Pilot Study Award Program
The Scripps Translational Science Institute (STSI) is committed to supporting researchers who strive to conduct transformative, innovative, translational research with the potential to change medicine.
STSI’s Pilot Study Award Program supports the development of preliminary data through translational research that has significant potential to impact human health. The Program is a component of the1UL1 TR002550-01 Clinical and Translational Science Award from the National Institute of Health.
Four grants will be awarded with budgets limited to $50,000 in Direct Costs. Research proposed in the application must be accomplished by April 30, 2019.
Eligibility and Criteria for Review
Faculty at The Scripps Research Institute (TSRI) are eligible to apply. In addition, Scholars currently enrolled in STSI’s KL2 Clinical Scholars Program and Scripps Health physicians are also able to apply, but the Principal Investigator must be a TSRI faculty member. Applications from individuals of under-represented minorities are highly encouraged.
Applicants should design studies that meet the following criteria:
- Multi-disciplinary; connecting basic and clinical science
- Potential to impact clinical practice in a relatively short span of time
- Soundness of hypothesis, research methodology and statistical considerations
- Track record of the applicant and the co-investigator(s)
- Likelihood of leading to future independent funding and scientific publication
- Integration or impact of community engagement principles into protocol design
Recipients of the Pilot Study Awards must adhere to all federal, state and local guidelines with respect to scientific conduct, conflict-of-interest policies, participation of human subjects, the use of animals, hazardous or radioactive materials and recombinant DNA in their research studies.
There will be a two-stage review process. The applications will be screened by an Administrative Committee to ensure that application requirements are addressed in the submission . The second stage peer review process will include 2-3 written critiques of each application followed by an NIH-style study section review and ranking by the STSI Science Committee composed of 15-20 scientists and physicians.
Applications will be scored on a 1-to-5 scale where 1 is excellent and 5 is poor. Half points may be given (i.e. 2.5). Applications that receive an overall score of 1.5 are generally funded.
Submission & Review Dates
- Letter of Intent (LOI) deadline – May 21, 2018
- Application deadline – June 11, 2018
- Initial Review (Stage 1) – June 18, 2018
- Reviewer Critiques deadline – July 10, 2018
- Study Section (Stage 2) – July 17, 2018
- NCATS Prior Approval Packet Due (only for studies with human subjects) – July 20, 2018
- Notice of Award – July 23-27, 2018
- Earliest Funding Start Date – August 1, 2018
Letter of Intent
The Letter of Intent (LOI) is a short summary of the proposal (1 page maximum) that must include the following:
- Project site(s)
- Names and affiliations of collaborators
Please send the LOI to Michelle Miller (email@example.com) by 12PM PST on May 21, 2018
Please complete all fields as accurately as possible, including project title, diseases targeted, Principal Investigator (PI), Co-Principal Investigator (Co-PI) if applicable, eRA Commons ID(s), institution, translational or clinical liaison (if applicable) as well as contact information. The cover page needs to be signed and dates.
eRA Commons ID
List the eRA Commons ID for all investigators listed on the Cover Page. If you do not have a registered eRA Commons ID, please contact Office of Sponsored Programs (OSP) Pre-Award to receive one using the following link: http://intranet.scripps.edu/osp/pre-award/era-commons.html
For additional assistance, contact the NIH eRA Commons Help Desk at firstname.lastname@example.org
Type of Investigator – Clinical or Translational
Check the box for ‘Clinical’ and/or ‘Translational’ to categorize the PI and Co-PI’s expertise. If neither is appropriate, check ‘N/A’ and then designate a translational and/or clinical research liaison. A liaison would be someone who is simply advising or mentoring the basic scientist or clinician researcher (PI or Co-PI) on the proposed project, but is not integrally involved in the project. A liaison is not required in the presence of a clinical/translational investigator. If there is no clinical/translational investigator, a liaison is required.
Please note: If a liaison is selected, you must include a letter of support from this individual.
Type of Research
Human Subjects Research
If the proposed project involves Human Subjects, check whether IRB protocol is approved or pending (JIT). If the proposed project does not involve Human Subjects, please check “Not Applicable”.
If the proposed project does involve Human Subjects, a copy of the IRB JIT or approval letter, must be submitted as part of the application. If the project is awarded, then a copy of the approved protocol page(s) will be REQUIRED within 30 days of funding notice. In addition, if human subjects are involved, please provide the “Identification of Key Personnel” form and a “Human Subject Research Minimum Education Certification Statement” for each individual listed on the Identified Key Personnel form.
Please note: If the proposed project involves Human Subjects, NCATS Prior Approval is required for all research involving human subjects. See Section D. for more details.
Animal Subjects Research
If the project involves Animal Subjects Research, check whether the IACUC protocol is approved, or pending (JIT). If the project does not involve Animal Subjects, please check “Not Applicable”.
If the project involves Animal Subjects, submit a copy of the IACUC JIT or approval letter as part of the application. If the project is awarded, then a copy of the approved protocol page(s) will be REQUIRED within 30 days of funding notice.
Stem Cell Research
If the project involves Stem Cell Research, check whether the ESCRO protocol is approved or pending (JIT). If the project does not involve Stem Cell Research, please check “Not Applicable”.
If the project involves Stem Cell Research, submit a copy of the ESCRO, or full approval face page, as part of the application. If the project is awarded funding, then a copy of the approved protocol page(s) will be REQUIRED within 30 days of funding notice.
The abstract should provide a brief and concise summary of the proposed study (approximately 500 words).
Translational Relevance to Disease/Health
The relevance to disease/health section should explain how the proposed study has the potential to impact clinical practice in a relatively short period of time (approximately 200 words).
Community Engaged Research (CEnR) is a collaborative process wherein community members—who are often the targets of research studies—are involved in the development, execution and dissemination of research endeavors that may affect them. The ultimate goal of CEnR is to improve the health of community members while simultaneously advancing research discovery in multiple areas of health and wellness.
Explain how the proposed project involves input from community members to advance health and wellness (approximately 200 words). For questions or concerns about writing this section, please contact Addie Fortmann (Fortmann.Adelaide@scrippshealth.org) or Athena Philis-Tsimikas (Philis-Tsimikas.Athena@scrippshealth.org).
The project/research proposal must include the following sections (3 page maximum):
- Specific Aims
- Background and Medical Significance
- Preliminary Data (if any)
- Research Design and Methods
- Figures are allowed within the proposal, but must remain within the page limit
- Margins must remain at 0.5 inches on all sides with STSI Logo in the header
Budget and Justification
Research proposed in the application must be accomplished by April 30, 2019, with an earliest start date of August 1, 2018.
Budget justification may be itemized by category, but must include the following sections:
- Personnel (list title, percent effort on project and requested salary including benefits)
- Supplies (itemized)
- Other Expenses
- Indirect Costs
To enhance the pilot study funding, candidates are encouraged to solicit matching funds. Sources of matching funds would be patient advocacy programs and societies, industry collaborations and /or unrestricted grants. If there are matching funds available for this application, please include the source of the funds.
List references for the proposal (maximum 10 references).
Biosketches are required for key personnel in the application. Please use the NIH formatted Biosketch. For instructions on how to prepare a Biosketch, please use the following link: https://grants.nih.gov/grants/forms/biosketch.htm.
TSRI Application Review Process (RACO)
Please provide the following to the Office of Sponsored Programs at TSRI:
- TSRI Internal Documents and Forms
- Certification of Disclosure of Conflicts of Interest and Commitment, and Training
- PI Assurance Form
- Animal and Human Subject Compliance
- Resources and Environmental/Facilities
- Complete STSI Pilot Award Application
- Cover Page
- Abstract Page, Performance Site and Key Personnel
- Budget and Budget Justification
- Biographical Sketch (for key personnel)
To initiate the RACO review process, please email materials to Pre-Award (email@example.com) by June 11, 2018.
Submit your completed application to Michelle Miller (firstname.lastname@example.org) by 5PM on June 11, 2018.
Human Subjects Prior Approval Packet
The NIH requires Prior Approval of research involving human subjects.
Download the Document Checklist form and start gathering the necessary information as required.
If you receive a fundable score on the Pilot Award application and the study involves human subjects, the NCATS Prior Approval packet must be submitted to Michelle Miller (email@example.com) by July 20, 2018, which will then be forwarded to NCATS for approval.
Please note: Approval can take 30-60 days so please get started on this early, otherwise the Notice of Award will be delayed.