Committee Member Resources

Below is a list of references that will help you be successful in your position. Please review the items in this list and familiarize yourself with the Checklists as these will help guide you in your reviews. 

Cayuse Human Subjects Module Instructions/Guidance

• Cayuse Human Ethics Reviewer Guide (PDF)

Protocol Review Process

• Full Board Minutes Worksheet (DOCX)
• Primary Reviewer Presentation Worksheet (DOCX)
• Expedited Review Guidance (DOCX)

Checklists

• Study Completeness Checklist (DOCX)
• Reportable Event Reviewer Checklist (DOCX)
• Criteria for Approval & Informed Consent Checklist (DOCX)
• Renewal/Continuing Review Approval Checklist

Training Presentations

• HIPAA and Expedited Review – May 2017 (PPTX)
• Reportable Events and Revised Common Rule – November 2018 (PPTX)
• Regulatory Issues – May 2017 (DOCX)

Federal/External Regulations & Guidelines

• Human Subject Regulations Decision Charts
• Guidance on the Genetic Information Nondiscrimination Act (GINA)
• DHHS Human Subjects Regulations (45 CFR 46) (contains a list of Exempt categories in 46.101)
• List of Expedited Review Categories (via OHRP Web Site)
• FDA IRB Regulations
• NIH Guidance: Inclusion of Children in Research
• NIH Guidance: Inclusion of Women/Minorities in Research
• National Bioethics Advisory Commission 
• Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the Belmont Report)
• The Declaration of Helsinki
• OHRP Guidance: Conflicts of Interest
• OHRP and NIH Guidance on Certificates of Confidentiality
• Additional OHRP guidance on numerous topics