COBRE CBHD Phase 2 Renewal RFA

Proposal Submission Deadlines and Award Announcements

Preliminary Application

Interested applicants are required to submit a Preliminary Application through the UFunds online portal no later than 5 p.m. ET on Monday, April 6, 2020.  

Non-Brown faculty must request access to UFunds. Non-Brown faculty should email [email protected] to request access to UFunds in order to submit an application.

Invitations to submit a full proposal will be announced the week of April 13, 2020.

Full Proposal

Invited full proposals must be submitted no later than 5 p.m. ET on Monday, May 18, 2020, through the UFunds portal.

Individuals from underrepresented minority groups are encouraged to apply.

Eligibility Requirements

  1. Applicants must have a faculty appointment (or equivalent) at Brown University or its affiliated hospitals at the time of application.
  2. Established investigators of any faculty rank may apply if they are making significant changes to their career goals and are proposing new lines of research that are significantly different from their current investigative program.
  3. Applicants must propose work that is consistent with the goals of the COBRE Center for Computational Biology of Human Disease.
  4. At the time of application, the applicant's home institution must demonstrate, in a letter(s) from the Dean, the Provost, or equivalent senior institutional official(s), a clear commitment to support a multi-year faculty appointment for the proposed COBRE applicant independent of the outcome of this grant application.
  5. Two Mentor(s) should be designated.  They should both be established faculty investigators of the rank of Associate Professor or above with experience and demonstrated success as research supervisors. One Mentor should have expertise in the biological or clincal approaches to human disease, and the other mentor should have expertise in computational or statistical approaches to human disease.
  6. The applicant cannot be receiving or have previously received external funding in the role of a PI or co-PI from an R01 or equivalent (e.g., VA Merit Review or NSF grant).
  7. A PI cannot hold funding from Advance-CTR, INBRE, COBRE, or any other IDeA mechanism of support at the same time as receiving COBRE CBHD funding.
  8. The proposed COBRE CBHD Research Project should not have significant scientific or budgetary overlap with another funded project.

Questions regarding applicant eligibility should be emailed to [email protected].

 

Overview

COBRE Center for Computational Biology of Human Disease (CBHD)

The goal of the COBRE Center for Computational Biology of Human Disease (CBHD) is to build a computational biology infrastructure for the greater Brown and affiliated hospital environments that will benefit the study of human disease across all of Rhode Island.  A central component of this COBRE Program is to support the research activities of junior investigators who are doing research in human disease-related areas that require significant computational analyses of large data sets and to provide mentoring to ensure their transition to independent R01-funded investigators.  Awardees will gain access to the Computational Biology Core of staff data scientists.

Funding Available

The COBRE Phase 2 Renewal Research Project Program will fund three to five research projects for two to three years at up to $175,000 per year.  Research Projects selected will be part of the Phase 2 renewal competing application that will be submitted to NIGMS by 5 p.m. on September 28, 2020. 

Performance Period

The anticipated performance period is 7/1/2021 to 6/30/2026.  The applicant should propose a project that can be completed in 2 years and are expected to graduate in 2 to 3 years; however, they will complete budget forms for 5 years. 

Awardee and Mentor Responsibilities

Investigators and mentor(s) will be expected to meet on a regular, pre-specified basis to review progress in the goals of the application. A mentorship plan must be established and submitted with the mentor(s) letter of support at the time of application. The mentorship plan should address:

  • A communications strategy that fosters consistent and intensive interactions to ensure completion of the project and any relevant training.
  • The nature and frequency of the interaction between the mentor(s) and investigators for the duration of the award.
  • How the training plan supports the proposed research.  

Awardee Responsibilities

Investigators selected for a Research Project award will be required to:

  1. Obtain IRB and IACUC approval, as applicable, before funding can be awarded. Applicants are strongly encouraged to have these processes underway at the time of application.
  2. Present a seminar describing the project and results at a COBRE CBHD Seminar Series session as well as at the COBRE CBHD External Advisory Committee Spring Meeting.
  3. Present a poster at the RI NIH IDeA Symposium and a talk, if invited.
  4. Complete FCOI assurance and training as detailed under their respective organization’s policy.
  5. Attend all required program-related seminars and conferences (to be specified).
  6. Complete quarterly progress reports.
  7. Complete a formal annual report.
  8. Complete COBRE CBHD and Computational Biology Core surveys, as requested.
  9. Acknowledge sponsorship from COBRE CBHD supported by the IDeA COBRE grant (P20GM109035) in all research publications during the performance period. Future publications related to this research must also acknowledge COBRE CBHD support.
  10. Report all presentations, publications, and extramural funding that arise from this award to COBRE CBHD by emailing [email protected].
  11. Maintain updated VIVO profiles if Brown University-affiliated.
  12. Acquire ORCID identifiers.
  13. Use the Computational Biology Core.
  14. Respond to COBRE CBHD queries for information after the grant ends.

Mentor Responsibilities

Mentors will be required to provide the awarded investigators with research guidance toward an independent research career through a planned series of meetings and activities as well as frequent discussions and guidance as needed. Mentors are also expected to review and complete quarterly reports with their mentees.

 

Application Instructions

To apply for a Research Project award, investigators must first submit a Preliminary Application to COBRE CBHD. Selected applicants will then be invited to submit full proposals.

Preliminary Application Submission Instructions

Prospective applicants must submit a Preliminary Application through the UFunds online portal no later than 5 p.m. on Monday, April 6, 2020.

Non-Brown faculty must request access to UFunds. Non-Brown faculty should email [email protected] to request access to UFunds in order to submit an application.

The Preliminary Application must include the following:

  1. Contact and academic information as requested via the UFunds application page.
  2. Structured one-page overview of research aims, significance, and approach.
  3. References.
  4. NIH-formatted biosketch for each investigator and mentor.
  5. Other Support document for each investigator
  6. Letter from dean, provost or other equivalent senior institutional official(s) from the project leader’s home institution demonstrating a clear commitment to support a multi-year faculty appointment for the proposed Research Project Leader independent of the outcome of the COBRE grant application.

Preliminary Applications will be reviewed according to criteria outlined in the Review Process and Selection Criteria section below. Applicants will be notified during the week of April 13, 2020, if they are invited to submit a full proposal.

The Advance-CTR website provides an article on the 8 Elements of a Successful Preliminary Application that provides excellent guidance for preparing your one-page COBRE CBHD Project preliminary application. 

Full Proposal Submission Instructions

Full proposals are due through UFunds no later than 5 p.m. on Monday, May 18, 2020. COBRE CBHD will not consider applications that are incomplete. Complete applications must include the following sections:

Proposal Content

Face Page: (PHS 398 Form Page 1)

The Face Page should include Contact PI name, academic title, institution, address, title of project, and the name of the institutional grant management official. (Note: This form does not need to be signed by an institutional official at the time of submission.)

Project Summary, NIH Page 2: (PHS 398 Form Page 2)

The Project Summary should be a succinct and accurate description of the proposed work. State the application's broad, long-term objectives and specific aims, making reference to the health relatedness of the project. Concisely describe the research design and methods for achieving the stated goals. The summary should be informative to other persons working in the same or related fields and, insofar as possible, understandable to a scientifically or technically literate reader. Avoid describing past accomplishments and the use of first person.

Additionally, the following sections of the Project Summary form should be completed:

  • Relevance: Describe the relevance of this research to computational biology of human disease. Be succinct (using no more than two or three sentences) and use plain language that can be understood by a general, lay audience.
  • Project/Performance Site Primary Location: Include the information pertinent to the contact PI’s home institution.
  • Additional Project/Performance Site Location: Include the information pertaining to any additional performance sites. If more than two performance sites will be used, list additional sites on the PHS 398 Project/Performance Site Format Page.
  • Senior Key Personnel: Include the Contact PI and mentor(s) for the project. Anyone listed in Senior Key Personnel must include a biosketch and Other Support document in the application.

Budget: (PHS 398 Form Page 4 and Form Page 5)

The anticipated budget period is 7/1/2021 to 6/30/2026. The applicant should propose a project that can be completed in 2 years and are expected to graduate in 2 to 3 years; however, they will complete budget forms for 5 years. 

Project Leaders must do 6 months of effort on this award each year.  Investigators providing effort without salary support are considered cost shared and must obtain a letter from an authorized organizational official (e.g., Director of Sponsored Projects Office) approving the cost share. Please reference the Letters of Support section below.

The guidelines below should be used to complete the PHS 398 budget form:

  • Personnel: Indicate the investigator’s name on the “PD/PI” line, number of calendar months dedicated to the proposed research, institutional base salary, requested salary, and associated fringe benefits. Investigators not receiving salary support should still be listed in the budget with effort indicated.
  • DO NOT INCLUDE MENTORS IN THIS BUDGET. MENTOR BUDGETS WILL BE REQUESTED SEPARATELY AND WILL COME FROM THE PARENT GRANT ADMINISTRATIVE CORE.
  • Consultant Costs: If consultant costs are budgeted, include the consultant’s rate and total costs.
  • Equipment: Equipment (durable items valued at $5,000+) is allowed for this award.
  • Supplies: Allowable supply costs include computer software necessary for the project, laboratory supplies and services, animal and per diem housing expenses, publication costs, and participant stipends. General office supplies are not allowed for this award.
  • Travel: Travel can be budgeted for travel related to research performance or dissemination of results. Please specify Domestic or Foreign Travel and include estimates for lodging, food, and travel.
  • Other Expenses: List any other costs itemized by category, if any.
  • Consortium/Contractual Costs: Include consortium or contractual costs required to accomplish the proposed research, if any.  Subawards cannot be given to non-COBRE states. 

Budget Justification: (PHS 398 Continuation Format Page)

Provide detailed justifications for all items requested in the budget(s). Separate justifications must be submitted for each institution requesting support.

Separate Mentor Budgets: (PHS 398 Form Page 4 and Form Page 5)

Each mentor should complete a separate budget for 0.5 months of effort each year to serve as mentor.  The anticipated budget period is 7/1/2021 to 6/30/2026. The mentor will serve for 2 to 3 years for the proposed mentee but will provide a 5-year budget as a placeholder for future mentors.

  • Personnel: Indicate the mentor’s name on the “PD/PI” line, number of calendar months or academic and summer months not to exceed 0.5 months dedicated to the mentoring activities on this grant, institutional base salary, requested salary, and associated fringe benefits.

Mentor Budget Justification: (PHS 398 Continuation Format Page)

Each mentor should provide a budget justification in the personnel section that describes their role as mentor as well as their experience and qualifications to mentor this project. 

Mentor Checklist: (PHS 398 Checklist Form Page)

A mentor checklist is only required if the mentor’s home institution is not Brown University, and is from a COBRE state.  Complete Section 3 only, “Facilities and Administrative Costs” using the home institution’s F&A rate.

For a mentor from a non-COBRE state, a checklist is not required since subawards are not allowed to non-COBRE states.  Non-COBRE state mentors will be set up using a Professional Service Agreement or Fee for Service Agreement that will pay 0.5 months effort including salary & fringe rates up to the NIH Salary Cap. 

Biographical Sketch (5-page maximum): (Biographical Sketch Format Page, Instructions and Sample)

A NIH-formatted biosketch is required for each investigator and mentor. If you do not have an eRA Commons user name, you must obtain one to include in the biosketch. Biosketches should not exceed 5 pages.  Be sure to include PMCID numbers for publications listed on your Biosketch.

The personal statement in the biosketch should briefly describe why your experience and qualifications make you particularly well-suited for a Research Project award. In the Research Funding section, include other grant support and explain the relationship of each grant to the proposed project, including any scientific or budgetary overlap. Please adhere to the NIH guidelines for your biographical sketch.

Biographical sketches should also be included for the mentors. The personal statement in the biosketches for the mentors should briefly describe the mentor’s experience and qualifications for being a mentor on this project.  

Resources: (PHS 398 Resources Format page)

Describe space, equipment, and other facilities available for the applicant to accomplish this research project. The Resources Format page must be completed for each Performance Site listed on PHS 398 Form Page 2.

Checklist: (PHS 398 Checklist Form Page)

Complete Section 3 only, “Facilities and Administrative Costs” using the home institution’s F&A rate.

Research Plan (6-page maximum): (PHS 398 Continuation Format Page)

The format of the Research Plan should follow the outline below exactly. Begin each section of the Research Plan with a section header (e.g., Specific Aims, Significance, etc.).

  • Specific aims: Describe the goals and objectives of the research project (up to 1 page).
  • Significance: Include overall significance of the project, including the previous research in the area and relevance to comnputational biology of human disease (up to 0.5 page).
  • Innovation: Describe both the conceptual and technical innovation of the proposed project (up to 0.5 page).
  • Approach: Describe the experimental design and methods, including an appropriate analysis plan. Present preliminary data if available (up to 3.5 pages).
    • Up to 0.5 page of the 3.5-page approach should focus on detailing the statistical analysis plan for the proposed project.
  • Timeline: Include approximate completion dates for the defined specific aims and above outlined awardee responsibilities (up to 0.5 page).

References

Provide a bibliography of any references cited in the Research Plan. Be sure to include PMCID numbers.

Future Funding Plans (500-word maximum, submitted in UFunds)

Describe plans to submit applications for future funding. This response should not be uploaded, but submitted via the appropriate UFunds query field.

The below table summarizes required proposal content outlined in this section:

Section

Description

Limits

Face Page

Provide the requested administrative information.

n/a

Project Summary

Complete the Project Summary, Relevance, Project/Performance Site Primary Location, and Senior Key Personnel.

n/a

Budget

Complete Pages 4 and 5 of the NIH 398 form for each applicant, mentor, and institution requesting support.

n/a

Budget Justification

Provide clear, succinct justification for each requested budget item for each applicant, mentor, and institution requesting support.

n/a

Biographical Sketches

Include for all proposed key personnel, including mentors.

5 pages (each)

Resources

Detail space, equipment, and other resources available for research.

n/a

Checklist

Complete Section 3 of PHS 398 Checklist Page for each institution.

n/a

Research Plan

 

6 pages

Specific Aims

Project specific aims.

1 page

Significance & Innovation

Overall significance of the project, including pertinent background information, previous research in the area, and relevance to health care needs in Rhode Island.

0.5 page

Innovation

Outline both conceptual and technical innovation.

0.5 page

Approach

Preliminary data* and research plan, including expected results, alternative approaches, and analysis plan. Include discussion of scientific rigor and biological variables.

(Note: up to 0.5 page should focus on detailing the statistical analysis plan for the proposed project.)

3.5 pages

Timeline

Indicate dates for completion of Specific Aims, manuscript submission, and extramural grant applications submission.

0.5 page

References

Provide citations for any references used in the Research Plan.

n/a

Future Funding Plans

Describe plans to submit application for future funding.

500 words

*Preliminary data are encouraged, but not required.

Regulatory Information

Be sure to address the Human Subjects, Vertebrate Animals, and Biosafety/Safety Agents sections as described below. Be sure to indicate the IRB and IACUC approvals or status as applicable to your proposed research. Human Subjects education certification(s) must be up-to-date and available upon request for all personnel involved in the conduct of human subject research.

 

PHS Human Subjects and Clinical Trials Information

Click here for PHS Human Subjects and Clinical Trials Information Instructions.

The PHS Human Subjects and Clinical Trials Form must be completed for ALL projects. NOTE: you must download the file and open it outside of a browser to view this form. 

Non-Human Subjects projects are required to complete the PHS Human Subjects and Clinical Trials Form.

Human Subjects projects must include:

To determine whether human subjects are involved, complete the “Am I doing Human Subjects Research?” Questionnaire. To help identify whether research that involves the use of human data or biological specimens is human subjects research, refer to this flowchart.

Vertebrate Animals Section

Refer to Vertebrate Animals NIH Instructions and the Worksheet for Applications Involving Animals. If vertebrate animals are involved, address each point below. Provide a concise, complete description of the animals and proposed procedures. While additional details may be included in the Research Plan, the responses to the four required points must be cohesive and include sufficient detail. 

If all or part of the proposed research involving vertebrate animals will take place at alternate sites (such as project/performance or collaborating site(s)), identify those sites and describe the activities at those locations.

Although no specific page limitation applies to this section, be succinct. Failure to address the following four points will result in the application being designated as incomplete and will be grounds for NIGMS to defer approval of the application. The three points are as follows:

  1. Description of Procedures: Provide a concise description of the proposed procedures to be used that involve vertebrate animals in the work outlined in the “Research Plan” attachment. Identify the species, strains, ages, sex, and total numbers of animals by species, to be used in the proposed work. If dogs or cats are proposed, provide the source of the animals.
  2. Justifications: Provide justification that the species are appropriate for the proposed research. Explain why the research goals cannot be accomplished using an alternative model (e.g. computational, human, invertebrate, in vitro). 
  3. Minimization of Pain and Distress: Describe the interventions including analgesia, anesthesia, sedation, palliative care and humane endpoints that will be used to minimize discomfort, distress, pain, and injury.
  4. Method of Euthanasia: Provide a justification for methods of euthanasia that are not consistent with the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals. o If answer is “No” to the question “Is method consistent with AVMA guidelines?”, describe the method and provide scientific justification in the text field provided.

Do not use the vertebrate animal section to circumvent the page limits of the Research Plan.

Biosafety/Select Agents

Refer to Select Agents NIH Instructions. Indicate Institutional Safety Committee approvals.

Letters of Support

  1. Research Administration: If the applicant or mentor is not employed by Brown University, a signed Letter of Intent (LOI) from the applicant or mentor’s home institution’s office of research administration must be included. If the applicant or mentor is not receiving salary support, the LOI(s) must explicitly approve of the cost share and list the dollar amount of the cost share.
  2. Department Chair(s): Letter(s) from the Department Chair(s) and/or supervisor(s) for each investigator documenting the availability of protected time for research must be included. If a Brown University PI is not receiving salary support, the letter must explicitly approve cost share and list the dollar amount of the cost share.
  3. Senior Institutional Official: Letter from dean, provost or other equivalent senior institutional official(s) from the project leader’s home institution demonstrating a clear commitment to support a multi-year faculty appointment for the proposed Research Project Leader independent of the outcome of the COBRE grant application.
  4. Mentor(s): Letter(s) from the mentor(s) agreeing to advise on the conduct of the proposed research and describing plans for mentoring the junior investigator(s) must be included with the application.

 

Application Format

Applications should follow an abbreviated NIH format with minor modifications. This application requires the use of the most recent version of the PHS 398 Forms.

Font: Arial, Helvetica, Palatino Linotype or Georgia typeface and a font size of 11 points or larger must be used. A Symbol font may be used to insert Greek letters or special characters; the font size requirement still applies. A smaller font size may be used for figures, graphs, diagrams, charts, tables, figure legends, and footnotes, but this type must follow the font typeface requirement and be readily legible.

Margins: Margins should be 0.5 inch.

 

Review Process and Selection Criteria

Preliminary Applications

Reviews of Preliminary Applications will be conducted by the COBRE CBHD Internal Advisory Committee (IAC) or a Committee chosen by them.

Reviews of Preliminary Applications will focus on:

  1. Responsiveness to eligibility requirements and program goals.
  2. Scientific Merit of the work.
  3. Potential for the award to provide a basis for further research support from external sponsors
  4. Potential impact of the research on human disease
  5. Use of computational  biology methods for data analysis
  6. Likelihood the proposed work will be completed during the award period
  7. Strength of the potential investigator to become a leading independent researcher.
  8. Factors that increase the inclusion of underrepresented groups.

Full Applications

Reviewers of the full applications will include the Internal Advisory Committee and others who have content area or method expertise relevant to the individual proposals. All reviewers will be highly qualified faculty from Brown University and its affiliated hospitals. Final selections will be made and sent to the COBRE CBHD External Advisory Committee and NIGMS for final approval.

Applications will be reviewed using the following criteria:

  1. Responsiveness to the RFA, including the project’s relevance to human disease-related areas that require significant computational analyses of large data sets
  2. Scientific impact and soundness of the experimental design, including plans for data analysis.
  3. Technical and conceptual innovation.
  4. Training and expertise of the applicants and their ability to perform the proposed research.
  5. Scientific and mentoring expertise of the mentor(s).
  6. Project environment, including facilities, resources, and adequacy of the patient population, if applicable.
  7. Reasonable and justified budget that is appropriate for the proposed research.
  8. Likelihood that the project will lead to external funding.

Funding is dependent upon final review and approval by the COBRE CBHD External Advisory Committee and NIGMS.

Since NIGMS requires IACUC and IRB approval PRIOR to funding, applicants are strongly encouraged to obtain or commence the regulatory approval process(es) at the time of application. IRB and IACUC approvals must be obtained by September 11, 2020 or applicants risk loss of funding.  

Dates and Deadlines

April 6, 2020                  Preliminary Application due

April 13-17, 2020            Selected applicants invited to submit a Full Proposal

May 18, 2020                      Invited Full Proposal due

June 15, 2020                      Research Project choices announced (anticipated)

July 15, 2020                       Final version of Research Project Proposals due

September 18, 2020            COBRE CBHD Phase 2 Competing Renewal submitted to BMRA

September 11, 2020            Regulatory approvals must be obtained

September 28, 2020            COBRE CBHD Phase 2 Competing Renewal submitted to NIGMS

March/April 2021                  NIH Scientific Merit Review

May 2021                             NIH Advisory Council Review

July 1, 2021                         Research Project funding begins (anticipated)

 

Questions

Address inquiries regarding the COBRE CBHD Research Projects Program to [email protected]