Where an activity receives funding or other support from a US federal agency, there are two special requirements that need to be met before the project begins:

(1) A Federalwide Assurance (FWA) must be in place

This is a commitment from the research sponsor that the research will comply with the minimum standards required by the US government.

Newcastle University has a valid FWA, (reference FWA00000197), and so, where Newcastle University is the research sponsor, no further action is required from the research team.  

(2) An Institutional Review Board (IRB) must review the project, if required

The Institutional Review Board (IRB) is an administrative body, approved by and registered with the Office of Human Research Protections (OHRP), established to protect the rights and welfare of human research participants.

A project will require review by an IRB, if it involves human participants and is conducted, supported or otherwise subject to regulation by a US federal department agency, as set out in the US Department of Health Services (HHS) Protection of Human Subjects regulations, as 45 CFR part 46. 

Researchers can apply for IRB approval from an external IRB or from Newcastle University's IRB (reference: IRB00010615), which is the Faculty of Medical Sciences Research Ethics Committee (FMS REC).

Where a project does not require review by an IRB, the researcher must still complete the Newcastle University online ethics form, to identify whether the project requires ethics review by another Research Ethics Committee.

If you wish to recommend any changes to the information above, please contact res.policy@ncl.ac.uk.