Federally funded research involving research participants

All research involving human participants that is funded by a federal department or agency must comply with the Federal Policy for the Protection of Human Subjects or the “Common Rule” (45 CFR 46). 

The University of Leeds Research Ethics Committee has been registered as an Institutional Review Board (IRB) under the University's Federalwide Assurance (FWA). 

As well as complying with the University of Leeds Research Ethics Policy there are a number of additional requirements for Federally funded grant holders

Additional requirements include

  1. Ethics approval must be sought if it is a funder requirement, even if it would not otherwise be required by the University of Leeds. 
  2. Grant-holders must submit an amendment form on an annual basis for review by the relevant FREC on behalf of UREC. Any updated versions of the ethics application and supporting documents should be submitted along with the amendment form. 
  3. The Senior Research Ethics Administrator must immediately be notified of any unanticipated problems involving risks to research participants or others; serious or continuing noncompliance with the applicable U.S. federal regulations or the requirements or determinations of the IRB(s); and suspension or termination of IRB approval.  

HHS informed consent checklist

UREC paper on FWA compliance, February 2016 
RMT paper on FWA compliance, May 2016 

In the case of collaborative research projects clarification of the requirements should be sought from the Senior Research Ethics Administrator