To comply with the provisions in the Paperwork Reduction Act and requirements for assurance at 45 CFR 46.103, OHRP is requesting the public to comment on their efforts to revise the Federalwide Assurance (FWA) form. The proposed changes to the Pre-2018 Common Rule requirements are expected to ensure a shorter, simplified FWA application process and reduce respondent burden.
Proposed changes to the FWA form include:
1) Removing the option for US institutions to “check the box”, or the option to voluntarily apply the Common Rule, or the Common Rule and subparts B, C, and D to all nonexempt human subjects research at the institution regardless of source of support
2) Eliminating the requirement that institutions designate one or more IRBs to review research to which an FWA applies
3) Removal of the requirement for institutions to provide a statement of ethical principles
4) Removing a requirement for institutions outside the US to provide the procedural standards they apply to human subjects research when assuring compliance with FWA terms
Proposed changes are expected to result in a simplified FWA application process. Implementing changes to the FWA form, once approved, will involve software system updates. As such, there may be a future pause in submitting and processing FWAs and IRB registration applications to allow for software upgrades.