Recent advances in endovascular thrombectomy offer a new opportunity to reconsider neuroprotective agents as adjunctive therapies to extend the time window for reperfusion and to improve long-term functional outcome. The purpose of this funding opportunity announcement (FOA) issued by NINDS is to invite applications for the Coordinating Center (CC) for the NIH Stroke Preclinical Assessment Network (SPAN). SPAN will facilitate testing of up to 6 promising neuroprotective drugs or interventions to be given prior to or at the time of reperfusion in experimental models of ischemic stroke (e.g., transient middle cerebral artery occlusion). The CC will work with the awarded network sites (RFA-NS-18-033) and will provide centralized administrative oversight and coordination of all aspects of the network. If successful, this network will accelerate the identification of the most promising neuroprotective therapies for future pivotal clinical trials and span the gap between preclinical and clinical testing, in a cost-and time-effective fashion.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
The purpose of this funding opportunity announcement (FOA) is to solicit applications for the Coordinating Center (CC) for the Stroke Preclinical Assessment Network (SPAN). SPAN will support late-stage preclinical studies of putative neuroprotectants to be given prior to or at the time of reperfusion, with clinically relevant long-term outcomes and comorbidities. Parallel testing of the most promising interventions will help to determine if an intervention can improve outcome as compared to reperfusion alone and/or extend the therapeutic window for reperfusion, and if so, guide the selection of the best agent(s) to transition to future Phase II clinical trials (to be conducted through StrokeNet). SPAN will consist of one CC and up to 6 network sites; this infrastructure is expected to test up to 6 compounds/interventions in animal models of transient cerebral ischemia. The SPAN program will not support any human subjects research.
Until 2015, intravenous recombinant tissue-type plasminogen activator (rt-PA) was the only FDA-approved therapy for acute ischemic stroke. Despite its overall efficacy and safety, rt-PA presents some limitations, such as increased risk of hemorrhagic transformation, a narrow time window of few hours from stroke onset, and a low success rate in lysing large clots. Over the past few years, acute endovascular therapy (EVT) with stent-retriever devices and access to advanced imaging modalities have transformed the standard of care, offering the opportunity to improve outcome significantly in selected patients that have salvageable tissue treated as late as 16-24 hours after their stroke. Despite the success of EVT in clinical trials, many patients still experience neurological deficits following therapy; thus, there is a need to develop adjunctive approaches to improve long-term outcomes. These recent advances offer a new and timely opportunity to further evaluate the potential benefit of neuroprotective agents in the context of mechanical revascularization.
The 2012 NINDS Stroke Research Priorities Meeting identified several priorities that are relevant to the proposed initiative:
Furthermore, this initiative builds on the recent NINDS-sponsored workshop "Translational Stroke Research: Vision and Opportunities", which recommended that preclinical multi-laboratory trials of a putative treatment may be valuable before investing in a clinical trial.
The overall goal of this program is to create a virtual preclinical stroke network to support late stage preclinical studies of potential neuroprotective strategies to be given prior to or during reperfusion. SPAN will test in parallel up to 6 compounds/interventions in animal models of transient cerebral ischemia following the same rigor and methodology characteristic of clinical trials. The parallel testing of multiple interventions, including an adaptive design approach that will eliminate compounds that do not demonstrate sufficient promise, will allow the identification of the most promising candidates to advance to clinical testing. Only drugs/ interventions that are supported by robust and rigorous preliminary data, have been shown to be safe in humans, and are likely to be ready for clinical testing by the end of the award will be eligible to be tested through the SPAN network.
The SPAN CC will contribute to these objectives by providing scientific and organizational leadership for implementation of preclinical protocols to be conducted within the network sites. The CC will promote high quality and efficiency in study execution and provide a central resource for protocol development, drug acquisition, formulation and distribution, study administration, data management, and statistical analysis. The CC additionally organizes the SPAN governance committees and oversees quality assurance for network performance. The CC is encouraged to be innovative in improving research efficiency and quality.
The Coordinating Center (CC) will provide scientific and organizational leadership to SPAN to achieve both efficiency and excellence in the implementation and performance of the neuroprotection protocols. The CC will work collaboratively with the network sites and NINDS to provide overall study coordination, including oversight of study protocols, monitoring of the individual sites, data management, data sharing, and reporting. Additionally, the CC will be responsible for acquisition, formulation, and distribution of active and control compounds. Candidate compounds/interventions for the network will be proposed through the companion FOA RFA-18-033 and selected following peer review.
Each Network site will propose one promising neuroprotectant to be tested in SPAN and will test, in a controlled, randomized, and blinded fashion, up to 6 interventions in parallel, including their own. The roles and responsibilities of the network sites are described more fully in the companion FOA, RFA-NS-18-033.
Expectations of the SPAN Coordinating Center
The CC provides scientific and organizational leadership to facilitate the conduct of preclinical studies within SPAN. The CC is the administrative center of the network, with responsibility for maintaining the network’s infrastructure relevant to best practices consistent with those routinely used in clinical trials. Expertise in preclinical models of transient cerebral ischemia is not a requirement for the CC. However, the CC is required to have strong expertise in data management; statistical analysis, including adaptive trial design; drug formulation; complex project coordination; randomization; and blinding. Expertise in stroke research is desirable, but not required. In addition, the CC leads and manages the key SPAN governance committees: SPAN Steering Committee and the External Advisory Board (described below). Specific activities could be performed through subcontracts, but the activities and the facilities need to be clearly described in the application.
Examples of responsibilities of the CC include the following:
The CC is expected to coordinate with the network sites to ensure that testing of the selected drugs/ intervention will start no later than 1 year after the award and will be completed in the remaining 2 years of the award.
SPAN Network Committees
1. The governing body of the network will be a Steering Committee, appointed by the CC in conjunction with NINDS, that will consist of the PD/PI of the CC, the PD/PI of each of the network’s testing sites, NINDS Program staff and 3 representatives from the NIH Stroke Clinical Trials Network (StrokeNet) Steering Committee (to facilitate a potential transition to clinical trials to be conducted in the future, if the intervention is successful in SPAN). The NINDS Director has the right to supersede any decision by the network at any time.
2. An independent External Advisory Board, appointed by and reporting to NINDS, will comprise basic and clinician scientists with expertise in neuroprotection, representatives from pharmaceutical and biotech industry, and experts in regulatory affairs, statistics, and clinical trial design.
The CC will be responsible for managing the logistics of committee activities, such as scheduling, soliciting agenda items, finalizing and distributing agendas, arranging and leading monthly teleconferences, preparing minutes, and making logistic and financial arrangements for annual in person SPAN meetings, including meeting space, accommodation, travel, per diem reimbursement, etc.
National Institute of Neurological Disorders and Stroke
The NINDS will be responsible for organizing and providing overall support for the SPAN network. NINDS Program and Grants Management staff will be responsible for the overall management of the SPAN network. In addition to regular grant stewardship, an NINDS Project Scientist will be involved substantially with the awardees as an NINDS partner, consistent with the Cooperative Agreement mechanism.
Applicants are strongly encouraged to consult with NINDS Scientific/Program Staff early during the planning phase of their application (See Agency Contacts, Section VII).
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
NINDS intends to commit $500,000 in direct costs per year to fund one award for up to three years.
Application budgets may not exceed $500,000 in direct costs per year but need to reflect the actual needs of the proposed project.
The maximum project period is 3 years.
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
The PD/PI(s) should have documented experience and technical resources to manage a multi-site geographically dispersed consortium or network, in statistical analysis and adaptive trial design, drug formulation, data monitoring, data sharing, randomization, blinding and other rigorous procedures that are routinely used in clinical trials and that will be adopted in the SPAN preclinical network.
The PD/PI should be willing to commit a minimum of 3 personmonths effort, have documented expertise in leading multiple complex projects in parallel. It is critical to the success of the SPAN Network that the CC interacts effectively with the network project sites/PIs and with the NINDS. Therefore, in addition to the required strong leadership and staff with highly specialized expertise, the project site must include a dedicated staff member as key personnel who will be the point of contact, is highly motivated, has excellent communication skills, has significant training and experience with information technology and biological data management.
The qualifications and experience of key personnel must be described, specifically documenting their respective abilities to organize and manage a CC.
Specific Aims: State the specific aims to outline a clear strategy for implementing the goals of this FOA.
Research Strategy: Organize the Research Strategy by Significance, Innovation, and Approach. A milestone plan, under separate heading, must be included in the approach.
Significance: The Significance section should describe how the proposed CC infrastructure and organization will address primary goal of rapid identification of neuroprotective interventions as adjunctive therapies to recanalization. This section should provide justification and rationale indicating that the proposed team and plan can fulfill the role of the CC as the network’s information, data, and administrative hub, and will work closely, collaboratively and effectively with the individual projects’ PIs and their teams, the NINDS/NIH Program staff and the Steering Committee and External Advisory Board.
Innovation: Describe the leading and innovative tools and approaches that the proposed CC offers to the network in terms of data management, communication strategies, information technology, approaches to organization of meetings and conference calls, drug development and distribution, and other activities under the purview of the CC.
Approach: The approach should address administrative commitment, resources and ability to carry out the duties of the CC. The application must describe the current and/or planned organizational structure under which it proposes to operate. If the CC has more than one component/affiliate institution, describe the relationship of component(s)/affiliate(s) to each other and to the CC. Include the distance between these institutions (including administrative offices and shared resources) and location of proposed personnel.
Relevant Accomplishments: describe the group’s accomplishments relative to implementing procedures routinely used in clinical trials, such as randomization, blinding, monitoring of the sites, that would be applicable to the SPAN network. Describe relevant experience in drug procurement and formulation.
Describe the overall management plan, organizational hierarchy of the CC, its administrative structure, the communication plan, and the conflict resolution plan. Describe how the CC will organize, coordinate and administratively drive network-specific activities including: establishing the Steering Committee (the External Advisory Board will be established by the NINDS); organizing the logistical components of all committee activities including, for example, scheduling, soliciting agenda items, finalizing and distributing agendas, arranging calls including conference calls, minutes (drafting, editing based on input, and finalizing); all logistic and financial requirements for in person network meetings including meeting space, accommodation, travel, per diem reimbursement, etc.; required sharing activities. The application should describe how the CC will work with multiple and de-centralized investigators and schedule large (dozens of participants) interactive conference calls including visual support. Indicate how members will be selected for Committees by nomination and vote. All Committees will be formed by 3 months after Notice of Grant Award. SPAN Committees will include members from both the individual sites/projects of the network and the CC, as well as representation from the NINDS/NIH.
Describe how the CC will establish infrastructure, including processes for real-time data entry, data management, including quality assurance (e.g. accuracy, completeness, and internal consistency), and sharing (within the network and with external scientists after appropriate publication). Indicate how the CC will facilitate efficient and accurate incorporation of new and/or extant data via electronic data entry from remote locations. Indicate how the CC will assist in developing and build into its infrastructure the core set of data elements agreed upon by the network. Detail how the CC will harmonize compatible but not identically coded extant data across platforms for sharing and metanalyses. The application should explain the CC’s statistical expertise to help inform adaptive design and analyses. A plan for how the CC will monitor performance across the individual network sites should be described.
Milestone Plan: The application must include a 1-year well-defined Milestone Plan in the approach section with a timeline for establishing the CC to full functionality within the expectations indicated below. Milestones should be unambiguous, quantifiable, and justified. The final milestone plan is subject to concurrence by the CC and NINDS. The timeline and milestones will be used to evaluate applications both in peer review and also in consideration of the awarded CC for funding of non-competing award years. See the section below on Cooperative Agreement Terms and Conditions of Award for specific guidance on content and timing of Milestones. The final Milestone plan is subject to approval by NINDS.
The application should describe the strategy used by the PD/PI and Institutional official to delegate leadership responsibility and how the responsibility is delegated among key/senior individuals. The qualifications, experience, and proposed duties of all proposed support personnel should be described.
Applicants should provide clear scientific, administrative, and institutional commitments to collaborate with other funded network project investigators/sites to maximize time- and cost-efficiency of testing in parallel up to 6 various neuroprotective interventions.
Letters of Support: If the application includes subcontracts or subawards for particular components of the CC’s operational structure, it should include letters of support from consultants and/or sub awardees detailing the required expertise and available infrastructure. If an application plans to utilize the infrastructure or resources of existing projects, whether funded by the NINDS, other governmental or nongovernmental entities, letters of support detailing the terms of collaboration and data sharing must be included, and must be from the appropriate authority/ies (e.g. institutional/foundation official, funding sponsor, and/or lead PI of the parent activity). Any conflicts with any known entities should be revealed and discussed. Review and approval for the use of samples and data must be completed and a letter of approval must be obtained prior to submission of an application under this FOA.
Applicants are strongly encouraged to consult with NINDS Scientific/Research staff early during the planning stage of their application (see Agency contacts, Section VIII). This early contact will provide an opportunity to clarify the applicant's understanding of NINDS’ goals, policies and guidelines. These discussions also provide important information and guidance on how to develop an appropriate application. To facilitate this, an Applicant Webinar will be scheduled to provide an overview of the FOA and answer questions. The webinar is open to all prospective applicants. Participation in the webinar is not a prerequisite for applying and is not required for a successful application. Information about how to participate in the webinar will be posted at http://www.ninds.nih.gov. Potential applicants are encouraged to submit their questions or comments firstname.lastname@example.org prior to the webinar. Afterwards, the webinar slides and a summary of the questions and answers will be posted on the same site. NIH will also post a list of Frequently Asked Questions (FAQs) and answers; this information may be updated without additional notice.
Important Update: See NOT-OD-18-228 for updated inclusion and human subjects review language for due dates on or after January 25, 2019.
Does the proposed Center address the needs of the research projects/network that it will coordinate/administer/serve? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research projects/network? Is there evidence that the proposed team and plan can fulfill the role of the CC as the network's information, data, and administrative hub? Does the CC demonstrate clear understanding of the SPAN goals and the commitment to work closely, collaboratively and effectively with the individual projects' PIs and their teams, the NINDS/NIH Program staff and the Steering Committee and External Advisory Board?
Is there evidence that the proposed team and plan can fulfill the role of the CC as the network?s information, data, and administrative hub? Does the CC demonstrate clear understanding of the SPAN goals and the commitment to work closely, collaboratively and effectively with the individual projects? PIs and their teams, the NINDS/NIH Program staff and the Steering Committee and External Advisory Board?
Are the PD(s)/PI(s)/Directors and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing complex multi-site network or consortium projects? Do the PD(s)/PI(s), collaborators, and the overall research team have expertise in drug acquisition, formulation, and distribution? Do the PD(s)/PI(s) have the required expertise in implementing procedures routinely used in clinical trials, such as randomization, blinding, inclusion/exclusion criteria, pre-registration, monitoring of the sites, that would be applicable to the SPAN network? Do the PD(s)/PI(s) have adequate expertise in statistical analysis, including sample size determination and adaptive trial design? Is the PD/PI committing a minimum of 3 person months effort to the project? Does the application identify a dedicated staff member as key personnel to be the point of contact who has high motivation, excellent communication skills, significant training and experience with information technology and biological data management?
Do the investigators demonstrate significant experience with coordinating collaborative research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?
Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research projects/network/ the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?
Does the CC offer innovative tools and approaches for data management, communication, information technology, organization of meetings and conference calls, and other activities under its purview? Does the application describe how an innovative preclinical adaptive design would be implemented?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex and age, for studies in vertebrate animals?
Are the current and/or planned organizational structure, administrative structure and commitment and resources of the CC clearly described and well-suited to accomplish the aims of the project? If the CC has more than one component/affiliate institution, are the relationship and distance of component(s)/affiliate(s) to each other and to the CC reasonable to allow efficient communication and operation? Does the CC have the required expertise in implementing procedures routinely used in clinical trials, such as randomization, blinding, inclusion/exclusion criteria, pre-registration, monitoring of the sites, that would be applicable to the SPAN network? Is the plan for drug formulation and distribution appropriate?
Does the application include well described and appropriate communication and conflict resolution plans? Does it include a feasible and appropriate description of how the CC will organize, coordinate and administratively drive network-specific activities including: establishing the Steering Committee; logistical components of committee activities including, for example, scheduling, soliciting agenda items, finalizing and distributing agendas, arranging calls including conference calls, minutes (drafting, editing based on input, and finalizing); all logistic and financial requirements for in person network meetings including meeting space, accommodation, travel, per diem reimbursement, etc.; required sharing activities? Is it indicated how SPAN network members will be selected for Committees by nomination and vote?
Is the description of how the CC will work with multiple and de-centralized investigators and schedule large (dozens of participants) interactive conference calls including with visual support feasible and appropriate?
Is it described how the CC will establish infrastructure, including for real time electronic data entry, to collect, curate for quality (e.g. accuracy, completeness, and internal consistency), display, house, and distribute data, including all relevant control data (within the network and with external scientists after appropriate publication) and how the CC will facilitate efficient and accurate incorporation of new and/or extant data via electronic data entry from remote locations? Is it described how the CC will assist in developing and build into its infrastructure the core set of de-identified data elements agreed upon by the network and how the CC will receive in real time, and by remote electronic submission, data from up to 6 sites, and distribute data to approximately the same number of sites? Does the application explain how the CC will harmonize compatible but not identically coded extant data across platforms for sharing and meta-analyses? Is the plan to monitor performance and collect data from the individual project sites included and appropriate?
Does the application include a description of appropriate procedures for data collection and study monitoring, as well as internal quality assurance plan and procedures of the CC? Assurance of quality is a joint responsibility of the CC and the individual project sites.
Is there a clear scientific, administrative, and institutional commitment to collaborate with other funded network project investigators/sites to maximize time- and cost-efficiency of testing in parallel up to 6 various neuroprotective interventions?
Does the project include an appropriate and feasible Milestone Plan, with a timeline for establishing the CC to full functionality?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?
Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research projects/network it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials. For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
As part of the scientific peer review, all applications:
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
The SPAN Network CC PD/PI(s) will have the primary responsibility for:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in typical research awards, as described below:
NINDS program staff will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination. However, the role of NINDS Project Scientists will be to facilitate and not to direct or drive the activities. The NINDS will establish a Steering Committee to assist in determining, in conjunction with the External Advisory Board Committee, the broad direction of the network.
NINDS Program staff will:
Areas of Joint Responsibility include: None. All responsibilities are divided between awardees and NIH staff as described above.
Dispute Resolution:Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: (1) a designee of the Advisory Committee chosen without NIH staff voting, (2) one NIH designee, and (3) a third designee with expertise in the relevant area who is chosen by the first two members; in the case of disagreement between the first two members, the third member will be chosen by the Consortium-elected Chair of the Steering Committee. This dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16
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