Special Considerations for Clinical Research

In general, HMS quad-based faculty do not engage in clinical care in the course of their research. Under certain circumstances, members of the Faculty of Medicine may elect to conduct clinical research at the hospital (s) where they hold an appointment or through their Department upon approval from the Office of the Vice Provost for Research (OVPR) Office. We recognize that a variety of complexities may converge on a particular research project necessitating a plan to facilitate clinical research through HMS. Accordingly ARI can help faculty facilitate discussion with and review by the OVPR.

In general, clinical care, the treating patients, is outside the mission of the University when it is pursued for its own sake, with two established exceptions: the provision of clinical care at Harvard School of Dental Medicine, and Harvard University Health Services. However, HMS supports its faculty members in pursuing clinical research, recognizing that some clinical research projects may have a clinical care component. HMS faculty members may submit grant applications to support such projects, but additional steps are required for the University to assure itself that risks to human subjects are minimized, that the University has sufficient and appropriate resources to support these activities and that the research project will comply with the complex sets of regulations relating to clinical activities.

The OVPR document Guidance: Provision of Clinical and Medical Services During Clinical Research provides insights into key areas of a Provost review, including the risk to human subjects and if HMS would need to engage outside services in order to properly discharge its duties to manage and monitor the proposed work.

Even if a faculty member is not planning to perform clinical research, they may be in receipt of Protected Health Information (PHI) as defined by the Health Insurance Portability and Accountability Act of 1996 (HIPAA). PHI requires a variety of additional privacy and security safeguards mandated by HIPAA. Please keep in mind that HMS is not a Covered Entity as defined by HIPAA, and that great care must be considered prior to the receipt of PHI under any research project. The OVPR Research Data Security Policy is designed to help faculty assess the applicability of certain information security requirements and to help identify resources to assist them in managing such requirements.