NICHD welcomes the opportunity to enhance its mission-relevant activities through the thoughtful use of collaborative relationships. The institute is committed to establishing and maintaining such partnerships in accordance with all relevant NIH and HHS policies and to assuring maximum benefit for all parties involved.
What is a PPP?
PPPs involve NIH in collaboration with any of a wide range of other organizations, including patient advocacy groups, foundations, pharmaceutical or biotechnology companies, and academic institutions. Partnerships may take many forms and range widely in size and scope. Partnership activities center on shared goals and mandates, leveraging knowledge, skills, resources, and services to achieve synergy.
All NIH partnerships are science driven, aim to improve the public health, and are structured to uphold the principles of transparency, fairness, inclusiveness, scientific rigor, and compliance with federal laws and NIH policy.
What activities may a PPP support?
A PPP may be used to carry out many different activities including:
- Support of extramural research
- Public health campaigns and outreach activities
- Conferences and workshops
How is a PPP established?
The first step in the establishment of any PPP is typically a series of discussions between NICHD and the potential partner to explore common interests, goals, and areas of mutually beneficial collaboration. Important aspects of these discussions include resources, responsibilities, and potential pitfalls, such as conflicts of interest. When an agreement to form a partnership is reached, it is often documented in the form of a memorandum of understanding or letter of agreement that outlines the goals of the partnership, as well as responsibilities, commitment of resources, evaluation plans, and other factors.
If you are interested in exploring the possibility of establishing a PPP with NICHD, contact the NICHD PPP Coordinator: Lisa Kaeser, J.D.
CRADAs and MTAs are technology transfer collaborations with NIH intramural laboratories or extramural research branches. A relationship solely comprising a CRADA, MTA, or a gift is not considered a PPP. NICHD negotiates these agreements with assistance from the NICHD Technology Transfer Center.
What is a CRADA?
A CRADA makes government facilities, intellectual property, and expertise available for collaborations designed to further the development of scientific and technological knowledge into useful, marketable products. CRADAs provide an exciting opportunity for NIH investigators to work with their colleagues from industry and academia in the joint pursuit of common research goals. Government scientists can leverage their own research resources, as well as serve the larger mission of the NIH, to facilitate the development and commercialization of health-related products. Companies also can leverage their own research and development efforts while collaborating in state-of-the-art NIH research.
What activities may a CRADA support?
Some characteristics of a CRADA include the following:
- All CRADAs must be consonant with the primary biomedical research mission of the U.S. Public Health Service (PHS), ensuring that no aspect of those missions are compromised.
- All CRADA research projects must be highly focused and delineated, and each proposed CRADA must be carefully assessed for its overall research objectives.
- CRADAs are authorized only with collaborators that will make significant intellectual contributions to the research project or that will contribute essential research materials or technical resources not otherwise reasonably available to the NIH.
- CRADAs cannot attempt to direct or restrict research. Sponsored research, such as routine, conventional testing, with no collaborative, intellectual contribution, is not appropriate for a CRADA.
- Under the PHS CRADA, NIH may provide personnel, services, facilities, equipment, or other resources, with or without reimbursement, but it may not provide funds to non-federal parties. The partner may provide funds, personnel, services, facilities, equipment, or other material and/or technical resources.
- The CRADA provides the non-federal party the option to negotiate an exclusive license to the resultant CRADA Subject Invention(s). The CRADA is the primary legal mechanism the federal government uses to convey such rights in advance of an invention.
What is an MTA?
An MTA is generally used when any proprietary material is exchanged, when the receiving party intends to use such material for his/her own research purposes, and when no research collaboration between scientists is planned. However, unlike a CRADA, neither a licensing option nor rights for commercial purposes may be granted under this type of agreement.
MTAs define the terms and conditions under which the recipients of materials, provided by either the NIH scientist or the other party, may use the materials. Included in the MTA are provisions addressing confidentiality, data access and dissemination, publication, and the requirement that the material be used only for research purposes. NIH also requires that that all materials received by their scientists originating from humans, be collected in compliance with 45 CFR 46, Protection of Human Subjects.
How can I get more information about CRADAs and MTAs?
Contact the NICHD Technology Transfer Coordinator:
Charlotte McGuinness
National Cancer Institute
Technology Transfer Center
Competitive Service Center for NICHD
6120 Executive Boulevard
Suite 450, MSC 7182
Bethesda, MD 20892-7182
(301) 435-3130
mcguinnc@mail.nih.gov
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