#human-subjects

Prepare an IRB (Institutional Review Board) application. Required elements: 1. Study purpose and design. 2. Participant recruitment and selection. 3. Informed consent process and forms. 4. Risks and benefits assessment. 5. Data collection procedures. 6. Privacy and confidentiality protections. 7. Data storage and security. 8. Vulnerable populations considerations. Determine review level (exempt, expedited, full). Address ethical principles (beneficence, justice, respect). Include all study materials. Plan for adverse events. Allow 4-8 weeks for review. Obtain approval before starting.