The purpose of this guidance is to help NYU investigators meet the regulatory requirements involved with conducting human subject research with other institutions located within the United States, as well as entities located outside of US territories.
NYU investigators who work with other institutions must fulfill requirements that may vary depending on the following factors:
With these issues in mind, some general principles to be aware of when seeking approval to conduct human research with other institutions include the following:
If an institution is engaged in human subjects research that is conducted or supported by any agency of the U.S. Department of Health and Human Services (HHS), the institution must have assurance of compliance with the HHS regulations (45 CFR 46.103) for the protection of human subjects. Assurance of compliance and federal oversight are managed by the Office for Human Research Protections (OHRP) under the provisions of the Federalwide Assurance (FWA) program. Links to additional information are provided below:
Obtaining an approved assurance from OHRP: Obtaining assurance is a two-step process:
NYU IRB policies and procedures for working with other institutions are consistent with guidance set forth by the Office of Human Research Protection (OHRP) and encompass ethical principles accepted internationally.