Federalwide Assurances (FWAs)

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Overview

All Rutgers IRBs are guided by the ethical principles regarding all research involving humans as subjects, as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (entitled: Ethical Principles and Guidelines for the Protection of Human Subjects of Research also known as, the Belmont Report), regardless of whether the research is subject to Federal regulation or with whom conducted or source of support (i.e., sponsorship/funding source).

All institutional and non-institutional performance sites for this institution, whether they are domestic or international, will be obligated by this institution to conform to ethical principles which are at least equivalent to those of this institution, as cited in the previous paragraph or as may be determined by the DHHS Secretary.

All Rutgers IRBs assure that they will comply with the Department of Health and Human Services (DHHS) regulations for the protection of human research subject, under 45CFR Part 46, as amended to include provisions of the Federal Policy for the Protection of Human Subjects (56FR28003) as Subpart A, which may be further amended during the approval period for this Assurance, where required or as applicable.
 
Federalwide Assurance (FWA) #: 00003913
(Rutgers University, All Campuses & All IRBs)
 
Subpart A also known as the “Common Rule”, which was published in 1991 and codified in separate regulations by 15 Federal departments and agencies, as listed below:

In addition, the Central Intelligence Agency must comply with all subparts of 45 CFR part 46 under Executive Order 12333.

Several non-HHS federal departments and agencies have additional regulations in place for research involving special populations or for human subjects research in general. Investigators are encouraged to review the regulations of the funding agency to determine whether additional regulations apply. Also, many agencies have not adopted subparts B, C, or D and grantees of those agencies are not necessarily bound by them. Investigators/Grantees should consult their respective funding agency for specific guidance and/or requirements.

More information regarding Federal Regulations can be found online at: http://www.hhs.gov/ohrp/index.html

Additional Information

Federalwide Assurances (FWAs) HHS.gov