Notice Number: NOT-NS-15-032
Key Dates
Release Date: July 9, 2015
Response Date: August 7, 2015
None
Issued by
National Institute of Neurological Disorders and Stroke (NINDS)
National Eye Institute (NEI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Center for Complementary and Integrative Health (NCCIH)
Purpose
Background
The BRAIN InitiativeSM
The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) InitiativeSM is a multi-agency federal effort aimed at revolutionizing understanding of the human brain. NIH is guided in its contributions to this effort by scientific and strategic recommendations laid out in the landmark report, "BRAIN 2025: A Scientific Vision," and by input from the NIH BRAIN Multi-Council Working Group (MCWG, Roster). Information about meetings of the MCWG are available at http://www.braininitiative.nih.gov/index.htm.
A central focus of the BRAIN Initiative is development of technologies for recording and modulating neural circuits. To bring these technologies to bear on human brain disorders, the BRAIN 2025 report recommended a new "streamlined path for developing, implementing and integrating new technologies for human neuroscience research, through cooperation of clinical and academic research teams and private companies in a pre-competitive space." Towards this end, NIH has initiated efforts to facilitate public-private partnerships with manufacturers of devices for stimulating and/or recording neural activity in humans, to make these devices available for NIH-funded research studies.
NIH BRAIN Public-Private Partnership Program
NIH intends to release a Funding Opportunity Announcement (FOA) for Fiscal Year 2016 to fund research partnerships between clinical investigators and manufacturers of latest-generation stimulating and/or recording devices that are FDA-designated as Class III (invasive, posing significant risk of harm), to conduct clinical research in the CNS. The goal is to spur human research to mitigate the cost and effort required to translate pre-clinical research with these devices into therapeutic outcomes.
The types of research NIH plans to support are IRB-approved Non Significant-Risk (NSR) clinical research studies, new Significant Risk (SR) clinical studies requiring amendments to existing Investigational Devices Exemptions (IDEs) from the FDA, or SR clinical studies in which a new IDE would require no or minimal additional non-clinical testing. Envisioned studies include exploratory research to obtain proof of concept for new therapeutic indications, identification of neural signals relevant for closed loop control of device therapies, and research into fundamental human neuroscience questions. For the RFA in Fiscal Year 2016, NIH is specifically interested in devices with existing pre-clinical safety and technical data that can be readily leveraged to enable new NSR or IDE clinical research studies without the need for significant additional pre-clinical testing.
In preparation for this FOA, NIH released a previous Request for Information on the overall goals of the planned effort (NOT-NS-14-054), and held a Workshop featuring representatives from industry, clinical researchers, government regulatory and funding agencies, and academic technology-transfer and contracting offices. The agenda and a summary of this workshop, plus links to the videocast workshop proceedings, are available on the NIH BRAIN website (http://braininitiative.nih.gov/meetings/June-2015-PPP.htm).
Template Agreements for Research Partnerships
To facilitate research partnerships between academic institutions and commercial device manufacturers, NIH drafted the following template documents, which were the focus of specific discussions at the aforementioned workshop.
1. Template Memorandum of Understanding for agreements between NIH and specific device manufacturers. The purpose of this document is to describe the nature of the Public-Private Partnership program and the signatory company's agreement to participate in the program. The document goes over the process under which Collaborative Research Agreements will be reached with academic researchers wishing to use the company's device(s) prior to their submission of NIH grant applications.
Each company signing this agreement with NIH is expected to provide a description of the materials (devices, software, surgical tools, etc.) and support the company is willing to make available for this purpose, which will be included as exhibits to the agreement and will be posted publicly to serve as a guide for investigators wishing to pursue agreements with manufacturers for specific research projects. Some companies have already made provisional draft descriptions available, and links to these drafts are included on the webpage linked below. Note these draft descriptions are tentative and subject to revision, and have only been provided for the purpose of giving context for responses to this RFI.
2. Template Collaborative Research Agreement, to be used as a starting point for negotiating agreements between device manufacturers and academic research institutions for clinical research studies. The goal of this document is to provide standardized terms covering essential components of such agreements (e.g., intellectual property, data and publications, reporting requirements, etc.) using language that has been deemed acceptable by many of the commercial and academic parties who expect to negotiate these agreements.
3. Template Confidential Disclosure Agreement, to be signed by academic researchers to discuss specific details with companies regarding device capabilities for their research.
Draft versions of each of these template documents are available for review at http://braininitiative.nih.gov/draft_template_agreements.htm.
NIH Goals for the Template Agreement Documents
In drafting these template documents and seeking feedback from major stakeholders in their formulation, NIH hopes to accomplish the following:
- Reduce barriers and time required for successful negotiation of research partnerships between academic research institutions and corporate manufacturers. We anticipate that the template Collaborative Research Agreement will speed negotiations by providing common language and terms that serve as an acceptable baseline for multiple parties. NIH recognizes that different devices and projects will need specific terms determined on a case-by-case basis, and these templates are not intended as endorsement of specific terms for any particular project. The goal is for the terms in the template to be useable "as is" in some cases, while expediting the process to arrive at final terms in other cases by providing a community-vetted and transparent starting point for negotiations.
- Provide transparent access to latest-generation devices and their associated capabilities for new clinical studies. Such devices may be available for exploratory research use under controlled conditions to ensure safety, but are not market approved for therapeutic indications and therefore might not otherwise be known to the research community. In addition, devices available for market often have expanded capabilities that can be "unlocked" for use in controlled research settings, subject to appropriate regulatory approval.
- Leverage manufacturers’ existing data demonstrating safety and utility of these devices, which are very costly to obtain, for the purpose of regulatory approval for new clinical studies.
We expect this framework will allow academic researchers to test innovative ideas for new therapies, or to address scientific unknowns regarding mechanisms of disease or consequences of device action, which will advance the goals of the BRAIN Initiative in understanding human brain circuits and progressing towards therapies for brain disorders. In addition, we expect the resulting research to have benefits for device manufacturers insofar as it serves to facilitate the creation of solid business cases for larger clinical trials required to take specific therapies to market.
Information Requested
This time-sensitive RFI, issued by the Institutes and Centers of the NIH BRAIN Initiative listed above, is for feedback on the general goals and the specific terms of the template documents described above, which will serve as a basis for collaborative partnerships for the intended RFA in Fiscal Year 2016.
NIH invites input from stakeholders including but not limited to researchers in academia and industry, healthcare professionals, patient advocates and advocacy organizations, scientific and professional organizations, federal agencies and other interested members of the public. Small businesses with appropriate technologies are especially encouraged to provide input.
Your feedback can include but is not limited to perspectives on the following topics:
- Intellectual property
- Confidentiality
- Data ownership, sharing, access, and privacy considerations
- Publications and other presentations arising from data generated under the collaboration
- Liability
- Reporting requirements necessary for patient protection and regulatory oversight
- Potential future opportunities capitalizing on this Pilot Public-Private Partnership Program
How to Submit a Response
To ensure consideration, responses must be received by August 7, 2015 and must be submitted electronically using the web-based format at http://braininitiative.nih.gov/rfi2-brain-initiative.htm. The web format will provide confirmation of response submission, but respondents will not receive individualized feedback.
Responses to this RFI are voluntary and may be submitted anonymously. Please do not include any personally identifiable or other information that you do not wish to make public. Proprietary, classified, confidential or sensitive information should not be included in your response. Comments may be compiled for discussion and may appear in related reports. Any personal identifiers (names, e-mail addresses, etc.) will be removed when responses are compiled.
This RFI is for informational and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the United States (US) Government, the NIH or the NINDS to provide support for any ideas submitted in response to it. Please note that the US Government, NIH and NINDS will not pay for the preparation of any information submitted, or for its use of that information.
Inquiries
Kip Ludwig, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1447
Email: [email protected]
and Human Services (HHS)
