Notice of Intent to Publish a Funding Opportunity Announcement for Practice-Based Research Integrating Multidisciplinary Experiences in Dental Schools (PRIMED) (U01 Clinical Trial Not Allowed)

Key Dates

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National Institute of Dental and Craniofacial Research (NIDCR)

The National Institute of Dental and Craniofacial Research (NIDCR), intends to promote a new initiative by publishing a new Funding Opportunity Announcement (FOA) to solicit applications for Practice-Based Research Integrating Multidisciplinary Experiences in Dental Schools (PRIMED). The purpose of this FOA will be 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, this FOA will support developmental and/or small-scale practice-based research studies that involve prospective enrollment of study participants, and in which clinical faculty and predoctoral/postdoctoral dental students/residents collect data from their consenting patients, conducted in the predoctoral/postdoctoral dental school clinic and/or affiliated extramural clinic setting.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects and to consider the requirements that are integral to this initiative. 

The FOA is expected to be published in Fall 2022 with an expected application due date in Winter 2022.

This FOA will utilize the U01 activity code. Details of the planned FOA are provided below.

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. Applicants 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:

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.

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.

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

TBD

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Please direct all inquiries to:

Dena Fischer, DDS, MSD, MS

 

National Institute of Dental and Craniofacial Research (NIDCR)

301-594-4876

Email:dena.fischer@nih.gov