The university manages human subjects research integrity/ethical/compliance matters and the IRB. The human subjects module of GW iRIS initiates and tracks the status of IRB applications.
Commercial IRBs are independent pay-for-service IRBs that provide regulatory and ethical review services for academic and non-academic institutions to conduct reviews of research involving human subjects.
(Please see UCLA: https://ohrpp.research.ucla.edu/irb-reliance-commercial-irb/)
Currently, all industry-sponsored trials are sent to WCG IRB for review. All other studies (federal and non-federal) should be sent to GWIRB for review. If you have questions, please contact the office at firstname.lastname@example.org
The Office of Clinical Research helps to make sure trials conducted at GW follow not only study protocols, but all applicable laws and regulations. We are continually assessing our systems to streamline clinical trials and ensure compliance.
Need Privacy Officer Approval?
Please send an email to email@example.com with the following documents attached:
- IRB Outcome letter
- HIPAA waiver reviewed by the IRB
- Protocol or application
- List of relevant data points
Turn-around is approximately one week.
If you have additional questions, please email the OCR at: firstname.lastname@example.org.
Common Regulatory Documents and the Regulatory Binder
We are identifying an eReg solution now. Other eRegulatory products that are commercially available to aid in compliance and efficiency, including SiteVault, Complion, Florence eBinders and Forte eReg.