飞行员赠款|Overview
Deadlines
意向书：2022年1月31日
最终申请：2022年4月8日
可用资金：2022年7月5日
Please submit LOIs and applications to theTRP。
Download the application instructions.
联系TRPtrp@childrens.harvard.edu与任何问题。
背景
The mission of the TRP is to stimulate the development of non-clinical and human clinical trials seeking to improve the care of children and to ensure adequate infrastructure to support non-clinical and clinical translational research projects.
定义
Translational research is defined as the translation of observations made in the research laboratories and clinical services at BCH and elsewhere into clinical studies involving humans, or the use of clinical observations to define basic research hypotheses or studies. Innovative use of clinical material in basic laboratories is considered translational research. A research study qualifies as translational if it:
- 使用新方法或发现来解决临床问题。
- 开发新的实验或诊断试剂和程序，以诊断和治疗儿童疾病和病情。
- Develops new models of human diseases and uses them to inform clinical issues involving children.
- Adapts approaches already in place in other disciplines to address pediatric diseases.
非临床翻译研究：非临床转化研究实验室research that leads to a plan or design for new or improved elements of child health care, whether intended for internal use or use by others outside of BCH. It includes the conceptual formulation, design, pre-clinical, and post-clinical test-ing of a range of diagnostic and therapeutic products and procedures, as well as health services process-es. The term “non-clinical” is preferred to “pre-clinical”, because non-clinical also encompasses laboratory testing done after the introduction and testing of an agent, device, or procedure in humans.
Clinical Translational Research:Clinical translational research is confirmation in human clinical testing or observation that the products, procedures and health services processes created to improve child health deliver the expected benefits without unacceptable side effects. This category includes feasibility and safe-ty pilot studies and traditional Phase I clinical trials, with assessments of safety and clinical effectiveness. In addition, clinical translational research encompasses the use of clinical observations or reagents to drive basic laboratory studies. Phase II trials will rarely be considered translational research.
赠款的目的
拟议的研究项目必须与转化研究计划（TRP）的目标有关。简而言之，已经建立了TRP，以鼓励基础科学家和临床医生之间的相互作用发展，以促进针对严重疾病儿童的非临床和临床研究的发展。因此，首选包括临床医生和基础科学家参与的研究。TRP的最终目标是促进利用通过此资助机制产生的发现的临床试验。
可用的赠款类型
- New research proposals：这些赠款是一年的支持。最大允许预算（直接费用）为100,000美元。获奖者的数量将取决于提案的质量，足够优异的提案的重新提交预算的总金额以及可用的资金。预计将在$ 50,000- $ 100,000范围内颁发5-7个奖项。在极少数情况下，可能会有第二年的资金；在明年的赠款审查周期中将考虑第二年资金的竞争续约申请。
- Competing renewal applications：对于先前由TRP支持的那些项目，可能会寻求第二年的支持。这些应用程序将以与新应用程序相同的方式进行审查。申请必须包括一个“截止日期”部分，并且必须令人信服地证明需要更多支持的必要性。
Cost-sharing
Applications for TRP Pilot Grants will require a specific sign-off from Department Chair-persons indicating their commitment to provide a ‘match’ (30% of direct costs awarded) in funding for successful applications. For the Department of Medicine, the Division Chief’s signature is required. The TRP will continue to provide rigorous, multi-disciplinary peer-review for these applications, 70% funding and individual guidance to each funded project during the funding period.
合格
波士顿儿童医院的所有学院将接受申请，包括护理，健康成果和其他具有高级学位的医疗保健学院（MD，PhD，MD，MD，PhD或同等学历）。强烈鼓励由基本和临床教师组成的学科和计划的一组。Fellows are not eligible.
过程
初始申请将由两页的意向书（LOI）组成。将筛选LOI以检查拟议的研究项目是否支持TRP的目标。筛查过程将由代表波士顿儿童既定研究人员的多学科委员会进行，并由转化研究计划主任主持。初始筛选后，将向选定的调查人员发送邀请以提交完整申请。
Letter of intent
For research proposals, the LOI consists of the application face page (see #1 below in "Composition of Research Proposal") and 1-2 pages of the hypothesis and specific aims page (see #9 below in "Composition of Research Proposal"). The aims should include a brief description of the research design and methods. All LOI applications must be submitted toTRP@childrens.harvard.edu。The LOI must be received by 5 pm on Jan. 31, 2022.
签名
The signature of the primary investigator (and co-investigator) is required in the Letter of In-tent initial application. Additionally, the signature of the primary investigator’s Department Chair is required and indicates his/her commitment to providing 30% match of direct costs (plus associated applicable overhead) should the proposal be awarded. For the Department of Medicine, the Divi-sion Chief’s signature is required.
完整申请
(Must be invited following review of LOI: Notifications will be sent out late February)
Invited, full applications must be submitted in single spaced text, one-half inch margins, and no smaller than an 11-point font. Arial or Helvetica typeface is preferred. The primary applicant’s name must appear in the upper right hand corner of each page. Proposal text must be limited to five pages (including figures but excluding references). Standard PHS 398 forms for budget, biosketch, other support, and resources may be used and may be submitted as separate files.
Required format:Applications must be submitted electronically (ideally, this includes an electronic ver-sion of the letter of support).
将组装建议的PDF文件发送到trp@childrens.harvard.edu。附加了申请表（从PHS 398修改）。
支持信
完整申请must include a letter of support from the primary applicant’s chairperson. Included in the letter of support must be a statement regarding the priority of the research proposal for the division, particularly as it relates to patient resources. The signature of the primary investigator’s Department Chair (for DoM, the PI’s Division Chief’s signature) is required and indicates his/her commitment to providing 30% match of direct costs (plus associated applicable overhead) should the proposal be awarded
研究建议的组成
- Face page (check all appropriate COMS, animal, IRB, or Radiation Safety approvals or indicate pending if submitted)
- 摘要（科学和外行）
- Tables of Contents
- 详细的预算（1年；使用PHS 398表格）
- Budget Justification
- BioSketch（ES）（包括PI和共同研究器；使用PHS 398形式）
- Other support (PHS 398 form)
- Resources (PHS 398 form)
- Hypothesis and Specific Aims
- 背景and Significance
- Preliminary Results or, if 2nd year renewal, Progress Report
- Research Design and Methods
- 建议如何支持TRP任务的陈述
- *商业化潜力的声明（包括任何知识产权问题）。
- 文献引用
- 支持信from Division chairperson
- *Letters of support from collaborators or consultants