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FDP Brochure 2012

FDP Brochure 2016



Presented by the FDP Human Subjects Protections Subcommittee

Table of Contents

  1. Background: FDP Projects for Reducing Regulatory Burden
  2. Does the Research Fall Under the Purview of the IRB?
    1. Examples of Not-Regulated Research
    2. What Constitutes “Engagement”?
    3. QI/QA versus Research
  3. Avoiding Over-review of Exempt Research
    1. Examples of Exempt Research for Each Category
    2. When Do Changes to Exempt Research Projects Require IRB Review?
    3. Ways to Make Your Study Exempt
  4. Conserving IRB Resources
    1. Staff Approval of Clerical Changes in Protocols
    2. Using Alternative IRB Models to Optimize Use of IRB Resources
      1. Avoiding Duplicate Review by Using IRB Authorization Agreements
      2. Independent IRB Review
      3. Facilitated IRB Review
      4. NIH Alternative IRB Models Chart
  5. Expediting Expedited Review
    1. Staff as IRB Members or Consultants for Protocol Review
  6. Customizing Informed Consent to Fit the Study
    1. Waiver of Informed Consent
    2. Flowchart of Criteria for Waiver or Alteration of Informed Consent
  7. Streamlining Continuing Review
    1. Simplified Criteria for Content of Continuing Review
  8. Collaborating with Outside Individuals
    1. Individual Investigator Agreement (IIA) Template
  9. Minimal Risk Research
  10. Community-based Participatory Research
  11. Protecting Privacy and Maintaining Confidentiality
    1. Data Security, Storage, and Sharing
  12. International Research
  13. ICH-GCP
  14. Tips for Post-Approval Monitoring


  1. Additional Links of Interest
  2. Practical Guide Working Group Membership