Checklists

Checklists are designed to help the Research Team and the IRB 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

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

IRB Members & Staff

IRB Review

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

Review of Problem Reports & New Information

Checklist Suspension or Termination

Waiver of Consent Process and/or Documentation

Basic & Additional Elements of Parental Permission & Informed Consent

Core & Required Elements of Authorization for Use & Disclosure of PHI for Research

IRB Coordinator QA

IRB Coordinator Submission Processing

Meeting Preparation

Meeting Conduct

IRB Minutes