NEGOTIATING CLINICAL RESEARCH AGREEMENTS
INTRODUCTORY NOTESFor some years, legal concepts regarding
Clinical Research Agreements (CRAs) have been evolving. As a result,
many clauses and even entire model and template agreements have been
suggested for NPC and Sponsor use in preparing a CRA for a proposed
research study. When a Sponsor agrees to support a research Study but
does not present its own specific format for the CRA, the recommended
clauses and sample or model agreements may be used as a starting point
for CRA negotiations. Use of any recommended clause or format is not
mandatory. Nor is the language contained in them the only appropriate
language.
At this time, a VA Model Agreement is being developed for the purpose
of expediting future negotiations. When it becomes available it will be
one more tool for an NPC to use as a starting point in negotiations.
In most cases, each Sponsor has a standard format that it uses with
research organizations. Since most of the research organizations that a
Sponsor deals with are not VA-affiliated NPCs, parts of those agreement
formats do not take the NPC-VA relationship into account. The sample
clauses approach CRA negotiations from the VA-affiliated NPC’s
perspective and address sixteen clauses that should be considered when
reviewing and negotiating Sponsor-initiated Clinical Research
Agreements. The recommended and alternative clauses can be used to
replace or modify equivalent clauses in the Sponsor’s standard
agreement.
The notes accompanying sample clauses help negotiators identify those
terms in the proposed CRA that need amending to reflect the unique
relationship of the NPC to its affiliated VA Medical Center and to
comply with Federal law. There will be times when a Sponsor and the NPC
cannot reach agreement on one or more of these sixteen clauses. At that
point legal assistance should be sought from a Corporation Panel
attorney, Regional Counsel or a privately retained attorney.
Some explanatory notes quote or paraphrase laws, regulations,
guidelines, VA publications, and IRS rulings. To facilitate reading
these notes, not all of the citations are included in the explanatory
notes. However, a list of the clauses and the respective laws,
regulations, guidelines, VA publications, and IRS rulings that apply are
provided in a linked document. The list is comprehensive but not
exhaustive. Also listed are website addresses that provide the full
texts of all cited materials.
Throughout the explanatory notes, “NPC” and “Institution” both mean a
nonprofit corporation established under 38 U.S.C. §§ 7361 – 7368 and the
term PI is used for Principal Investigator.
All explanatory notes are in italics. Suggested and alternative
clauses as well as suggested letters are in regular type.
