Sponsors & Compliance

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.

Office of Human Research

Commercial IRBs

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 clinicalresearch@mfa.gwu.edu

Involving Students in Research

GW medical student research contact David Leitenberg.
https://smhs.gwu.edu/research

IRB Amendments for medical students
https://smhs.gwu.edu/sites/default/files/IRBAmendments-Nov2020.pdf

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.

Billing & Invoicing

A major function of the OCR is to assist investigators and coordinate contracts with an Institutional Review Board, negotiate budgets, payments and terms, and insure research billing and internal invoicing. In this process, we serve as a financial spoke for human subjects research to the GW university grants and contracts Pod 3.

We work with GW OVPR on Clinical Trial Agreements that serve as key legal documents that govern the conduct of clinical trials, including CDAs, DUAs, and MTAs. For more information, please contact Melanie Bossi at mbossi@mfa.gwu.edu.