Checklists are designed to help the Research Team and the Institutional Review Board comply with Nemours' policies regarding application and review of Human Subject Research. At times, the Investigator or Reviewer may find that it is helpful to complete a checklist and submit it to the IRB with an application, or with a review. Follow the instructions within the Checklists and reference the associated Policies and Procedures.
Note: IRB Applications and Templates are located on www.irbnet.org
Research Team
- HSP Training
- Enrollment of Research Participants
- Application Assistance
- Advertising for Research
- Humanitarian use Device
- Blood Drawing Guidelines
- Reportable Problems & Events
- Risk Assessment of Common Procedures
- Emergency Use of an Investigational Article
- Expanded Access (Treatment or Compassionate Use)
- Planned Emergency Research
- Reciprocal Initial Approval
- Data Safety Plans
- Short Form Consent Process
- Genetic Research
- Data & Tissue Respository
IRB Members & Staff
- Initial IRB Review
- IRB Time Standards
- Reviewer Thinking Points
- Review of Permission & Consent
- Review of Investigational Drugs or Biologics
- Review of Investigational Devices
- Review of Amendments
- Review of Closures
- Research Determination (Is it Research?)
- Review of Exempt Research
- Review by Expedited Procedure
- Suspension or Termination
