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DEPARTMENT OF VETERANS AFFAIRS
Office of the General Counsel
Washington DC 20420
In Reply Refer To. 023
Teresa L. Wright, MD
Chief, Gastroenterology Section 111B
VA Medical Center
4150 Clement Street
San Francisco, California 94121
1. At the request of the VA Chief of
Patient Care Services, you asked our office to review a research
proposal to be funded by a gift from the Schering-Plough Corporation.
2. In addition to the information you
submitted, we have spoken with the Chief of Patient Care Services and
with the Executive Director of the Northern California Institute for
Research and Education (NCIRE). NCIRE is located at the San Francisco VA
Medical Center and is an authorized and established VA research
corporation pursuant to 38 U.S.C. § 7361 (the "corporation statute").
During these discussions, we learned that the proposal contemplates that
NCIRE would administer funds for the research and that it would be a
multi-center study conducted at VA Medical Centers across the country.
The principal investigator would be based at the San Francisco VA
Medical Center. We understand that the concern of the Chief of Patient
Care Services is whether the multi-center aspect of the proposal renders
it unlawful. Based on these discussions, the legal question presented is
whether research that research corporations may lawfully support
includes "multi-center" research.
3. The corporation statute conveys
authority for corporations to be established "at any…medical center…to
provide a flexible funding mechanism for the conduct of research at
the medical center." 38 U.S.C. § 7361(a)(emphasis added). This
implies that a corporation could lawfully support only those parts of a
multi-center project which were being carried out at the specific
medical center where the corporation had been established. However, VA
manual provisions demonstrate that for at least two years before
enactment of the corporation law in 1988, VA research was authorized to
be conducted on a multi-center basis. VA Manual M-31 Part I, ch. 1, para.
1.01f., 1.011. (1985) (defining “cooperating investigator,”
“collaborating investigator,” and “cooperative study” as involving more
than one health care facility).
4. Moreover, we understand that most
projects have one principal investigator and would typically, therefore,
be managed from one medical center, i.e., the duty station of that
investigator. In that sense, even a project being carried out at more
than one medical center would constitute -research “at a medical
center.” In our view, therefore, when Congress added funding flexibility
for research “at any” or “at the” medical center, it did not intend to
preclude flexibility for multi-center research being managed at the
medical center that a corporation would be organized to support. From
discussions regarding this proposal, our understanding is that it
describes a project that could lawfully be supported by NCIRE, the
corporation organized to support the San Francisco VA Medical Center.
5. Your letter mentions that in addition
to NCIRE, the research corporation supporting the Miami VA Medical
Center would be administering funds for the research called for in this
proposal. In our view, the corporation law conveys sufficient
flexibility to permit two research corporations to administer support
for different portions of the same research. We do believe, however,
that consistency with the purposes of the corporation law would require
that the addition of the second corporation not be permitted to decrease
the monies that are applied directly to the research. Thus, the amount
of any administrative charges drawn off by both corporations would not
properly exceed the customary amount that either corporation by itself
would withhold in supporting a similar project.
Leigh A. Bradley
cc: Chief, Patient Care Services
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