Answer;
-Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB.
Step-by-step explanation;
-HHS human subject protection regulations and policies necessitate that any institution that is involved in non-exempt human subjects research conducted or supported by HHS must submit a written assurance of compliance to OHRP.
- The Federalwide Assurance (FWA) is the only type of assurance of compliance accepted and approved by OHRP.