Policies and Guidance

• VCU IRB Written Policies and Procedures (WPPs) – text searchable policies and procedures for the IRB, investigators, and research personnel.
• Federalwide Assurance (FWA) and  Terms of the Federalwide Assurance

• Involvement of Non-VCU Institutions in VCU Human Subjects Research (pertains to non-exempt, federally supported research) (v. 3-29-07) 

• How do I determine if my project is 'human subjects research? (v. 3-29-07)

• The "Belmont" Report
  more info »The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at the Smithsonian Institution's Belmont Conference Center supplemented by the monthly deliberations of the Commission that were held over a period of nearly four years.
• Declaration of Helsinki
  more info » The Declaration of Geneva of the World Medical Assembly binds the physician with the words, "The health of my patient will be my first consideration," and the International Code of Medical Ethics declares that, "A physician shall act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient."
• Nuremberg Code
  

• OHRP Decision Charts #2-7
• WPP II-2; WPP VIII-1

• OHRP Guidance and OHRP Decision Chart #8
• WPP VIII-2

• Community-based participatory research (CBPR) and the IRB
  Materials for a 6 part audioseminar on CBPR and research ethics. 
• Ethics and Research in the Community
  A training tutorial for lay individuals who do research in the community, funded by the Office of Research Integrity. Training topics include: "The Research Protocol", "Recruiting Participants", "Confidentiality", "Professionalism", and "Applications."

• ICH E6: Good Clinical Practice Guidelines
• ICH E10: Choice of Control Group and Related Issues in Clinical Trials

     HIPPA - Information; WPP XII-3; HIPAA and Research     

• Informed Consent Tips (OHRP web site)
• Informed Consent Checklist (OHRP web site)
• Informed Consent Evaluation Instrument
• Waiver of Consent & Waiver of Documentation (v. 3-29-07)
• WPP XI-1; WPP XI-2; WPP XI-3

• Using the Internet to Conduct Research: What Investigators and IRB Members Should Know (v. 8-31-06)

• Post-Approval Study Evaluation Tool (facilitates self-monitoring)
• WPP X-3

• Protecting Privacy and Maintaining Confidentiality of Data Collected for Research Purposes: IRB Perspectives (v. 12-7-07)
• Privacy and Confidentiality: IRB Considerations and PI Requirements (v. 5-31-07) 

• Example of exempt study using students enrolled in a class as subjects.
• In addition to the “mock” exempt study listed above, several VCU investigators have graciously agreed to share their IRB protocol (i.e., research synopsis) and related documents as examples for others to review as they prepare their submissions.  These are confidential documents to be used by VCU personnel as examples only. Click here to access more examples of IRB Protocols (requires VCU eID and password)

• DHHS 45 CFR Part 46 (includes Subparts A, B, C, and D)
• FDA Regulations:  21 CFR Parts: 50 - Human Subjects; 54 - Financial Disclosure; 56 - IRB; 312 - IND; 812 - IDE
• Searchable Code of Virginia:  § 32.1-162.16 (Def.); § 32.1-162.18 (Inf. Consent)

• Reviewer Guide
• Exempt Review Sheet (Pilot use only by Panel E)
• Review Sheets (Required)

  Review Type	Special Populations
  Exempt Review Program Access	Children
  Expedited Review Sheet	Pregnant Women, Fetuses and Neonates
  Full Board Review Sheet	Prisoners

• Planning to Conduct Research in the Schools: Working with the Schools and the VCU IRB
  Powerpoint presentation developed in collaboration with the VCU School of Education faculty, Richmond-area school divisions, and the IRB.

• Protecting Vulnerable Research Participants (v. 3-29-07)

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