Federal / Not for Profit Studies – Study Start-Up
(approx. 8-24 months from Grant submission to enrollment)
Study Start-Up Checklist and Forms:
1. Contact BRI Grants and Contracts or VMMC Foundation with proposal and submission materials. Note: depending upon the type of Grant or Foundation application, approval of the research may take upwards of 2 years.
For more information review the BRI Compliance Brochure (helpful information about the Grants and Contracts process, e.g., pre-award or post-award details).
2. Research Requirements
- Prepare Request for IRB and Funding Numbers form (includes Key Personnel list)
- Complete Ethics/GCP Training(all key personnel)
- Submit BRI / Investigator Compact (new investigators only)
- Obtain Final Protocol
- Draft Informed Consent(s)
- Draft Internal Budget
- Complete and send Impact Statements (contact your unit manager for more information)
Device Impact Statement Radiology Impact Statement Pharmacy Impact Statement CRC Impact Statement
CRC Med Order Sample
Nursing Impact Statement Laboratory/Pathology Impact Statement
***MUST have Grants and Contracts approval before proceeding to Step 3***
3. Submit Institutional Review Board (IRB) documents to the IRB office at MS: D4-CRP (click here for BRI IRB meeting/deadline schedule).
- BRI IRB Full Review Application
- Attach all applicable documents including Informed Consent Form, HIPAA Authorization, questionnaires, recruitment materials, Final protocol, etc. as applicable) via hardcopy to BRI IRB.
- CIRB Facilitated Review Application Checklist
- CIRB Model Consent Template
- CIRB Procedures and Responsibilities
- CIRB Division of Responsibilites
For additional assistance, contact the IRB at IRB@BenaroyaResearch.org
***Grants and Contracts to provide official notice when a study may begin activity***