RFA DE-18-012 Webinar Information To join the webinar, follow the link below: https://nih.webex.com/nih/onstage/g.php?MTID=ea57648b49315e407c4291084ed0bea1e • Meeting number: 620 438 493 Meeting password: NIDCR • Audio access for the webinar by phone: 1-650-479-3208 Meeting access number: 620 438 493 • Ask questions by phone/type questions into the Q&A box. • See also: Answers to Questions posted on the NIDCR website: https://www.nidcr.nih.gov/research/DER/NIDCR-Dental-Specialty-and-PhD-Program.htm • The webinar is open to all prospective applicants, but participation in this webinar is optional and is not required for the submission of an application in response to RFA-DE-18-012. 1/10/2018 1
Transcript
RFA DE-18-012 Webinar InformationTo join the webinar, follow the link below:
• Audio access for the webinar by phone: 1-650-479-3208Meeting access number: 620 438 493
• Ask questions by phone/type questions into the Q&A box.
• See also: Answers to Questions posted on the NIDCR website: https://www.nidcr.nih.gov/research/DER/NIDCR-Dental-Specialty-and-PhD-Program.htm
• The webinar is open to all prospective applicants, but participation in this webinar is optional and is not required for the submission of an application in response to RFA-DE-18-012.
and PhD research effort requirements• DSPP/K12 Eligibility Requirements • Application Requirements – select topics• Review Criteria - select topics• Q&A
1/10/20185
Dental Specialty and PhD Program (DSPP)
• Provide support for early career dentist scientists to facilitate their transition to careers as independent investigators in dental, oral and craniofacial research
• Provide intensive supervised research training and career development experiences leading to a PhD in a field relevant to dental, oral and craniofacial research, and advanced clinical knowledge and skills development in one of the nine dental specialtyprograms recognized by the American Dental Association.
• Integrated clinical and PhD training programs– sustain research progress– maintain interest in attainment of PhD – enhance likelihood of pursuing research career
• Multidisciplinary/collaborating programs• Team science approaches• Institutional support
– financial support for scholar’s salary – research resources and support– coordination between clinical and PhD programs/PDs
1/10/20187
Goals
RFA DE-18-012 Key Information
• Letter of Intent Due Date: January 09, 2018
• Application Due Date: February 09, 2018, by 5:00 PM local time of applicant organization. No late applications will be accepted for this Funding Opportunity Announcement.
• Only one application per institution is allowed
• Scientific Merit Review: May/June 2018
• Advisory Council Review: August 2018
• Earliest Start Date: September 1, 2018
1/10/20188
RFA DE 18-012 (K12) Award Budget Information • Funds Available & Number of Awards: NIDCR intends to commit $1,000,000 in FY
2018 to the DSPP (RFA DE-18-003 and RFA DE-18-012)• Award Budget: Application budgets are not limited, need to reflect actual needs of the
project• Award Project Period: Maximum is 5 years• Personnel Costs: Including PD(s)/PI(s), administrative and clerical costs, or other staff
directly associated with managing the DSPP may not exceed 10% of total direct costs in any year.
• Scholar Costs: Up to $100,000 per year for salary and fringe benefits Salary request must be based on a full-time, 12-month staff appointment; be consistent with the established salary structure at the institution
• Research and Career Development Support: Up to $25,000 per year for each Scholar. Allowable expenses include: (a) supplies, equipment, technical personnel; (b) tuition and fees related to the required PhD program; (c) travel to scientific meetings for scientific training; and (d) technical support for statistical services including personnel and computer time.
• Indirect Costs: 8% of modified total direct costs (exclusive of tuition and fees)
RFA DE 18-012 (K12) DSPP Key Features and Requirements
1. K12 supports PhD research training of 1 or 2 scholars each year of the K12 award
2. Each scholar must be appointed to the K12 for a minimum of 3 and up to 5 consecutive years of support.
3. All K12 appointments must be 12 months in duration.
4. K12 Scholars must devote 3 years at a minimum of 9 person months (equivalent to 75% of full-time professional effort) the PhD program.
5. K12 Scholars appointed for 4 or 5 years may devote 1 or 2 of those years, respectively, at a minimum of 6 person months (equivalent to 50% of full-time professional effort) to the PhD program.
6. A minimum of 50% continuous and consistent full time professional effort towards research must be maintained during all PhD research periods.
For example, 75% full time professional effort could be met by – 6 months at 50% effort and 6 months at 100% effort– 12 months at 75% effort
The structure, phasing and level of effort devoted to the dental specialty and the PhD research training in each year of the DSPP should be described in the Career Development Program Plan.
1/10/201810
Example of Six Year DSPP
Year in DSPP Specialty Training Effort
PhD ResearchEffort
Specialty Training Support
K12 AppointmentPhD Support
Year 1 100% 0% Other source Not appointed
Year 2 25% 75% Other source 12 mo. appointmentK12 year 1
Year 3 25% 75% Other source 12 mo. appointmentK12 year 2
Year 4 25% 75% Other source 12 mo. appointmentK12 year 3
Year 5 50% 50% Other source 12 mo. appointmentK12 year 4
Year 6 50% 50% Other source 12 mo. appointmentK12 year 5
1/10/201811
Note: An individual may begin or complete specialty training prior to or following K12 support
Example of Six Year DSPP
Year in DSPP Specialty Training Effort
PhD ResearchEffort
Specialty Training Support
K12 AppointmentPhD Support
Year 1 100% 0% Other source Not appointed
Year 2 25% 75% Other source 12 mo. appointmentK12 year 1
Year 3 25% 75% Other source 12 mo. appointmentK12 year 2
Year 4 25% 75% Other source 12 mo. appointmentK12 year 3
Year 5 50% 50% Other source 12 mo. appointmentK12 year 4
Year 6 50% 50% Other source 12 mo. appointmentK12 year 5
1/10/201812
Note: An individual may begin or complete specialty training prior to or following K12 support
5 years of K12 support
Example of Six Year DSPP
Year in DSPP Specialty Training Effort
PhD ResearchEffort
Specialty Training Support
K12 AppointmentPhD Support
Year 1 100% 0% Other source Not appointed
Year 2 25% 75% Other source 12 mo. appointmentK12 year 1
Year 3 25% 75% Other source 12 mo. appointmentK12 year 2
Year 4 25% 75% Other source 12 mo. appointmentK12 year 3
Year 5 50% 50% Other source 12 mo. appointmentK12 year 4
Year 6 50% 50% Other source 12 mo. appointmentK12 year 5
1/10/201813
Note: Dentist may begin or complete specialty training prior to or following K12 support
5 years of K12 support Specialty Training Begins Prior to PhD Research Training
Example of Six Year DSPP
Year in DSPP Specialty Training Effort
PhD ResearchEffort
Specialty Training Support
K12 AppointmentPhD Support
Year 1 100% 0% Other source Not appointed
Year 2 25% 75% Other source 12 mo. appointmentK12 year 1
Year 3 25% 75% Other source 12 mo. appointmentK12 year 2
Year 4 25% 75% Other source 12 mo. appointmentK12 year 3
Year 5 50% 50% Other source 12 mo. appointmentK12 year 4
Year 6 50% 50% Other source 12 mo. appointmentK12 year 5
1/10/201814
Note: Dentist may begin or complete specialty training prior to or following K12 support
Integrated Clinical and PhD training
Example of a Six-Year DSPP
Year in DSPP Specialty Training Effort
PhD ResearchEffort
Specialty Training Support
K12 AppointmentPhD Support
Year 1 100% 0% Other source Not appointed
Year 2 25% 75% Other source 12 mo. appointmentK12 year 1
Year 3 25% 75% Other source 12 mo. appointmentK12 year 2
Year 4 25% 75% Other source 12 mo. appointmentK12 year 3
Year 5 50% 50% Other source 12 mo. appointmentK12 year 4
Year 6 50% 50% Other source 12 mo. appointmentK12 year 5
1/10/201815
REQUIRED: 3 consecutive years, minimum 75% effort devoted to the PhD
An individual may begin or complete specialty training prior to or following K12 support
Example of a Six-Year DSPP
Year in DSPP Specialty Training Effort
PhD ResearchEffort
Specialty Training Support
K12 AppointmentPhD Support
Year 1 100% 0% Other source Not appointed
Year 2 25% 75% Other source 12 mo. appointmentK12 year 1
Year 3 25% 75% Other source 12 mo. appointmentK12 year 2
Year 4 25% 75% Other source 12 mo. appointmentK12 year 3
Year 5 50% 50% Other source 12 mo. appointmentK12 year 4
Year 6 50% 50% Other source 12 mo. appointmentK12 year 5
1/10/201816 ALLOWED: 2 of 5 years, minimum 50% effort devoted to the PhD
REQUIRED: 3 consecutive years, minimum 75% effort devoted to the PhD
An individual may begin or complete specialty training prior to or following K12 support
Example of a Six-Year DSPP-Budget
Year in DSPP Specialty Training Effort
PhD ResearchEffort
Specialty Training Support
K12 AppointmentPhD Support
Year 1 100% 0% Other source Not appointed
Year 2 25% 75% Other source 12 mo. appointmentK12 year 1
Year 3 25% 75% Other source 12 mo. appointmentK12 year 2
Year 4 25% 75% Other source 12 mo. appointmentK12 year 3
Year 5 50% 50% Other source 12 mo. appointmentK12 year 4
Year 6 50% 50% Other source 12 mo. appointmentK12 year 5
1/10/201817 Applicant Institution Describes Source of Dental Specialty Training Support
PhD Research Effort Supported by K12
An individual may begin or complete specialty training prior to or following K12 support
Example of K12 Salary Support for PhD Component
Year in DSPP Institution salary for full time 12 month
appointment
PhD ResearchEffort
K12 AppointmentSalary Award
Year 1 $100,000 0% $0 (100 % SpecialtyTraining, no K12
appointment)Year 2 $100,000 75% $75,000
Year 3 $100,000 75% $75,000
Year 4 $100,000 75% $75,000
Year 5 $100,000 50% $50,000
Year 6 $100,000 50% $50,000
1/10/20181850% effort of $100,000 salary is $50,000
Dental Specialty and PhD Program (DSPP)Characteristics
• Well-established research, research career development, and clinical programs
• Adequate numbers of highly qualified faculty in clinical departments and departments supporting graduate research training
• Highly qualified and eligible pool of potential DSPP scholars
Should consider:
• Developing innovative and multidisciplinary programs that maximize the research and educational resources of the institution, any collaborating institutions and organizations such as Schools of Dentistry, Medicine and Departments of Chemistry, Engineering, Computational Biology and Bioinformatics, and not-for-profit and private organizations
• Developing Scholar networking and mentoring opportunities with other early career investigators and clinician scientists
• Leveraging resources available at the institution or among dental schools or other organizations such as national scientific or professional organizations to foster a robust DSPP experience for the scholars
1/10/201819
Applicant Institutions
Dental Specialty and PhD Program (DSPP)
• Must have a dental specialty component and a PhD research component
• Successful completion of the DSPP documented by Specialty Certificate or Master's degree and a PhD (or equivalent) degree
• Activities associated with the advanced clinical specialty training are expected to be integrated with the PhD research training, but are not supported by the K12 award.
• Research experience may use a basic, translational science or clinical science approach to problems in dental, oral and craniofacial health research
• Scholars may gain research experience in a clinical trial led by a mentor or co-mentor, as part of their research and career development; Scholars may not lead an independent clinical trial NEW
• Programs should consider instruction and participation in team science-based research approaches, and
• Should provide grant writing experience - Scholars are expected to apply for individual career development/transition awards (e.g., K08, K23, K99/R00)
1/10/201820
K12 DSPP Eligibility Requirements: PD(s)/PI(s)
• Established and active investigator in dental, oral and craniofacial (DOC) research• Experience training PhD students and/or postdocs• Capable of administrative and scientific leadership in the development and
implementation of research training programs• Active peer-reviewed research funding, ongoing independent peer-reviewed research
support at NIH R01 or R01 equivalent levels in DOC research – includes Industry and Foundation support, e.g., $200,000 or more direct cots per year, 3-5 years.
Multiple PD(s)/PI(s) encouraged– Complementary expertise and the potential to enhance multidisciplinary/
interdisciplinary research training opportunities– One PD/PI must have active peer-reviewed research support at the time of
application, and expected to have ongoing peer-reviewed research funding.– Example: Investigator with active peer reviewed research funding, experience with
PhD and/or postdoctoral research training; Clinician who is director of a dental specialty program or has experience with dental specialty training
1/10/201821
Program Director(s)/Principal Investigator(s)
K12 DSPP Eligibility Requirements: Scholars ELIGIBLE• DDS, DMD or equivalent clinical doctoral degree from an accredited
domestic or foreign institution• US citizens, noncitizen nationals, or permanent residents at the
time of K12 appointment. • NIH encourages appointment of individuals from underrepresented
racial and ethnic groups as well as individuals with disabilities.
NOT ELIGIBLE• Dentists who have completed a PhD or equivalent research degree,
or who have completed clinical training in one of the nine ADA recognized dental specialties.
• Individuals who have had previous individual (K) or institutional (K12) mentored career development award support.
• Current and former PD(s)/PI(s) on NIH research project grants or equivalent non-PHS peer-reviewed research grants over $100,000 direct costs per year.
1/10/201822
K12 DSPP Eligibility Requirements: Program Faculty/Mentors
Recommend Two Mentors per DSPP Scholar:• Mentor for the dental specialty training component, such as dental specialty Program
Director or program faculty • Mentor for PhD research training, expected to have active research support, experience
mentoring PhD students and/or postdocs • Mentors from diverse backgrounds, including racial and ethnic minorities, persons with
disabilities, and women are encouraged
Research Mentors: • Research accomplishments: publications and successful competition for research support in
the area(s) of the proposed DSPP • Record of mentoring and research training: PhD students or postdocs who transition to
subsequent research careers such as academia/industry, have peer reviewed research publications, patents, independent peer reviewed research funding
• Research resources: laboratory facilities and resources to support the Scholars’ PhD dissertation research projects
Additional mentors optional: Should provide unique expertise to expand/enhance the scholar’s research training experience.
Mentors expected to work as a team to support Scholar’s successful completion of the DSPP
1/10/201823
RFA-DE-18-012 Specific Application InstructionsPHS 398 Research Training Program Plan
• Career Development Program Program Plan
• Program Administration• Proposed Career Development Program• Program Evaluation
Institutional Environment and Commitment to the Program
• Plan for Instruction in the Responsible Conduct of Research
• Faculty, Scholars and Training Record • Program Faculty• Scholar Candidates
Participating Faculty Biosketches Letters of Support Training Data Tables: 2, 4, 8C Part III Recent Graduates
• Appendix
1/10/201824
NOTE: Substitute the term “scholars” for all references to “trainees” in the SF424 (R&R) Application Guide, and substitute the term “career development” for all references to “training” in the SF424 (R&R) Application Guide.
RFA-DE-18-012 Application InstructionsPHS 398 Research Training Program Plan
Program PlanProgram AdministrationProposed Career Development Program• Describe the objectives of the proposed DSPP, including the dental specialty training
components and the PhD graduate research areas offered under the DSPP.
• Detail the structure, phasing, and duration of the combined Dental Specialty and PhD Program, along with the level of effort devoted to the dental specialty and/or PhD research training in each year of the DSPP.
• Clearly identify the PhD research phase supported by the K12, including the 3 to 5 consecutive years of 12 month scholar appointments, and the required minimum of 9 person month (equivalent to 75% full time professional effort) devoted to the PhD component, per year, for no less than three years.
• Scholars appointed to the K12 for four to five consecutive years may devote a minimum of 6 person months (equivalent to 50% full time professional effort), for one or two of those years, respectively. Note, a minimum of 50% continuous and consistent full time professional effort towards research must be maintained during all PhD research periods.
Program Evaluation
1/10/201825
RFA-DE-18-012 Application InstructionsPHS 398 Research Training Program Plan
Institutional Environment and Commitment to the Program• The sponsoring institution must assure support for the proposed K12 program
including assurance that sufficient time will be allowed for the PDs/PIs and other Program Faculty to contribute to the proposed program, and that there will be protected time for scholars appointed to the K12 that matches the structure and phasing of the proposed DSPP.
• Appropriate institutional commitment to the program includes– Provision of adequate staff, facilities, and educational resources to support the proposed
program– Commitment may include PD(s)/PI(s) salary, administrative support, DSPP Scholar’s salary
or tuition support, or other commitments essential to a successful DSPP – Plans and a description of commitment to support DSPP scholars if continued K12 funding
from NIDCR is not available must be included
1/10/201826
RFA-DE-18-012 Application InstructionsPHS 398 Research Training Program Plan
Program Plan Program FacultyFaculty, Scholars and Training Record - Training Data Tables
Training Data Table 2: Participating Faculty Members Information allows reviewers to assess the distribution of participating faculty by rank (junior vs. senior), by research interests, and by department or interdepartmental program.
Mentoring records of participating faculty permit an evaluation of their experience in facilitating the career progression of predocs and postdocs
Include participating Clinical Faculty for Dental Specialty training and PhD research Faculty Mentors
Summarize these data in the Research Training Program Plan, within the Background Section and the Program Faculty Section of the Program Plan. Use the narrative to describe the distribution of participating faculty by academic rank, department or interdepartmental program, areas of research emphasis, and the rationale for the faculty selected to participate in the training grant. Analyze the data in terms of the overall experience of the faculty in training predoctorates and/or postdoctorates. Comment on the inclusion of faculty whose mentoring records may suggest limited, recent training experience at either training level (predoctoral or postdoctoral).
1/10/201827
RFA-DE-18-012 Application InstructionsPHS 398 Research Training Program Plan
Program Plan Program FacultyFaculty, Scholars and Training Record - Training Data Tables
Training Data Table 4. Research Support of Participating Faculty Membersprovides evidence of:
• strength of the research environment• the availability of funds to support research conducted by the scholars• appropriateness of participating faculty in terms of active research support
Summarize these data in the Program Plan (Program Faculty Section) of the Research Career Development (Training) Program Plan.
• analyze the data in terms of total and average grant support. • comment on the inclusion of faculty without research grant support in the
proposed training program, and • explain how the research of scholars who may work with these faculty
RFA-DE-18-012 Application InstructionsPHS 398 Research Training Program Plan
Program PlanFaculty, Scholars and Training Record Section Scholar Candidates
• Describe the size and qualifications of the pool of potential DSPP scholars, including information about their prior clinical and research training experiences.
• Describe the nomination and selection process for scholars who will be offered admission to the program and appointed to the K12.
• Include criteria for scholar's evaluation and reappointment to the program.
• Present any novel strategies for recruiting qualified dentist scholars.
• Refer to Table 8C Part III, if applicable
1/10/201829
RFA-DE-18-012 Application InstructionsPHS 398 Research Training Program Plan
Faculty, Scholars and Training Record Table 8C. Program Outcomes: Postdoctoral; Part III. Recent Graduates:
For RFA DE-18-012: Table 8C Part III should provide the outcomes of dentist scientists completing programs in the past five years who may or may not have been eligible for appointment to the K12 DSPP program (U.S. citizens and non-citizens).
Applicants should summarize, in the body of the application, key data that highlight the characteristics of the applicant pool, faculty mentors, the educational and career outcomes of individuals with similar experiences in pursuing dental specialty training and PhD research training in a combined and integrated program, and other factors that contribute to the overall environment of the program.
List sequentially all postdoctorates completing the proposed program in the last five years who would have been eligible for appointment, if an NIH training or related award were available.
Summarize the data in the Research Training Program Plan, in the Program Plan SectionRationale• Information on the effectiveness of the proposed research career development program• Data permit evaluation of the effectiveness of similar supported research career
development programs in achieving the research career development objectives
1/10/201830
RFA-DE-18-012 Application InstructionsPHS 398 Research Training Program Plan
1/10/201831
Item 2. Program Plan Section C. Recruitment Plan to Enhance DiversityContent: Proposed Plans New Applications: Include a description of plans to enhance recruitment, including the strategies that will be used to enhance the recruitment of trainees from underrepresented backgrounds.
Item 3. Plan for Instruction in the Responsible Conduct of ResearchAddress each point in the application instructions: 1. Format, 2. Subject Matter, 3. Faculty Participation, 4. Duration of Instruction, 5. Frequency of Instruction
Item 5. Multiple PD/PI Leadership Plan (if applicable) Provide rationale for choosing a multiple PD/PI approach. Describe the governance and organizational structure of the leadership team and the training program, including communication plans, processes for making decisions, and procedures for resolving conflicts. The roles and administrative, technical, and other responsibilities for the training program should be delineated for the PD/PIs and other collaborators.
RFA-DE-18-012 Application InstructionsPHS 398 Research Training Program Plan
1/10/201832
Item 7. Participating Faculty Biosketches: Highlight the relevant experiences of the proposed program faculty according their role(s) and participation in the DSPP.
Item 8. Letters of Support: Include letters of support from participating dental specialty program directors, graduate schools, departments or organizations involved in the DSPP, and any Senior/Key Persons. If the applicant institution has negotiated non-federal support from other partner organizations to support clinicians during the dental specialty training phase of the DSPP, letters describing this commitment must be provided.
K12 Grant Application Page Limits
Section of Application Page Limits *
(if different from FOA,FOA supersedes)
Project Summary/Abstract 30 lines of text Project Narrative Three sentences Introduction to Resubmission Application (if applicable) 3 Program Plan (Attachment 2, PHS 398 Research Training Program Plan form) For K12A. BackgroundB. Program Plan
a. Program Administration (justify MPI, also attach #5 MPI leadership plan)b. Program Faculty (refer to Tables 2 and 4) c. Proposed Training Career Development Program (Describe DSPP)d. Training (DSPP) Program Evaluation e. Trainee Scholar Candidates (number, qualifications, recruitment, selection)f. Institutional Environment and Commitment to DSPP Trainingg. Qualifications of Trainee Scholar Candidates, retention, success/outcomes
(refer to Table 8C Part III) C. Recruitment Plan to Enhance Diversity
25
Plan for Instruction in the Responsible Conduct of Research (Attachment 3 of PHS 398 Research Training Program Plan form) For K12 3
• NIH Guide Notice NOT-OD-17-119; due dates on or after January 25, 2018• Changes relevant to RFA DE-18-012
– Updated appendix policy (see NOT-OD-17-098)– New PHS Human Subjects and Clinical Trials Information Form
All updates to form instructions are listed at: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general/g.120-significant-changes.htm
Beginning with applications submitted to the NIH for due dates on or after January 25, 2018, the only allowable appendix materials are:
• Blank data collection forms, blank survey forms and blank questionnaire forms -- or screenshots thereof
• Simple lists of interview questions
For clarification, these blank forms and lists are not and do not include items such as: data, data compilations, lists of variables or acronyms, data analyses, publications, manuals, instructions, descriptions or drawings/ figures/diagrams of data collection methods or machines/devices
How to Address Human Subjects in the K12 Application
1/10/201837
• K12 DE-18-012 Clinical Trials Not Allowed• Appointed Scholars may propose to gain research experience in
a clinical trial led by a mentor or co-mentor, as part of their research and career development.
• This FOA will not support Scholars proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary study to an existing trial, as part of their research and career development.
PHS Human Subjects and Clinical Trial Information
1/10/201838
T.220 R&R Other Project Information Form
1. Are HS involved? If activities involving human subjects are planned at any time during the proposed project, check “Yes.” Check “Yes” even if the proposed project is exempt from regulations for the Protection of Human Subjects, or if activities involving human subjects are anticipated within the period of award but plans are indefinite. Need help determining whether your application includes human subjects? See the NIH Research Involving Human Subjects website for information https://humansubjects.nih.gov/ and
Infopath Questionnaire designed to walk applicants through the decision process https://humansubjects.nih.gov/questionnaire
If activities involving human subjects are planned at any time during the proposed project, check “Yes.”
If HS research is not planned at any time during scholar’s K12 support, select “No” and skip the rest of the "Are HS involved" section.
• If answer “Yes” or “No” to “Are Human Subjects Involved?”, answer will populate the relevant field in the T.500 – PHS Human Subjects and Clinical Trials Information form.
• Follow the T.500 – PHS Human Subjects and Clinical Trials Information form instructions to complete the relevant questions in that form.
1/10/201839
Section T. 500 If YES to Human SubjectsIf you answered “Yes” to the question “Are Human Subjects Involved?” on the T.220 - R&R Other Project Information Form, add a study record for each proposed study involving human subjects by selecting “Add New Study” or “Add New Delayed Onset Study,” as appropriate.
• K12 applications, if HS yes, expect: Delayed Onset Human Subject Studies
Definition: Human subjects research is anticipated within the period of award but definite plans for this involvement cannot be described in the application.
• Follow instructions for Delayed Onset Stud(ies) provide Study Title Justification Attachment
1/10/201840
Vertebrate Animals – if YES
T.220 R&R Other Project Information FormQuestion 2: Are Vertebrate Animals Involved? Answer YES • If activities involving vertebrate animals are planned at any time
during the scholar’s K12 support period • If animal involvement is anticipated but plans are indefinite
See BOX: Additional Instructions for Training (also K12)• Prior to conducting any animal activities, grantee must submit the
detailed information about the use of animals as required in the instructions in T.420 - PHS 398 Research Training Program Plan, Vertebrate Animals. This detailed information must be submitted to NIDCR for prior approval.
1/10/201841
Vertebrate Animals
T.420-PHS 398 Research Training Program Plan Form
Item 10. Vertebrate Animals if Yes in section T.220 Trainee (Scholar) Participation Only in Research Involving Vertebrate Animals that is Part of Other Research Project Grants: Describe how the institution will ensure that trainees participate only in IACUC-approved vertebrate animal research if the following two conditions apply: • the training (K12 career development) program uses live vertebrate animals
only as part of other research project grants, and • the training (K12 career development) grant does not support the purchase,
use, or husbandry of live vertebrate animals.
After K12 appointment, if scholar will design and conduct their own independent vertebrate animal research, follow T.420 Vertebrate Animals instructions and submit to NIDCR for prior approval
1/10/201842
Application Review Information
For RFA-DE-18-012 DSPP (K12):Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed career development program will prepare individuals for successful, productive dental, oral and craniofacial research careers as dentist scientists with both clinical and research competencies, and thereby exert a sustained influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
• Protections for Human Subjects• Inclusion of Women, Minorities, and Children • Vertebrate Animals • Biohazards
• 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.
1/10/201845
Generally N/A because K12
Scholar research
projects not described –are delayed
onset
Reviewers will evaluate the following items while determining scientific and technical merit, and in providing an overall impact score. Individual scores are not provided.
Additional Review Considerations
Recruitment Plan to Enhance Diversity: Reviewers will examine the strategies to be used in the recruitment of individuals from underrepresented groups.Rated as ACCEPTABLE or UNACCEPTABLE
Training in the Responsible Conduct of Research: Taking into account the specific characteristics of the career development program, the level of scholar experience, and the particular circumstances of the scholars, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components.Rated as ACCEPTABLE or UNACCEPTABLE
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).
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.
1/10/201846
Should not consider these items in providing an overall impact score
Questions?
NIDCR has posted Answers to Questions regarding RFA-DE-18-012, see https://www.nidcr.nih.gov/research/DER/NIDCR-Dental-Specialty-and-PhD-Program.htm.
Potential applicants are encouraged to submit additional questions in by email to [email protected]
RFA-DE-18-012 Application InstructionsPHS 398 Research Training Program Plan
Program PlanProposed Career Development Program• Describe the objectives of the proposed DSPP, including the dental specialty training components and the PhD
graduate research areas offered under the DSPP. Detail the structure, phasing, and duration of the combined Dental Specialty and PhD program, along with the level of effort devoted to the dental specialty and/or PhD research training in each year of the DSPP.
• Clearly identify the PhD research phase supported by the K12, including the 3 to 5 consecutive years of 12 month scholar appointments, and the required minimum of 9 person month (equivalent to 75% full time professional effort) devoted to the PhD component, per year, for no less than three years. Scholars appointed to the K12 for four to five consecutive years may devote a minimum of 6 person months (equivalent to 50% full time professional effort), for one or two of those years, respectively. Note, a minimum of 50% continuous and consistent full time professional effort towards research must be maintained during all PhD research periods.
• Include information about planned courses, seminars, workshops, mentored research experiences, and any activities that will be incorporated into the career development program. Identify activities that will foster the research career development of the scholars, including instruction and training in laboratory and project management, in oral and written presentations, and skills needed to apply for NIH individual career development (K) awards or research grant support. All scholars should be expected to submit applications for individual career development awards (K) before they complete the DSPP.
• Provide a plan and timeline to monitor progress of the scholars in the DSPP, and an administrative structure that facilitates successful adherence to this anticipated timeline, including potential corrective measures if plans and any milestones are not met.
• Describe how program activities will foster the career development of clinician scientists and develop the working knowledge needed for scholars to select among and prepare for the next step in research career options available in the biomedical, behavioral and social science research workforce. Consider team science-based research approaches, depending upon the goals of the proposed DSPP.
1/10/201849
RFA-DE-18-012 Application InstructionsPHS 398 Research Training Program Plan
Program PlanProgram Administration• Describe the acknowledged strengths, leadership and administrative skills, mentoring experience, scientific
expertise, and active research of the PD(s)/PI(s). If multiple PD(s)/PI(s) are proposed, describe their complementary leadership and expertise in administering the program, and relate these strengths to the proposed management of the K12 career development DSPP. Describe the respective roles of those in leadership positions and the planned strategy and administrative structure to be used to oversee and monitor the program. Include milestones to be used to monitor scholar progress in the dental specialty component and the PhD component, and in the coordination of activities in the overall DSPP. If there are multiple PDs/PIs, then the plan for Program Administration is expected to synergize with the “Multiple PD/PI Leadership Plan” section of the application.
• Institutions must provide evidence of the ability to establish or successfully implement an integrated specialty and PhD training program for dentist scientists, including coordination among participating schools and departments within the dental, medical and other graduate schools.
• Describe recruitment plans and criteria for selecting dentists to participate in the DSPP and to be appointed as K12 scholars. A timeline of activities for the DSPP, including recruitment activities, and the selection and appointment of scholars should be included.
• Institutions with existing research training or career development programs must explain what distinguishes this K12 program from the others, how their programs will synergize with one another, if applicable, and make it clear that the pool of faculty, potential scholars, and resources are robust enough to support an additional K12 program. When a program administrator position is planned, a description of the scientific expertise, leadership, and administrative capabilities essential to coordinate a program for developing investigators must be included in the application.
1/10/201850
RFA-DE-18-012 Application InstructionsPHS 398 Research Training Program Plan
Program Plan Faculty, Scholars and Training Record SectionProgram Faculty
• Provide information about the program faculty who will serve as mentors for the dental specialty training and for the PhD research training components of the DSPP, and who can provide guidance and expertise appropriate to the experiences of the DSPP scholars intended to be supported by the K12. Describe mentor training programs or other resources for mentor development that are available to program faculty to ensure effective mentoring experiences.
• Each scholar must have two mentors, one mentor with expertise in the scholar’s dental specialty training and a primary mentor for research career development, who will work together to provide mentored supervision and support of the integrated specialty training and research training. These mentors must be supportive of the scholar's activities and progress in achieving the goals of the DSPP. Additional mentors are optional. The process of selecting mentors, assessing the mentoring relationships with the scholars and among program faculty, and mediating any challenges should be provided.
• If a mentor will supervise a scholar proposing to gain research experience in a clinical trial, provide documentation of his/her expertise, experience, and ability to provide appropriate guidance and help the scholar to meet the study timelines.
1/10/201851
Application Review InformationProgram Director(s)/Principal Investigator(s) (PD(s)/PI(s)• Do the PD(s)/PI(s) and Research Administrator (if applicable) have the experience
to develop, direct and administer the proposed program?• Does the leadership team bring complementary and integrated expertise to the
program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives?
• Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed career development program?
• Are the PD(s)/PI(s) currently engaged in research relevant to the scientific area of the proposed program?
For applications designating multiple PDs/PIs:• Is a strong justification provided that the multiple PD/PI leadership approach will
benefit the career development program and the scholars?• Is a strong and compelling leadership approach evident, including the designated
roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the career development program and the complementary expertise of the PDs/PIs?
1/10/201852
Application Review InformationCareer Development Program and Environment• Does the proposed program clearly outline a plan to recruit and develop well-qualified junior
investigators for successful careers as biomedical or clinical researchers?• Is there evidence of an adequate pool of potential scholars who could benefit from receiving career
development support? • Are the content and duration of any proposed didactic, training-related, and research-related activities of
the program appropriate? • Are appropriate timelines indicated for career progression and transition to independence? • Does the institutional environment (e.g., research facilities and other relevant resources) in which the
program will be conducted contribute to the probability of success? • Does the proposed career development program benefit from unique features of the scientific
environment, subject populations, or employ useful collaborative arrangements? • Is the institutional commitment to the proposed program appropriate? • If multiple sites are participating, is this adequately justified in terms of the career development and
research experiences provided? • Is there sufficient assurance that the required effort of the PD(s)/PI(s), mentors and scholars will be
devoted directly to the research training, career development, and related activities? • When applicable, is there adequate documentation describing the responsibilities of the advisory
committee with regards to the provision of input, guidance and oversight of the proposed Career Development Program?
1/10/201853
Application Review InformationCareer Development Program and Environment• Are the plans for identifying and recruiting dentists likely to ensure the selection and
matriculation of qualified individuals who are committed to completing the DSPP and pursuing independent research careers?
• Does the structure and content of the DSPP incorporate the unique research development and clinical specialty training needs of DSPP scholars that will enable these individuals to complete the dental specialty and PhD research programs with requisite competencies in both areas?
• Are plans for monitoring scholars' progress and meeting milestones in the DSPP likely to ensure timely and successful completion of the program? Are corrective measures included if progress or milestones are not met?
• Is the proposed DSPP likely to ensure scholars will be well prepared for academic research careers?
• Are the program's career development activities likely to enhance the scholars' ability to compete successfully for individual NIH career development awards or other independent research support?
• Is the proposed overall evaluation of the program likely to provide informative metrics and feedback on the institution's DSPP and identify specific strengths and areas to enhance the program?
1/10/201854
Application Review InformationMentors• Do the mentors have appropriate expertise and experience, as well as track
records of past successful mentoring and training PhD graduate students or dentists pursuing specialty training?
• Are the quality and extent of the mentors’ roles in providing guidance and scientific advice and career development to the scholars acceptable?
• Do the clinical mentors have relevant experience as directors of dental specialty programs or as participating faculty of dental specialty programs?
• To what extent are the mentors currently engaged in dental, oral and craniofacial research?
• Are appropriate plans in place to ensure effective co-mentoring, and mediation if necessary, to ensure a scholar's successful and timely completion of the DSPP?
• If a Scholar is proposing to gain experience in a clinical trial as part of his or her research career development, is there evidence of the appropriate expertise, experience, and ability on the part of the mentor(s) to guide the Scholar during participation in the clinical trial?
1/10/201855
Application Review InformationScholars• Is a recruitment plan proposed with strategies likely to attract high quality scholars?
Are there well-defined and well justified recruitment and selection strategies?• Is there evidence of a sufficiently large, competitive scholar pool to warrant the
proposed size of the career development program?• Are the content, phasing, and proposed duration of the career development plan
appropriate for achieving scientific independence of the scholars?• What is the likelihood that the career development plan will contribute significantly to
the scientific development of the scholars?
Training Record• Is there evidence of a successful past training record of the PD/PI and mentors,
including the success of former scholars in seeking independent research support and establishing productive scientific careers?
• Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the proposed K12 career development program and objectives?
