PRETERM BIRTH INITIATIVE. Application deadline: December 4, 2018

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PRETERM BIRTH INITIATIVE Application deadline: December 4, 2018

TABLE OF CONTENTS Key Dates and Program Background 3 Eligibility Requirements 4 Important Notes 5 Selection Process 5 Terms of Grant / Use of Funds 6 Application Process Overview 7 Application Process 7 How to Submit an Online Proposal Application 7 Proposal Elements and Checklist 7 Submission Process 9 2 BWF PRETERM BIRTH INITIATIVE

KEY DATES Application deadline December 4, 2018, 4:00 pm (EDT) Finalist in-person interviews April 10, 2019 Notice of award May 20, 2019 Award start date June 1, 2019 Initial installment July 15, 2019 Award end date March 31, 2023 PROGRAM BACKGROUND The Preterm Birth Initiative was created to increase the understanding of the biological mechanisms underlying parturition and spontaneous preterm birth and will provide $500,000 over a four-year period ($125,000 per year). The initiative is designed to stimulate both individual scientists and multi-investigator teams to approach the problem of preterm birth using creative basic and translation science methods. Postdoctoral fellows nearing their transition to independent investigator status through senior established investigators are encouraged to apply. Molecular and computational approaches such genetics/genomics, immunology, microbiology, evolutionary biology, mathematics, engineering, and other basic sciences hold enormous potential for new insights independently or in conjunction with more traditional areas of parturition research such as maternal fetal medicine, obstetrics, and pediatrics. The formation of new connections between reproductive scientists and investigators who are involved in other areas will give preterm birth research a fresh and unique look, and stimulate a new workface to tackle this challenge. Despite medical and technological advances, the rate of preterm births in the United States remains higher today than 20 years ago. Approximately 10 percent of births in the U.S. are considered preterm, which is defined as birth occurring prior to 37 weeks of gestation. Many health and social problems can be attributed to preterm delivery including cerebral palsy, respiratory distress syndrome, chronic lung disease, seizures, learning difficulty, hearing loss, behavioral problems, and others. Preterm birth is currently the leading cause of neonatal morbidity and mortality in children. For a medical problem that has such grave health and social consequences little is known about its causes. Up to six (6) research grants will be awarded in this award cycle. REQUEST FOR PROPOSALS 3

ELIGIBILITY REQUIREMENTS n Proposals must be submitted from degree-granting institutions in the United States or Canada. n The principal investigator must be a postdoctoral fellow in the final 1-2 years of postdoctoral training or hold a faculty appointment (assistant/associate/ professor-level status) at a degree-granting institution in the U.S. or Canada. n Proposals should address the biomedical causes and molecular mechanisms underlying (preterm) parturition including but not limited to peri-implantational events, placentation, fetal determinants, fetal-maternal immune responses, biological basis for racial-ethnic disparities, mechanisms relating preterm birth to other adverse pregnancy outcomes, biology of normal labor, genomics, evolutionary influences and other approaches. Proposals seeking to identify biomarkers predicting preterm birth are welcome. n Researchers working at research institutes, national laboratories, within the federal government, or outside of North America may be partners or collaborators but all funding must be channeled through the U.S. or Canadian degree-granting institution of the principal investigator. n Citizens and non-citizen permanent and temporary residents of the U.S. and Canada who are legally qualified to work in the U.S. or Canada are eligible. n Candidates who are temporary U.S. residents must hold a valid U.S. visa (J-1, H1B, F-1 or O-1 visas). n Temporary Canadian residents must hold a valid Canadian visa (Study Permit, C-43, C-44, C-10, or C-20 work permits/visas). n If you are a postdoctoral candidate, your visa status must allow you to remain in the U.S. or Canada during the project period of the grant. If a grant is awarded and your visa does not allow for such a stay, BWF may terminate the grant. BWF will not intercede on behalf of non-citizens whose stay in the U.S. or Canada falls out of visa compliance. n Proposals can be submitted by individual investigators or research teams designating a contact principal investigator. At least one member of the team must have training and expertise outside the traditional areas of reproductive science. n Proposals that cross institutional boundaries (partnerships between multiple universities or collaborations within larger universities) are welcomed. n Current or active BWF preterm birth grant recipients are not eligible to reapply. n Former BWF preterm birth recipients whose grant has been completed may reapply for another award provided the proposal submitted is a substantially different proposal (must not be a continuation or slight modification of previous work). The principal investigator must demonstrate successful outcomes and highlight significant achievements from the earlier award. Note: Postdoctoral fellows nearing transition to independent investigator status are strongly encouraged to contact contact Senior Program Officer Rolly Simpson directly at rsimpson@bwfund.org or (919) 991-5110 about their planned proposal, competitiveness for the award, transferring to a new institution, and other issues. For additional information regarding permitted use of funds, see Terms of Grant. 4 BWF PRETERM BIRTH INITIATIVE

IMPORTANT NOTES n BWF strongly encourages applications from women and underrepresented minorities, including Blacks or African-Americans, Hispanics or Latinos, Native Americans, Alaskan Natives or Native Hawaiians. n The Preterm Birth award can only be made to degreegranting institutions in the U.S. or Canada. An Internal Revenue Service determination letter of the institution s non-profit status will be requested by BWF staff if said letter is not on file in our database. n Candidates who currently hold a Burroughs Wellcome Fund award must contact BWF staff (dholmes@bwfund.org) prior to beginning an application. SELECTION PROCESS BWF utilizes an interdisciplinary Advisory Committee to review applications, interview finalists, and make recommendations for approval by the Fund s Board of Directors. Selection will be based on the creativity, novelty, and innovation of the proposal as well as the likelihood of a significant impact in the area of parturition and the prevention of spontaneous prematurity. BWF does not provide critiques or written comments of unfunded proposals. REQUEST FOR PROPOSALS 5

TERMS OF GRANT/ USE OF FUNDS Indirect costs may not be charged against the awards. Institutional overhead may not be charged against BWF grants. Awards are made to U.S. or Canadian degree-granting institutions on behalf of the awardees. The principal investigator s institution is responsible for disbursing the funds and for maintaining adequate supporting records and receipts of expenditures. Scientific publications or presentations that result from these awards must acknowledge the awardee s receipt of a Burroughs Wellcome Fund Preterm Birth Initiative award. Copies of journal articles and other publications should be sent to BWF along with the annual progress report. Awardees should follow their institutions patent, copyright, and intellectual property policies regarding discoveries that result from research conducted under these awards. Awardees must adhere to all federal, state, and local regulations regarding the participation of human subjects, and the use of animals, radioactive or hazardous materials, and recombinant DNA in their research projects. BWF expects the appropriate federal, state, and local guidelines with regard to scientific misconduct are in place and enforced at all institutions with which BWF awardees are affiliated. Awardees should share scientific findings in a timely manner via the standard means of scientific communication, including publications and/or presentations in scientific forums. BWF will not retain any rights to published results or patents that result from the research. Awardees must provide BWF with an annual progress report detailing scientific progress. Institutions must provide an annual financial report. Both reports must be submitted (on forms that will be provided) by June 1 of each award year. Continued funding will depend on both the timely submission of these reports and their favorable review by BWF and its program advisory committee. The support allocated for research is under the control of the awardee and may be used flexibly for items such as equipment, consumable supplies, travel to scientific meetings, and laboratory personnel working with the awardee. Prior approval by BWF is required when, within an award year, purchases of equipment exceed $20,000 or travel costs exceed $8,000. During the award period, unused research funds may be carried over to the succeeding year. Awardees may receive a no-cost extension; requests explaining why an extension is needed must be submitted in writing at least two months prior to the end of the award. At the termination of the grant period, grant balances of $500 or less may be retained by the institution. For grant recipients in the U.S., the administrative fee is intended to cover the cost of medical insurance and other benefits, such as retirement. For awardees in Canada, the administrative fee is to be used as a contribution to the employer s benefit plan. Award recipients may not hold concurrent BWF awards. Up to six (6) research grants will be awarded. Research grants will provide $500,000 over a four-year period ($125,000 per year) and are expected to begin June 1, 2019. 6 BWF PRETERM BIRTH INITIATIVE

INSTRUCTIONS ON HOW TO PREPARE AND SUBMIT A COMPLETE PROPOSAL Application Process Full proposals. A completed full proposal consists of data entry fields submitted through the online Internet Grant Application Module (IGAM) plus a single PDF attachment. Application Deadline: December 4, 2018 by 4:00 pm (Eastern). Proposal Elements: n Contacts List (template provided) n Scientific and Lay Abstract (one page; templates provided) n Research Plan (12-page limit) n Biographical Sketch of Principal Investigator and all Collaborators or Partners n Letters of Support from all Collaborators or Partners (9 maximum) n Budget (template provided) n IRB Certification n Animal Care Certification n Reprints/Publications (10 maximum) n Institutional Certification form (template provided) n Signature Page (template provided) All communications, including the invitation to interview and declinations, will be made through email. How to Submit an Online Proposal Application To begin a proposal submission and access the application form on or after August 6 use this link: proposal To return to a saved proposal already in progress you must use this link: saved proposal It is recommended that applicant bookmark this page to return to an application in progress. Proposal Elements and Checklist A complete proposal consists of fields submitted through the online IGAM application plus a single PDF attachment. The detailed components of the complete proposal are shown below. Online application form available through IGAM (see links above) n Applicant Information n Applicant Demographics n Institutional Information (degree-granting only) n Signing Official Information (degree-granting only) n Proposal Information BWF does not provide critiques or written comments of unfunded proposals. Download Forms and Tempates REQUEST FOR PROPOSALS 7

Single PDF Attachment: Prepare in advance the following required documents. Combine and order the supporting materials and upload into one (1) PDF file. Name the file using this format only: Last Name, First Name PTB 2019 A. Contacts List Using the template provided enter the contact information only of all investigators involved in the proposed project (maximum of 10 including PI). List principal investigator first. At least one member of the team must have training and expertise outside the traditional areas of reproductive science. B. Scientific Abstract (one page) Using the template provided, describe the proposed work, including specific aims that is understandable to a multidisciplinary group of scientific reviewers. Use 11- or 12-point font for the text. C. Lay Abstract (one page) Using the template provided, describe a brief summary of your research project to explain the significance, innovation, impact, and relevance of the proposed research to people who do not have prior knowledge about the subject. D. Research Plan (12-page limit) Using the standard NIH-format, allow one-page limit for Specific Aims and remaining 11 pages for the Research Plan, including tables, graphs, figures, diagrams, and charts. Your plan should describe the interdisciplinary nature of the proposal, the research plan, and the impact of the work on preterm birth or parturition. It should be a complete, cohesive, and coherent scientific document that tells a story. Use a standard 11-point font for the text, and no smaller than a 9-point font for figures or tables. Text must be single-spaces, with one-inch or larger margins on all sides. Number the pages of the research plan. A bibliography or reference list is optional and not considered part of the 12-page limit. The list of literature references should be directly related to the research plan. Published papers may be cited. E. Biographical Sketches Provide the standard NIH biographical sketch of the Principal Investigator and at least one scientist working outside the area of reproductive science, and all other collaborators/partners. Each biosketch should not exceed five pages. Do not exceed 10 biosketches. A five-page CV may be substituted for applicants at Canadian degree-granting institutions. F. Letters of Support from all Collaborators or Partners Provide letters of support from all collaborators or partners discussing their expertise and role(s) in this research project and include at least one letter from one scientist working outside the area of reproductive science. Maximum of nine letters. G. Budget Using the template provided, complete the budget and justification that explains how this research grant will be spent over four years. The proposed budget may be used for consumable supplies, equipment, travel expenses, administrative personnel, student stipends, salaries and benefits, and other appropriate expenses relative to the research. 8 BWF PRETERM BIRTH INITIATIVE

The principal investigator is allowed up to $20,000 per year to be used for salary support, including fringe benefits. There is no limit for salary support including fringe benefits for other laboratory or clinical personnel working with the award recipient. Equipment purchases should not exceed $20,000 per year and travel costs should not exceed $8,000 per year without written authorization. No indirect costs or institutional overhead can be charged to this grant. H. IRB Certification Certification from all collaborating institutions IRB if human subjects are to be used one page approval sheet only. Note: IRB certification must be obtained by the start date of the award (June 1, 2019). I. Animal Care Certification Certification from all collaborating institutions Animal Care and Use Committee if animal models are to be used one page approval sheet only. Note: Animal care certification must be obtained by the start date of the award (June 1, 2019). J. Reprints/Publications Include relevant publications or manuscripts submitted for publications that demonstrate your capabilities and research accomplishments. Maximum of 10. K. Institutional Certification Form Using the template provided, complete the form including signature of an authorized signing official (grants/contracts office, sponsored programs) of the principal investigator s degree-granting institution. L. Signature Page Form Using the template provided, complete the form including signature of the applicant. Submission Process Upload the combined file of supporting documents as one attachment on the Attachments tab of the online application. Click the Review Your Application on the Attachments tab to see if any errors are identified in your application. All information and required attachment must be provided before the SUBMIT button is available. Click the SUBMIT button to transmit the application. An automated message will confirm that the application was successfully submitted. Note to Applicants: Proposals will not be accepted after 4:00 pm Eastern Time on December 4, 2018. The online application system shuts down automatically at the deadline and the SUBMIT button will no longer be available. Plan to submit your application well in advance of the grant deadline to allow adequate time to troubleshoot any issues. Out of fairness to all applicants, late submissions will not be accepted. No exceptions or extensions will be granted. After the deadline, applicants with incomplete proposals and those not adhering to instructions will be disqualified without prior notice. Only proposals submitted through BWF online application website IGAM will be accepted. Questions? Questions and Eligibility inquiries should be directed in advance to BWF program staff by contacting: Rolly L. Simpson, Jr., Senior Program Officer rsimpson@bwfund.org, 919-991-5110 Debra J. Holmes, Senior Program Associate dholmes@bwfund.org, 919-991-5134 Kendra Tucker, Senior Programs Assistant ktucker@bwfund.org, 919-991-5115 REQUEST FOR PROPOSALS 9