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FDA regulations generally require IRB review and approval of research involving FDA-regulated products (e.g., investigational drugs, biological products, medical devices and dietary supplements) (21 CFR Part 56).

Apply for IRB Review Step 1: Determine if your project requires IRB approval. ... Step 2: Complete the Mandatory Online Certification for Researchers. ... Step 3: Complete the IRB Research Project Application. ... Step 4: Make adjustments as necessitated by IRB Review until approved.

The IRB application is used to provide information to the IRB whose responsibility it is to ensure the university adheres to federal regulations in the protection of human participants in research. No recruitment or data can be collected until an application is approved by the IRB.

IRB Submission Checklist Application. Consent Document(s) Recruitment Materials. Study Instrument(s) Permission Letters (if applicable) Certificate of Education (if not already on file) Grant proposal narrative (if applicable) The application materials have been made into one PDF.

Under FDA regulations, an Institutional Review Board is group that has been formally designated to review and monitor biomedical research involving human subjects. In ance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.

Apply for IRB Review Step 1: Determine if your project requires IRB approval. ... Step 2: Complete the Mandatory Online Certification for Researchers. ... Step 3: Complete the IRB Research Project Application. ... Step 4: Make adjustments as necessitated by IRB Review until approved.

Examples of Studies that Generally Require IRB Review with subjects, such as surveys (paper, online, telephone, etc.), interviews, focus groups, cognitive testing, etc. Research studies that include subjects to examine devices, products, food, drugs, supplements, etc.

IRBs are administered on a federal level by the Office for Human Research Protections (OHRP), an office within the Department of Health and Human Services. OHRP assists IRBs in their work and receives and investigates claims of inappropriate research practices.