M E M O R A N D U M
TO: University Research Community
FROM: George E. Klinzing
Vice Provost for Research
DATE: October 2, 2000
SUBJECT: Principles and Guidelines for Recipients of NIH Research
Grants and Contracts on Obtaining and Disseminating Biomedical
Research Resources
The National Institutes of Health ("NIH") recently issued Principles and
Guidelines for Recipients of NIH Research Grants and Contracts on
Obtaining and Disseminating Biomedical Research Resources (64 FR 72090)
("Principles"). These Principles were issued by NIH to provide guidance
and direction to NIH funding recipient institutions to balance the need to
protect intellectual property rights with the need to broadly disseminate
new discoveries. This memo is to call attention to the issues cited in
the Principles and to ask for your help in ensuring our compliance. A copy
of the complete Principles can be obtained at the NIH web site:
www.nih.gov/od/ott/RTguide_final.htm
The Principles apply to all NIH-funded entities, and it is particularly
important that they be communicated to investigators and persons who
assist with material transfer agreements. The Principles apply
specifically to biomedical research tools, which are broadly defined to
include cell lines, monoclonal antibodies, reagents, animal models,
combinatorial chemistry libraries, clones and cloning tools, databases and
software (under some circumstances).
The Principles were developed in response to complaints from researchers
that restrictive terms in material transfer agreements were impeding the
sharing of research resources. These restrictions came both from industry
sponsors, and less frequently, from research institutions. The NIH urges
recipient institutions to adopt policies and procedures to encourage the
exchange of research tools. This memo summarizes the steps the
University is taking to implement the Principles.
There are four major points that the Principles address.
1. Minimizing administrative impediments to the exchange of
biomedical research tools.
The University has followed the Principles to develop a simple Material
Transfer Agreement letter to be used in the transfer of biomedical
research tools developed at the University to third parties for research
purposes. There are two forms of this letter: one for nonprofit
institutions and another for commercial firms. These forms, copies of
which are attached and are also available on the Office of Research web
site (www.pitt.edu/~offres/proposal/mta_intro.html), should be used by
investigators who wish to transfer biomedical resources to third parties.
In certain cases, a more stringent letter for a Material Transfer
Agreement may be warranted, and the researcher is advised to check with
the Office of Research and the Office of Technology Management if any
questions arise as to the appropriate format.
2. Ensuring academic freedom and timely disclosure of research
findings.
Delays in publication can hinder the advancement and dissemination of
knowledge and as such, can be both costly and detrimental to the
University's mission. It is the responsibility of researchers to publish
their results so that the research community can learn of important
findings that advance the frontiers of knowledge to the benefit of all.
The Principles make clear that Aexcessive publication delays or
requirements for editorial control, approval of publications, or
withholding of data all undermine the credibility of research results and
are unacceptable. When dealing with commercial firms, the University of
Pittsburgh is careful to emphasize that it does not do secret research.
Similarly, in negotiating contracts with these firms, the Office of
Research and the Office of Technology Management are scrupulous in
insisting that research results are free to be published. Short delays in
publication (of no more than 60 days) are permitted to enable the
sponsor's review of material deemed proprietary. Further delay to seek
patent protection may be accommodated, but the total delay period should
not exceed 180 days. Investigators must not accept terms from sponsors
that unduly limit the right publish research results.
3. Ensuring appropriate implementation of the Bayh-Dole Act.
Under the Bayh-Dole Act, the Office of Technology Management ("OTM") is
responsible for reporting to the federal government on inventions that
have been developed by the University with any federal funding support.
The researcher must disclose to OTM the details of the financial support
that was used in developing an invention so that accurate records can be
transmitted to the federal government. Title to such inventions is vested
in the University, and the Bayh-Dole Act places responsibility on the
University to promote the commercialization of the invention. Where the
invention is primarily a research tool, the Principles discourages
patenting and exclusive licensing.
Where a biomedical research tool has been patented, a wide distribution on
a nonexclusive license basis is encouraged. OTM and the Office of General
Counsel will prepare these licenses in compliance with both University and
government policies and procedures. OTM has the institutional
responsibility for negotiation and management of the licenses that result
from the intellectual property of the researcher.
4. Ensuring dissemination of research resources developed with NIH
funds.
Researchers often are funded from multiple sources, including NIH funds
and funds from industrial sponsors. Industrial sponsors may request terms
that conflict with the NIH Principles. The NIH urges recipient
institutions to share the Principles with such sponsors to ensure that
biomedical research tools may be broadly disseminated.
Your cooperation in sharing these new Principles will help the University
in carrying out its research mission. Please be aware that research tools
obtained or derived from human tissues may be subject to further
restriction to ensure compliance with informed consent restrictions. Any
questions concerning such research tools may be addressed to the
Institutional Review Board.
Attachments