The Southern California Environmental Health Sciences Center (SCEHSC, scehsc.usc.edu) and USC Center for Translational Research on Environmental Health (USC R-TEN) are pleased to announce the 2022 Pilot Projects Program, supporting one-year research projects that aim to promote the understanding of environmental exposures and human disease. The goal of the program is to provide investigators with an opportunity to collect preliminary data and/or validate the utility of specific methods or techniques to establish the feasibility of larger-scale research projects and ultimately seek external (especially NIEHS) funding. Special consideration will be given to early-stage investigators.

Eligibility
Individuals with a full-time faculty appointment in any department or school at the University of Southern California are eligible to apply. Applicants are encouraged to pursue multidisciplinary collaborations, including with investigators at other institutions affiliated with the Center (UC Irvine, UCLA, UC Riverside, UCSD, Caltech, CSUN, Kaiser Permanente Southern California, and CHLA).

Postdoctoral researchers at USC with a full-time faculty sponsor may submit proposals for up to $10,000 in direct costs, subject to the same application requirements and deadlines.

*Proposals which incorporate translational research on environment and metabolic diseases including human and experimental approaches may submit proposals up to $90,000 in direct costs.

Key Program Dates
Request for Applications – July 19, 2022
Letter of Intent & Specific Aims Deadline – September 9, 2022 at 5pm PT
Invitation to Submit Application – September 12, 2022
Full Application Deadline – October 12, 2022 at 5pm PT
Notification of Award – January 2023
Anticipated Award Start Date – March 1, 2023

For questions for more information, please contact Sarah Rock (srock@usc.edu)

Full proposal guidelines available at: 

Prospective applicants must submit a non-binding, one-page Letter of Intent along with one page of final Specific Aims. The letter should include the project title, a brief summary of project objectives, identification of the key participating investigators. All proposed projects should have a clear and identifiable environmental health emphasis. Please submit Letter of Intent and Specific Aims as one PDF file by the deadline, September 9, 2022 at 5pm Pacific Time.

Successful Letter of Intent applicants will be invited to submit a full proposal for up to $50,000 ($10,000 for postdoctoral applicants). For proposals involving translational research including both human and experimental approaches, up to $90,000 is available- see below. Instructions for full proposal submission can be found below and on the SCEHSC website. Please submit full applications to the link provided in invitation to submit as a single PDF by the application deadline, October 12, 2022 at 5pm Pacific Time.

Invited Full Applications should include the following, in this order:

1. Cover Sheet – Including the full title of the project; name, contact information, institution, and department of the Principal Investigator (PI); and the name, institution, and department of any co-investigators or faculty sponsors.

2. Project Abstract (300 words or less) – A brief summary of the project.

3. Specific Aims (1 page) – Concise goals of the proposed research and a summary of expected outcomes, including specific objectives.

i. Significance – Describe the importance of the problem or critical barrier that the project addresses, and explain how the project will improve scientific knowledge, technical capability, or clinical practice if the proposed aims are achieved.

ii. Innovation – Describe how the proposed research seeks to shift research practice paradigms and how any methodologies or theoretical concepts that are being developed or used in the project may have an advantage over existing practices.

iii. Approach – Describe the overall strategy, methodology, and analyses to be used to accomplish specific aims, including how data will be collected. Discuss potential problems, alternative strategies, and benchmarks of success.

5. Grant Potential (1 page) – Clear description of how a successful pilot project and/or expansion of the project will lead to an R01 (or equivalent) submission.

6. Project Timeline (1 page) – A proposed timeline of study performance should be included, identifying specific tasks and milestones in project progress for the estimated 11-month period of performance.

7. Budget – A budget table of personnel, equipment, supplies, travel, and other estimated costs to perform the proposed project. Additional direct costs to the award resulting from indirect (F&A) costs associated with any subcontract to other universities must be included within the $50,000 (or $90,00 for proposals involving translational research including human and experimental approaches). Postdoctoral applicants may budget up to $10,000 for direct costs.

8. Budget Justification – A detailed explanation and justification of the funding request.

Non-allowable expenses:
i. Salaries for Associate and Full Professors
ii. Salaries for investigators and staff at institutions outside of USC
iii. Tuition for graduate students

1. If human subjects research (see Appendix) –
       i. NIH-Format Protection of Human Subjects section
       ii. NIH-Format Planned Inclusion Enrollment Report
       iii. Human Subjects training documentation for the PI, co-investigators and faculty          sponsors (CITI Human Subjects Training)
       iv. If clinical trial, a data safety monitoring plan is also required

2. If proposal includes foreign component (see Appendix II for description of foreign component):
       i. Brief description of research activities at foreign site(s):
       ii. Complete institution address
       iii. Email, and phone numbers of contact PI at foreign site(s):
       iv. Amount of funds going to each foreign site:
       v. Are human or animal subjects involved at the foreign site(s)?
       vi. Institutional Federal Wide Assurance Number, IRB, or IEC approval for work 
       performed at foreign site(s):
       vii. Will the collaboration with investigators at the foreign site(s) result in 
       co-authorship?

11. Facility Core Usage and Correspondence – The SCEHSC provides technical support to our Center investigators and pilot project awardees. A wide range of capabilities, including biostatistical support, analytical sample preparation/processing, and biological sample measurements are available. For more information on the Center’s Facility Cores, please read our core descriptions. Early discussion with Core Directors is strongly encouraged. SCEHSC Facility Core Directors should be contacted to provide an electronic letter of support as part of the full project application submission. If Facility Cores are NOT proposed to support pilot project performance, written justification must be provided in the project application.

Core Directors may be contacted as follows:
• Integrative Health Sciences Facility Core (Director: Carrie Breton, PhD, breton@usc.edu)
• Biostatistics Facility Core (Director: Jim Gauderman, PhD, jimg@usc.edu)
• Exposure Factors Facility Core (Director: John Wilson, PhD, jpwilson@usc.edu)

The anticipated period of funded project performance will be March 1, 2023 through February 28, 2024. IRB/IACUC approval letters must be received as soon as possible to avoid any delays in funding. Funded projects will be expected to submit initial IRB applications immediately following the notice of award. Funded projects which include a foreign component will be required to undergo review by NIEHS (see Appendix II for description of foreign component and additional application requirements).

In addition, all pilot project grantees are required to submit an Annual Progress Report each fall. The progress report will contain updates on the project, publications directly related to findings from the project, and grants directly associated with project results. Grantees may be asked to present a poster or short oral presentation on pilot progress at an SCEHSC workshop dedicated to pilot project grantees.

All publications resulting from pilot funding must include the following acknowledgement:
“This work was supported by the Southern California Environmental Health Sciences Center, NIEHS grant #P30ES007048.”

Applications will be reviewed by a multidisciplinary panel of scientists. Awardees will be selected following the review, and funding is anticipated to begin March 1, 2023. Notification of award will be in January, 2023.

Major review criteria include:

Relevance and potential to identify solutions to environmental health problems

Scientific quality, approach and significance

Stimulation of interdisciplinary activity, particularly with other centers, initiatives, or programs

Likelihood of leading to R01 or other external funding

Novelty and innovation of ideas.

Instructions for Human Subjects Research Additional Requirements

For non-exempt studies: The NIH-Format “Protection of Human Subjects” section is required.

In summary, the “Protection of Human Subjects” section should include the following. For complete instructions, see Section 3.1 of the NIH Application Guide.

1. Risks to Human Subjects

a. Human subjects involvement and characteristics; vulnerable populations
b. Sources of materials – what, how, access to identifiers
c. Potential Risks – physical, psychological, social, etc.

2. Adequacy of Protection Against Risks

a. The consent process
b. Procedures to minimize risks
c. Additional protections for vulnerable subjects

3. Potential Benefits of Proposed Research to Research Participants and Others

a. May not be direct benefit to subjects
b. Discuss risks in relation to anticipated benefits
c. Should not include monetary compensation

4. Importance of the Knowledge to be Gained

a. Discuss knowledge in relation to risks

For exempt studies: The full NIH-format “Protection of Human Subjects” section is NOT required. Instead, please provide the following:

1. Description of study
2. What human data/samples will be used
3. Where these data/samples will be obtained from

NIH-format Planned Inclusion Enrollment Reports are required for all non-exempt human subjects studies. NIH instructions can be found here.

CITI Human Subjects Training Certificates are required for the PI and all co-investigators and faculty sponsors for any human subjects study (exempt and non-exempt). CITI training must be up-to-date at time of application submission and must be active at time of funding.

If the pilot is a clinical trial, the NIH-Format “Data and Safety Monitoring Plan” is required. For complete instructions, see Section 3.3 of the NIH Application Guide.

In summary, the “Data and Safety Monitoring Plan” should include the following:

1. Overall framework for data and safety monitoring commensurate with risk
2. Responsible party for monitoring, including details such as whether a single person, multiple people, or a data safety monitoring board will provide monitoring and what type indicate what type of entity will provide the monitoring (e.g., PD/PI, Independent Safety Monitor/Designated Medical Monitor, Independent Monitoring Committee, Safety Monitoring Committee, Data and Safety Monitoring Board, etc.)
3. Procedures for reporting Adverse Events/Unanticipated Problems
4. Trial monitoring by individual(s) or group:

a. Data and Safety Monitoring Board (DSMB) required for multi-site trials with greater than minimal risk, and generally, for all Phase III trials