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Human Research Protection Program

  • At Einstein, the Human Research Protection Program has been developed with a commitment to protecting the rights and welfare of subjects in human research and promoting excellence in all aspects of human research.

    The Albert Einstein Healthcare Network (AEHN) has a Federalwide Assurance (FWA) agreement with the Department of Health and Human Services (DHHS) 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. The approved AEHN FWA registration number is FWA00000762 and is on file with the Office for Human Research Protections (OHRP) in the DHHS. The most current information pertaining to the AEHN FWA is available on the OHRP database for approved FWAs. More information on the OHRP and FWAs can be found at the OHRP's website.

    To comply with federal and state laws, as well as to satisfy our institutional policies, any human subject research to be conducted at Einstein must be submitted to the Einstein Institutional Review Board for review and consideration of approval prior to initiating any research activity. This includes chart reviews that are done for the purpose of research.

    The Institutional Review Board (IRB) is a committee whose purpose is to protect the rights and safety of individuals who volunteer to participate in human subject research. The AEHN Institutional Review Board (AEHN IRB) is registered with the OHRP and can be found on the OHRP Database for Registered IORGs and IRBs, and Approved FWAs.

    To initiate a human subject research activity at Einstein, all researchers must submit relevant human subject research documents in accordance with Einstein IRB policy and procedures.

    Researchers are expected to comply with the Financial Disclosure Policy or the Conflict of Interest Policies. Questions related to either policy or disclosures should be directed to the Director of the Office of Research and Technology Development.

    Detailed information about the type of research that the Einstein IRB is required to review and consider for approval can be found on the U.S. Department of health and Human Services’ website.