St. Baldrick's -- Ewing Sarcoma

RFA – Research for Ewing Sarcoma St. Baldrick’s Foundation St. Baldrick’s Foundation REQUEST FOR APPLICATIONS: Martha’s Better Ewing Sarcoma Treatment (BEST) Grant for All Letter of Intent (LOI) Due: July 12, 2019 5pm ET Full Proposal Due: August 30, 2019 5pm ET Purpose: This Request For Applications (RFA) seeks to support research to find cures for Ewing sarcoma. Proposals should explore novel concepts with the potential for high impact and quick movement to improvements in outcomes for patients. Applications that are innovative, risktaking, and use novel tools and methods will be prioritized.

Applications may be from individuals or teams, with collaboration highly valued. This grant is administered by the St. Baldrick’s Foundation, through the generosity of an anonymous donor, in honor of a teenager battling Ewing sarcoma. Award Amount: The award will total $325,000/year for 3 years, distributed annually. Funding starting from the 2nd installment will be evaluated based on research progress. Requirements and Considerations:

• Applications with the potential to lead to clinical trials within three years will be prioritized. • Projects involving gene therapy, immunotherapy or the use of novel techniques like CRISPR will be well received.

• If basic science, applications must have the potential for game-changing results. • Proposals without clear path to the therapeutic interventions will receive a low priority. • Both hypothesis-driven and hypothesis-neutral (e.g., drug screening and genome-wide molecular characterization) approaches will be considered, as long as the outcome of the project leads to actionable therapeutic intervention within the suggested time frame.

• Cross discipline collaboration is encouraged, with each investigator’s role and responsibility clearly outlined in the proposal.

• Applications must include proposed timeline with anticipated milestones.

• The Principal Investigator will report progress in person or by videoconference every six months and will submit a written report of progress annually. • Applications may come from any country and must be submitted online through proposalCentral, in English.

• St. Baldrick’s funds may not be used for human embryonic stem cell research. RFA – Research for Ewing Sarcoma St. Baldrick’s Foundation Key Dates: Letter of Intent (LOI), application and required documents must be submitted by the Principal Investigator, in English, online through ProposalCENTRAL (https://proposalcentral.com/) before 5 p.m. EASTERN TIME on the deadline.

• Letter of intent due: 07/12/2019 before 5pm EASTERN TIME • Letter of intent approval: 08/1/2019 • Full proposal due: 08/30/2019 before 5pm EASTERN TIME • Notification of award: November • Project start date: 1/1/2020 Reporting:

• The recipient will meet with the funder in person or by videoconference every six months to report progress; this will consist of a brief informal presentation followed by questions and answers. • A 5-page written report must be submitted online via ProposalCENTRAL every 12 months, using the template provided.

• Annual report of expenditures must be submitted online via ProposalCENTRAL within 60 days of the end of each grant year, using the template provided. • All expenditures are expected to follow the approved budget. Expenditure reports should separate the costs for each year and not be cumulative. (For a three-year award, the report for year three should only cover expenses in that year.) These reports must be submitted online via ProposalCENTRAL and should include the grantee name, reporting period, and breakdown of expenditures by budget categorical items. LOI/Application Requirements :

• Category/Cycle specific Letter Of Intent Instructions/Requirements are available in ProposalCENTRAL upon starting the LOI and on the St. Baldrick’s website (stbaldricks.org/for-researchers). • LOI, application, and required documents must be submitted by the Principal Investigator, in English, online through ProposalCENTRAL (proposalcentral.com) before 5 p.m. EST on the deadline. • All application instructions and templates/requirements will be available in ProposalCENTRAL upon approval of an LOI. • Applicants can enable other users to access their proposal (e.g., department or grants administrators) in the full proposal section of ProposalCENTRAL. • It is the responsibility of the applicant to ensure and to verify that the application is RFA – Research for Ewing Sarcoma St. Baldrick’s Foundation received by the deadline and that the application is complete and correct prior to submission.

• St. Baldrick’s Foundation funds biomedical research to better understand the causes of pediatric cancers and to advance its prevention, treatment, and cure. The main output of this research is new knowledge. To ensure this knowledge can be accessed, read, applied, and built upon in fulfillment of our goals, St. Baldrick’s Foundation encourages researchers to share data with the research community in accordance with the NIH policy on data sharing and expects its grantees to publish their findings, including but not limited to publication in peer reviewed journals. Applicants will be asked to provide data sharing plans as part of the application. •

Please review this helpful document for instructions on creating an LOI/Application using proposalCENTRAL: https://docs.proposalcentral.com/CreateApp.pdf Application Details All detailed application instructions and templates/requirements will be available in ProposalCENTRAL upon approval of an LOI, to include: • Executive summary: 1 page including one graphical abstract • Rationale: 0.5 to 1 page • Existing data: 1 to 2 pages (Existing data may include both investigators’ own data and others’ relevant data) • Research plan: 1 to 2 pages (There is no lower or upper limit of specific aims.) • Timeline (Gantt chart): 0.5 to 1 page • Budget • Budget rationale, to include each team member’s role • Resource Sharing Plan • Scientific Rigor and Transparency Note 1: References are not counted in page limit and can be included in the appendix. See appendix guidelines available in ProposalCENTRAL. Note 2: When a grant is approved for funding, the transfer of funds is contingent upon all legal documents being signed and approved by the St. Baldrick’s Foundation Reviewing process and criteria: Because one application will be funded from an anticipated field of many, LOI’s will be reviewed carefully to select those to be invited for full applications. (See schedule above.) LOI status shall be relayed through ProposalCENTRAL, by mail, email, or by phone. All rankings and evaluations are considered confidential. All application evaluations are considered confidential and are available to scientific reviewers, the Foundation’s Board of Directors, and the administrative personnel of the St. Baldrick’s Foundation and the anonymous donor representatives only. RFA – Research for Ewing Sarcoma St. Baldrick’s Foundation • Proposals will be reviewed by a minimum of 3 reviewers based on expertise and scored based on: o Potential therapeutic effect (curing being the highest; no therapeutic benefit being the lowest) o Innovative approach o Scientific rationale ○ Probability of success (based on previous data, expertise of the investigator, and the environment).

Eligibility: • Applications will be accepted from both individual researchers and teams, with collaborative approaches preferred. • Applications will be accepted from any country. • An institution may submit more than one application for this RFA. • A researcher can only apply once as the lead Principal Investigator. • Applicants should hold at least a M.D., D.O., Ph.D., or international equivalent degree by the date the award becomes effective Grant Terms •

When an application is approved for funding the transfer of funds is contingent upon all legal documents being signed and approved by the St. Baldrick’s Foundation. • No Cost Extensions must be requested and approved by email: Grants [at] StBaldricks.org. Requests must be submitted, stating the amount of funds remaining, a brief report of progress, an explanation of why the extension is necessary, and the length of time requested. • This is a three-year award; the Principal Investigator may request that funds be moved from a previous or current period into a future period. Carry-forward requests should be submitted in writing (email: Grants [at] StBaldricks.org) with an explanation for the unexpended balance, a plan for the use of funds, and a side-by-side comparison between the original budget and future budget categorical items. Funds cannot be carried forward between two different award types. • Re-budget requests should be submitted in writing (email: Grants [at] StBaldricks.org) with an explanation of each change and a side-by-side comparison between the original budget and revised budget categorical items. Re-budgeting that results in expansion of scope will be reviewed by St. Baldrick’s scientific advisors for approval. 

  • The institution’s public relations staff will ensure all requirements detailed in the Publicity Form are understood and met. This form will be provided with the award acceptance paperwork. • Grant recipients/Grantee will work with the Foundation to coordinate a joint press release to announce the grant and will give recognition to the St. Baldrick’s Foundation where funders are listed on the institution’s website and in its annual report. RFA – Research for Ewing Sarcoma St. Baldrick’s Foundation • Grant recipients will become familiar with the St. Baldrick’s Foundation and be prepared to speak publicly about its work, when appropriate. The Foundation encourages participation by grant recipients in St. Baldrick’s events held in the geographic vicinity of their institution. Shaving one’s head is not required; there are many ways to participate, including speaking at the event, helping to connect patients or survivors and their families to the Foundation to be honored, and participating in your favorite activity to raise funds for pediatric cancer research (i.e. running, walking, climbing a mountain, hosting another event, etc.). • Grantee shall, at all times during the Grant Term and for a period of three years after the Grant Term maintain all records applicable to the research grant, including all records related to use of grant funds and records related to research supported by the grant. The Grantee shall at any time requested by the Foundation, whether during or after completion of this Grant Term and at Grantee’s own expense, make such records available for inspection and audit (including copies and extracts of records as required) by the Foundation, within 30 days of a written request for such records made by the Foundation. Such records shall be made available to the Foundation during normal business hours at the Grantee’s office or place of business. • St. Baldrick’s has the right to review the performance of the Grantee and the Institution based on, among other things, the criteria set forth in the agreement, the grant application and budget, and the Institution’s governance. • Misconduct by a Grantee or Institution receiving St. Baldrick’s Foundation support is contrary to the interests of the Foundation and its constituents, as well as the integrity of research and stewardship of donor funds. It is the responsibility of the Institution to immediately report to the St. Baldrick’s Foundation if it has a reasonable good faith basis to believe there has been Misconduct (as defined below), and to report any Misconduct or change in the funded researcher’s employment status with the Institution, including administrative leave, which may occur during the Grant Term of any award that is pertinent related to the work described in the grant application. Failure to abide by the terms above, or any other St. Baldrick’s Foundation policies and procedures in connection the application and/or grant, may result in SBF suspending grant funding or canceling the grant, to be decided by the St. Baldrick’s Foundation in its sole discretion. If a grant is discontinued, the Grantee shall receive a 30-day written notice. Any funds unspent at the time the notice is issued shall be returned to the St. Baldrick’s Foundation. • “Misconduct” is defined as: acts by the Grantee or Institution, including its employees performing work directly relevant to this grant (to the extent the act relates to the employees employment) relating to any (i) fraud, embezzlement, theft or other felonious conduct; (ii) willful or negligent acts damaging to the reputation of the Grantee; (iii) intentional violation of any law or regulation; (iv) failure to adhere to ethical research/medical standards; (v) financial mismanagement; or (vi) loss of certification. • If requested, upon 30 days written notice, but no more than once every six months, Institution representative agrees to meet with the Foundation (via phone conference, video conference, or in person subject to St. Baldrick’s preference), to discuss any concerns the Foundation may have with respect to use of grant funds or Grantee’s operations or any allegations of Misconduct. RFA – Research for Ewing Sarcoma St. Baldrick’s Foundation • If awarded, funds will be released upon receipt and sufficiency of all paperwork by the St. Baldrick’s Foundation. Any inconsistency noted relative to the award shall be resolved by giving precedence in the following order: The signed award acceptance form; and, The St. Baldrick’s Foundation Grant Application Information and Guidelines. • All awards will be payable to the research institution (or to its foundation or funding arm) to administer for the purposes of this grant only. (Consortium grant funding will be made payable to the lead institution to administer on behalf of the consortium.) IDENTIFICATION The St. Baldrick's Foundation Martha’s BEST Grant for All shall be identified as a funding source in all printed and/or electronic publications regarding the research project. Identification with the Foundation shall also be made in any news released pertaining to the research project by the public relations department or its equivalent at the sponsoring institution. TRANSFER Requests for transfers by a grantee to another institution while the research grant is in effect will be considered on a case-by-case basis and will require justification of an urgent need for the transfer as well as written approvals. Continuation of funding at the new institution is contingent on prior written approval from the Foundation after its review of the written request. The grantee must submit a request for transfer and appropriate documentation of justification accompanied by a letter of support from the new institution at least forty-five (45) days prior to the date of transfer. Notification of approval or denial of the transfer shall be in writing. LEAVE OF ABSENCE If the grantee’s funding period is interrupted for any reason, written permission must be obtained from the Foundation if the grantee’s term is to be continued at a later date. Leaves of absence are limited to not more than one year. In the event a grantee’s term is not completed due to incapacitating illness or death, the prorated, unexpended funds must be returned to the Foundation. Requests for a leave of absence from the Foundation should be submitted in writing thirty (30) days before the date of commencement for the leave of absence. REINSTATEMENT OF AWARD Funds will not be reinstated after the Foundation has received notification in writing from the grantee of the intent to terminate research. Those wishing to resume funding are welcome to submit a new application, which will compete on an equal basis with all others during the subsequent funding cycle. PUBLICATIONS Please notify the St. Baldrick’s Foundation (email: Grants [at] StBaldricks.org) as soon as you know of a publication’s acceptance, to allow time for preparation for any publicity, blog stories, etc., to be coordinated between St. Baldrick’s and your institution. Grant recipients must submit publications online via ProposalCENTRAL prior to or within thirty (30) days of publication date. RFA – Research for Ewing Sarcoma St. Baldrick’s Foundation HUMAN INVESTIGATION All human subject research or research on human tissue which is supported by St. Baldrick’s must comply with the regulations applicable to that supported by the National Institutes of Health. As part of the application, the applicant will be asked to submit documentation of approval of the study by his or her Institutional Review Board, along with the Institution’s Human Subjects Assurance Number. Approval is not required at the application stage but will be required prior to issuing funds. If the grantee’s research plan changes after the award to include human subjects or tissue, the grantee must submit proper documentation of IRB approval to St. Baldrick’s. BIOHAZARDS During the application process, the institution shall submit an acknowledgment of potential biohazards involved and provide an institutional statement of assurances regarding potential biohazards and safeguards pertaining to this aspect of the research proposed in the application to the Foundation. Projects which do not involve biohazards must so state. The St. Baldrick’s Foundation assumes no responsibility or liability for any such biohazard and shall be held harmless from the results of the use of any such biohazard. LABORATORY ANIMALS The Foundation adheres to the most current guidelines applicable to the care and treatment of animals used in laboratory work as outlined by the National Institutes of Health. Prior to award of the grant, the institution must submit a statement that the institution meets and adheres to these policies. Failure to notify the St. Baldrick’s Foundation of compliance with these guidelines or the use of laboratory animals may result in termination of the grant. BUDGET GUIDANCE • All budgets must be justified, meet the test of reasonableness, and be consistent with institutional policy. • No institutional overhead or indirect funding is provided under the terms of the grant. • Fringe/benefits are allowed for up to 30% of the salary requested per individual, on all grants. • Fringe benefits are generally defined as medical and dental insurance, life insurance, and retirement benefits and are payable only for eligible participation in such programs. • Overlap in funding is not permitted. St. Baldrick’s policy on overlap applies to Scientific, Budget, and Commitment Overlap as defined by the NIH. o Scientific Overlap: Scientific overlap occurs when substantially the same research is proposed in more than one application or is submitted to two or more different funding sources for review and funding consideration; or when a specific research objective and the experimental design for accomplishing that objective are the same or closely related in two or more pending applications or awards, regardless of funding source. RFA – Research for Ewing Sarcoma St. Baldrick’s Foundation o Budget Overlap: Budgetary overlap occurs when duplicate or equivalent budgetary items (i.e., equipment, salary) are requested in an application but are already funded by another source. o Commitment Overlap: Commitment overlap occurs when any project-supported personnel has time commitments (i.e., percent effort) exceeding 100%, regardless of how the effort/salary is being supported or funded. • Situations may occur when an applicant has similar applications pending with different agencies that, if all funded, will present overlap issues. If an overlap occurs before award is accepted, it must be addressed with the St. Baldrick’s Foundation before the new award can be accepted and will be considered on a case-by-case basis. • If overlap occurs during an award, all grantees must be forthright regarding their support and notify the foundation within 30 days by emailing Grants [at] StBaldricks.org. Adjustments will be considered on a case-by-case basis. • Reasonable travel costs are allowable. • Publication and meeting-related poster printing costs are allowable. • All equipment purchases must be included in the original budget; re-budgets for additional equipment will not be considered. • Unused and remaining amounts of $100 and over must be returned to the Foundation at the end of each grant year, unless an approved carry forward or No Cost Extension is on file. • All budgets and expenditure reports must be submitted in USD. • Expenditure reports are expected to follow approved budgets. Any budget line item that changes more than 25% from approved budget to expenditure report (without an approved Carry Forward on file) will result in follow up from the Foundation for explanation. Explanations will be reviewed for approval. • The Foundation does not provide funds for items such as: o Secretarial/administrative salaries. o Student tuition (tuition is allowable for International Scholar awards). o Office and laboratory furniture. o Office equipment and supplies. o Recruiting and relocation expenses. o Non-medical services to patients (travel to a clinical site or patient incentives are allowable expenses). o Construction, renovation, or maintenance of buildings/laboratories. o Professional association membership dues. o Scientific publication subscriptions. RFA – Research for Ewing Sarcoma St. Baldrick’s Foundation CONTACTS For grant inquiries: St. Baldrick’s Foundation Department of Grants Administration Grants [at] StBaldricks.org (626) 792-8247, extension 236 For help using the online application system: ProposalCENTRAL Customer Support pcsupport [at] altum.com (800) 875-2562