Institutional Review Board

Background

The Institutional Review Board (IRB) is a hospital committee formally required by government regulation. IRBs are most commonly employed for studies in the fields of health and the social sciences.  Such studies may include clinical trials of new drugs or devices; studies of personal or social behavior, opinions or attitudes; or studies of how health care is delivered and might be improved.

The purpose of an IRB is to protect the rights and welfare of human research subjects participating in the hospital's biomedical and behavioral research. The IRB reviews proposed studies to ensure that any potential risks to human subjects are minimized and that those risks are justified by the relative importance of the study and the knowledge it could produce. The IRB’s critical oversight functions are scientific, ethical, and regulatory.

All human subject research conducted at NewYork-Presbyterian/Queens must be prospectively reviewed and approved by the NYP/Queens IRB or an IRB designated by NYP/Queens.  

The IRB at NewYork-Presbyterian/Queens (NYP/Queens) reviews every research proposal submitted by a medical center investigator to determine whether it meets the appropriate criteria for human subject research. This body has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction, as specified by both federal regulations and local institutional policy.

The Western Institutional Review Board (WIRB) is an independent commercial IRB contracted by NewYork-Presbyterian/Queens to review, approve and monitor the institution’s industry sponsored and federally funded human subjects’ research, and such other research as may be determined from time to time by the IRB Administrator.  WIRB complies with NYP/Queens policies and reviews research in accordance with Federal Regulations. Although WIRB serves as the IRB of record for the industry and federally sponsored studies all active research is subject to NYP/Queens policies and procedures and standard operating procedures related to conduct of all research at the institution.   

Determination of eligibility for WIRB Review will be made by the Staff at the Lang Center for Research and Education (Director of the Center, IRB Administrator). No human subject research may be initiated or continued at NYP/Queens or by NYP/Queen’s employees or agents without prospective approval of a designated IRB.

IRBs were established under the National Research Act of 1974, in direct response to significant research abuses in the early 20th century. Most notably, these included the experiments of Nazi physicians during World War II (Nuremberg Code, http://ohsr.od.nih.gov/guidelines/nuremberg.html) and the Tuskegee Syphilis Study, a project conducted between 1932 and 1972 by the U.S. Public Health Service on black men in rural Alabama (Belmont Report, http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html)

IRBs are currently regulated by the Department of Health and Human Services (HHS) Offices for Human Research Protections (OHRP), http://www.hhs.gov/ohrp, and  the U.S. Food and Drug Administration (FDA), http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials.


 
Site Map | Contact Us | Privacy Notice | Privacy Policy | Term of Use
For a medical emergency, please call 911 and go to the nearest emergency room.
Copyright © NewYork-Presbyterian/Queens
56-45 Main Street, Flushing, NY 11355