CRISP: CTSI’s Research Initiative for Special Populations

Overview

The CRISP (CTSI’s Research Initiative for Special Populations) Pilot Awards are now accepting applications for the 2022 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 2022 competition, applications that demonstrate meaningful integration of a community ambassador into the research team may be eligible for an additional $5,000 in bonus funding to support the ambassador position (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 this 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
• Prisoners
• Older adults

While all projects are required to focus on special populations, CRISP proposals do not 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).

CTSI Resources

Potential applicants are strongly encouraged to contact the Special Populations Facilitators 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 Facilitators helps investigators 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 Facilitator, please contact Denise Smalley, ISP Administrator, at smalleyd@pitt.edu

Key Dates

Funding Information

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 submitted or ready for submission.

Community Ambassador Bonus Award Eligibility
Applications that demonstrate a meaningful partnership or collaboration with a community ambassador as part of the research team will be eligible for the community engagement bonus award as described on the Bonus Award page. A meaningful partnership or collaboration would include demonstration of contribution to the research project from inception to implementation as a team member providing unique insight into the special population of interest.

For example, the Community Ambassador could:

• Provide feedback on project ideation, recruitment, implementation or dissemination of results.
• Coordinate in conjunction with CTSI facilitators to hold community engagement studios around the research project to provide additional feedback on the research project and implementation plan.
• Support investigators to disseminate results through a lunch and learn/Courier article supported through the CTSI Community Partners Core.

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 ctsipilots@pitt.edu

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:

1. Study Title: Include the title of the proposal at the top of the page, along with the PI name and contact email.
2. 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.
3. 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).
4. 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, May 27, 2022. Additional or supplemental materials cannot be accepted after the deadline and will not be reviewed.

SUBMISSION PORTAL

 

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.

Whether proposals apply for or do not apply for a bonus funding will not impact whether or not an investigator is asked to submit to the second round.  If you are interested in having a community ambassador on your team and need assistance in connecting with an appropriate individual, please consult the ISP facilitators to assist in this process.

 

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, July 1, 2022. 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:

1. Scientific Abstract (250-word limit): Briefly summarize the proposed work.
2. 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:

1. Specific Aims
2. Significance
3. Innovation
4. Approach

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​

^*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.

G. NIH Biosketches (no page limit): Include biosketches for the Principal Investigator and key members of the research team. Use new as of September 2017.