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 protection of the rights and welfare of all human subjects participating in New York State Psychiatric Institute research studies. It is staffed by 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. The consent process and documentation of research procedures are routinely audited on a random basis for most protocols. 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 Office of Research Protections also provides consultation to the investigators and research clinic administrators, interpreting and educating about federal and state rules and regulations affecting research procedures and documentation.

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 for Mental Hygiene, 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.

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.

In year 2001, monitoring staff was increased by 0.5 full time employee to 2 full time Research Monitors. This resulted in an increased volume of auditing, almost doubling the number of records reviewed. Nine hundred twenty-four records of one hundred ninety nine IRB approved outpatient and inpatient studies were reviewed for protocol compliance and quality of care by the Research Monitors. Over the year, departures from protocol compliance included only twenty-six non-serious findings. Of nine hundred twenty-four records reviewed these were only .03% of the whole.

The Principal Investigators completely and promptly corrected all findings as required.

Special monitoring efforts by the ORP, requested by the IRB, included auditing the medical records of every participant in the protocols of two principal investigators as well as in-depth reviews of serious adverse events that occurred during the year.

A plan to have direct observation of the consent process by research monitors was completed. It was initiated successfully late in the year with Eating Disorders patients and will continue next year with individuals with schizophrenia, autism and children with ADHD.

In addition, considerable progress was made on the plans to develop a computerized database for the Office of Research Protections regarding protocol monitoring. It is expected to be viable mid 2002. This will allow for a more effective use of time, elimination of duplication of effort, and clearer, more meaningful reports to the IRB.

The review of records from all outpatient research clinics represents a significant accomplishment in extending the scope of human subject protection activities. These chart reviews are conducted by designated liaisons within each clinic, who submit monthly reports to the ORP Research Monitor who in turn, reviews these with the Director of the Office of Research Protections. With increased education and training, the research clinics have substantially improved the quality and quantity of their record keeping this year. In 2001, 829 records for 93 protocols were reviewed by research staff members in the outpatient research clinics including off-site activities with very few findings.

For the first quarter of 2002, an additional 248 records for 474 protocols were reviewed by the ORP Research Monitor and the outpatient research clinics.

Additionally, in 2001, the Director of Office of Research Protections joined the Risk Management Committee where serious adverse events in research protocols are discussed and corrective actions and/or recommendations for protocol revisions may occur. This has facilitated communication between the Director of Quality Management, the Office of Research Protections and the IRB.