Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the 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.
I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The purpose of this Big Data to Knowledge funding opportunity (FOA) announcement is to support the development of new or significantly adapted interactive digital media that engage the public, experts or non-experts, in performing some aspect of biomedical research via crowdsourcing. To be responsive to this FOA, each application is expected to pose a challenging biomedical research problem and propose the development of engaging interactive digital media that incorporates crowdsourcing as a fundamental component of how the problem is addressed. The biomedical research problem should be amenable to one or more human computation approaches, as the users must be active participants in the analysis and/or interpretation of data, rather than acting primarily as data collectors or sources of data.
For the purposes of this FOA, "crowdsourcing" is defined as: a mechanism of distributing specified subtasks amongst a large group of individuals ("the crowd") and then using the aggregate contributions of these individuals to perform a larger task. Interactive digital media and research interfaces that use crowdsourcing employ an approach where different individuals contribute small portions to the overall research project. This FOA solicits applications for the development of interactive digital media that, at the end of the funding period, should be useable and engaging public-facing interfaces to crowdsourced biomedical research that can be expected to lead to publishable scientific results. The interactive digital media developed under this FOA should demonstrate feasibility via being used by the crowd and by making some measurable initial progress at addressing the biomedical research problem identified in the application.
In response to the opportunities and challenges presented by the dawning era of big data in biomedical research, the NIH launched the Big Data to Knowledge (BD2K) initiative as a trans-NIH initiative to cultivate the digital research enterprise within biomedicine, to facilitate discovery and support new knowledge, and to maximize community engagement.
In the BD2K initiative, the term "Biomedical Big Data" is inclusive of the diverse digital objects which may have impact in basic, translational, clinical, social, behavioral, environmental, or informatics research questions. Such data types may include imaging, phenotypic, genotypic, molecular, clinical, behavioral, environmental, and many other types of biological and biomedical data. They may also include biologically-relevant data generated for other purposes (e.g., social media, search histories, economic, geographical, or smart phone data). Finally, they also encompass the metadata, data standards, and software tools involved in data processing and analysis.
BD2K supports a variety of related efforts designed to enhance the utility of biomedical big data. As part of that larger effort, this FOA focuses on the development of interactive digital media that enable biomedical research via crowdsourcing.
Many components of biomedical research require human eyes and intuition to iteratively solve puzzles, recognize patterns, form strategies, and provide new insights and connections. Interactive digital media such as research games and engaging research interfaces can offer an ideal environment for performing such tasks, and such tools have been successfully used to crowdsource biomedical data analysis and problem solving to the public, resulting in innovative solutions and scientific breakthroughs. Biomedical problems that are amenable to innate human abilities including visual perception, language comprehension, abstraction and creativity are often particularly well-suited to such approaches.
The development of effective interactive digital media incorporating crowdsourcing involves the identification of a research question that is not readily solved by existing approaches and is amenable to being parceled into smaller tasks that can be distributed to individuals (often non-experts) in an efficient manner. Once the crowd participants perform these subtasks, subsequent processing of these individuals' contributions often requires methods for evaluating their quality, accuracy, or success. It also involves designing an interactive, compelling, and adaptable interface, as well as core design considerations for how to enable participants to quickly learn how to use the interface for performing the tasks, how to keep participants involved by challenging them with higher levels of difficulty when they have mastered easier tasks, and how to adapt and evolve the interactive digital media as the community of participants evolves while still addressing the overall research question.
In addressing a biomedical problem, the design of interactive digital media as an interface to crowdsourced research typically must give careful consideration to both the "in-game" representations (whether literal or figurative) of underlying biomedical data and the mechanics of how participants interact with and analyze it. As research-focused interactive digital media must also provide an engaging and enjoyable user experience, it is common to provide feedback to participants to assess their progress, and interfaces and available participant actions are often tailored to a particular platform (mobile, desktop, console, etc.). Interactions between participants often depend upon both how they compete, collaborate, or work alongside one another, and how subtasks are distributed amongst them (such as by role or level of experience).
This FOA solicits development of new or significantly adapted interactive digital media that engages the public, experts or non-experts, in some aspect of biomedical research via crowdsourcing, with the objective of addressing current and emerging needs of the biomedical research community for using, managing, and analyzing the larger and more complex data sets inherent to biomedical big data.
Interactive digital media projects in the biomedical research space address challenging problems that are amenable to being solved via crowd sourcing. It is expected that these projects will be comprised of both an engaging interactive digital media concept that includes the interface themes and creative design elements, and a research approach encompassing the mechanics of how the software and participants go about solving the problem. Additionally, the engagement of participants in the use of such software is critical to the success of these projects, along with metrics for evaluating the quality of and confidence in the crowdsourced data analyses and research results. It is anticipated that responsive projects will require teams containing expertise from both the biomedical sciences research and game development or interactive media domains, along with their computational collaborators and others as necessary, to bring sophisticated interactive media approaches to biomedical research by designing engaging interactive software that addresses the question posed by the investigators. Due to the iterative nature of the interactive digital media/game development process, proposed projects are expected to emphasize a strategic plan for proceeding from the initial conceptual design to the final design. At the end of the funding period, feasibility for the interactive software as a biomedical tool should be demonstrated by having a crowd of participants use the software and by showing that they are able to make some measurable initial progress toward addressing the biomedical research problem identified in the application. While this FOA is intended to foster the development of new interactive digital media incorporating crowdsourcing, submissions consisting of significant research-focused adaptations of existing interactive digital media are also invited.
Biomedical research areas amenable to interactive digital media and crowdsourcing approaches include, but are not limited to, the following:
Examples of project areas that are not responsive to this FOA:
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to 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
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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:
In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the "Apply for Grant Electronically" button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
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 by e-mail to:
David J. Miller, Ph.D.
National Cancer Institute (NCI)
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed
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. Additionally, explain how the team contains the expertise necessary from both the biomedical research and game development or interactive media domains to bring sophisticated and quality interactive digital media design approaches to biomedical research.
All instructions in the SF424 (R&R) Application Guide must be followed. The annual budget must include funds for travel by the PD(s)/PI(s) to participate in a required BD2K Consortium meeting held within the United States, at a location to be determined by NIH staff.
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:
Research Strategy: As part of the Research Strategy section, applications should clearly address the following:
1. Define the challenging problem for biomedical big data research that the proposed interactive digital media will address, and describe how a solution to this problem can be attained via interactive digital media incorporating crowdsourcing.
2. Describe the mechanics of how the proposed interactive digital media will address the biomedical problem, e.g., what data are presented to participants for analysis, how participants are able to interact with and analyze the data, and how participant analyses are captured for further evaluation or processing.
3. Describe the subtask(s) that participants are given to perform and the plan and metrics for evaluating the quality of and confidence in both the analyses performed and information generated by the participants.
4. Describe the initial conceptual elements of the interactive digital media, including any initial creative design themes and elements. In addition, describe the design strategy for how the design will be developed from the initial proposed concept to the envisioned final design.
5. Describe the plan for engaging participants and for attaining participants to use the interactive digital media.
Appropriate justification for the proposed work can be provided through literature citations (included via the Bibliography and References Cited attachment on the SF424(R&R) Other Project Information form), data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for UH2 applications; however, they may be included if available
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, with the following modification:
A software dissemination plan, with appropriate timelines, is expected to be included in the application. There is no prescribed single license for software produced through awards responding to this announcement. However, NIH does have goals for software dissemination, and reviewers will be instructed to evaluate the dissemination plan relative to these goals:
1. The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
2. The terms of software availability should permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
3. To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.
4. The terms of software availability should include the ability of researchers to modify the source code and to share modifications with other colleagues. An applicant should take responsibility for creating the original and subsequent official versions of a piece of software.
5. To further enhance the potential impact of their software, applicants may consider proposing a plan to manage and disseminate the improvements or customizations of their tools and resources by others. This application for funding may include a plan to incorporate the enhancements into the official core software, may involve the creation of an infrastructure for plug-ins, or may describe some other.
Any software dissemination plans by the institution (and its subcontractors as applicable) represent a commitment to support and abide by the plan.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. 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.
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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.
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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.
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, NIH, and for responsiveness by the NIH BD2K Targeted Software Development Subcommittee. Applications that are incomplete, non-compliant, or non-responsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
This FOA uses the UH2 exploratory/developmental grant mechanism which supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. UH2 grant applications in response to this FOA need not have extensive background material or preliminary information. Accordingly, in addition to the review criteria below, the evaluation will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding.
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 project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
In addition, specific to this FOA: Does the proposed staffing (including PD(s)/PI(s), research staff, consultants, and collaborators) combine the biomedical science domain-relevant expertise with the game design and development or interactive digital media expertise critical to address the identified research question via interactive digital media incorporating crowdsourcing?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
In addition, specific to this FOA: Is there innovation either in the interactive digital media proposed or in how it is taken from one field and applied in another? Does the proposed interactive digital media incorporating crowdsourcing constitute a novel/innovative approach to the identified biomedical problem, a new direction for methods research within the chosen biomedical research area, or a significant adaptation of prior software or methods?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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?
In addition, specific to this FOA: Does the application describe how a solution to an identified biomedical research problem can be attained via interactive digital media incorporating crowdsourcing? Does the application describe a development strategy for how the design will progress from the initial proposed concept to the envisioned final design? Does the application describe the plan and metrics for evaluating the quality of and confidence in the analyses and information generated by the participants, and does the application describe a plan for engaging participants and for attaining participants to use the proposed interactive digital media?
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 scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
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 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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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.
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.
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 Wide Association Studies (GWAS) /Genomic Data Sharing Plan.
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 by the CSR, 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:
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. 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 Cancer Advisory Board. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described 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.
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.
Cooperative Agreement Terms and Conditions of Award
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) Authorities and Responsibilities
The Program Director(s)/Principal Investigator(s) will have the primary responsibility for defining the details for the projects within the guidelines of this FOA and for performing all scientific activities. The PD(s)/PI(s) will agree to accept the close coordination, cooperation, and participation of the NIH staff (Project Scientists and other appropriate BD2K Program Staff) in those aspects of scientific and technical management of the projects as described below. Specifically, the PD(s)/PI(s) supported by this BD2K Targeted Software Development Program award will:
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
NIH Staff Responsibilities
A designated NIH Program Staff member, acting as Project Scientist, will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The role of the Project Scientist will be to facilitate and not to direct. This includes facilitating the partnership relationship between NIH, the BD2K Consortium, and the BD2K Targeted Software Development Program awardees. The Project Scientist's role includes helping to maintain the overall scientific balance in the program commensurate with new research and emerging research opportunities, facilitating communication and coordination among the awardees, and ensuring that the activities of the awardees are consistent with the mission of BD2K. Specifically, the NIH Project Scientist will:
To help carry out these duties, Project Scientists may consult with non-NIH experts in the field.
Additionally, an NIH Program Officer will be responsible for the normal scientific and programmatic stewardship of the awards and will be named in the award notice. The Program Officer may also have substantial programmatic involvement to coordinate and facilitate collaborations with other awardees and ensure the activities of the project are consistent with BD2K and the goals of this FOA. The Program Officer may be the same person as Project Scientist, in which case, the individual involved will not attend peer review meetings, or will seek NIH waiver according to the NIH procedures for management of conflict of interest.
Areas of Joint Responsibility
The NIH Project Scientist(s) and the PDs/PIs of the BD2K Targeted Software Development Program will be jointly responsible for the coordination of intra-program activities and the scientific integration of individual projects with other appropriate NIH programs. Joint responsibilities include:
Although the BD2K Targeted Software Development Program will not have any separate formal governing body, the awardees' activities may involve the formation of a Coordinating Group. The primary role of the Coordinating Group will be to serve as an interface between the individual projects funded under this FOA and appropriate NIH programs. Such a Coordinating Group, if formed, will:
The NIH Project Scientist(s) will initiate the formation of the Coordinating Group and will facilitate its activities.
The NIH Project Scientist(s) may additionally form an External Scientific Panel (ESP) composed of senior non-federal scientists who are not directly involved in the activities of the BD2K Initiative. The ESP would advise NIH on the progress of the BD2K Targeted Software Development Program, on the contributions of individual projects and/or project collaborations within the consortium, and on the progress and effectiveness of the consortium as a whole.
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 academic members who are not involved in the study will be convened. 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 HHS regulation 45 CFR Part 16.
A final progress report, 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.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
eRA Commons Help Desk (Questions regarding eRA Commons
registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
David J. Miller, Ph.D.
National Cancer Institute (NCI)
Raymond Jacobson, Ph.D.
Center for Scientific Review (CSR)
National Cancer Institute (NCI)
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 Parts 74 and 92.
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