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NAVREF Response to the April One
OGC Advisory
April 6, 2005
The National Association of Veterans’ Research and Education Foundations
(NAVREF) is very concerned that OGC is unaware of the full implications
of the April 1 OGC advisory regarding “Intellectual Property and
Non-Profit Research Corps.” Our concerns and recommendations are
detailed below.
NAVREF requests immediate withdrawal of the April 1 OGC advisory
regarding “Intellectual Property and Non-Profit Research Corps” pending
development of reasonable accommodations in clinical research agreements
(CRAs) and implementation of viable alternatives to CRAs. Our reasons
for this request are as follows:
1. The advisory leaves NPCs with no means to negotiate research
agreements with sponsors for the foreseeable future. If unable to
initiate new industry sponsored studies for even just a short time, NPCs
will have to sharply curtail or even eliminate entirely the broad
support they provide for facility research programs and VA principal
investigators. Additionally, veterans will lose access to
state-of-the-art treatments offered to participants in NPC-administered
clinical studies and the additional care provided to study
participants. This is particularly tragic for veterans with conditions
for which there is only an experimental treatment.
Absent the requested withdrawal of the advisory, NPCs will soon have to
1) begin terminating research personnel, including clinicians hired to
support research programs, compliance officers, animal facility workers,
research administrative staff, and research pharmacists, etc.; 2)
terminate or go into default on contractual commitments for equipment
such as laboratory and office machines, research support services and
facility renovations, etc.; and 3) stop paying for travel, education and
supplies as well as a myriad of other support they provide for VA
investigators and staff. One NPC currently underwrites the entire cost
of the facility IRB out of clinical study income and another is poised
to start building a new research facility under a revocable license.
Both are in very real jeopardy as a result of the advisory as is
significant NPC support for mandatory compliance activities.
2. “Conditional gift agreements” are outdated and are not an
acceptable alternative to clinical research agreements. The June 1
advisory recommendation to use "conditional gift agreements" appears to
be a reference to the obsolete 1994 version of the NPC manual chapter
which contained a sample "gift agreement." However, that mechanism was
quickly found to be inadequate for NPC use and unacceptable to
sponsors. In any case, the sample referenced the need for a separate
agreement which was the clinical research agreements already commonly in
use at that time. The gift agreement concept was eliminated when the
handbook was updated by OGC in 2001 and it is not specified in the
current handbook.
3. At this time, CRADAs are not a viable replacement for clinical
research agreements. As pointed out in the advisory itself, CRADAs
cannot be accommodated under the CTAA arrangement in place at most VA
facilities. During the very recent March 29, 2005, VA NPC Oversight
Board meeting involving the General Counsel and the Acting Under
Secretary for Health, it was noted that VA has not yet initiated a
process or communications necessary to begin amending the CTAAs and that
university cooperation may not be universal. As a result, it will
undoubtedly be many months before CRADAs are even a possibility.
Further, the office responsible for reviewing CRADAs apparently was not
a part of the decision making process involved in the advisory and
appears to be unprepared to respond to the projected volume resulting
from the advice to pursue them - NPCs currently initiate administration
of an estimated 150 clinical studies per month - and the complexity of
the submissions. We understand that few VA attorneys and VA research
offices have experience with CRADAs and of course, nor do NPC
personnel. Moreover, VA’s model CRADA is not conducive to industry
sponsored Phase III studies.
4. We are dismayed that OGC takes the position that NPC clinical
research agreements appear to bind VA, much less that they do so
inappropriately. Dr. Perlin’s June 24, 2004, memo to NPC executive
directors even encourages NPCs to use the sample clauses offered on the
NAVREF web site. Over the past 15 years, OGC has been offered numerous
opportunities to review and provide input on sample clinical research
agreement clauses developed in cooperation with VA attorneys. The most
recent formal opportunity was in 2003, prior to a two-day workshop on
appropriate negotiation of terms that was conducted primarily by VA
attorneys. Additionally, the samples are updated whenever needed to
reflect changes in the clinical research regulatory environment and VA
policies.
NPC clinical research agreements largely reiterate positions supported
by VA itself. That is, CRA clauses are largely informational to ensure
that sponsors understand VA positions and to prevent misperceptions on
the part of sponsors.
Also, CRAs are consistent with commitments that are components of the
normal R&D Committee review and approval process, including service
chief approval of commitments of VA personnel time and resources. By
statute, all NPC-administered studies must have R&D Committee approval.
If the R&D Committee does not approve the study and commitment of VA
resources, the NPC cannot execute the agreement and the study will not
be conducted at that VAMC.
VA is responsible for the conduct of the research, and VA policies - not
CRA assurances - govern study protocols, informed consent, publication
rights, VA disclosures to third parties, privacy and confidentiality.
CRA assurances regarding these matters, if any, are intended to be
consistent with VA policies and desires. Further, VA is not bound by
terms or assurances in CRAs. Neither VA nor PIs are parties to these
agreements. Should there be a failure to abide by the agreement terms,
the sponsor will look to the NPC, not VA, for corrective action.
If OGC had brought its concerns to NAVREF and its own OGC Corporations
Panel, we are confident that revisions in sample clauses could have been
made to address OGC’s concerns and still retain CRAs as an appropriate
means to establish relationships with study sponsors. NAVREF has been
entirely open about the recommendations it makes to its members and
engages VA personnel in their development whenever possible. It is
disturbing that OGC did not previously voice its concerns to NAVREF or
as we understand, even to the VA attorneys specifically tasked to
provide expert advice and assistance. Nor does OGC appear to have made
an effort to engage stakeholders or panel members, those with an
understanding of these complex relationships and the value such studies
bring to veterans and VA research, in developing reasonable
accommodations pending amendment of the CTAAs and implementation of
workable CRADA processes.
In conclusion, we feel release of the advisory was premature in the absence
of appropriate and timely alternatives to CRAs and that the advisory is
seriously detrimental to the VA research program. Again, we strongly
recommend an immediate retraction of the advisory and reinstatement of
VA attorney assistance in negotiating appropriate CRA terms. NAVREF is
more than willing to cooperate in development of revised sample clauses
toward this end.
Thank you for considering our views. Additionally, NAVREF board members
and I are available to discuss these matters at any time.
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