General Information

The HackensackUMC Institutional Review Board is comprised of scientists, non-scientists, and community members. Members serve one-year terms and are appointed by the medical center's Board of Governors. The Institutional Review Board (IRB) meets the first and third Wednesday of the month; the Data Safety Monitoring Board (DSMB) meets the second Wednesday of every month, and the Institutional Biosafety Committee (IBC) meets the third Tuesday of each month. 

Responsibility

All research involving human subjects (as defined below), and all other activities, which even in part involve such research, regardless of sponsorship, must be reviewed and approved by the institution's IRB(s). No intervention or interaction with human subjects in research, including recruitment, may begin until the IRB has reviewed and approved the research protocol. Specific determinations as to the definition of "research" or "human subjects", and their implications for the jurisdiction of the IRB under institutional policy, are determined by the IRB.

The IRB's purpose and responsibility is to protect the rights and welfare of human subjects. The IRB reviews and oversees such research to ensure that it meets well - established ethical principles and that it complies with federal regulations at 45 CFR 46 and 21 CFR 50 and 56, that pertain to human subject protection, as well as any other pertinent regulations and guidelines, such as the Good Clinical Practice (GCP) Guideline (E6) of the International Conference on Harmonization.

To access the forms, templates, policies and procedures of the HIRB, please click here.

What is a ' Human Subject ' in Research?

A Human Subject is defined by the FDA as "an individual who is or becomes a participant in research, either as a recipient of the test article or as a control." A  human subject in research  may be either a healthy individual or a patient. For research involving medical devices, a human subject is also an individual in either normal health or with a medical condition or disease on whose specimen an investigational device is used or who participates as a control.