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Facility Human Protection Program (FHPP)
For the convenience of NAVREF members, documents relevant to the FHPP fee are assembled below.
Please note: The FHPP directive requires the ACOS/R to submit a report to ORD by October 31. To complete the report, the ACOS/R will required specified information from the NPC. Questions about the report should be directed to
Amy Centanni, director of the VA NPC Program Office. Amy.Centanni@va.gov or 202-254-0199
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June 17, 2003 |
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TO:
NAVREF Members
FROM:
NAVREF Board of Directors
SUBJECT: VHA
FHPP Directive
On
June 13, 2003, VHA distributed Directive 2003-031, Establishment of a Facility
Human Protections Program (FHPP). See below for a link to a PDF of the
directive. The final policy is different from the draft shared with NAVREF
members in early May and a subsequent version provided to NAVREF by Dr. Wray on
May 22 so NPCs are encouraged to review it carefully. Previous versions
provided that:
- NPCs
would have the flexibility to accrue the FHPP contribution on an annual
basis.
- The
10% requirement would be applied to the per patient direct costs and would
be proportionate to the number of enrolled patients.
- Only
studies that actually enroll patients would be included in the base for
determining the annual allocation; no minimum would be required for approved
studies that fail to enroll at least one patient.
The
final directive is less clear on these issues and assigns responsibility for
implementation to the ACOS/R rather than the R&D Committee, raising
potential conflict of interest concerns for these statutory NPC board
members. Also, NAVREF is somewhat perplexed by a policy that references
industry grants “accepted by VA,” but “funded through NPCs.” It
has been well established that the NPCs are separate from VA. Also, while 38 USC 8301 (cited in 2.b.) may
provide VA with authority to accept the funds the directive requires NPCs to
make available to the ACOSs/R, we are uncertain of its relevance to “industry
funds accepted by VA” in the context of this policy. Section 8301 of Title 38
is the authority by which VA itself accepts “gifts, devises and bequests, ”
generally for administration by General Post Funds.
As
implemented, the directive presents a significant new challenge for the NPCs.
Executive
directors should bring the policy to the attention of the NPC board of
directors and ensure that study budgets are structured to accommodate the
FHPP requirement.
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