Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

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.

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.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

PURPOSE

The National Institute of Dental and Craniofacial Research (NIDCR) is continuing its support for dental practice-based research by soliciting research to be conducted in the dental school predoctoral/postdoctoral clinic setting. Dental school clinics and/or extramural clinics affiliated with dental schools offer a diverse and robust clinical environment, including patients with a spectrum of oral and general health needs and disease presentations, general dentistry and specialty clinics, and faculty with a wide range of clinical and research interests and expertise. The diversity and variety of oral disease presentations in patients who attend dental school clinics may spark new avenues of practice-based research exploration.

The purpose of Practice-Based Research Integrating Multidisciplinary Experiences in Dental Schools (PRIMED) is to provide clinical faculty and predoctoral/postdoctoral students/residents with skills development opportunities and patient-oriented clinical research experiences through intra/inter-institutional collaborations and peer and student mentoring partnerships. Additionally, applicants to this FOA must describe a developmental and/or small-scale practice-based research study that involves prospective enrollment of study participants and in which clinical faculty and predoctoral/postdoctoral dental students/residents collect data from their consenting patients, to be conducted in the predoctoral/postdoctoral dental school clinic and/or affiliated extramural clinic setting.

Applications to the PRIMED FOA must include the following four required components: 1) Clinical research skills development through coursework and/or research education/training opportunities; 2) intra- and/or inter-institutional collaborations in which the participating dental school must collaborate with another intra- or inter-institutional entity; 3) peer and student mentoring partnershipsbetween faculty members who are research-focused and those who are clinically-oriented, and between faculty members and predoctoral/postdoctoral dental students/residents; and 4) practice-based clinical research conducted in dental school predoctoral/postdoctoral clinics and/or affiliated extramural clinics, by incorporating practice-based research activities into the dental clinical educational setting.

The goals of PRIMED are to foster a culture of scientific inquiry during predoctoral/postdoctoral dental education, encourage scientific partnerships between students/residents, clinically-oriented faculty and research faculty, and stimulate additional clinical research pursuits by conducting practice-based research in dental school clinics and affiliated clinics.

Clinical trials will not be supported by this FOA. Applicants interested in proposing a clinical trial are directed to the NIDCR Guidance on Applications for Investigator-Initiated Clinical Trials.

BACKGROUND

Dentist/physician-scientists have made broad contributions to biomedical research and have served as leaders in academia, industry, and government. However, there have been growing concerns about the reduction in the dentist/physician-scientist workforce, which may impact dental, oral, and craniofacial scientific contributions and the pipeline of future oral health leaders. Recent data through 2016 suggest that only ~30% of dentist-scientist graduates enter academia and contribute to the dentist-scientist pipeline. In efforts to revitalize the dentist-scientist workforce, oral health leaders have emphasized the importance of engaging dental students in research activities and the utilization of evidence-based principles as part of the dental school curriculum to acquire the critical thinking skills necessary to evaluate and incorporate new knowledge into practice. Practice-based research has not been introduced into the dental predoctoral/postdoctoral curriculum and presents an opportunity to engage dental students in research experiences throughout their education.

Practice-based research can generate important and timely information to guide the delivery of health care and improve patient outcomes. Dental practice-based research provides clinicians with an opportunity to propose or participate in oral health research studies, conducted in the real-world environment of dental practices/offices with consenting patients. One benefit of practice-based research is the ability to collect data from clinicians 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 clinician or outside of the clinic visit. Another benefit is the ability to efficiently enroll large numbers of patients from a variety of practice settings/types, with each clinician contributing a relatively small number of patients. An important characteristic of practice-based research is the ability to address emerging topics of public health interest, by scaling-up study participation and launching studies in a timely manner when the needs arise. Further, dental practice-based research studies have the potential to accelerate the dissemination and implementation of evidence-based treatments for use by dental clinicians to prevent and manage dental, oral, and craniofacial diseases.

National Dental Practice-Based Research Network (PBRN)

The NIDCR has supported dental practice-based research since 2005, when it launched three regional dental PBRNs. The current National Dental PBRN comprises one Network Administrative and Resource Center and one Network Coordinating Center, which support the infrastructure for and implementation of multiple observational studies and clinical trials.

Proposed research may utilize the National Dental PBRN infrastructure to support study development and implementation.Potential applicants interested in utilizing National Dental PBRN resources are strongly encouraged to review available National Dental PBRN resources at: https://www.nidcr.nih.gov/research/clinical-trials/researchers-preparing-grant-application. Optional National Dental PBRN resources may include utilizing:

• Network Administrative and Resource Center resources. The Network Administrative and Resource Center personnel have expertise serving as liaisons to practicing clinicians and their patients and can provide input about dental office/clinic flow and operations, study procedures that would be feasible for the practice-based research setting, and clinician training materials.

• Network Coordinating Center resources. The Network Coordinating Center personnel have expertise developing and managing study-specific data management systems that allow for electronic data capture in clinics and designing a strategy for data collection that is appropriate for each individual research study.

OVERALL SCOPE

Required Components

Applications to the PRIMED FOA must include the following four required components:

Component 1: Clinical research skills development. Clinical research skills development opportunities for clinically-oriented faculty and dental predoctoral/postdoctoral students/residents must be proposed in the grant application. Education in clinical research skills development may occur through courses and other training activities offered through one or more of the participating dental schools, online/virtual learning, or other opportunities leveraging resources through the National Center for Advancing Translational Sciences Clinical and Translational Science Awards (CTSA) programs. Depending on the strength of and resources available at the applicant institution, clinical research skills enhancement activities may vary in how they are formalized and integrated; various strategies may be utilized. Examples include:

• Clinical faculty and dental students/residents participating in clinical research methodology training offered through the institution’s CTSA program;
• Clinical faculty and dental students/residents participating in a virtual, self-paced clinical research methodology and skills development course available through one of the participating institutions.

Component 2: Intra- and/or inter-institutional collaborations. The participating dental school must collaborate with at least one other institutional entity, within one educational entity (such as a dental school collaborating with another professional school at the same institution) and/or between the dental school and another institution (such as more than one dental school). The intra- or inter-institutional collaborations may provide additional clinical sites to increase the size and/or diversity of the patient population, leverage research resources across or between institutions, or provide other collaborative opportunities. Examples include collaborations between:

• One or more dental school clinics located at a high research-resourced academic institution collaborating with clinics in less research-resourced dental schools and/or high minority-serving dental schools. Each participating clinic would conduct the same practice-based research study;
• Unique specialty care clinics located at more than one dental school collaborating to conduct the same practice-based research study;
• Dental school and its clinics collaborating with the institution’s CTSA for research support;
• Dental school and its clinics collaborating with other school(s) at the same institution, such as medical, pharmacy, nursing, public health, etc for research and/or clinical care collaborations;
• One or more dental school intramural clinic(s) collaborating with extramural affiliated clinics to conduct the same practice-based research study.

Component 3: Peer and student mentoring partnerships. Research-oriented faculty members will partner with clinically-oriented faculty to conduct patient-oriented research. In turn, the clinically-oriented faculty will engage and mentor dental predoctoral/postdoctoral students/residents in these research activities with consenting patients in dental school clinics and/or affiliated dental educational clinics. Peer and student mentoring partnerships must be described in the grant application and may involve:

• Research-focused faculty of a dental school will serve as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) of the proposed research.
• Research collaborators involved in the intra- and/or inter-institutional collaboration may serve as Multiple PD(s)/PI(s) or co-Investigators. Clinically-oriented faculty members may also serve as co-investigators, depending upon their role on the research team.
• The research-focused faculty will partner with clinically-oriented faculty members and predoctoral/postdoctoral dental students/residents at participating dental school clinics to conduct practice-based research activities, including recruiting and enrolling patients, contributing research data, and collecting research data from their patients.
• The research-focused faculty will oversee the conduct of the research study.

Component 4: Practice-based clinical research. A developmental and/or small-scale practice-based research study with prospective enrollment of study participants must be described in the grant application. The practice-based research study will be conducted in dental school predoctoral/postdoctoral clinics and/or extramural clinics affiliated with dental schools. Clinical faculty and students/residents will participate in the research by recruiting and consenting patients who seek care in dental school and affiliated clinics and collecting research data from their consenting patients. The proposed research should be conducive to practice-based research, in which research data collection is integrated into the workflows and is conducted during the course of patient care.

At the minimum, the practice-based clinical research activities must involve the following:

• Research staff will train clinical faculty and student/resident providers on the practice-based research study protocol and procedures. Following training, clinical faculty and student/resident providers will recruit and consent patients in dental school and affiliated clinics based upon eligibility criteria;
• Clinical faculty and student/resident providers will provide research data and collect research data from their patients who have consented to study participation.

Additional practice-based clinical research activities may include:

• Clinical faculty and student/resident providers participate in clinical study development activities, such as developing/refining study documents, ensuring study operations align with clinical workflows in the practice-based setting, developing/contributing to provider training materials;
• Clinical faculty and student/resident providers participate in meetings/presentations in which study results are discussed and/or contribute to study result dissemination activities, such as presenting research at conferences, contributing to journal articles, etc.

Research Objectives

A variety of study designs may be appropriate for developmental and/or small-scale practice-based research conducted in the dental school clinic setting. Examples of such studies include those ascertaining feasibility of and refining a future intervention, assessing willingness and acceptability of practitioners and patients to perform study procedures or introducing additional clinical care practices into their clinic work flow, or developing technology for use by practitioners and patients. Further, small-scale retrospective/prospective or prospective-only observational studies with clearly defined and measurable outcomes may be considered to develop evidence for the prevention, diagnosis, management and/or treatment of oral diseases and conditions. For retrospective/prospective studies, medical diagnoses and/or oral health treatment data may be available retrospectively in electronic health records (such as a diagnosis of Sj gren’s Syndrome, when an implant was placed, or when orthodontic treatment was initiated), and medical and/or oral health outcomes would be collected prospectively. Examples of retrospective/prospective or prospective-only observational study designs include cohort studies that provide longitudinal follow-up of prevention or treatment practices, case-control studies with longitudinal follow-up, and health economics research of prevention or treatment practices in which health outcomes and health-related behaviors are the primary focus (see NOT-OD-16-025). Applicants should propose the strongest research design that is appropriate, acceptable and feasible to answer the research questions.

The NIDCR will be substantially involved with awardees 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 practice-based research study in dental school clinics and incorporating the four required components of clinical research skills development, intra- and/or inter-institutional collaborations, peer and student mentoring partnerships, and practice-based clinical research into grant applications.

Examples of practice-based research studies that might be conducted in dental school clinics and/or extramural clinics affiliated with dental schools include but are not limited to:

• Research to determine impactful innovations to dental practice that reduce the risk of virus transmission and ensure the safety of personnel and patients in dental practices;
• Research collaboration between a high research-resourced dental school and high minority-serving dental school to understand racial, ethnic, and/or sex/gender differences in dental care recommended and/or received;
• Research to develop or improve diagnostic criteria, reliable markers, and/or imaging techniques for assessing the onset and progression of oral disease, such as caries, periodontal disease, pulpitis;
• Research collaboration between a dental school and other professional school to determine the prevalence or incidence of occupational risks in dentistry or plan interventions to minimize these occupational risks;
• Research collaboration between a dental school and other professional school or clinic(s) to assess the impact of gender-affirming surgery of the craniofacial region upon individuals lived experiences and their mental health and well-being;
• Research collaboration between a dental school and medical/nursing school or clinic(s) to develop medical condition and risk behavior screening approaches in dental care settings, and to facilitate referral to treatment;
• Retrospective/prospective cohort studies assessing the impact of early interventions and/or nonsurgical treatment on later clinical outcomes in individuals born with oral clefts or other craniofacial anomalies;
• Research conducted in orofacial pain clinics at more than one dental school to assess sex/gender, racial, and ethnic differences in chronic orofacial pain diagnosis, management, and treatment outcomes;
• Research to optimize opioid risk mitigation clinical tools, such as those encouraging the use of prescription drug monitoring programs (PDMPs) and counseling prior to prescribing opioids for acute pain management to plan for a future intervention;
• Partnership between oral health and educational or technology development researchers to examine the extent to which electronic devices, social media apps could be used to promote positive oral health behaviors;
• Partnership between oral health and behavioral science or education researchers from collaborating institutions to develop and assess the feasibility of incorporating nutritional counseling into oral health care visits.

Additional Information

(1) Applicants to this FOA may be required to utilize a single IRB, consistent with NIH’s Single IRB Policy as described in NOT-OD-16-094 and the revised Common Rule cooperative research requirement (45 CFR 46.114).

(2) Applications to this FOA may propose to utilize the National Dental PBRN infrastructure to support study development and implementation. If National Dental PBRN infrastructure resources are proposed, the specific Network Administrative and Resource Center and/or Network Coordinating Center resources will be clearly described in the grant application, and an appropriate budget for the resources will be proposed.

(3) Participating clinicians may undergo training on study procedures, but it is not feasible for clinicians to undergo 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.

(4) The proposed clinical study must meet all applicable NIH and Office for Human Research Protections (OHRP) policy requirements. Awardees may be required to comply with the NIDCR Clinical Terms of Award for research that involves human subjects. 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 will be deemed non-responsive to this FOA and will not be reviewed.
• Applications for which the contact Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) does not have a primary appointment as a faculty member of a dental school in the United States will be deemed non-responsive to this FOA and will not be reviewed.
• Applications that do not include the four required components of clinical research skills development, intra- and/or inter-institutional collaborations, peer and student mentoring partnerships, and practice-based clinical research will be deemed non-responsive to this FOA and will not be reviewed.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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 not 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.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women 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.

The contact PD(s)/PI(s) must have a primary appointment as a faculty member of a dental school in the United States.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

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, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide 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.

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

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.

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 application must contain a Schedule of Events, which must be uploaded as a separate pdf file with the name 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.

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

A detailed budget with budget justifications must be included for the entire grant project period. Budget justifications must be included. The length of the project period should reflect the actual needs of the project. The maximum project period is 5 years; project periods of less than 5 years will be accepted.

The budget should include travel funds for the PD(s)/PI(s) to attend an annual face-to-face administrative meeting of PRIMED award recipients in the Bethesda, MD/Washington DC/northern Virginia area.

The U01 budget may include:

• Patient remuneration for study participation
• Study-specific costs required for National Dental PBRN personnel, resources, operations and/or data systems if the application proposes to utilize National Dental PBRN Administrative and Resource Center and/or Network Coordinating Center resources
• Budgetary items required to ensure the four required components of clinical research skills development, intra- and/or inter-institutional collaborations, peer and student mentoring partnerships, and practice-based clinical research are included in grant applications
• Travel funds to allow clinical faculty and/or students/residents to present research at meetings, conferences, etc.

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.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy

Significance:

Provide a rationale for and describe the significance of the planned activities for clinical research skills development, intra- and/or inter-institutional collaborations, peer and student mentoring partnerships.

The significance, biological and clinical relevance of the practice-based research study must be stated clearly. It should be supported by the following:

• A clear statement of the question(s) the study will address and its importance.
• The scientific rationale and clinical need for the study, including an assessment of previous preclinical and/or clinical studies and their quality (if applicable).
• The potential for the study results to impact knowledge or clinical practice.

Investigator(s):

• Describe the expertise of the study team and the team’s ability to foster partnerships with clinical faculty and engage and mentor predoctoral/postdoctoral students on clinical research, plan and implement the practice-based research study, and perform appropriate analyses of data collected.

Approach:

The Approach section must address the following four required components:

1. Clinical research skills development through coursework and/or research education/training opportunities;
2. Intra- and/or inter-institutional collaborations in which the participating dental school must collaborate with another intra- or inter-institutional entity and provide a rationale for the collaboration(s);
3. Peer and student mentoring partnerships between research-focused faculty members and those who are clinically-oriented, and between faculty members and predoctoral/postdoctoral dental students/residents; and
4. Practice-based clinical research conducted in dental school predoctoral/postdoctoral and/or affiliated dental educational clinics and involving clinically-oriented faculty and dental predoctoral/postdoctoral students/residents who, at a minimum, will recruit and consent dental clinic patients and collect research data from their consenting patients.

In addition, for the practice-based research study in the dental educational setting:

• Address the feasibility of recruiting participants who are eligible for the planned research.
• Provide a concise snapshot of the planned clinical study. It is expected to:
  • Clearly state the study objectives.
  • Describe and provide rationale for the study design, including study groups.
  • Specify the primary and important secondary outcome measures that align with each objective and provide justification for selection of the study outcomes.
  • Describe how the primary and important secondary outcome variables will be collected and the criteria for measuring the outcomes.
  • Describe the study population, including the sample size, pertinent demographic information, required health status or disease condition, and geographic location. Explain why the study population is an appropriate group to address the study objectives. Do not duplicate information described in Section 2 (Study Population Characteristics) of the Study Record: PHS Human Subjects and Clinical Trials Information form.
  • Provide a statistical analysis plan, including power calculations, data analysis approaches, and plans for handling missing data.
• Discuss potential biases or challenges in the planned study and how they will be minimized and/or addressed.

Environment:

• Provide rationale for which dental school clinics and/or affiliated clinics will be utilized for the planned research and why the proposed dental school clinics are an appropriate setting for the planned study.
• Describe resources and other opportunities in the dental school(s) that will support the four required components of clinical research skills development, intra- and/or inter-institutional collaborations, peer and student mentoring partnerships, and practice-based clinical research.

Letters of Support: Letters of support may be included from research partners, institutional 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:

• All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan describing the plan to make final datasets available in the public domain, managed by the grant applicant institution.

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.

Additional instructions are provided for the following sections:

• 2.5 Recruitment and Retention Plan
• 2.7 Study Timeline

Section 2 - Study Population Characteristics

2.5 Recruitment and Retention Plan

Describe the plan to recruit/enroll the patient population of interest for the clinical study within dental school clinics and/or extramural clinics affiliated with dental schools, including outreach activities and pre-study assessments of the ability of participating clinics 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 clinician and patient recruitment. Describe approaches to be used for retention and follow-up of enrolled participants.

2.7 Study Timeline

Provide an overall grant timeline to implement the four required PRIME components of clinical research skills development, intra- and/or inter-institutional collaborations, peer and student mentoring partnerships, and practice-based clinical research.

Provide a timeline for implementing and completing the practice-based research study, including the estimated time to: a) open study to enrollment; b) complete data collection; and c) complete final data analysis.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

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.

5. Intergovernmental Review (E.O. 12372)

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 fieldof the Senior/Key Person Profile form. 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 unique entity identifier provided on the application is the same identifier 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 NIDCR, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

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:

Participating clinicians may undergo training on study procedures, but it is not feasible for clinicians to undergo 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.

Overall Impact

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).

Scored Review Criteria

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?

Specific to this FOA:

To what extent does the application provide a rationale for and describe the significance of the planned activities for clinical research skills development, intra- and/or inter-institutional collaborations, peer and student mentoring partnerships?

To what extent does the practice-based research 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?

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?

Specific to this FOA:

To what extent do the investigators have sufficient ability to partner with clinical faculty and engage and mentor predoctoral/postdoctoral students/residents on clinical research?

To what extent do the investigators have sufficient expertise to plan and implement the practice-based research study and perform appropriate analyses of data collected?

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?

Approach

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?

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?

Specific to this FOA:

To what extent does the clinical research skills development training provide faculty and students with opportunities to enhance their clinical research skills?

To what extent does the application describe feasible and robust plans and sound rationale for intra- and/or inter-institutional collaborations between the participating dental school and another intra- or inter-institutional entity?

To what extent are there feasible and robust plans for peer and student mentoring partnerships between faculty members who are research-focused and those who are clinically-oriented, and between faculty members and predoctoral/postdoctoral dental students/residents?

To what extent does the grant application describe a feasible practice-based clinical research study to be conducted in dental school predoctoral/postdoctoral clinics and/or affiliated clinics that involves clinically-oriented faculty and dental predoctoral/postdoctoral students/residents who, at a minimum, will recruit and consent dental clinic patients and collect research data from their consenting patients?

To what extent is there a feasible recruitment plan?

Evaluate the extent to which the study objectives are stated clearly. Evaluate the extent to which there is a description of the proposed study design and the appropriateness to address the study objectives.

To what extent are the primary and secondary outcome variables described and justified, and to what extent is there a description of how they will be collected and measured?

To what extent is the study population appropriately described and justified?

Evaluate the appropriateness of the statistical analysis plan .

To what extent does the application address potential biases or challenges, and are plans to minimize these biases appropriate?

Evaluate the extent to which there is an adequate discussion of potential challenges that are anticipated during planning and study implementation, and how they will be addressed.

Data Sharing: To what extent does the application describe how final datasets will be made available in the public domain?

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?

Specific to this FOA:

To what extent does the application provide sufficient rationale for the proposed dental school clinics and/or extramural clinics affiliated with dental schools serving as an appropriate setting for the planned study?

To what extent does the application describe how the dental school environment resources will successfully support the four required components of clinical research skills development, intra- and/or inter-institutional collaborations, peer and student mentoring partnerships, and practice-based clinical research?

Additional Review Criteria

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.

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?

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

Not applicable

Renewals

Not applicable

Revisions

Not applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

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) Sharing Model Organisms; and (2) 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.

2. Review and Selection Process

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.

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 Advisory Dental and Craniofacial Research Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

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, Recipients, and Activities, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, 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 (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of the 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, 2 CFR Part 200, 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 recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a cooperative 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 reside with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have primary responsibility for:

• Providing overall leadership for the 4 required PRIMED components of clinical research skills development, intra- and/or inter-institutional collaborations, peer and student mentoring partnerships, and practice-based clinical research.
• Providing scientific leadership for all aspects of the study, including any modification of study design, the conduct of the study, quality control, data analysis and interpretation, preparation of publications, dissemination of data, tools, and technologies, and collaboration with other investigators. The PD(s)/PI(s) agrees to accept close coordination, cooperation, and participation of NIDCR staff in those aspects of scientific and technical management of the study as stated in these terms and conditions;
• Adhering to the NIDCR Clinical Terms of Award requiring that studies be monitored commensurate with the degree of the potential risk to study subjects and the complexity of the study;
• Upon implementation of the study, following the procedures required by the protocol regarding study conduct and monitoring, participant management, data collection, and quality control;
• Retaining custody of and having primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies;
• Managing involvement of industry or any other third party in the study. Except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by the NIDCR;
• Managing procedures to comply with the requirements of 45 CFR Part 46 for the protection of human subjects and the NIH policy requirements for the inclusion of women, minorities, and children;
• Making all study materials, procedure manuals, and final datasets available in the public domain, managed by the recipient institution. Recipients are expected to publish and publicly disseminate results, data, and other products of the study, concordant with NIH governance policies and protocols. Publications and oral presentations of work performed under this agreement will require appropriate acknowledgment of support by the NIH/NIDCR;
• Obtaining prior written approval of the NIDCR Grants Management Specialist, in consultation with the NIDCR Program Officer, for changes in any of the key personnel identified in the Notice of Grant Award.

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:

• Serve as a resource to provide programmatic support during implementation of the required PRIMED components of clinical research skills development, intra- and/or inter-institutional collaborations, peer and student mentoring partnerships, and practice-based clinical research.
• Serve as a resource to provide scientific/programmatic support during implementation of the research by providing input on experimental and clinical approaches and study protocols, and advising in the management and operational aspects of the research;
• Participate in teleconferences with PD(s)/PI(s) to monitor study progress, adherence to the study protocol, the conduct of the study, and recruitment and retention of study participants;
• Review the progress of the study through consideration of routine reporting, site visits, oversight committee recommendations, etc. This review may include, but would not be limited to, compliance with the study protocol, meeting participant enrollment targets, adherence to uniform data collection procedures, and the timeliness and quality of data reporting.

An NIDCR Program Official will be assigned. The NIDCR Program Official will:

• Carry out a continuous review of all activities to ensure that the objectives are being met and that all regulatory, fiscal, and administrative matters are handled according to NIH guidelines;
• Have the option to withhold support to a participating institution if technical performance requirements are not met;
• Perform other duties required for normal program stewardship of grants.

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, retention, and/or NIH policy requirements for the inclusion of women, minorities, and children; data reporting and dissemination; quality control or other major breaches 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:

None, all responsibilities are divided between recipients and NIH staff as described above.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel comprising 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 recipient. This special dispute resolution procedure does not alter the recipient'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.

3. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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.

Section VII. Agency Contacts

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: 301-480-7075

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]

Section VIII. Other Information

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, 2 CFR Part 200, and 45 CFR Part 75.