February 15, 2000

 

 

 

TO:                 PRIMARY REPRESENTATIVES OF MEMBER UNIVERSITIES

 

FROM:            Kate Phillips

 

SUBJECT:            NIH Research Tools Policy Requires Utmost Attention

 

In response to public criticism, the National Institutes of Health recently developed a Statement of Principles and Guidelines, which addresses the expectations which NIH funded recipients should meet as they exchange biomedical research materials and tools with other academic institutions and with industry.

 

The enclosed document highlights the key points of the detailed NIH policy statement in brief and succinct form. In addition, we offer suggestions on how universities may deal with the impact of this policy. NIH funded universities are expected to pay careful attention to the Principles and Guidelines and compliance is likely to have noticeable impact on existing university staffing and financial resources. Although NIH chose to issue the policy at this time in form of guidelines, it is clear that serious consequences may result if the NIH expectations are not met.

 

The presentation of the material allows you to use all or parts of the document for different audiences and different purposes, with appropriate deletions or by adding new campus specific sections.  It may be useful for staff training, faculty orientation or in budget discussions regarding resource allocations, or as a reference in negotiations with industry. 

 

Looking beyond the daily management of material transfer agreements, universities face broader issues of proper management of received materials that may raise legal liability and insurance exposure. Given that the volume of MTA management in the COGR membership constitutes at least twice the volume of negotiated licenses, this is clearly a growing problem.  Several schools have explored the setting up of databases to track biomedical resource materials on campus. 

 

Institutions also need to consider carefully how they license patents on research tools and unpatented biomedical materials in order to be sure they are preserving the availability of these tools and materials for use in future academic research. 

 

NIH has stated that it will observe how well the grantee community complies with the promulgated principles and recommended implementing guidance. In the same manner, the COGR Board hopes to hear from the membership whether further guidance on the management of biomedical resource material may be needed.  

 

Enclosure

 

 

Guidance to Campuses on NIH “PRINCIPLES AND GUIDELINES FOR RECIPIENTS OF NIH RESEARCH GRANTS AND CONTRACTS ON OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES:” (Principles and Guidelines)

 

On December 23, 1999, NIH released Principles and Guidelines to provide guidance to recipients of NIH funding with respect to in transferring research materials and tools on December 23, l999 (64 FR 72090). The foundation for the Principles and Guidelines is that scientific advancement depends on broad access to research tools.  NIH expects recipient institutions are advised to develop proactive policies to ensure that this goal is met. 

 

The challenge for institutional officials is to balance these expectations with the on-going needs of scientists.  A balance also must be achieved between broad dissemination and the legitimate need to protect proprietary interests to encourage investment and ensure that discoveries achieve practical use through commercial development. NIH emphasizes that these dual obligations require careful management. It is possible that implementation of Principles and Guidelines will necessitate additional negotiation of agreements in offices already burdened by such activities.  Further, these guidelines imply a high level of diligence on the part of institutional officials both to educate and advise faculty and manage the process of disseminating and importing research tools. 

 

To assist recipient institutions, COGR has prepared  as summary of the Principles and Guidelines along with more in-depth guidance for technology transfer offices and sponsored programs offices.this document which presents the key points of the detailed NIH policy statement in succinct form. The document also offers suggestions as to what resources schools might consider for meeting the NIH policy expectations.

 

 

 

WHAT IS THE PURPOSE OF THE PRINCIPLES AND GUIDELINES?

 

·        To ensure access to unique research tools;

 

·        To help institutions ensure that terms and conditions facilitate further biomedical research; and

 

·        To ensure consistency between the requirements of the Bayh-Dole Act and NIH funding agreements.

 

What universities should consider:

·        The Principles and Guidelines are not regulations enforceable by law.  They represent an effort on the part of NIH to provide its funding recipients with guidance to assist them in achieving the appropriate balance between ensuring broad dissemination of research tools and protecting legitimate proprietary interests and incentives for commercial development. However, where grantees fail to demonstrate progress in implementing the Principles and Guidelines, NIH may, on a case-by-case basis, enforce its expectations in the form of specific grant requirements. 

 

·        Universities should exercise judgment in implementing the Principles and Guidelines in specific circumstances.

 

·        Universities should make greater use of the Uniform Biological Materials Transfer Agreement and consider adopting the new NIH Simple Letter Agreement (copy attached).

WHO IS AFFECTED BY THE PRINCIPLES AND GUIDELINES?

 

·        At institutions that receive NIH funding -

·        Investigators (principal investigators, faculty, postdoctoral fellows and all other research staff)Technology transfer officials;

·        All administrative offices that assist with material transfer agreements (technology transfer and sponsored research officials)Sponsored research staff; and

·        Technology transfer officials as they make patenting decisions and as they license research tools and materials.Investigators

What universities should consider:

·        Meeting the expectations set forth in the Principles and Guidelines will have broad impact on campus, on faculty, laboratory staff and administrative personnel;

 

·        How they will Developing campus expertise and policies to manage agreements and provideing information and training to affected parties;

 

·        Who they should Ddesignateing  as responsible offices; and

 

·        How to Ccommunicateing expectations to campus constituents so that parties anticipate to greater compliance which may result in longer turnaround on documents. 

HOW DOES NIH DEFINE RESEARCH TOOLS?

·        Cell lines

·        Monoclonal antibodies

·        Reagents

·        Animal models

·        Combinatorial chemistry libraries

·        Clones and cloning tools such as PCR

·        Databases and computer software to the extent these are used as unique research tools

What universities should consider:

·        NIH recognized that databases and software present unique questions that could not be fully explored in the Principles and Guidelines.  Therefore, this guidance may or may not be provide final answers useful in specific cases. 

 

WHAT DO THE PRINCIPLES AND GUIDELINES SAY? TELL NIH FUNDED INSTITUTIONS?

·        To Eensure academic freedom and timely disclosure of research findings –

 

Ř      NIH recipients should avoid signing agreements that unduly limit the freedom of investigators to collaborate and publish.

 

Ř      Authorship on publications arising from NIH sponsored research should be appropriate and not be dictated by the terms of an agreement.

 

Ř      Certain restrictions to protect the confidentiality of sponsor information and brief delays in publication to permit patents to be filed may be acceptable.

 

·        To eEnsure Aappropriate Iimplementation of the Bayh-Dole Act –

 

Ř      NIH funded research is subject to the Bayh-Dole Act and various other laws and regulations that require recipients to maximize the use of their research findings either through dissemination to the research community and the public or through timely commercialization.

 

Ř      Research tools may not require benefit from patenting unless further research or investment is necessary to foster their usefulness.  Restrictive licensing could hinder their utilization and public availability.

 

Ř      In the absence of a commercial application for a research tool, Bayh-Dole requirements can be met through widespread, non-exclusive licensing or deposit in a repository such as the American Type Cell Culture. 

 

Ř      When a research tool also has a non-research commercial application, an exclusive license might be limited to a commercial field of use with the right to distribute as a research tool reserved by the licensor.

 

Ř      Proprietary rights should not be used in such a way that would either overstate the value of the tool or discourage dissemination and use.

 

·        To Mminimize Aadministrative Iimpediments to Aacademic Researchresearch –

 

Ř      Recipients are encouraged to use the new Simple Letter Agreement (which is no longer limited to biological materials) to streamline exchanges between non-profits.

Ř      NIH recommends its recipients transfer research tools with as few encumbrances as possible when the use will be internal.

 

·        To dDevelop and implement clear policies articulating acceptable conditions for importing resources –

 

Ř      Institutions should not agree to unacceptable unreasonable terms proposed by providing organizations. 

 

Ř      Recipients should be sensitive to legitimate industry concerns that provision of certain materials could result in the loss of control over a proprietary tool and thus aid competitors.

 

·        To Eensure Ddissemination of Rresearch Rresources Ddeveloped with NIH Ffunds –

 

Ř      Unique research resources must be broadly and promptly available to the scientific research community in order to advance science.

 

Ř      Wide distribution on a nonexclusive basis should be encouraged.

 

Ř      NIH endorses distinguishing internal use by for–profit companies from commercial development and sale and/or the provision of services for a fee.

 

Ř      Exclusive licenses to distributors who will make the research tool widely available on reasonable terms are also acceptable. 

 

Ř      Institutions should carefully manage interactions (such as industry-sponsored research agreements and exclusive licenses) that have the potential to restrict sharing. 

 

Ř      Where collaborations involve NIH and other funding, the NIH recipient is expected to share the Principles and Guidelines with its partner and ensure that agreements are consistent with the Principles and Guidelines and the Bayh-Dole Act.

Actions universities might consider doing:How might institutions respond to these  guidelines?

·        Develop and implement clear campus policies consistent with the NIH guidelines;

 

·        Summarize and distribute the Principles and Guideline to faculty, deans, chairs, and others;

 

·        Create a database tracking system and consider linking it to the database for sponsored research agreements;

 

·        Coordinate Integrate the training and education efforts of the sponsored programs office and the technology licensing office to identify and understand the implications of material transfer agreements, to assure understanding and compliance; and

·        Recognize the need to devote resources to managing material transfer agreements.

 

WHAT RESOURCES ARE AVAILABLE TO HELP RECIPIENT INSTITUTIONS?

·        The Principles and Guidelines, released December 23, l999 (www.nih.gov/od/ott/RTguide_final.htm) states NIH expectations regarding reasonable terms and conditions for exporting research tools and outlines acceptable terms and conditions for importing research tools. 

 

·        The AUTM brochure on Material Transfer Agreements is an excellent educational piece on MTAs and offers a sample questionnaire to aid in evaluating transfers. (www.autm.net)

 

·        The COGR brochure entitled Materials Transfer in Academia provides a timely explanation of the implications of material transfer agreement terms and conditions and offers suggestions for minimizing their possible negative impact on future research.  (www.cogr.edu)

 

·        Developing Sponsored Research Agreements: Considerations for Recipients of NIH Research Grants and Contracts (November 18, l994) provides guidelines for sponsored agreements with commercial entities where such research may be partially funded by NIH. (http://grants.nih.gov/grants/guide/l994/index.html)