Are there any requirements of the PI after receipt of IRB approval?
Yes , all proposals approved by Expedited or Full Board Review are required to submit an annual report. In addition, any changes to the Protocol, Methods, and Measures, must receive IRB approval. Consent documents MUST be annually renewed with the filing of the annual report. Proposals that receive Exemption require no additional approval from the IRB as long as the scope of the research remains the same. Any changes to a previously Exempted study requires re-review by the IRB.