Guide to Services

Protocol Approval

On a sponsor-initiated clinical trial, typically the pharmaceutical company supplies a protocol and HJF and you make appropriate modifications to it to conform to military service requirements. HJF also works with you to develop the budget at this time.

The Clinical Trials Department will review your proposed patient accrual rate, project timeline and operation plan and will develop your project budget. It will be based on good faith estimates of the anticipated costs using established federal guidelines and current costs. The budget will include estimates for personnel, pharmacy support, equipment, supplies, any activities required for the project's success and Facilities & Administrative (F&A/indirect) costs. The F&A rate covers the costs of HJF's comprehensive services. The rate is determined each year through a collaborative process with federal agencies

Within each medical center, informed consent is documented by the use of a written consent form approved by the IRB of each institution and its higher headquarters. The document is usually the institution's generic boilerplate or the sponsor's informed consent document, which has been modified by study as needed to meet the requirements of your institution and good clinical practices.

Before the agreement can be finalized, the agreement must receive the appropriate second-level approval required by each branch of the military. The Navy has delegated final approval to the regional Naval Medical Centers. However, a final approval is sent to the Naval Medical Education and Teaching Command. The Army, Navy and Air Force medical centers each have an IRB in full compliance with all federal, DoD, state and local guidelines for human subjects research. All medical centers strictly adhere to the federal guidelines found in 21 CFR 56 for assurance of the protection of the rights and welfare of human subjects participating in research.

The Clinical Trials Department will review your protocol to verify that all facility, Service and HJF requirements are met. When all parties approve your protocol, HJF's president and an official from the sponsoring company will sign the agreement.