Statement of Compliance
New York State Psychiatric Institute (NYSPI) Institutional Review Board (IRB) is duly constituted, has written procedures for initial and continuing review of clinical trials; prepares written minutes of convened meetings, and retains records pertaining to the review and approval process; all in compliance with requirements of FDA regulations 21 CFR Parts 50 and 56, HHS regulations 45 CFR 46, and International Conference on Harmonisation (ICH) E6, Good Clinical Practice (GCP), as applicable.
What is an IRB?
Institutional review boards at academic research centers, hospitals, and universities across the U.S. are part of a federal oversight system created some thirty years ago to safeguard the rights and well-being of people who volunteer to take part in research. Within this system of “research protections,” institution-based ethics review boards (i.e. IRB’s) provide prior review and approval of research with “human subjects.” The IRB promotes an institution’s application of the core ethical principles related to research and supports compliance with federal, state, and local research regulations.
About NYSPI IRB
The New York State Psychiatric Institute is the oldest and among the most highly regarded psychiatric research centers in the United States. The Institute’s success and its reputation derive not only from leadership in clinical science, but from the commitment of its researchers and research staff to excellence in the practice of research and patient care. Individuals who seek treatment through research at NYSPI or who volunteer in other research studies can be confident of this.
Through prior and continuing review of research, investigator training, consultation, and ongoing quality improvement activities, the IRB helps support and guide the Institute’s research activities. Our membership provides expertise in the ethical, regulatory and scientific dimensions of human subject research. Diversity in background, gender, race and ethnicity enrich the Board's experience and cultural sensitivity. Our devoted lay membership brings the perspectives of patients, their families, and the community to our work. IRB leadership works closely with NYSPI leadership to foster a local culture consistent with our ethical ideals and our commitment to excellence.
How IRBs Began
Historically, the notion that research subjects require institutional protection from research risk arose amid controversy and public outrage related to exploitation of research subjects in the name of science or the "common good." These now familiar stories of Tuskegee, Willowbrook, and the federal government’s radiation experiments have served to reshape clinical research. Today’s research and researchers are of a new era that reflects lessons learned from the past. As the ethical practice of research has evolved, so too has the role of the IRB.
Research Ethics Today
Today, training in research ethics is mandatory for all researchers and IRB members. IRB staff here and elsewhere are part of a profession with expertise in IRB procedures and regulatory compliance. So, while a fundamental tension between the interests of the scientist and the interest of the individual subject will always exist, today’s researcher, research institution, and IRB are far better equipped to address this tension in a manner which places the interests of the individual research subject first. At NYSPI, the IRB and the researchers whose studies we review work together to set and meet the highest standards for research and research protections.
A Federalwide Assurance (FWA) is an agreement between NYSPI and the Office for Human Research Protections (OHRP) in the Department of Health and Human Services to comply with federal regulations concerning research involving human subjects, including the ethical principles outlined in the Belmont Report and the DHHS regulations 45 CFR Part 46.Our Institution’s FWA Number is : FWA00006105
Our HHS IRB registration number is: IRB00000488