What are the IRB Registration and Federal Wide Assurance (FWA) Numbers?
• 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. (Top) • What are the consequences of noncompliance in research involving human subjects? The IRB reserves the authority to suspend or terminate approval of research. Anyone conducting human subjects research without the approval of the IRB may be subject to a finding of research misconduct. (Top) • Are there University procedures for the reporting injuries ( Adverse Events ) that occur during an approved research project? Yes, there are detail
