CRISP: CTSI’s Research Initiative for Special Populations
The CRISP (CTSI’s Research Initiative for Special Populations) Pilot Awards are now accepting applications for the 2019 funding cycle. CRISP offers campus investigators up to $25,000 in funding to support research initiatives that work with groups that are frequently underrepresented in research. For the 2019 competition, applications that demonstrate a meaningful partnership with a community organization may be eligible for an additional $5,000 in bonus funding (see the bonus round section below for additional information).
What Are Special Populations?
The term “special populations” refers to groups or communities of individuals that are routinely underrepresented in biomedical research. A variety of complex factors contribute to this discrepancy. Concerns about unnecessary risks means that some populations—such as pregnant and nursing women, fetuses, and neonates—are often explicitly excluded from studies. Similarly, working with some populations can present investigators with additional regulatory questions to address (e.g., informed consent requirements for individuals with cognitive disabilities, or ensuring that research participation is voluntary if working with prisoners). While the concerns are legitimate, they can subtly influence study design and participant recruitment.
Additionally, socioeconomic or demographic factors may lead to the systematic under representation of populations as well, even if they are not explicitly excluded from research participation. Isolated populations, both rural and urban, can lack proximate medical facilities. Similarly, studies requiring multiple clinic visits could be a deterrent to individuals with limited mobility. Also, historical, highly publicized cases of research misconduct have lead some communities to harbor deep-seated distrust of the medical community.
For an overview of the need for greater equality in research participation, please see the following article from JAMA. It provides an excellent overview of the need for greater equality in research participation, the challenges involved in reversing the trend, and recommendations for alternative study designs.
CRISP Program Aims and Requirements
The CRISP pilots were created to help address this imbalance. To be eligible for funding, proposals must investigate a biomedical or psychosocial health-related phenomenon in one or more of the following groups:
- Ancestral, ethnic, or cultural minorities
- Fetuses, neonates, and children
- Gender or sexual minorities
- Individuals with intellectual/cognitive disabilities
- Pregnant or nursing women
- Isolated urban or rural communities
- Individuals with physical disabilities
While all projects are required to focus on special populations, CRISP proposals do need to actively recruit new participants. Investigators conducting animal studies, bench or basic science research, or using computational modeling will be considered, provided the scope of work illuminates a biomedical or psychosocial mechanism relevant to one of the special populations. Neither are proposals required to work exclusively with special populations: Studies that include a comparison between a special population and the general population are eligible.
Examples of appropriate ways to involve a special population include:
- A researcher may expand ongoing work with a traditional research population to include a special population by comparing or stratifying by the type of population (e.g., a study of pharmacokinetics in the general population expands to include a study arm of individuals with physical disabilities).
- A researcher already working with a special population may expand their work by adding an additional, overlapping special population category (e.g., a study of African-American adolescents in Pittsburgh that adds a comparison between rural and urban populations).
- A researcher already working in a special population seeks to deepen the study by adding a novel, translational dimension that requires a new research collaboration (e.g., a researcher studying contraception in morbidly obese women collaborates with a colleague to examine the effect of adipose tissue on estrogen metabolism).
Potential applicants are strongly encouraged to contact the Special Populations Liaisons at CTSI. An initiative of the Integrating Special Populations (ISP) Program, this group is comprised of research staff with unique expertise in the engagement of special populations across the lifespan. The liaisons are supported by the “Mind Bank,” a panel of expert scientists and faculty members with expertise in research across the lifespan or with special populations. The Mind Bank helps investigators and liaisons develop strategies to integrate special populations into their studies. Together, the CTSI ISP team: 1) advises research on the special population dimensions of cohorts included in their research; 2) helps formulate hypotheses relevant to or inclusive or special populations; 3) identifies research gaps, opportunities, and collaborators that facilitate a more inclusive approach to recruitment of special populations; 4) provides guidance on best practices for recruitment, specimen collection, and research methodologies; and 5) helps identify resources that may facilitate outreach to special populations.
If you would like to meet with the Special Populations Liaisons, please contact Denise Smalley, ISP Administrator, at firstname.lastname@example.org
- Round 1: Letter of Intent Due
Friday, June 14, 2019 by 11:59 p.m.
- Round 2: Full Application Due
Friday, August 9, 2019 by 11:59 p.m.
- Anticipated Start of Funding
Sunday, December 1, 2019
- Notification to Advancing Projects
Monday, July 8, 2019
- Notification of Award Decisions
Tuesday, September 17, 2019
Award funding of up to $25,000 is available to cover direct costs; no indirect support will be provided. The award period will last for 12 months, beginning when all regulatory and administrative approvals have been received. The CRISP pilots do not have any mechanism for no-cost extensions; any funds that are not spent during the award period will be forfeited.
Before any funding can begin, awardees must provide documentation of all necessary regulatory approvals (IRB, IACUC, hSCRO, IBC, CORID, etc.). Once regulatory documentation is provided, awarded projects will undergo an administrative review from NCATS, which may take up to 30 days. Funding cannot begin until projects have been approved by NCATS. Because of this, all applicants are strongly encouraged to have the necessary regulatory documents ready for submission.
Community Bonus Award Eligibility
Applications that demonstrate a meaningful partnership or collaboration with an underrepresented community will be eligible for an additional $5,000 of funding if awarded one of the CRISP $25,000 awards. A meaningful partnership or collaboration would include demonstration of a stakeholder contribution to the research project or commitment to participate in the proposed project. Examples include:
- Community stakeholder advisory group that has reviewed or participate in the development of the research proposal at the level of developing the research question to ensure that the proposed research is relevant to the community, or review of recruitment methodology to ensure lack of barriers to community participation.
- Letter of support from community toward active participation in the proposed research study.
Who Can Apply?
The Principal Investigator must be a University of Pittsburgh faculty member; postdoctoral trainees and trainees in clinical training programs are not eligible to serve as PI. Faculty member on early-career training awards or clinical research scholars (i.e. recipients of K-series or similar career development grants) are eligible. New PIs are strongly encouraged, but submissions from established investigators will be accepted if there is clear evidence that the pilot project represents a distinctly new direction from their previously funded work.
Study teams that involve cross-disciplinary collaborations are strongly encouraged. Co-investigators may be from other universities; however, CTSI’s primary mission is to promote research at the University of Pittsburgh, so applicants should justify extensive off-campus collaboration. Partnerships with non-academic community partners are also acceptable.
Questions? Contact the CTSI Pilot Core at email@example.com
How to Submit
Round 1: Letter of Intent
Please submit a letter of intent that summarizes the proposed research. Each submission must include the following sections:
- Study Title: Include the title of the proposal at the top of the page, along with the PI name and contact email.
- Abstract and Scope of Work (500 word limit): Please provide a high-level overview of the study and the proposed work. Be sure to indicate how the study will include underrepresented populations and how the proposal represents a new direction for the PI. Additionally, if the proposed work will include a meaningful community partnership and should be considered for the bonus funding, please be sure to describe the nature of the partnership.
- Study Team: Please provide the names and affiliations of all members of the study team and a brief description of their roles (25-50 words per person).
- Suggested Reviewers: To facilitate the final round of review, please suggest two to three faculty members, not from your department, who may be qualified to serve as scientific reviewers. Include email addresses for each suggested reviewer.
Applications should be in the form of a single PDF document; please use Arial size 11 font with margins of 0.5 inches. All materials must be submitted before 11:59 p.m. on Friday, June 14, 2019. Additional or supplemental materials cannot be accepted after the deadline and will not be reviewed.SUBMISSION PORTAL
Using the Powered by PInCh® Submission Platform
CTSI uses the Powered by PInCh® grant submission platform to collect and review all pilot project submissions. If applicants have not previously used this system, they should be aware that they will be required to create a new project before they are able to upload their PDF submission. Project creation should only take a few minutes and asks applicants to register their project in the system by providing the following information:
- A title for their project (50-character limit)
- A short description (200-character limit) of the project
- A brief project summary (500-word limit) that should match the abstract and scope of work provided in the Letter of Intent
These fields are used primarily for internal reference and can be edited after the project has been registered.
If you have any questions while using the system or encounter any errors while submitting, please contact Will Hierholzer, CTSI Pilot Funding Core Administrator, at firstname.lastname@example.org or 412-864-3484.
Round 1: Review Criteria
The review of letters of intent will be conducted by the faculty and staff of CTSI. Proposals will primarily be evaluated based on the inclusion of underrepresented populations and the biological or psychosocial impact for those populations, as well as the overall scientific impact of the proposed work. The results of this evaluation will determine which investigators will be invited to submit a full proposal for the second round of CRISP.
Proposals that include a meaningful collaboration with an underrepresented community may be eligible for an additional $5,000 in funding. However, the presence of such a collaboration or partnership will not impact whether or not an investigator is asked to submit to the second round.
Round 2: Full Packet Submission
Applications should be in the form of a single PDF document; please use Arial size 11 font, with margins of 0.5 inches. All materials must be submitted before 11:59 p.m. on Friday, August 9, 2019. Additional or supplemental materials cannot be accepted after the deadline and will not be reviewed.
Include the following sections, beginning each section on a new page:
A. Project Overview (one page): The first page should include the following:
- Scientific Abstract (250-word limit): Briefly summarize the proposed work.
- Inclusion of Special Populations (100-word limit): Indicate which populations will be impacted by the proposed work, and how the proposed work represents a new direction for the investigators.
B. Research Plan (three-page limit, including tables and figures): This section should include the following elements from a traditional NIH proposal to best allow reviewers to address the review criteria:
- Specific Aims
C. References (no page limit): Literature cited does not count toward the Research Plan's three-page limit.
D. Budget with Budget Justification (no page limit): Use PHS 398 Form Page 4 and Page 5. The budget justification should include sufficient detail for reviewers to assess whether appropriate resources have been requested.
Grant funds may NOT be budgeted for:
- Salary support for the PI or faculty collaborators*
- Effort for post-doctoral trainees or fellows
- Routine office supplies or communication costs, including printing
- Meals or travel, including to conferences, except as required to collect data
- Professional education or training
- Computers or audiovisual equipment (exceptions require clear justification)
- Manuscript preparation and submission
- Indirect costs
Community Bonus Award: Proposals that are eligible for the $5,000 community bonus award will be instructed to submit a budget for $30,000. The determination of eligibility will be made during the review of the first round, and eligible teams will be informed when they are notified of their acceptance into the second round.
*Effort is required of the principal investigator and must be reflected on the budget page. This effort should be cost shared by the department or other entity that will support such effort. Reviewers understand that this may be a very small proportion of effort given the size of this award, but will be cautious if investigators do not appear to have sufficient time to complete a project.
Any salary support requested in a submitted budget should reflect federal fringe benefit rates. If an award is made, a budget meeting will be held between principal investigators, their respective research administrators, and financial administrators from the CTSI. If necessary, adjustments to the requested budget will be made at that meeting.
E. Proposal Timeline (up to half a page): Describe milestones and timeline for completion of the project. These milestones are critical for the pilot program, because all awards must be expended during the one-year award. The CTSI Pilot program does not have mechanisms to allow no-cost extensions. In the event an award is made, investigators should immediately confer with CTSI staff if any delay in initiation or completion of the project is anticipated.
F. Human and/or Animal Subjects (no page limit): NIH supported pilot awards must address Protection of Human Subjects, Adequacy of Protection Against Risks, Data and Safety Monitoring Plans, Inclusion of Women and Minorities, and Inclusion of Children.
Human Research Protection Office (HRPO) approval is not required prior to submission. However, HRPO approval is required for all projects involving human subjects before NCATS will approve project funding. Likewise, the Institutional Animal Care and Use Committee (IACUC) must approve any projects involving animal subjects prior to final funding approval.
Applicants must describe any human and/or animal subject issues, as well as the sources of materials that will be obtained from human subjects. If human subjects are involved, provide a description of their involvement and characteristics, specific risks to subjects who participate, and protection against those risks. Reviewers may consider whether significant delays in approval are an anticipated barrier for project completion when selecting projects. Evidence of prior or ongoing HRPO / IACUC review is encouraged. Similarly, this section should discuss if other special regulatory approval is required prior to funding: Human Stem Cell Research Oversight (hSCRO), Institutional Biosafety Committee (IBC), Committee for Oversight of Research Involving the Dead (CORID), Radiation Safety Office (RSO), etc.
It is a requirement that review of CTSI pilot proposals should address the NIH review criteria. Reviewers will score final applications on an NIH scale (1-9) in the domains of Significance, Investigators, Innovation, Approach, and Environment. Special emphasis will be given to a rating of the overall impact of the proposed project. Note that the review (based on the criteria below) will be adjusted to the pilot nature of the award.
NIH Review Criteria:
1. Overall Impact: The likelihood for the project to exert a sustained, powerful influence on the research field
2. Significance: Does the project address an important problem or a critical barrier to progress in the field?
3. Investigators: Are the PD/PIs, collaborators, and other researchers well suited, sufficient, and able to conduct the project?
4. Innovation: Does the project shift current research or clinical practice paradigms use novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?
5. Approach: Are the strategies, methods, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?
6. Environment: Are the personnel, equipment, and other physical resources available to the investigators to perform the proposed research within the time frame allotted?
7. Inclusion of Special Populations: Does the project appropriately address the scope of the RFA by meaningfully addressing an issue relevant to a special population, as opposed to repurposing existing research aims to capture funding? (See examples above under: CRISP Program Aims and Requirements)
8. Biological Significance: Does the project indicate a clear path to discovering underlying biological differences in the populations being studied?
Questions? Contact the CTSI Pilot Core at email@example.com