National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
U24 Resource-Related Research Projects Cooperative Agreements
Reissue of RFA-NS-15-010 - The NINDS Human Biomarkers Biospecimen and Data Repository (U24)
August 28, 2020 - Notice of Correction to Eligibility in NIH Funding Opportunity Announcements. See Notice NOT-OD-20-171.
None
93.853
This Funding Opportunity Announcement (FOA) invites applications to serve as the National Institute of Neurological Disorders and Stroke (NINDS) Human Biospecimen and Data Repository in Neurological Disorders. This repository will maintain the current collection of biospecimens as well as support expansion of the collection in accordance with the NINDS mission. The NINDS Human Biospecimen and Data Repository will distribute biospecimens broadly to qualified academic and industry researchers to advance basic, translational and clinical research in neurological disorders.
30 days prior to the application due date
October 20, 2020
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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.
Not Applicable
February 2021
May 2021
July 2021
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
Background
The National Institute of Neurological Disorders and Stroke (NINDS) invites applications to serve as the NINDS Human Biospecimen and Data Repository for Neurological Disorders. The repository, the Biospecimen Exchange for Neurological Disorders (BioSEND) was established in 2015 to acquire, maintain, and distribute existing NINDS biospecimen collections for biomarker research in disorders such as Parkinson's Disease, Huntington's Disease, and Frontotemporal Dementia. Subsequently, the repository has expanded to support active clinical studies supported by NINDS in Parkinsonisms, Lewy Body Dementia, Epilepsy, Traumatic Brain Injury, Myalgic encephalomyelitis/Chronic Fatigue Syndrome, and Spinocerebellar Ataxia. To date the repository has distributed over 18,300 samples worldwide to both academic and industry researchers.
This open competition FOA requests applications from organizations to serve as an integrated and comprehensive biospecimen resource for the NINDS. The repository will manage the existing collection and expand the collection to bank well-annotated high-quality clinical biospecimens to foster discovery and validation of neurological biomarkers as well as complementary basic, translational, and clinical research. It is expected that biospecimen resources supported within this FOA will continue to be broadly distributed to both qualified academic and industry researchers worldwide following government guidelines and regulations
Scope
Activities required under this FOA include:
A successful application will have strengths in four major areas of emphasis: 1) Biobanking; 2) Dedicated coordination with clinical research teams; 3) Data Management; and 4) Efficient and effective biospecimen distribution and outreach to the research community. Qualifications for applicants should include academic excellence in the fields of biobanking operations for complex clinical studies, neuroscience, data management and curation.
The administrative structure should be such that it provides leadership and program management to the entire project. Because this is a cooperative agreement, extensive collaboration and management input from the NINDS will occur, and milestones will be used to make go/no go funding decisions. This overall structure is intended to ensure that stakeholders including academic and industry scientists, and research subjects will be served by the resource. The repository is likely to expand to include biospecimens from other neurological disorders during the duration of this project. Receipt, processing, storage, and the national and international distribution of biospecimens will be required.
Applications that propose to develop non-human cell resources are non-responsive to this funding announcement.
Due to the unique requirements of this project, applicants are strongly encouraged to consult with NINDS Scientific/Research Staff early on during the planning for an application.
A webinar will be held prior to the receipt date to provide an overview of the initiative and to answer questions from potential applicants pertinent to preparing applications.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Need help determining whether you are doing a clinical trial?
NINDS intends to commit up to $1,500,000 total costs in FY 2021 to fund 1 award.
The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
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.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Christine Swanson-Fischer, Ph.D.
Telephone: 301-496-5680
Email: [email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
For this specific FOA, the Research Strategy section is limited to 30 pages.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Highlight, how the Research Team has appropriate expertise (without duplicating information in the biosketches) in:
All instructions in the SF424 (R&R) Application Guide must be followed.
If appropriate, the applicant should budget for the intake of the existing repository collection.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: Provide a succinct description of how the proposed work will meet the overall scientific goals, the expected outcomes, and the impact should those goals be achieved.
Goals should include:
Research Strategy: Propose plans that describe how valuable existing and new biospecimens from projects identified by NINDS will be managed by the repository. Plan should address how the proposed procedures and processes will ensure standardized banking and distribution of verified, high-quality, uncontaminated samples that will advance biomedical research. Address each of the following key areas:
Sub-section A. Biobanking Administration
Sub-section B. Biobanking Operations
Sub-section C. Data Management and Informatics
Specific guidelines and requirements for these sub-sections are described below.
Sub-section A. Biobanking Administration
Provide an overall description of the proposed organizational structure and project management plan. Describe the strategy for effectively carrying out each specific aim. Applicants must present an integrated plan that will be responsive to and flexible regarding the evolving needs of the scientific community. In particular:
Sub-section B. Biobanking Operations
This sub-section should address all essential aspects of biobanking operations, including QA/QC and human biospecimen-related legal and ethical issues. Specific items to be covered include but are not limited to
Sub-section C. Data Management and Informatics
The applicant must describe plans for maintaining a computerized data management system for cataloging, querying, and retrieval of biospecimen-related information. The data management plan must present a system that is effective for quality control, tracking of samples, order fulfillment, billing methods for cost reimbursement, shipment, and inventory tracking. Present plans for a back-up system to protect against accidental loss of valuable data. The design and development of the database should provide user-friendly accounting of the repository's holdings, and ensure data integrity, accuracy, and security. Such information should include but is not limited to: a global unique identifier (GUID), sample type, sample volume/weight/aliquot size, inventory data, and processing data, including QC for individual specimens (such as such as time between collection, shipping, freezing or other temperature changes, processing, needle bore, centrifugation, etc.)
Applicants must address their strategy to provide the following:
Data management. Data management activities must dovetail with a variety of other data management resources in academic and industry settings. The data management capabilities must be 1) nimble in sharing inventory and cataloging data on a regular basis; 2) able to receive de-identified clinical and other sample associated data, to ensure that data follows the FAIR data principles (findable, accessible, interoperable, and reusuable); 3) able to track and notify submitters and requestors regarding sample status (via an electronic system); 4) able to fully share data with NINDS Program staff and their designees is expected in real time. Dedicated staff with IT and data management experience must be available for trouble-shooting any data management aspects of the project.
Integrating with Related Projects. Flexible, innovative, and novel problem solving approaches towards unique situations for various shareholders is essential. Present a general plan for how you will integrate with research projects and their data management approaches. There may be designated data form structure requirements for sharing data with other projects to facilitate this activity as appropriate. If none exists for certain special projects (ie, those with data generated via unique technologies), these must be created collaboratively.
Web-based Catalog. Describe plans for a Web-based electronic catalog, which must be made available for collections where such resources do not/will not exist. Note that for some active studies, a catalog will be hosted by the awardee; in others, by the clinical project itself via NINDS funding (such as is being done, for example, by the PDBP DMR). If hosted by the awardee, the catalog must outline the policies and procedures for governing the submission and requesting of samples. This should list the available samples with associated information, including a GUID, detailed phenotype and molecular genotype data, links to related genetic databases, pedigree structure when relevant and available, assay results, and all quality assurance information. Provide a strategy of tracking performance of the resource including metrics such as distribution, website traffic, publications citing the source, and other utilization of the resource. Novel approaches may be employed to support the implementation of a user-friendly web-based access portal.
Customer Service. Describe plans for customer service, including plans for a user-friendly customer service interface, such as a help-desk. This help-desk function should serve not only those with IT and data management related concerns, but the entire spectrum of Research and Resource activities. For example, this help-desk function would provide support for the following activities: protocol clarification, QC processes and results, sample submission, sample requests/ordering, and shipping questions. The customer service plan must include timelines regarding estimated responsiveness on any query. Applicants should also describe plans to incorporate end-user feedback into improvements in the repository.
Publicizing Repository Collections. Describe plans and innovative outreach approaches to publicize repository collections. Efforts may include publishing articles in relevant scientific journals that describe specific repository collections or the general purpose and operation of the repository, presentations at scientific meetings to represent the scientific activities and collaborations, or other activities. The aim of the activities should be to increase the use of repository collections, to promote awareness of repository services to the scientific community, and/or to aid in recruitment of additional samples for the repository collection when appropriate. Additionally, the public website should serve as a means to educate patients with neurological diseases and the other members of the lay public about what the repository does, whom it serves, how to participate, information about biomarker research, and news items regarding recent discoveries by users, among other items.
Additional Application Elements:
Milestones. Specific milestones must be presented that will need to be met in order to accomplish the aims. Annual milestones must be provided in the context of a study timeline. These milestones will provide clear indicators of a project's continued success or emergent difficulties. Milestones are goals that create go/no-go decision points in the project and must include clear and quantitative criteria for success. Milestones may include (but are not limited to):
Achievement of milestones will be evaluated by NINDS, and funding of non-competing award years will depend on milestone accomplishments.
Letters of Support: Statements of Institutional Commitment, if appropriate, should be included in this section. In addition, a letter from the applicant must be included and titled "Procedures related to materials obtained from human subjects" that provides documentation of the following:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
With the following modifications:
Applicants may include the following items (if available) in the Appendix:
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
Applications responsive to this FOA support the management, maintenance expansion, and distribution of human biospecimen resources that will play a significant role in advancing basic science and drug discovery efforts for neurological disorders supported by NINDS. Accordingly, since the biospecimens will be broadly distributed to the research community, reviewers will emphasize the technology capabilities, quality assurance standards and the level of innovation that will be applied to ensure the research value of this resource.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the proposed [Center] address the needs of the research resource that it will serve?
Is the scope of activities proposed for the repository appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research resource? What will be the effect of these research resources on other scientific activities that drive this field? Is there convincing evidence that the proposed plan for the biobanking resource will stimulate and facilitate neurological biomarker and clinically relevant research efforts by optimizing access to high-quality, well-characterized biospecimens and data? How well does the proposed repository address the needs of the scientific community?
Are the PD(s)/PI(s) and other personnel well suited to their roles in the resource? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing biospecimen research? 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 biorepository? Does the applicant have experience overseeing selection and management of subawards, if needed?
Does the applicant/organization have demonstrated expertise in laboratory biorepository science, and hands-on leadership experience in operating a large-scale clinical biospecimen operation as well as providing efficient and equitable access to biospecimens?
To what extent do the PD(s)/PI(s) have experience in providing high-quality research resources and services for neurological disorders to the scientific community?
To what extent does the PD(s)/PI(s) have experience in Human Subjects research including understanding of HHS and NIH guidelines and regulations as well as compliance with HIPAA?
To what extent are the PD(s)/PI(s) committed to the principles of free and open sharing of research resources for neurological disorders?
Do the applicant and research team have experience in biomarker research, such as evaluation of batch effects, protocol development and standardization, and analyte quality control measures?
Does the applicant have experience in data management and web-based IT design and support, including a customer service component?
Does the applicant have a track record which would facilitate understanding and serving the needs of academic communities?
Does the application propose novel organizational concepts or management strategies in coordinating the research resource the repository will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? To what extent does the proposed repository employ novel concepts, approaches, or methods for the production and sharing of research resources, the integration of biorepository data into a central warehouse, the integration of that data with other public resources, and the implementation of a single user-friendly, web-based access portal?
Is there a high likelihood that the activities proposed will remain scientifically current to the greatest extent possible, given rapid advances in biospecimen science, molecular biology, and information technologies?
Is there evidence of innovative approaches to outreach to the scientific community?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research resource the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the biorepository, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the resource is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the biorepository? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?
Are plans for publicizing repository collections appropriate and likely to promote awareness of repository collections to the scientific community and/or aid in recruitment of additional biospecimen collections to the repository in a cost-effective manner?
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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Is the management plan well integrated and likely to facilitate achieving repository goals and objectives? Does the application inspire confidence regarding an ability to recognize the priorities of the scientific community relevant to neurological biomarkers and clinically relevant research?
Are repository collection acquisition plans appropriate well-reasoned, timely, and appropriate?
Are appropriate plans in place for training staff and assuring continuity of activities in the case of staff turnover?
If applicable, is the plan for transfer of existing collections clear and feasible?
Are plans for characterization of newly acquired specimens robust and likely to be broadly valuable? Are plans for quality control, data collection and analysis, and diagnostic verification likely to result in distribution of high-quality, well-characterized samples to the biomedical research community?
Does the proposed database provide a user-friendly accounting of the resource's holdings and ensure data integrity, accuracy, and secure cyberinfrastructure? Is the plan for a back-up facility appropriate? Are plans for customer service likely to facilitate acquisition of biospecimen resources by academic and industry researchers? Are plans for a web catalogue and query system presented and feasible? Is integration with other projects data management systems likely to be successful?
Does the application appropriately address evaluation of processes and implementation of improvement plans of the resource's procedures and programs when feedback is given via users or the NIH staff, and is this plan nimble and flexible?
Does the application requisitely address a need for broad sharing of protocols and standard operating procedures, and an approach for ensuring that these occur?
Does the application give adequate evidence of how protocols will be shared, including via web-based and other methods?
Are reasonable, appropriate, and timely methods described to track and monitor repository use, both submitting and accessing, and the outcomes of such use, including data and publications?
Does the application provide an adequate strategy to address any intellectual property issues?
Is an appropriate budget estimate provided regarding costs of accepting existing sample collections and banking future samples of various types for individual researchers who choose to submit samples? Is the estimate specific enough to judge the reasonableness of the costs for these banking activities prospectively?
Does the application provide appropriate milestones that will need to be met to accomplish the work set out above in a five-year time frame?
Is an appropriate budget estimate provided regarding costs of accepting existing sample collections and banking future samples of various types for individual researchers who choose to submit samples? Is the estimate specific enough to judge the reasonableness of the costs for these banking activities prospectively?
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). Does the sharing plan provided factor in existing resources and is it responsive to the broad sharing as desired in this FOA?
Will the institutional environment in which the repository will operate contribute to the probability of success in facilitating the research resource it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the repository proposed? Will the repository benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
Is there an appropriate alternative off-site location been identified for storing duplicate samples in case of natural or man-made disaster?
Is the plan in case of equipment or other failure which might jeopardize samples reasonable and feasible? Are personnel available in case of equipment failure or other malfunction at all times?
Is there adequate server capacity to support a variety of activities including biospecimen data management, clinical data management, data query, file protocol sharing, genomics and other data banking and management?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
For research that involves human subjects but does not involve one of the 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 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 individuals of all ages (including children and older adults) 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.
Not Applicable
For Renewals, the committee will consider the progress made in the last funding period.
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Not Applicable
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).
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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened bythe National Institute of Neurological Disorders and Stroke (NINDS)}, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Applications will be assigned to the National Institute of Neurological Disorders and Stroke (NINDS). Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Neurological Disorders and Stroke (NANDS) Council . The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
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 Part 75, 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:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Additionally, an NINDS Program Official will be responsible for:
NINDS reserves the right to terminate or curtail the resource (or an individual component of the resource) in the event of inadequate progress, data reporting, or insufficient use of this resource.
Areas of Joint Responsibility include:
NINDS Human Biospecimen and Data Repository Scientific Advisory Committee
The NINDS Human Biospecimen and Data Repository Scientific Advisory Committee will meet annually, along with teleconferences as needed, to review progress, advancements, innovations and external demand for the Repository and identify areas within the Repository Program that could benefit from additional reporting, technology development, resources provided or infrastructure. Members of the Scientific Advisory Committee will be selected by the PI after consultation with NINDS. NINDS will reserve the option to add ad hoc and permanent members during the course of the project.
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. The three members will be: a designee of the awardee, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two. This special 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.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Christine Swanson-Fischer, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-5680
Email: [email protected]
Daniel Miller, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-5680
Email:[email protected]
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email: [email protected]
Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.