COMMON RULE AND OTHER FEDERAL REGULATIONS INTERPRETATION AND APPLICATION

Human subject protection programs and institutional review boards are governed by the Common Rule (45 CFR 46) and other federal rules and regulations. These are the subject of numerous guidances issued by OHRP. It is likely that you cannot always keep up with those guidelines or that you may not be aware of their existence. We can assist your organization in maintaining compliance with the applicable rules and regulations in the following ways,

1. Review of your institutions policies and procedures for compliance with the regulations and guidances
2. Review of the actions of the IRB for compliance with the Common Rule
3. Review of the standards applied by the IRB in the project review process including the risk/benefit and scientific analysis employed
4. Analysis of your institution's continuing review process