Collaborative research involving human subjects
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:
- The role the collaborating organization plays;
- The type of regulatory infrastructure in place – namely whether the institution has a governing Institutional Review Board (IRB), Research Ethics Board (REB) or an Independent Ethics Committee (IEC); and
- The source of funding for the research.
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:
- Research at other institutions, domestic and foreign, requires review by the IRB at NYU – the University Committee on Activities Involving Human Subjects – and review from the IRB/REB/IEC at other location(s).
- NYU researchers who function as the lead investigator, prime grant holder or serve as a coordinating site for a multi-site study are responsible for:
- Obtaining NYU review for the overall project,
- ensuring that other sites receive IRB review at their respective institutions, and
- ensuring that relevant safety information is appropriately recorded and shared between engaged sites.
- Each institution where research activities satisfy the federal definition of engagement in human subjects research must have its own IRB review.
- For federally funded studies, each institution that must have IRB review also must have assurance under the Federalwide Assurance (FWA) program.
Federalwide Assurance (FWA) of Compliance
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:
- The IRB(s) designated under the Assurance must be registered with the OHRP. If not, submit the registration.
- Complete the FWA application.
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.