PRACTICAL GUIDE FOR REDUCING REGULATORY BURDEN

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

Appendices: 

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