The program supports investigators from any BIGDATA and CAMBAC users. This program is primarily intended to support new investigators. Those with previous or active K-awards are encouraged to apply. Established investigators with a previous history of funding may apply, providing justification in the Declaration of Eligibility sections related to how the proposed aims represent a major shift from his/her scientific portfolio to date and/or the proposed work advances ongoing research to a later stage of translation. Individuals with a faculty appointment with a start date on or before the award date are eligible – a letter of support from the Department Chair substantiating the upcoming appointment are welcome additions to the applications. Established investigators are discouraged from serving as the principal investigator on behalf of others. All projects should directly represent the ideas of the principle investigator. Projects already supported by extramural funding should not be proposed, as they cannot be considered for funding.

BIGDATA and CAMBAC have committed up to $50,000 to this program. Project(s) will be selected for one year of funding beginning August 2023 (anticipated). Projects will be awarded based upon alignment with focus of CAMBAC/BIGDATA and innovative use of the BIGDATA and CAMBAC Core Resources. Up to half of the award must utilize dedicated to support of BIGDATA Core Services.

All lines of investigation supported by BIGDATA and CAMBAC Pilot Program require appropriate regulatory approvals (IRB, IACUC, as applicable). These approvals must be in place in advance of human subjects and/or animal work and must remain in good standing throughout study implementation.

Application proposals are submitted as a single PDF using RED-ASSIST, a REDCap-based project designed to facilitate proposal submission and review. Project information is captured via both the pre- application proposal and the RED-ASSIST online submission form.

Application Proposal

Applications should be prepared as a single PDF containing a Summary Page, Research Plan and NIH Biosketches as follows:

1. Summary Page (1-page maximum)

   • Project Title

   • Declaration of Eligiblity

     Briefly explain (2-3 sentences) how the PI(s) meet the eligibility criteria for this funding mechanism. See “Eligibility” section for details.

   • Project Abstract

     Briefly explain (half-page) the proposed work’s long-term objective, aims, design, outcomes and relevance to BIGDATA and CAMBAC’s mission.

2. Application Research Strategy (4-page maximum)

   • Significance

     • Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses.

     • Address the rigor of prior research that serves as the key support for the proposed project.

     • Provide a clear and concise description of the central theme and goals of program.

     • Explain how the proposed project will improve scientific knowledge, technical capability, clinical practice, clinical services and/or interventions in one or more broad fields.

     • Please comment on how the proposed work fits the definition of Translational Research, which refers to the integration of fundamental, patient-oriented and population-based research with the goal of improving health and healthcare delivery.

   • Innovation

     • Explain how the application challenges and seeks to shift current research or clinical practice paradigms.

     • Describe any novel theoretical concepts, approaches or methodologies, instrumentation or interventions to be developed or used, and any advantages over existing methodologies, instrumentation or interventions.

     • Explain any refinements, improvements, or new applications of theoretical concepts, approaches, methodologies, instrumentation, or interventions.

   • Approach

     • Include statements of specific aims and corresponding hypothesis.

     • Describe any strategy to establish feasibility, and address the management of any high- risk aspects of the proposed work.

     • Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project in a robust and unbiased manner (that is appropriate for, presumably, a feasibility-level study). Include how the data will be collected, analyzed, and interpreted as well as any resource sharing plans as appropriate.

   • References Cited

     • Provide a bibliography of all references cited. Use whatever format you want. This section is not included in the 4-page maximum.

3. Recruitment and Retention Plan (if applicable, no page limit)

   If the proposed project requires human subject participation, please provide a Recruitment and Retention Plan.

4. Authentication of Key Biological and/or Chemical Resources* (1-page maximum)

   Briefly describe methods to ensure the identity and validity of key biological and/or chemical resources used in the proposed studies including the frequency of authentication. Key biological and/or chemical resources include cell lines, specialty chemicals, antibodies, other biologics and beyond (see examples here and here). Do not include authentication data in your plan.

5. NIH Biosketch (5-page maximum each)

   The biosketch provided for the PI(s) must conform to the NIH Biosketch requirements. Biosketches are not required for coinvestigators, collaborators or other significant contributors. Investigators with a faculty appointment starting on or before the award start date may append a Letter of Support from their Department Chair substantiating their upcoming appointment may be appended to their NIH Biosketch. Biosketches are an opportunity to describe why you’re well suited for your role in a project.

6. Budget (1-page maximum)

   Applicants may request up to $50,000 Direct Costs. Awards are limited to 12 months in duration. Budgets are very specific to any given project and represent the financial implementation of the scientific aims. Applicants should utilize the PHS398 Form Page 4: Detailed Budget for Initial Budget Period to submit their budget. The following are a list of allowable and non-allowable costs.

   • Allowable expenses may include personnel, supplies, inpatient / outpatient care costs and other expenses (e.g. core services).

   • PI salary may not exceed 15% of the total direct cost budget. In the case of multiple PIs, salary of each PI may not exceed 15%.

   • Additional personnel expenses (e.g. research associates) are permitted to enable the performance of outlined investigation, as needed.

   • Tuition is allowable given the graduate student is among the co-investigator team according to the accounting policies of the PI’s institution.

   • Alterations, renovations, publication costs and travel expenses are not permitted under this mechanism.

   • Core services or shared expertise requires sign-off by the faculty member responsible for the service in BIGDATA consultation summary document described below.

   • Please do not include indirect costs in pilot project budgets. Indirect costs are part of the award at the institution’s current, published rate.

7. Budget Justification (no limit)

   All budget expenses must be well justified. Please download and use this Budget Justification Template or organize your budget justification as outlined by the “PHS Form Page 4: Detailed Budget for Initial Budget Period” as follows: Personnel, Consultant Costs, Equipment, Supplies, Travel (Not Applicable), Inpatient Care, Outpatient Care, Alterations and Renovations (Not Applicable), Other Expenses. Please see the NIH Guidelines for more information on what should be included in a “Detailed Budget Justification”.

8. Consultation Summary (2-page maximum)

   Summaries of BIGDATA core services/facilities are provided below. Applicants are expected to participate in a BIGDATA consult, which BIGDATA will automatically help coordinate. Applicants can also engage expert consultation regarding regulatory considerations, informatics, clinical support(s) and other shared resources, as needed, by reaching out to BIGDATA team at (https://www.uab.edu/medicine/BIGDATA/contact-us/request-a-consultation ). Please download and use this BIGDATA Consultation Summary to report consultations in your Application. Should core services appear in the budget, a facility representative’s signature is required in BIGDATA Consultation Summary.

   • Biostatistics, Epidemiology and Research Design (BERD)

     BIGDATA’s Methodologic Core works closely with Biostatistics, Epidemiology and Research Design (BERD). BERD unit supports a multidisciplinary team of biostatisticians, epidemiologists, and methodologists who collaborate with researchers to serve fundamental, clinical and translational research. Services may include, but are not limited to, study design, sample size and power calculations, database design, data preparation for analysis, data analysis, graphical presentation of analysis results, interpretation of analysis results, training in statistical software, etc. Investigators are required to work with BERD to access in-person, directed consultation via walk-in clinics and / or scheduled expert consultation. The BIGDATA team will connect you to a member of the BERD group.

   • BIGDATA Resource Core - As Applicable

     BIGDATA Resource Core is committed to connecting investigators to analytic expertise across the spectrum of informatics research in support of the collection and the analysis of structured clinical and / or genomic data for clinical, translational and outcomes research from bench to bedside and back. Scientific consultation may include data mining, collection and management of information, analysis of genetic, next-generation sequencing, epigenetic, genomic, exome, transcriptome, microbiome and other ‘-omic’ datasets, metagenomic analysis, custom software development and methodologic innovation. Services may include, but are not limited to, study design, cohort estimation, information management solutions, genomic, proteomic, and other bioinformatics /medical informatics based data analysis, display of data and results, interpretation of results, custom applications, etc.

9. Project Timeline (1-page maximum)

   Summaries of BIGDATA core services/facilities are provided below. Applicants are expected to participate in a BIGDATA consult, which BIGDATA will automatically help coordinate. Applicants can also engage expert consultation regarding regulatory considerations, informatics, clinical support(s) and other shared resources, as needed, by reaching out to BIGDATA team at (https://www.uab.edu/medicine/BIGDATA/contact-us/request-a-consultation ). Please download and use this BIGDATA Consultation Summary to report consultations in your Application. Should core services appear in the budget, a facility representative’s signature is required in BIGDATA Consultation Summary.

Please submit applications by 5pm CT on the posted deadline via RED-ASSIST.

Applications will be scored (1-9) on aspects of significance, research team, innovation, approach and overall impact. Additional review criteria address Human Subject/Animal Protections, Budget & Timeline and Extramural Competitiveness.

• Significance. Is the proposed research set in the context of health conditions that disproportionately affect our region with feasibility-level research plans that lie at any point along the translational science spectrum – from biological basis of health or disease to interventions aimed at improving health of our community? Will the proposed work lead to new approaches to the prevention, diagnosis and management of conditions that disproportionately impact the health of our region? Are the principles underlying the research plan translatable to one or more broad fields?

• Investigator(s). Are the PI, collaborator(s), and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Are they significantly changing research directions to be eligible for this pilot award?

• Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms? Are the concepts, approaches or methodologies, instrumentation, or interventions being refined, improved or new? Are they novel to one field of research or in a broad sense?

• Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aim(s) of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Given the experience of the research team, is this feasible for the proposed time frame?

• Overall Impact. Upon completion of the sections above, applications receive a score (1-9) to indicate the rating of the overall scientific merit of this pilot proposal taking into account all review criteria. The score should represent a global view; an application does not need to be strong in all categories to be judged likely to have major scientific impact, and the score does not need to be a mathematical reflection of the sections above.

Award Notices -Meritorious applications will receive formal notice in the form of a Notice of Selection (NoS). Any costs incurred before receipt of the NoS are at the recipient's risk. Any application awarded in response to this RFA will be subject to terms and conditions listed in the NoS.

Regulatory Approvals -All lines of investigation supported by BIGDATA and CAMBAC Pilot Program require appropriate regulatory approvals (IRB, IACUC, as applicable). These approvals must be in place in advance of human subjects and/or animal work and must remain in good standing throughout study implementation.

Project Development Teams - BIGDATA and CAMBAC will work with you to set up a Project Development Team. These teams will bring together content experts and methodologists to meet with you and to assist with project troubleshooting and progress. This panel will meet in the first week of the award period to outline all immediately urgent issues (e.g., IRB approval). The group will meet quarterly thereafter.

Career Development Enrichment - BIGDATA and CAMBAC are committed to fostering the growth of early-stage investigators and promoting competencies in translational research. To formally enhance understanding and appreciation for rigor, reproducibility, and transparency, BIGDATA and CAMBAC pilot awardees must complete and pass the R2T module of Kaizen during the award year. Awardees must also attend two BIGDATA and CAMBAC enrichment events. Awardees are encouraged to submit an abstract to an annual meeting, such as American College of Rheumatology Convergence, or other appropriate venue.

Progress Reports - In addition to meeting with your Project Team, you will be asked to submit scientific progress reports – a template and the deadline(s) of such reports will be provided.

Citing BIGDATA AND CAMBAC - According to National Institutes of Health (NIH) grants policy, all grantees publications (including research manuscripts, press releases and other publications or documents about research) that are funded by NIH, must include a specific acknowledgment of grant support. For example - "Research reported in this [publication/press release] was supported by the P30 BIGDATA core grant NIH P30AR072583.” The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health."

Compliance with the NIH Public Access Policy - Award recipients are required to comply with the NIH Public Access Policy. This includes submission to PubMed Central, upon acceptance for publication, of an electronic version of a final peer-reviewed manuscript resulting from research supported in whole or in part by the NIH.