|
DEPARTMENT OF VETERANS AFFAIRS
Office of the General Counsel
Washington DC 20420
September 30, 1996
In Reply Refer To: 024M
Ms. Barbara West
Executive Director
National Association of Veterans' Research and Education Foundations
5018 Sangamore Road, Suite 300
Bethesda, MD 20816
Dear Ms. West:
This is in response to your inquiry of
March 15, 1996, requesting our legal opinion as to whether VA nonprofit
research corporations (NPCS) may enter into Cooperative Research and
Development Agreements (CRADAS) with VA Medical Centers. This
correspondence was a result of a meeting you had with Dr. Richard
Levine, in his capacity as Chairman, Institute for Clinical Research,
Inc., Washington, DC, and Ms. Bea Pacheco of my staff.
As you know, NPCs were set up by Congress
to provide a flexible funding mechanism for the conduct of approved
research at VAMCS. 38 USC § 736l. The NPCs do not conduct research, and
OGC opinions have held that NPCs are not “agents" for VA and thus may
not agree to any terms or conditions that affect such research. An NPC
appears to be limited, therefore, to administering funds it receives
from outside entities in accordance with the approved research protocol.
Prior opinions have also held that NPCs
may not enter into CRADAs on behalf of VAMCS. CRADAs are
contracts and NPCs have no contractual authority to bind the agency, nor
are they "Government operated laboratories" within the definition of the
Federal Technology Transfer Act (FTTA). You indicated you were aware of,
and in fact provided copies of, prior OGC opinions in this regard.
However, you argue that the FTTA authorizes the VAMC to enter into a
CPADA with the NPC and a third party.
The FTTA provides that each Federal
agency may permit the director of any of its Government-operated
laboratories to enter into CRADAs "with other Federal agencies...public
and private foundations...nonprofit organizations, or other persons..."
Thus, you are correct that broad authority exists under FTTA with regard
to what entities VA may contract with for cooperative research.
However, we find no authority to justify
a three-way agreement such as the one you have contemplated under FTTA.
The subject of any CRADA is "cooperative research." It is unclear what
an NPC would be bringing to a CRADA. The statutory language with regard
to what may be defined as “cooperative research" is broad (for example,
we have held that patient studies are "cooperative research" and
properly the subject of CRADAS). As noted earlier, however, the NPC does
not conduct research of any type. Clearly the FTTA contemplates a joint
undertaking between parties who share a common interest and commitment
to undertake a joint research endeavor.
As possible benefit to NPC involvement to
a CRADA, you noted the NPC's ability to hire personnel not subject to
FTEE restrictions to conduct the research. However, recent amendments to
the FTTA (Pub. L. No. 104-113, March 7, 1996), now provide that the
federal laboratory may hire personnel to conduct research under CRADAs
without agency FTEE restrictions when funded through the CRADA
agreement. 15 USC § 3710A(B)(3)(b).
We question the need for NPC involvement
in any CRADA. The "flexible funding mechanism" that may be necessary for
other types of research agreements is not necessary here because the
FTTA gives authority for VAMCs to accept and administer funds under a
CRADA. Additional potential benefits you noted were NPC administration
of CRADAs and locating potential CRADA partners. While these may be
matters that would be beneficial to the VAMCS, they do not reflect legal
justification for an NPC to be a party to a CRADA. These are services
that an NPC may perform without the necessity of being a party to a
CRADA.
We hope the above is of assistance to
you. If you have any further questions in this regard, Ms. Pacheco is
available to assist you and may be reached at 202-273-636S.
Sincerely yours,
Neal C. Lawson
Assistant General Counsel
|
