Our IRB members possess extensive and diverse backgrounds including service on institutional, academic and independent institutional review boards. Members of our review boards also have extensive expertise regulating and examining research for its ethical implications, including research involving vulnerable populations such as pediatrics, critically ill and cognitively-impaired participants.
We support all phases of drug, device and biologics development, as well as social, behavioral and international research through:
- Daily IRB meetings to ensure timely review and response
- Priority review meetings when needed
- 24/7 access to the IRB submission management system (CIRBI)
- Certified non-English translations of IRB-approved materials
- Recruitment guidance for all media strategies and materials
- On-call consultation on all aspects of study submission and review
- Availability to attend and present at investigator meetings
- Collaboration with the Chesapeake IRB operations team
Chesapeake IRB Roster
Chesapeake IRB is organized and operates in compliance with FDA regulations 21 CFR Parts 50 and 56, DHHS regulations 45 CFR Part 46, and the International Conference on Harmonization (ICH) and The Common Rule as appropriate. We also operate in compliance with portions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA Privacy Rule) that apply to research, as described in 45 CFR Parts 160 and 164. We have been audited by the FDA (“no findings” determinations), sponsors, CROs, SMOs and individual research sites.