Steps to Developing a Public-Private Partnership with NIH
Have an idea! —Ideas ripe for development as PPPs will represent an aspect of the mission of the NIH or one of its Institutes or Centers (ICs) that will be better accomplished by using a combination of resources from the NIH and others. Resources contributed by partners may include: intellectual capital; skills, and expertise; equipment and technologies; and reagents, samples, funds, and materials.-
Identify potential partners — Partnerships may include other Federal agencies, academic and research institutions, foundations, patient advocacy groups, pharmaceutical or biotechnology industry members, and trade associations. It may be that:
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you already know the individuals or organizations with whom to partner. In this case, you may contact them directly and discuss possible partnerships with them, but remember that NIH policy prohibits its employees from requesting, suggesting or otherwise soliciting funds or other resources to support activities. For further clarification please refer to “Principles of Ethical Conduct for Government Officers and Employees “ Section 101.
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you have not identified potential partners or seek additional partners, whether from among the NIH ICs or outside entities.
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Consider partnership options — Partnerships can be:
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established directly between the NIH (as a whole or through one or more ICs) and one or more outside entities;
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developed via the Foundation for NIH (FNIH). The FNIH is an independent public charitable foundation established by Congress to support the activities of the NIH. The FNIH can be an important ally in building effective partnerships.
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involve one or more other charitable foundations.
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Obtain approval for the PPP from the NIH IC — Since PPPs involve NIH resources and prioritization, IC leadership should be involved in designing PPPs and IC Director approval may be required. Please check the NIH Manual Chapter 1167 for further guidance.
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Develop a Memorandum of Understanding (MOU) — PPPs are memorialized through MOUs. A MOU is an agreement that outlines the terms and details of an agreement between parties, including each party’s expected activities and goals. MOUs should be thoroughly vetted internally within the IC. NIH employees are encouraged to send all draft MOUs to the Office of the General Counsel and to Public-Private Partnerships Program office by email to: pppartnerships@od.nih.gov for suggestions and comments before seeking final approval. Current policy requires that certain MOUs be cleared by the U.S. Department of Health and Human Services through the NIH Director of Financial Management.
Each partnership is based on agreements between or among the partners regarding the aims and goals of the partnership, roles of the partners, and governance. Other issues such as the management of intellectual property, data access and data sharing, and human subjects concerns require careful consideration and planning. The NIH Manual Chapter 1167 provides further guidance regarding when and how to consider PPPs.
NIH PPP program staff can help you to:
- identify potential or additional partners.
- decide whether to establish your partnership directly or to approach the FNIH or another foundation.
- articulate the structure and policies of your PPP.
- define approaches and coordinate consultations with the FNIH, or other foundations, the Office of the General Counsel, the Office of Technology Transfer, and other relevant resources.
