Office of Research Protections

Office of Research Protections

Ruth Corn, M.S.W., Director

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 Director of the Institute.

All new and continuing human-subject protocols were 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 was the primary activity. There was 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 received specialized monitoring tailored to specific needs of that population. The consent process and documentation of research procedures was routinely audited on a random basis for most protocols. The Office of Research Protections also provided consultation to the investigators and research clinic administrators, interpreting and educating them about federal and state rules and regulations affecting research procedures and documentation.

In the year 2000, 511 records of 159 protocols were audited by the research monitors of the ORP with monthly reports to the IRB. In addition, 448 records were audited by staff in the outpatient research clinics for quality of care with reports submitted and reviewed by the director of the ORP.

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 participant's 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 and to other inquiries regarding research at the Institute.

Furthermore, the Office of Research Protections initiated the formation of a Community Advisory Board to provide input regarding unmet needs and community concerns regarding psychiatric research and also provided information to the community regarding the research activities at the Institute. The Community Advisory Board met twice and had presentations about the child psychiatry and substance abuse research programs.

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