hospital-based IRBs were disbanded and replaced by a statewide IRB. The previous hospital-based research protocol review process was replaced by a multi-tiered one. This complexity may have caused fewer protocols to be submitted, fewer to be completed, and fewer to be approved. (Note: the author served as chair of Whiting Forensic Institute Human Investigation Committee (1987–1996), and as a member (1997–2005) and co-chair (2005) of the CVH Research Committee.) The review process needs to be examined more closely to understand why researchers find it daunting. They must first apply to the hospital-based Research Committee for approval of their investigation, filling out a five-page application. It is similar to those used throughout the country, reflecting federal and regional statutory guidelines as well as local requirements. A primary reviewer examines the application, typically suggesting clarifications and other changes. The hospital-based Research Committee that meets monthly then reviews the application, often more than once if the study description is either complex, insufficiently specific, or otherwise incomplete. Approval by the hospital-based committee may thus take several months. It is then followed by prompt reviews carried out by the hospital’s Chief of Professional Services, Chief of Fiscal Affairs, and finally the CEO, who forwards it to the Commissioner of the Department of Mental Health and Addiction Services (DMHAS). Only then is the protocol forwarded to the DMHAS IRB. The mission of the IRB is to examine the scientific merit of the proposed study and to ensure that human participants, the study “subjects” of older days, are adequately informed and protected. The IRB follows the federal mandate to ensure that all protocols involving forensic patients are given additional scrutiny on par with those afforded prisoners. At this point in the review process, the researcher fills out the DMHAS IRB application and submits it to the IRB. This application is considerably more detailed than the hospital Research Committee application. A priDr. Hillbrand is Chair of Psychology, Connecticut Valley Hospital, Middletown, CT, and Assistant Clinical Professor of Psychiatry, Yale University School of Medicine, New Haven, CT. Address correspondence to: Marc Hillbrand, PhD, Connecticut Valley Hospital, 70 O’Brien Drive, Middletown, CT 06457. E-mail: marc.hillbrand@po. state.ct.us