About RPO

• The next deadline for submission of new protocols, modifications to protocols, and annual progress reports, requiring full board review, is July 31, 2009.
• Frequently Asked Questions for Research with Human Participants (rev. 3/09)
• RPO Newsletter - May 2008
• How to Change a Protocol

Policies, Procedures, Regulations & Guidance

• Does my Project need IRB Review?
• Brown University Policies and Procedures for the Protection of Human Participants in Research
• Brown University Education Program in the Protection of Human Research Participants (CITI)
• Who May Serve as Principal Investigator on a Human Research Protocol - (effective 7/1/06)
• IRB approval and the Brown University MRI Research Facility
• Brown University Policies and Procedures Relating to Research Privacy
• Federal Regulations and Oversight:
  • Office for Human Research Protections (OHRP) - formerly known as OPRR
  • OHRP Regulations
  • Belmont Report
• Federalwide Assurance of Compliance (FWA 00004460, expires 9/5/2010)

Resources

• Meeting Dates/Deadline for Receipt of Protocols (rev. 1/09)
• Frequently Asked Questions (rev. 3/09)
• Protocol Checklist and Submission Procedures (revised 12/08)
• What Makes a Complete Protocol? (PDF) (revised 1/09)
• Categories of Protocol Review
• Progress Report Checklist and Submission Procedures
• Checklist Form for Research Involving the Use of Prisoners as Study Participants
• Guidance for Graduate Student Principal Investigators (including medical students) on Human Research Protocols (revised 4/13/06).
• HIPAA at Brown
• Department Contact Information
• IRB Open Hours
• How to Change a Protocol
• OHRP - International Compilation of Human Research Protections; 2009 edition

Forms

• Human Research Protocol Coversheet - IRB Form # 1 (rev. 6/30/06) (Microsoft Word)
• Continuing Progress Report Form (Microsoft Word)
• Protocol Checklist and Submission Procedures (Microsoft Word) (rev. 12/08)
• Checklist Form for Research Involving the Use of Prisoners as Study Participants (PDF)
• NIH Certification of IRB Approval (Optional Form 310) (Microsoft Word) (rev 1/09)
• Brown University Certification Regarding Education in the Protection of Human Research Participants (Microsoft Word)
• Modification form/format(Microsoft Word) (rev. 1/09)

Other Links

• ClinicalTrials.gov provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions. The U.S. National Institutes of Health (NIH), through its National Library of Medicine (NLM), has developed this site in collaboration with all NIH Institutes and the Food and Drug Administration (FDA).