The NICHD welcomes the opportunity to enhance its mission-relevant activities through the thoughtful use of collaborative relationships, including those described below. The Institute is committed to establishing and maintaining such partnerships in accordance with all relevant NIH and DHHS policies and to assuring maximum benefit for all parties involved.
Public-Private Partnerships (PPP)
What is a PPP?
PPPs involve the NIH in collaboration with any of a wide range of other organizations, including (but not limited to) 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 the shared goals and mandates of the partners, 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 (but not limited to):
- 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 the NICHD and the potential private 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 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 the NICHD, please contact the relevant program officer or the NICHD PPP Coordinator: Lisa Kaeser, J.D.
Cooperative Research and Development Agreements (CRADAs) and Material Transfer Agreements (MTAs)
CRADAs and MTAs are collaborations with NIH intramural laboratory(ies) or scientist(s). A relationship solely comprising a CRADA, MTA, or a gift is not considered a PPP.
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-care pharmaceuticals and 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?
Because advances in biomedical and behavioral research depend on a continuum of research efforts, from those designed to discover new knowledge or expand existing knowledge, to those designed to develop new procedures and products, there is not always a clear distinction or a concise definition of which activities are appropriate for a CRADA. However, some characteristics of a CRADA include the following:
- All CRADAs must be consonant with the primary biomedical research mission of the Public Health Service (PHS) and the specific laboratory involved, 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 undertaken 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 in an NIH laboratory. Sponsored research, such as routine, conventional testing, with no collaborative, intellectual contribution, is not appropriate for a CRADA.
- Under the PHS CRADA, the NIH laboratory may provide personnel, services, facilities, equipment, or other resources, with or without reimbursement, but 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 utilized 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. The NIH also requires that that all materials received by their scientists originating from humans, be collected under 45 CFR 46, Protection of Human Subjects.
How can I get more information about CRADAs and MTAs?
For information on establishing a CRADA or MTA with the NICHD, please contact the NICHD Technology Transfer Coordinator:
National Cancer Institute
Technology Transfer Center
Competitive Service Center for NICHD
6120 Executive Boulevard
Suite 450, MSC 7182
Bethesda, MD 20892-7182