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COVID-19 Response: Outpatient Studies in Human Subjects, Spring 2020

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Stanford University’s Innovative Medicines Accelerator (IMA) aims to accelerate the prototyping of innovative medicines, and to enable hypothesis-driven studies on human subjects. The purpose of this request for proposals (RFP) is to leverage emerging capacity and infrastructure at Stanford to address the current COVID-19 pandemic. Through this RFP, IMA seeks to support research projects aimed at testing hypotheses in human subjects that, if validated, have the potential to yield powerful new tools for the modeling, diagnosis, or management of COVID-19 in individuals or populations. Competitive projects will have a strong mechanistic basis and will leverage Stanford’s newly established outpatient COVID-19 Clinical and Translational Research Unit (CTRU), where outpatients can be safely tested and/or treated. An example of an ongoing experimental human biological study in this CTRU is NCT04331899 on www.clinicaltrials.gov.

Support Provided: Successful applicants will receive $50K-$100K (total direct) for 6-12 months with the possibility to apply for follow-up funding, contingent upon progress and scientific needs to address the rapidly evolving COVID-19 pandemic. Projects may be fully or partially funded. Awarded projects will also receive access to the COVID-19 CTRU.

Deadline: All application materials must be received by May 29, 2020.

Eligibility: All Stanford faculty with PI eligibility are welcome to apply. Faculty in the Clinical Educator line are also eligible to apply.

Instructions: Submit one PDF file containing the following materials in the order indicated below. All documents should be single-spaced, Arial 11-point font with 0.5-inch margins.

  1. Title page (1 page)
    • “COVID-19 Response: Request for Proposals for Outpatient Studies on Human Subjects - May 2020”
    • Project title
    • Investigator(s): Name, department, address, phone number, email address
    • Application summary (150 words) – Please provide a high-level description of the project. Describe the medical need the project will address and how it will impact clinical practice and patient outcomes for COVID-19 if successful. Emphasize what is novel about the approach.
  2. Proposal (2 pages maximum)
    • Explain background, hypothesis, and aims of the proposed research project. Aims must be achievable within 12 months following IRB approval. Describe the significance and innovation of the hypothesis and aims.
    • Include a description of the sample types, how the samples will be used, and approximate volumes required for the proposed studies. If your project is funded, CTRU leadership will work with you on the IRB protocol to enure that your IRB protocol is compatible with the CTRU consenting process. Indicate whether your study requires IRB approval. See guidance on Stanford’s Research Compliance Office’s website: https://researchcompliance.stanford.edu/panels/hs/policies/guidances.
  3. References
  4. Budget with justification
  5. NIH-format biosketch for each investigator

Applications should be submitted directly to ChEM-H through the SlideRoom portal found here: https://chemh.stanford.edu/covid-19-outpatient-studies-human-subjects. You do not need to submit your applications to your Research Process Manager (RPM) in RMG or through your Office of Sponsored Research (OSR) Contract and Grant officer (CGO) for their approval at this time.

Selection Process & Timeline: Proposals will be reviewed by a faculty panel knowledgeable in translational research and evaluated according to the following criteria:

  1. Proposal's potential to advance understanding of the pathogenesis, population biology, diagnosis, or management of COVID-19 in human subjects
  2. Access to and use of human subjects or samples
  3. Availability of needed materials and access to required facilities
  4. Achievable aims within 12 months
  5. Clear description of anticipated limitations and alternative approaches Finalists will be selected by July 1 for immediate launch of research projects.

Contact: For questions about the funding opportunity, please contact the program manager:

Elizabeth Sefton, Ph.D.

Scientific Program Manager, Stanford ChEM-H 

esefton@stanford.edu

For questions about IMA, please contact:

Chaitan Khosla, Ph.D.

Baker Family Co-Director, Stanford ChEM-H

Professor, Departments of Chemistry and Chemical Engineering

khosla@stanford.edu