Office of Research Protections

The Office of Research Protections was established in June 1999 with the main purpose of strengthening the protection of the rights and welfare of all human subjects participating in New York State Psychiatric Institute research studies. It is staffed with a Director, two Research Monitors, and an administrative assistant. The Director reports directly to the Executive Director of the Institute.

The Office has several functions. All new and continuing human subject protocols are reviewed by the Director for consistency with the mission of the Institute and the Office of Mental Health, and for issues relating to the rights and safety of research participants. Overseeing and monitoring protocol compliance as specified by the Institutional Review Board (IRB) and/or Institute administration is a primary activity. There is close collaboration with the IRB on all issues related to ensuring the rights and welfare of research subjects. Some protocols identified by the IRB by level of risk and vulnerability of the subject population receive specialized monitoring tailored to specific needs of that population. The consent process and documentation of research procedures are routinely audited on a random basis for most protocols. The Office of Research Protections also provides consultation to the investigators and research clinic administrators, interpreting and educating them about federal and state rules and regulations affecting research procedures and documentation.

Future plans include the development of an "in person" consent auditing process and the development of a subject satisfaction questionnaire to be administered post-protocol participation in a effort to ascertain the participantís comprehension of the research study and procedures as well as satisfaction with its implementation.

In addition, the Office of Research Protections acts as liaison with the central office of the New York State Office of Mental Health, with the Research Foundation, the Director of the Research Division and the Public Relations staff regarding agency responses to Freedom Of Information Law (FOIL) requests, to media, to the federal Office of Human Research Protection and to other inquiries regarding research at the Institute.

Furthermore, the Office of Research Protections coordinates a newly developed Community Advisory Board that is designed to inform the Institute about unmet community needs and concerns regarding psychiatric research and is in turn informed about the research activities at the Institute. The Community Advisory Board meets quarterly.

Overall, the guiding principle of the Office of Research Protectionsí activities is to enhance the protection of human subjects in mental health research studies at New York State Psychiatric Institute.