Regulatory Advisors — Building Your Ship
Your strategic partners in study design and regulatory planning.
Areas of support:
- Aligning study design with research objectives
- Protocol and consent development
- Risk minimization strategies
- Determining whether IRB review is required / whether work is human subjects research
- Regulatory requirements and compliance guidance
- Preparing new IRB submissions (forms and requirements)
- Advanced consultation for complex issues (e.g., deferrals, regulatory strategy)
You can contact the HRPP team through the SHIP portal or by email at: regulatoryadvising@brown.edu
Navigators — Smooth Sailing During IRB Review
Hands-on support during submission, review, and study maintenance.
Areas of support:
- IRB submission preparation and form completion
- Huron / IRB system technical troubleshooting
- Responding to IRB comments and required modifications
- Questions on active studies (continuing review, modifications, RNI)
- Complex submission or review issue resolution
Multi-Site & Collaborative Research
“Balancing order, movement, and nuance”
Areas of support:
- Guidance for multisite studies reviewed by Brown IRB
- Guidance for studies relying on external IRBs
- Determining IRB review and reliance pathways
- Execution and management of reliance agreements
You can contact the HRPP team through the SHIP portal or by email at reliance@brown.edu.
Post-Approval Monitoring (PAM)
“Being a Guiding Light”
The PAM program supports responsible, high-quality research through:
Protecting participants
- Ensuring studies are conducted as approved
- Maintaining compliance with federal regulations (45 CFR 46) and institutional policies
- Reducing risk to research participants
Supporting researchers
- Providing education and compliance guidance
- Identifying potential issues early
- Assisting teams in correcting and strengthening processes
Improving research quality
- Promoting best practices across studies
- Supporting consistent, high-quality research operations
You can contact the HRPP team through the SHIP portal or by email at: IRB_PAM@brown.edu
Stay on Course with HRPP Compass
HRPP Compass enables timely, clear, and effective collaboration between researchers and the HRPP—supporting safe, compliant, and high-quality research across the Ocean State and beyond.