RFP

 REQUEST FOR PROPOSAL

https://lri.hms.harvard.edu

 

Release date: Monday, April 4, 2022

Full proposal due: Monday, May 23, 2022 

Funding start date: Thursday, September 1, 2022

 

Background and Purpose: The Fairbairn Family Lyme Research Initiative at Harvard Medical School (LRI) is designed to support basic and applied research in Lyme disease. The goal of this RFP is to deepen our understanding of the drivers of the diverse presentation of Lyme disease, with the expectation that improved scientific understanding of the disease will help guide diagnosis and treatment. 

 

The RFP’s main purpose is to support rigorous basic and applied research proposals that advance our understanding of the pathogenesis of Lyme disease and its diverse clinical manifestations. LRI aims are to encourage collaborative research that will bring new approaches to bear on the disease. Emphasis will be placed on studying the biology of Borrelia infection, identifying mechanisms responsible for different pathologies using a multidisciplinary approach, and dissecting the interactions between Borrelia and the host’s immune and nervous systems. This program aspires to facilitate further understanding of the complex pathogenesis and presentation of Lyme by fostering a multidisciplinary, collaborative effort by the research community with application of emerging fields.

 

Examples of areas of focus include, but are not limited, to:

  • Deeper understanding of the biology of Borrelia spp
  • Host-pathogen dynamics and interaction with the host’s immune and nervous systems
  • Development of new model systems to study host-pathogen interactions
  • Pathogenesis of neurologic and rheumatic effects in Lyme disease
  • Sequelae related to pathogenicity of Borrelia (e.g., immunologic, neurological)
  • The possible role of strain variability or tick co-infection with Borrelia and other pathogens driving the diversity of disease phenotypes
  • Role of multifactorial triggers (e.g., environmental) and underlying conditions in Lyme disease
  • Possible new diagnostics or therapeutics in Lyme disease

 

The LRI will provide funding and other support to help faculty in the HMS Quad and HMS-affiliated institutions identify promising, Lyme-related projects and conduct cutting-edge, multidisciplinary research to unravel pathogenic mechanisms of Lyme disease.

 

This RFP will be overseen by the LRI Scientific Review Committee, which is chaired by HMS senior leadership and comprised of faculty from HMS and the HMS-affiliated institutions. The program will be managed by the HMS Therapeutics Translator. Applicants and awardees will receive scientific project management support to advance and expedite proposals and projects.  

 

I. Application Timeline

Monday, April 4, 2022

 

RFP release  

Monday, May 23, 2022     

 

Deadline for submission of full proposals (5 pm ET)

Monday, July 11, 2022    

 

Notification of new awards for 2022

Thursday, September 1, 2022    

 

Funding start date for new awards

II. Program Eligibility

Applicants Eligible for Funding:  Assistant professors, associate professors, and professors who have research programs located in the HMS Quadrangle or the Harvard-affiliated hospitals and institutions are eligible to apply for funding as lead Principal Investigator (PI).  

 

Faculty members with appointments as assistant professor, associate professor, or full professor at HMS, other Harvard Schools, or HMS-affiliated hospitals and institutions are eligible as Co-PIs. Proposals are encouraged to include one or more Co-PIs, although inclusion of a Co-PI is not required. Instructors, Lecturers, and trainees (e.g., students, clinical trainees, postdoctoral fellows, and clinical fellows) cannot serve as the Lead PI or Co-PI of an application.

 

Inclusion of Collaborators Outside the Harvard Community:  Lead PIs who meet the eligibility requirements may request to include Co-PIs outside the Harvard Community if the collaborator’s involvement is essential to the project. Any applications utilizing such collaborators must include a paragraph in their cover page stating the reason for this specific collaborator’s involvement and the need to seek a collaborator’s expertise outside the Harvard community. The Co-PI from the collaborating institution must have PI status at his/her institution. The application must include a separate PHS 398 Face Page for the Co-PI, with signature from an institutional authorized official.

 

 

Activities Eligible for Funding:  The focus of the proposal should be basic or applied research that has the potential to unravel pathogenic mechanisms, mechanism of action, and/or host-pathogen interactions that advance our understanding of the pathogenesis of Lyme disease and its diverse clinical manifestations.  The committee has a broad view and will consider projects involving basic and applied research within the fields of microbiology, immunology, neurobiology, and related areas.

 

 

III. Award Types and Funding Levels

Awards are intended to support early-stage research, proof-of-concept research, and other research activities that (if successful) would establish a basis for a subsequent proposal for funding by public or private agencies, other institutional sources, or potentially industry. Within established budgetary parameters (see below), projects will be funded at the level deemed necessary to achieve the proposed research objectives. It is anticipated that up to 3 new awards will be made in 2022.

 

Awards will be funded at a level of up to $75,000 (total costs) over a period of up to one (1) year. Collaborative projects that have one or more Co-PIs will be funded at a level of up to $100,000 (total costs) over a period of up to one (1) year. 

 

IV. Proposal Submission, Review, and Selection Process

  1. Full proposals (submission deadline: Monday, May 23 2022 at 5:00 PM ET)

The format for full proposals is shown in Appendix A. The LRI Scientific Project Manager will be available to work with PIs to assist in the development of full proposals, in particular with respect to describing the impact and establishing a research plan and timeline. Full proposals will undergo a confidential review process by the LRI Scientific Review Committee with consultation, as needed, from expert reviewers selected from the HMS community or external sources. The LRI Scientific Review Committee will make all funding recommendations.  

 

2. Evaluation criteria

The goal of LRI funding is to support innovative, investigator-initiated research that will lead to a better understanding of the pathogenesis of Lyme disease. The Scientific Review Committee will review all submitted proposals, including research plan, timeline and budget. Proposals will be evaluated based on their scientific merit and relevance, including their potential for impact and for contributing to a better understanding of the pathobiology and host-pathogen interactions in Lyme disease. The Scientific Review Committee anticipates notification to all final selected awardees by July 2022. Applicants may contact Dr. Isabel Chico-Calero (Isabel_chico-calero@hms.harvard.edu) and Dr. Joseph Beyene (joseph_beyene@hms.harvard.edu) with questions about the proposal submission, review, and selection process.

 

 

V. Budget and Funding Period

 

The period of performance is one year.  Ongoing and frequent project review will be conducted during the life of the award. No-cost extensions may be granted, subject to demonstrated progress and approval by LRI.

 

Funding may be used only for research directly related to and budgeted under the project, and may not be used for any other purpose. Budget items may include PI salary and capital equipment but not computers or travel.

 

Indirect costs required by lead PIs and Co-PIs at other Harvard affiliated institutions must be budgeted within the award amount and are capped at a maximum rate of 15% of total direct costs allocated to such institution. No additional funds to cover indirect costs will be provided. 

 

Re-budgeting within and between budget categories will be allowed to meet unanticipated needs and to adjust for post-award findings, changes in personnel, etc. Funds may be rebudgeted without prior approval as long as no single direct cost category in the budget changes by an amount that exceeds 25% of the total costs awarded. Changes to the budget that lead to an increase or decrease in a single direct cost budget category of more than 25% of the total costs awarded require prior approval.

 

VI. During the Award

For each LRI project, the research team (PI and research personnel) will be supported by the LRI Team.

 

  1. Other Requirements: Anticipated Terms and Conditions of the Award  
  2. Time and Effort:  All personnel on funded projects must commit time and effort appropriate to their roles on the project. HMS PIs and Co-PIs are expected to budget at least 1% of institutional base salary (not NIH-capped salary) and effort on the awards. HMS-affiliated PIs and Co-PIs should follow their institutional policies regarding time and effort committments. PIs who are not permitted to budget salary on applications of this type (e.g., HHMI investigators) should budget effort but not salary

 

2. Inventions and Intellectual Property:  

If any PI or other individual (except for any individual enrolled as a full-time student at Harvard) employed by an HMS-affiliated institution creates intellectual property through work on a project funded by the LRI, the employing institution will own his or her interest in that intellectual property in accordance with the institution’s intellectual property policy; and if any PI or other individual employed by or enrolled as a student at Harvard creates intellectual property through work on a project funded by the LRI, Harvard will own his or her interest in that intellectual property in accordance with Harvard's intellectual property policy.

 

3. Research Plan:  Each LRI award will require a research plan and timeline. Ongoing project review will be conducted during the life of the award.

 

4. Funding Restrictions: In the event that a proposed project secures funding support from industry or another external (e.g., NIH) or internal source (e.g., Q-FASTR) during the interval between the time the proposal is submitted to LRI and the time funding decisions are made, Dr. Isabel Chico-Calero must be informed immediately. If a project is awarded LRI funding, and funding support for the same project is secured from another source during the funding period, then Dr. Isabel Chico-Calero must be informed promptly. Subject to compliance with the terms of any such funding support, any overlapping funds provided by LRI may be reallocated to other activities provided that those activities are directly related to the funded project and are approved in writing by LRI.

 

5. Research ComplianceThe PI, department, and research institution are responsible for meeting all compliance requirements associated with the award, including any IRB or animal research approvals. Any such required approvals must be submitted via email to lri@hms.harvard.edu prior to disbursement of any award funds.

 

6. Publications: The “Fairbairn Family Lyme Research Initiative at Harvard Medical School” must be cited in all publications that describe work supported by LRI. Electronic reprints and/or links to an electronic version of all publications containing this acknowledgment should be provided to Dr. Isabel Chico-Calero.

 

7. Reporting Requirements: A final progress report must be submitted to Dr. Isabel Chico-Calero (Isabel_chico-calero@hms.harvard.edu). The final report should summarize the results of the research, including any intellectual property and statement of inventions, and publications produced from the research. The report should also list the personnel who have been involved in the project during the reporting period.

 

Appendix A: Full proposals

Full proposal submission deadline: Monday, May 23, 2022 at 5:00 PM ET

LRI staff will be available to work with PI’s in the development of full proposals, particularly with respect to describing the impact, including a research plan and timeline of the project. Sections 1 and 2 together should not exceed 5 pages. The cover page and Sections 3, 4, and 5 are not counted toward the page limit. Full proposals require institutional signature from Lead PIs at Harvard affiliated Institutions. 

 

Cover Page (not included in page limit)

  1. Lead PI name, department and Organization/School
  2. Name of any Co-Investigators and Organizations/Schools (If Co-PI’s are outside the Harvard Community, include a paragraph stating the reason for this specific collaborator’s involvement and the need to seek a collaborator’s expertise outside the Harvard community)
  3. Project title
  4. Anticipated Total Budget Request for the Period of Performance

 

Section 1: Executive Summary (250 word maximum)

  1. Describe the impact, need/opportunity, and relevance to the biology and/or therapeutics in Lyme disease
  2. State the major research objectives of the project and how they will advance the current status of the field and enhance its impact

 

Section 2: Background, Significance, and Research Plan

  1. Brief introduction to the area of investigation. Describe the unmet need and relevance of your proposed research in your area of investigation.
  2. Summarize significant recent research related to this proposal, including your own work and that of others in the field
  3. Specific research objectives and the experiments planned to achieve each. Describe how the proposed research will advance the knowledge of Lyme disease biology and therapeutic applications.
  4. Research plan and timeline

 

Section 3: Intellectual Property (not included in page limit)

Describe any inventions that have already been made related to the proposed research, if applicable.

 

Section 4: Detailed budget (not included in page limit)

A detailed budget and budget justification should be provided for the entire proposed funding period, using PHS 398 form Page 4. Pass-through awards are not allowed; a separate award will be made to each funded PI at their respective institution.  Each PI receiving funds should submit a NIH facepage, PHS 398 form Page 4 and written budget justification. See Section V for allowable costs. 

 

Section 5: Supporting Information (not included in page limit)

  1. References: Please list references cited in Sections 1 and 2 on a separate page and keep the length of the reference list to a maximum of one page
  2. NIH biosketch for the principal investigator, Co-PIs, and any other key project participants
  3. Identify all prior, current, and pending sources of support to the PI’s lab related to the proposed research project
  4. Support letters: A support letter must be included if any research objective will require substantial involvement of collaborators (e.g., use of any core facility, collaboration with investigators who are not directly funded by LRI for the proposed work).  Support letters are not required from contract research organizations, but CRO quotes may be submitted in the budget justification
  5. Relevant publications/manuscripts, provided as PDF files (maximum of 3)

 

Full proposal submission: Proposals must be received by 5:00 PM ET on May 23, 2022 as a single PDF file.  Applications should be submitted via the Harvard Medical School Internal Awards Submission Portal: https://forms.hms.harvard.edu/f/2022lri_fullproposal