Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)
New
PAR-20-073 - National Dental Practice-Based Research Network Infrastructure Access (X01 Clinical Trial Not Allowed)
93.121
The National Institute of Dental and Craniofacial Research (NIDCR) is continuing support for research conducted within a dental Practice-Based Research Network (PBRN). The National Dental PBRN Administrative and Resource Center and National Coordinating Center support the infrastructure for and implementation of multiple observational studies and clinical trials. This Funding Opportunity Announcement (FOA) is soliciting applications for clinical trials and large clinical observational studies to be conducted in the National Dental PBRN through a milestone-driven UG3/UH3 cooperative agreement mechanism. Each UG3/UH3 award will support an individual project which will utilize the National Dental PBRN infrastructure and resources for study planning and implementation. This FOA supports a UG3 clinical study planning phase and potential transition to a UH3 implementation phase. Progression to the UH3 phase is based on an administrative review and is dependent on success in meeting UG3 milestones, consideration of the dental PBRN as an appropriate venue for conduct of the research, NIDCR program priorities, and availability of funds.
The main goals of the dental PBRN are to streamline the implementation of national oral health research studies in dental practices on topics of importance to practitioners and their patients, to provide evidence useful in daily patient care, and to facilitate the translation of research findings into clinical practice. This FOA encourages applications proposing research studies that align with the goals of the dental PBRN.
30 days prior to the application due date
New applications: November 19, 2020, February 9, 2021, June 9, 2021, and October 8 2021; February 9, 2022, June 9, 2022, and October 7 2022; February 9 2023, June 9, 2023, by 5:00 PM local time of applicant organization.
Resubmission and revision applications: November 19, 2020, March 9, 2021, July 9, 2021, and November 9 2021; March 9, 2022, July 8, 2022, November 9 2022; March 9 2023, July 7, 2023, by 5:00 PM local time of applicant organization.
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.
January 7, 2021, May 7, 2021, and September 7 2021; January 7, 2022, May 7, 2022, September 7 2022; January 7, 2023, May 7, 2023, September 7 2023. All applications are due by 5:00 PM local time of applicant organization.
All types of AIDS and AIDS-related 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.
Standard dates apply
Standard dates apply
Standard dates apply
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.
PURPOSE
The National Institute of Dental and Craniofacial Research (NIDCR) is continuing support for research conducted within a dental Practice-Based Research Network (PBRN). The National Dental PBRN Administrative and Resource Center and National Coordinating Center support the infrastructure for and implementation of multiple observational studies and clinical trials. The NIDCR provides two pathways to propose studies that utilize the dental PBRN infrastructure. This FOA describes one of the pathways and is soliciting applications for clinical trials and large clinical observational studies to be conducted in the National Dental PBRN through a milestone-driven UG3/UH3 cooperative agreement mechanism. Each UG3/UH3 award will support an individual project which will utilize the National Dental PBRN infrastructure and resources for study planning and implementation. This FOA supports a UG3 clinical study planning phase of up to 2 years in duration, with potential transition to a UH3 implementation phase. The entire UG3/UH3 project period must end by May 31, 2026. Progression to the UH3 phase is based on an administrative review and is dependent on success in meeting UG3 milestones, consideration of the dental PBRN as an appropriate venue for conduct of the research, NIDCR program priorities, and availability of funds.
The main goals of the dental PBRN are to streamline the implementation of national oral health research studies in dental practices on topics of importance to practitioners and their patients, to provide evidence useful in daily patient care, and to facilitate the translation of research findings into clinical practice. This FOA encourages applications proposing research studies that align with the goals of the dental PBRN.
This FOA cannot be used to test an FDA-regulated drug, biologic or device. Applications proposing such trials will be deemed non-responsive and will not proceed to review. Applicants interested in conducting such efficacy trials are directed to the NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3).
BACKGROUND
Practice-based research networks can generate important and timely information to guide the delivery of health care and improve patient outcomes. A dental PBRN is a unique venue in which to conduct clinical research. It provides practitioners with an opportunity to propose or participate in research studies, conducted in participating dental offices with consenting patients. Dental PBRN studies draw on the experience and insight of practicing clinicians to address issues faced by dental practitioners in the daily care of their patients. Dental PBRN studies also have the potential to accelerate the dissemination and implementation of evidence-based treatments for use by dental practitioners to prevent and manage dental, oral, and craniofacial diseases.
One benefit of practice-based research is the ability to collect data from practitioners about factors contributing to decision-making and procedures performed, and separately, to collect data from a patient's perspective, either during a patient's visit with the practitioner or outside of the office visit. Another benefit is the ability to efficiently enroll large numbers of patients with a wide geographic distribution and from a variety of practice settings/types; many practitioners can be engaged in dental PBRN studies, with each contributing a relatively small number of patients. An important characteristic of the dental PBRN is the ability to address emerging topics of public health interest, taking advantage of the existing infrastructure and capacity for launching studies in a timely manner.
In 2005, the NIDCR launched the first phase of the dental PBRNs by supporting three regional dental PBRNs, which conducted multiple clinical studies over seven years. To build upon the strengths of the regional dental PBRNs and coordinate their efforts, NIDCR launched the second phase of the dental PBRNs in 2012 by funding one national, geographically diverse network. In this third phase funded in 2019, NIDCR has continued to support a national infrastructure, to facilitate the conduct of research within a dental PBRN setting and build on the knowledge gained from the previous two phases.
OVERVIEW OF NATIONAL DENTAL PBRN INFRASTRUCTURE
The dental PBRN infrastructure comprises one National Dental PBRN Administrative and Resource Center and one National Coordinating Center, funded as companion awards.
The National Dental PBRN Administrative and Resource Center is responsible for recruiting practitioners for network membership, which comprises dental practitioners representing general dentistry/specialty affiliation and a variety of practice settings/types. The National Dental PBRN is organized into 6 regional Nodes or administrative hubs with wide geographic distribution that, combined, are capable of reaching interested participants within all states in the US. In addition, there is one specialty dentistry Node that operates across all network geographic areas, and the network will establish a unique patient population Node, which may comprise practitioners linked by certain practice types (e.g. federal services, dental public health clinics) or those who treat patients with certain disease-specific conditions that may affect oral health. The Administrative and Resource Center also manages a single Institutional Review Board (IRB), ensures that practitioners and office/clinic staff receive responsible research conduct training required by NIH and IRBs, and coordinates study deployment across Nodes. Further, the Administrative and Resource Center infrastructure includes the following resources that are equitably available to the research teams: a) Practitioner Recruitment and Engagement Component, b) Practitioner Training Component, c) Practitioner and Patient Compensation System, and d) Communication and Dissemination Component. A practitioner Executive Committee will provide input about the feasibility and clinical interest of research topics.
The National Coordinating Center is the central locus for data coordination/management of studies conducted within the National Dental PBRN. The National Coordinating Center functions include developing and managing study-specific data management systems that allow for electronic data capture in practices and utilize flexible and innovative technologies to capture research data, including the capability to accomplish research participant follow-up independent of in-office visits.
Node Directors and Node Coordinators from the Administrative and Resource Center, who serve as liaisons to practitioners and their patients, will participate on study teams of projects selected for UG3/UH3 funding during the planning and implementation phases to provide input about network resources and operations. Node personnel functions will include: providing input about office flow/operations as teams develop clinical research documents, study procedures/processes, and study training materials; recruiting practitioners for participation in research studies; providing study-specific training to practitioners and office/clinic staff, enabling them to recruit, enroll, and collect data on their patients in their offices/clinics; developing systems to assist practitioners in maintaining high rates of patient enrollment and retention; and performing quality management activities and monitoring study execution by practitioners and office/clinic staff.
National Coordinating Center personnel will also serve on study teams of projects selected for UG3/UH3 funding. UG3/UH3 study teams are required to use Coordinating Center resources for some study activities and may choose to use optional Coordinating Center resources. The National Coordinating Center will provide the following required study-specific support: developing and maintaining a data management system for study data; designing and implementing a strategy for data collection that is appropriate for each individual research study; providing training on data collection systems; providing randomization support if applicable; developing processes for and supporting study-specific data quality management activities; maintaining primary responsibility for study-specific reporting to study teams, the PBRN personnel, NIDCR, and Data and Safety Monitoring Boards (DSMBs); providing unblinded biostatistical support if applicable; and providing final datasets ready for analysis by individual study teams.
Optional Coordinating Center study-specific data coordination/management functions may include: providing additional scientific expertise to study teams; providing biostatistical leadership or support to study teams for statistical design, including sample size calculations or simulations, and data analyses; providing a Study Manager who will serve on a study team to manage study development/implementation progress and assist teams in the preparation of study protocols, case report forms, and other study-related documents.
OVERALL RESEARCH SCOPE
The NIDCR provides two pathways to propose studies that will utilize the dental PBRN infrastructure. One pathway, described in PAR-20-073, is intended for small developmental/exploratory, feasibility (pilot), and/or survey studies of practitioners and/or patients; these studies will be supported through infrastructure funds. This FOA describes the second pathway and is soliciting applications for clinical trials or large observational clinical studies involving prospective and/or retrospective data collection from National Dental PBRN-participating practitioners and their patients. UG3/UH3 awards will provide project-specific funds to support the development and implementation of clinical research studies to be conducted in the National Dental PBRN. The UG3/UH3 funding mechanism supports projects in two phases, and the entire UG3/UH3 project period must end by May 31, 2026. The study development activities and study implementation plans should be well-developed, and the final design of the UH3 clinical study should be defined in the UG3/UH3 grant application. The NIDCR will be substantially involved with the UG3/UH3 awardees as a partner in providing overall scientific and operational guidance, consistent with the Cooperative Agreement mechanism.
Potential applicants are strongly encouraged to contact NIDCR Scientific/Research staff well in advance of the application due date to discuss the suitability of conducting the proposed study within the dental PBRN infrastructure. Pre-application consultation may include an introductory conference call with NIDCR Scientific/Research staff and National Dental PBRN Administrative and Resource Center and National Coordinating Center personnel. Potential applicants are strongly encouraged to review the process for potential grant applicants to interact with and utilize National Dental PBRN resources, available at: https://www.nidcr.nih.gov/research/grant-applicants.
UG3 Clinical Study Planning Phase
The UG3 planning phase will provide up to two years of support for development of study documents (e.g., study protocol, data collection instruments, Manual of Procedures, study procedure/training documents for practitioners) and finalization of study procedures and operations necessary to implement a clinical study in the dental PBRN setting. Additional planning activities are allowable, such as data collection or intervention delivery for the purpose of user acceptance testing, establishing acceptability and feasibility of the study procedures and/or study intervention delivery/fidelity monitoring, and piloting study procedures to streamline data collection and flow within a busy dental office/clinic setting. The UG3 phase cannot be used to test for intervention efficacy.
Activities supported during the UG3 phase may include, but are not limited to, development of the following:
Milestones and UG3/UH3 Transition
All projects must be driven by well-defined milestones for the UG3 planning phase and annual milestones for the UH3 implementation phase. A milestone is defined as a scheduled event in the project timeline, signifying the completion of a major project stage or activity. All UG3 grants will need to meet milestones to have an opportunity to move to the UH3 implementation phase. At the completion of the UG3 planning phase, the applicant will be required to submit a detailed transition request package, which will undergo an administrative review to determine whether the study will be awarded funding for the UH3 implementation phase. The UH3 funding period will provide support to implement the clinical study in the National Dental PBRN, and the entire research project must be completed by May 31, 2026. Continued funding during the UH3 phase will be dependent upon meeting annual UH3 milestones, and it is expected that the study will be completed within the UH3 grant period.
Prospective applicants should note that initial funding of the UG3/UH3 cooperative agreement does not guarantee funding of the UH3 phase. Transition to the UH3 phase is dependent on having successfully met the UG3 planning milestones, with consideration of the dental PBRN as an appropriate venue in which to conduct the proposed research, NIDCR program priorities, and availability of funds. The quality of the study-related documents and plans are given key consideration when the NIDCR considers the transition to the UH3 phase.
Research Objectives
The National Dental PBRN will conduct multiple national oral health clinical studies of relevance to general dental practice and will also have the capability to incorporate projects of interest to dental specialists and other dental professional groups, specific dental practice settings/types (e.g., federal services, dental public health clinics), and patient advocacy groups. Numerous study designs may be appropriate for clinical research conducted in the dental PBRN. Applicants should propose the strongest research design that is appropriate, acceptable and feasible to answer the research questions.
Clinical trial designs may be used where appropriate to establish efficacy or effectiveness of strategies for the prevention, diagnosis, management and/or treatment of oral diseases and conditions. Potential applicants are strongly encouraged to review NIH’s Definition of a Clinical Trial to determine if the proposed study meets NIH’s definition of a clinical trial and would be required to adhere to NIH policies for clinical trials. Studies proposing behavioral or social interventions intended to change provider or patient behaviors related to dental, oral, or craniofacial health must include a test of the hypothesized mechanisms of action of the behavioral intervention.
Monitoring the degree to which a study intervention is delivered as it was intended (i.e., with fidelity) is expected for clinical trials research. Fidelity monitoring will ensure the intervention is being delivered in a standardized manner across study sites (dental practices) and amongst interventionist personnel. Fidelity monitoring procedures should be described in the grant application or developed during the UG3 planning phase.
Applicants may propose other types of clinical studies such as retrospective or prospective observational studies with clearly defined and measurable outcomes. Examples of other study designs include cohort studies prospectively ascertaining risk factors for oral disease development, studies that provide longitudinal follow-up of prevention or treatment practices, case-control studies with longitudinal follow-up, cost-effectiveness or efficiency assessments of prevention or treatment practices, and retrospective database analyses proposing extraction of oral health data from individual electronic health records with adjudication of findings.
Public-private partnerships may be proposed as part of the recruitment or research plan (e.g. private partner contributing to recruitment strategy to promote practitioner participation in dental PBRN studies). If so, the rationale for this approach should be provided.
Examples of clinical research studies that might be conducted in the dental PBRN include but are not limited to:
Additional Information
(1) Applicants to this FOA will be required to incorporate the National Dental PBRN infrastructure into their proposed study plans, including central study coordination and operations through the National Dental PBRN Administrative and Resource Center and data collection and management through the National Coordinating Center. Applicants will be required to use the single IRB that has been established for the National Dental PBRN and is consistent with NIH’s Single IRB Policy as described in NOT-OD-16-094.
(2) National Dental PBRN Administrative and Resource Center and National Coordinating Center personnel will serve on study teams of UG3/UH3 studies funded through this FOA, in the capacity described in this FOA. NIDCR Program staff will work with awardees and their study teams to develop the proposed study in the UG3 phase and implement the study during the UH3 phase.
(3) Applications to this FOA must include study-specific Node Coordinator support in the budget, as described in Section IV, R&R Budget. The number of Nodes should be determined by the following: Each Node will enroll ~25-40 practitioners, and each practitioner will enroll ~20-40 patients.
(4) Applicants to this FOA should clearly indicate whether or not they intend to utilize study-specific biostatistical leadership available through the National Coordinating Center, or if biostatistical leadership will be supported and budgeted through the grant application.
(5) Applicants to this FOA should also clearly indicate whether or not they intend to utilize a study-specific Study Manager available through the National Coordinating Center, or if the Study Manager role/responsibilities will be supported and budgeted through the grant application.
(6) Participating practitioners may undergo training on study procedures, but it is not feasible for practitioners to undergo network-wide calibration of study procedures. Consequently, proposed clinical data and/or biospecimens obtained in practice-based research studies should be limited to data for which high-quality data collection could occur via procedural training only.
(7) Priority of funding for dental PBRN studies deemed to be highly meritorious by peer review will be based on factors including infrastructure capacity and availability of the patient population within the National Dental PBRN. Further, timing of funding will be determined by the NIDCR to assure that studies can be developed and conducted within the proposed study timeline for the UG3/UH3 grant period included in the Study Record: PHS Human Subjects and Clinical Trials Information of the grant application. It is understood that the proposed timeline for study implementation activities in the UH3 phase may be revised as activities in the UG3 phase progress.
(8) At the time of an award, the PD(s)/PI(s), dental PBRN personnel, and NIDCR will negotiate a project work scope and study development activity timeline (for UG3 award) and implementation activity timeline (for UH3 award). The project work scope and timeline will include identifying the primary individual or entity and other contributors responsible for study development, start-up and implementation activities, and the timeline for completion of these activities.
(9) The proposed clinical study must meet all applicable NIH and Office for Human Research Protections (OHRP) policy requirements. Awardees are required to comply with the NIDCR Clinical Terms of Award and the NIDCR Policy on Data and Safety Monitoring for any planning phase activities that involve human subjects and all UH3 studies. It is recommended that applicants use the NIDCR tools and templates for development of the clinical study documents, located in the NIDCR Toolkit for Clinical Researchers
Applications Not Responsive to this FOA
Applications proposing clinical trials to test a drug, biologic or device regulated by the FDA will be deemed non-responsive to this FOA and will not be reviewed.
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?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications
The UG3 phase is limited to a total of $275,000 in direct costs over the entire UG3 phase. Application budgets for the UH3 phase are not limited but need to reflect the actual needs of the proposed project.
The maximum period of the UG3 phase is 2 years. The UG3 phase may be no less than 1 year; the UH3 phase may be no less than 1 year. The entire project (combined UG3 and UH3 phases) must be completed by May 31, 2026.
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:
Yasaman Shirazi, PhD
Telephone: 301-594-5593
Fax: 301-480-8303
Email: [email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
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.
Other Attachments: The application must contain the following information, according to the instructions below. The information provided here will be considered by reviewers and is meant to supplement, not duplicate, information provided in the Research Plan or the Study Record: PHS Human Subjects and Clinical Trials Information form. The following documents must be uploaded as separate pdf files with the names indicated below.
1. Schedule of Events. The filename "Schedule of Events" should be used to name this attachment.
Provide a schematic, table, or text description of the protocol-specified schedule of events for an individual study participant. It should capture each study visit/assessment time point and planned activity(ies) for each time point.
2. Milestone Plan. The filename "Milestone Plan" should be used to name this attachment.
A milestone is defined as: a scheduled event in the project timeline that signifies the completion of a major project stage or activity. The Milestone Plan must describe objective, measurable milestones with separate milestones for the UG3 and UH3 phases. The milestone plan must include clearly stated milestones that will be reached at the end of the UG3 planning phase and annual milestones that will be completed during the UH3 implementation phase. The milestone plan should address anticipated challenges to meeting milestones and propose potential mitigation or corrective action strategies.
Milestones may be refined and finalized in consultation with NIDCR Program Staff at the time of the UG3 phase award and the UH3 phase award, if granted.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
A detailed budget should be provided in the UG3/UH3 application and should include a detailed budget for the UG3 and UH3 phases. Budget justifications must be included.
The UG3/UH3 budget should include travel funds for the PD(s)/PI(s) to attend an annual face-to-face administrative meeting of dental PBRN infrastructure personnel, up to $1500 per person per trip.
For the roles of primary Biostatistician and Study Manager, the budget justification must clearly state whether each of these personnel will be supported by the National Coordinating Center or through the UG3/UH3 budget.
The UG3/UH3 budget must include:
The UG3/UH3 budget may include:
The budget will not include personnel and resource costs that are already covered by the National Dental PBRN infrastructure. Costs for Key Personnel of the National Dental PBRN Administrative and Resource Center or National Coordinating Center awards will not be included in the budget. Funds to travel to a National Dental PBRN-supported research meeting for practitioners should not be requested, as these travel funds should be paid through National Dental PBRN infrastructure funds.
Node Coordinator activities included in the budget will support:
The following activities supported by the National Coordinating Center should not be included in the budget, but may be described in the budget justification as being supported by the National Coordinating Center:
If parts of the costs of the study are to be borne by sources other than NIH, these contributions must be presented in detail in the budget justification. These outsourced costs do not constitute cost sharing as defined in the current NIH Grants Policy Statement and should not be presented as part of the requested budget.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Other Plan(s):
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims
Provide the overall goals for the entire application and indicate separately Specific Aims to be accomplished in the UG3 phase and in the UH3 phase. Clearly label them as UG3 Specific Aims and UH3 Specific Aims.
Research Strategy
Significance:
The significance, biological and clinical relevance of the proposed study must be stated clearly. It should be supported by the following:
Investigator(s):
Approach:
The Approach section should have a clear demarcation of the UG3 and UH3 portions of the application.
For the UG3 phase:
For the UH3 phase, if the proposed study design is not a clinical trial:
For the UH3 phase, if the proposed study design is a clinical trial:
Environment:
Letters of Support: Do not submit letters of support from the National Dental PBRN Administrative and Resource Center or National Coordinating Center. Letters of support may be included from research collaborators, patient organizations, or other groups with whom the investigators propose to work.
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:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
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.
Section 2 - Study Population Characteristics
2.5 Recruitment and Retention Plan
The National Dental PBRN infrastructure personnel will contribute towards recruiting practitioners for participation in studies conducted within the National Dental PBRN and developing systems to assist practitioners in maintaining high rates of patient recruitment, enrollment, and retention.
Describe the plan to recruit/enroll the practitioner population of interest for the clinical study and the plan for patient recruitment with National Dental PBRN-participating offices/clinics, including outreach activities and pre-study assessments of the ability of participating practices to recruit the proposed target number of participants. Include a discussion of any study design strategies and/or methods to minimize selection bias and maximize flexibility for practitioner and patient recruitment. Describe the plan to meet the studyR#8217;s retention targets. Include a discussion of strategies for retention of practitioners and their patients, including any methods to maximize flexibility for data collection after baseline (e.g., data collection independent of office visits).
2.7 Study Timeline
Applicants should provide separate project performance timelines for the UG3 planning phase and the UH3 implementation phase of grant period. The UG3 timeline should include the estimated time for completion of each of the UG3 milestones (see "Other Attachments"). UH3 timeline should include the estimated time to: a) open study to enrollment; b) complete data collection; and c) complete final data analysis. Project performance timelines will be refined and finalized in consultation with NIDCR Program Staff and National Dental PBRN personnel at the time of the UG3 phase award and the UH3 phase award, if granted.
Section 3 - Protection and Monitoring Plans
3.3 Data and Safety Monitoring Plan
Section 3.3 must be completed for all applications, including those that do not propose a clinical trial. Data and safety monitoring will be the joint responsibility of the study team, the National Dental PBRN Administrative and Resource Center, and the National Coordinating Center. The National Coordinating Center will develop a data management system for study data collection and adverse event recording. The study team will maintain primary responsibility for reporting adverse events, unanticipated study events and protocol deviations to ensure participant safety.
Describe the study-specific plan to ensure data and safety monitoring, including plans to assure the integrity of the clinical study data being collected, proposed methods and systems for data collection (e.g., paper or electronic data collection systems) and data entry, and procedures for data quality management and study monitoring. Do not name members of any oversight board in the application. The NIDCR will appoint members of any oversight committees after consultation with the investigators.
3.5 Overall Structure of the Study Team
Section 3.5 must be completed for all applications, including those that do not propose a clinical trial. Indicate that National Dental PBRN Administrative and Resource Center personnel will participate on study teams to provide input about network resources, activities, and operations, and National Coordinating Center personnel will serve on study teams to provide data coordination/management functions and input about National Coordinating Center resources and activities.
Biostatistician and Study Manager: If the study team intends to work with a primary biostatistician not affiliated with the National Coordinating Center, describe the roles and responsibilities of the biostatistician for the proposed project. If the study team intends to work with a Study Manager not affiliated with the National Coordinating Center, describe the roles and responsibilities of the Study Manager.
Section 4 - Protocol Synopsis
4.7 Dissemination Plan
UG3/UH3 applicants must submit a plan for the dissemination of NIH-funded clinical trial information that will address how the expectations of the NIH Policy on the Dissemination of NIH-funded Clinical Trial Information will be met. Responsibility for adhering to this policy lies with the UG3/UH3 grantee institution, not with the National Dental PBRN Administrative and Resource Center or National Coordinating Center awardees.
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.
Do not enter a delayed onset study.
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.
Requests of $500,000 or more for direct costs in any year
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide. Applicants must follow the NIDCR-specific instructions for applications requesting $500,000 or more in direct costs for any year.
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.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
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:
(1) Successful UG3/UH3 applications will utilize the National Dental PBRN Administrative and Resource Center and National Coordinating Center infrastructure and resources for study planning during the UG3 phase and, if criteria are met to transition to the UH3 phase, study implementation during the UH3 phase.
(2) The dental PBRN is a unique venue in which to conduct clinical studies. The National Dental PBRN infrastructure will provide centralized study operations, data management, and coordination. The National Dental PBRN includes a strong, flexible network of practitioners and offices/clinics (sites) with capacity to implement large, national clinical studies. Study enrollment and retention will be overseen by the National Dental PBRN infrastructure.
(3) Participating practitioners may undergo training on study procedures, but it is not feasible for practitioners to undergo network-wide calibration of study procedures. Consequently, proposed clinical data and/or biospecimens obtained in practice-based research studies should be limited to data for which high-quality data collection could occur via procedural training only.
In addition, for applications involving clinical trials:
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
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.
Significance
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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?
To what extent does the proposed study have a clear statement of the question(s) that the study will address and its importance? Does the application provide sufficient scientific rationale and clinical need for the study?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Specific for this FOA: For Phase III trials, is there potential for generalizability of study findings to US populations?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?
Does the overall team have sufficient expertise to develop and implement the planned study and perform appropriate analyses of data collected?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? Is the organizational structure appropriate?
Innovation
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, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Is the recruitment plan feasible? Are the study objectives stated clearly? Is there a description of the proposed study design, and is it appropriate to address the study objectives? Are the primary and secondary outcome variables described, justified, and is there a description of how they will be collected and measured? Is the study population appropriate and justified? Is the statistical analysis plan appropriate? Does the application address potential biases or challenges, and are plans to minimize these biases appropriate? Is there an adequate discussion of potential challenges that are anticipated during planning and study implementation, and how they will be addressed?
For the UG3 planning phase: Are the plans clear for developing a final study protocol, final data collection instruments (e.g. case report forms) and other study-related documents?
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?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Are the methods used to assign participants, deliver interventions, train interventionists, and monitor for intervention fidelity adequate? Is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified? For behavioral interventions, does the application demonstrate that the intervention engages the mechanism of action target(s) it intends to, and that target engagement can be measured?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Environment
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?
Will the research benefit from utilization of National Dental PBRN resources? How well does the project leverage resources of and ensure collaboration with the National Dental PBRN?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial in dental offices/clinics as the clinical sites?
If multi-sites/centers, is there evidence of the ability of the individual dental offices/clinics (clinical sites) to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
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.
Study Timeline
Is the project performance timeline for the UG3 phase feasible to accomplish the proposed study development activities within the proposed timeframe? Is the project performance timeline for the UH3 phase feasible to implement and complete the study within the proposed timeframe? Does the UH3 timeline include the estimated time to: a) open study to enrollment; b) complete data collection; and c) complete final data analysis?
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
Other Attachments
Regarding the additional documents included as "Other Attachments":
Schedule of Events
Is the Schedule of Events for an individual study participant appropriate for the study design and data to be collected? Are the procedures and frequency of visits in the proposed schedule of events for the study reasonable and feasible?
Milestone Plan
Are the milestones and activities clearly stated? Are appropriate, measurable milestones clearly defined for the UG3 phase? Is it likely that the investigator team will meet these milestones within the proposed UG3 project period? Are appropriate, measurable annual milestones clearly defined for the UH3 phase? Are the annual milestones feasible to be accomplished during the proposed UH3 project period? Does the application address contingency plans in the event the UG3 and/or UH3 milestones are not achieved?
Protections for Human Subjects
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.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
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.
Vertebrate Animals
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.
Biohazards
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.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
Not applicable
Revisions
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
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.
Applications from Foreign Organizations
Not applicable
Select Agent Research
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).
Resource Sharing Plans
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).
Authentication of Key Biological and/or Chemical Resources:
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.
Budget and Period of Support
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 NIDCR, 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 on the basis of established PHS referral guidelines 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 Advisory Dental and Craniofacial Research 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.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all 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.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
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 primary responsibility for:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
An NIDCR Project Scientist will be assigned. The NIDCR Project Scientist will:
An NIDCR Program Official will be assigned. The NIDCR Program Official will:
An NIDCR Medical Officer will monitor the studies and serve as the Medical Monitor.
The NIDCR reserves the right to terminate or curtail a study or any portion of a study in the event of (a) failure to implement the study protocol, (b) a substantial shortfall in participant recruitment and retention, data reporting and dissemination, quality control or other major breach of the protocol, (c) substantive changes in the agreed-upon protocol with which the NIDCR does not concur, (d) reaching a major study objective substantially before schedule with persuasive statistical evidence, or human subject ethical issues that may dictate a premature termination.
Areas of Joint Responsibility include:
As appropriate to the funded study, the following collaborative responsibilities will be incorporated into the grant award:
Dispute Resolution:
With the exception of the decision about transitioning to the UH3 phase, 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. Members will be: a designee chosen by the PD/PI, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. 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.
Data Management and Sharing
Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.
Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
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: 301-637-3015
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Dena Fischer, DDS, MSD, MS
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4876
Email: [email protected]
Yasaman Shirazi, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5593
Email: [email protected]
Diana Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
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.