IRB

Welcome to the Psychiatric Institute IRB, the Institutional Review Board of the New York State Psychiatric Institute and the Department of Psychiatry of Columbia University. We encourage you to seek further information by following the links above for Investigators, Board Members, and Research Volunteers. You can quickly find the NYSPI IRB contact information by following the IRB Administration link above.

  • 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

    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.

  • To Learn More

    You can learn more about the IRB and our authority and responsibilities, please see the Links and Resources under the Frequently Used Services section of our Home page. If you are thinking of taking part in research, see the link under Research Volunteers on the menu above. Researchers and research staff can see the link under Investigators on the menu above to access information on policies, procedures and guidance related to research proposal design, submission, consent forms, multi-site research, and much more.

  • 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 Harmonization (ICH) E6, Good Clinical Practice (GCP), as applicable.

  • How did the IRB system evolve?

    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 research participant 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 participant 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.

  • FWA Assurances

    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

    The FWA is on file at OHRP.

    Our HHS IRB registration number is: IRB00000488

    The IRB Signed Authorization Agreement (.pdf)