Willingness to Participate (W2P) Pilot Awards

The Clinical and Translational Science Institute (CTSI) at the University of Pittsburgh seeks applications for the Willingness to Participate (W2P) Pilot Awards. Increasing the diversity and number of people who participate in clinical research will increase the generalizability, validity, and pace of research in general [Clark 2018]. This Pilot award will support research on how people choose to participate in research. The W2P Pilot awards will support projects that help increase understanding of research receptivity and engagement of the general public or specific populations, as well as to projects that test solutions to increase receptivity and engagement. Responsive applications will provide insight and knowledge into specific barriers or facilitators of participant recruitment and retention for a research field. 

CTSI is particularly interested in finding solutions that can increase research participant recruitment and retention for many studies. Projects to boost enrollment in a single trial or a single research program are not responsive to this request. The W2P pilots must provide insight into participant readiness in general. 

Beliefs about research or researchers may act as barriers to enrolling different communities in some types of research.  For example, an individual may lack trust in the clinical trial process and fear “being a guinea pig” for someone else’s benefit [Clark 2018].   Other individuals may fear loss of privacy, resent the inconvenience of extra clinical visits, lack transportation or have other defined barriers to participation.  Finally, there may be specific features of “typical research studies” that reduce their appeal to the general public.   Examples might include complex consent forms, forms of payment or lack of payment, and reliable communication of results.  

In contrast, participation in research is normalized or elevated in some disciplines.  For example, patients with cancer may perceive a clinical trial as an opportunity to benefit from cutting-edge therapies and approaches [Agrawal 2006].  Alternatively, patients who do participate in cancer trials may be constitutionally predisposed to make that decision [Jansen 2016].  Understanding how a participatory culture has developed more fully in one field or for one group could inform how to improve research participation in other fields and groups.

Proposed research should help to understand the relative importance and prevalence of barriers and facilitators in the general population and in specific communities.  Proposals may test potential solutions to increase public receptivity to research.  For example, how research studies are presented to potential participants also can influence enthusiasm for engagement [Jacobsen 2012].  Interventions to improve team behaviors may improve recruitment and retention [Donovan 2016].  Different approaches might be required for different groups [Ding 2007].

Examples of projects might include but are not limited to the following:

• Methods to increase receptivity to research;
• Comparing perceptions of remote consent vs. in-person consent;
• What factors influence trust or mistrust of research by specific groups;
• How to better communicate in order to engender trust in research;
• How to identify bias created by mistrust on scientific research or on implementation of results of scientific research;
• Changes in willingness to participate in research as a result of COVID-19;
• Impact of specific factors on participant recruitment and retention:  e.g. same-gender or same-race researcher vs. discordant-gender or discordant-race researcher; 
• Impact of recruitment by clinical research coordinator vs. recruitment by a physician or other provider.

Research facilitators at CTSI are available to assist investigator at any stage of a project (https://ctsi.pitt.edu/research-services/research-facilitator-services/). Facilitators can advise on finding collaborators, regulatory issues, human research protection, other required approvals, and research design or conduct.

Limited statistical consulting on projects is available from CTSI (https://ctsi.pitt.edu/research-services/core-services/biostatistics-epidemiology-research-design/).

Applicants can request up to $25,000 in direct costs, with a maximum funding period of one year.

The funding cycle will be for 12 months after the start date; no extensions of this award period will be made. Funding cannot start until all necessary regulatory approvals have been received (IRB, hSCRO, IBC, CORID, IACUC). Projects must start within 3 months of Notification of Award.  Projects that do not start within 3 months will be forfeited.

CTSI pilots do not have any mechanism for no-cost extensions; any funds that are not used during the award period will be forfeited.

This award is eligible for CTSI Bonus Awards as described on the Bonus Award page.

The Principal Investigator (PI) must be a University of Pittsburgh faculty member. Postdoctoral trainees and trainees in clinical training programs are not eligible to serve as PI. Faculty members 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, and applicants should justify any extensive off-campus collaboration. Partnerships with non-academic community partners are also acceptable.

Questions? Contact the CTSI Pilot Core at ctsipilots@pitt.edu.

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, with the PI name and contact email.
2. Abstract/Scope of Work (500 word limit): Provide a high-level overview of the project and the proposed work.
3. Study Team: 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 second round of review, please suggest two Pitt/UPMC faculty members to potentially serve as non-conflicted scientific reviewers. For each suggested reviewer, list their name, title, department, and contact email. 

Letters of Intent should be in the form of a single PDF document. The font should not be smaller than Arial 11; margins must be no smaller than 0.5 inches. All materials must be uploaded to the Powered by PInCh® web site by 11:59:59 PM on March 14, 2022. Additional or supplemental materials cannot be accepted after the deadline and will not be reviewed.

The review of letters of intent will be conducted by the faculty and staff of CTSI. Proposals will primarily be evaluated based on responsiveness to the funding opportunity announcement, 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.

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 April 18, 2022. Additional or supplemental materials cannot be accepted after the deadline and will not be reviewed.

Applications must include the following sections. Please start each new section on a new page.

• Cover Sheet (one page): Include the following details:
  • Project Title
  • Names, titles, affiliations and preferred contact email for the:
  • Co-Principal Investigators (faculty members)
  • Scientific Abstract (maximum 250 words): Summarize your proposal
• Research Plan (maximum five pages including tables/figures): Please follow the traditional NIH proposal format including the following:
  • Specific Aims
  • Significance
  • Innovation
  • Approach
  • Future Impact: A well-defined path from the pilot to future larger research efforts (maximum 250 words)
    
    
•  References (no page limit): Literature cited does not count toward the five-page limit for the Research Plan.
  
  
• Budget with Justification (no page limit): Use PHS 398 Forms Pages 4 and 5. The budget justification should include sufficient detail for reviewers to assess whether appropriate resources have been requested.

An additional page should be included for the budget justification. All pieces of equipment, including any type of computer or related device, must be explicitly justified as critical to the performance of the proposed research. Any salary requested should include federal fringe benefit rates.

Grant funds may not be budgeted for:

• Salary support for the PI or faculty collaborators*
• 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 Investigators and must be reflected on the budget page, cost-shared by the respective departments. 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. Please note, an applicant who is currently the recipient of a mentored career development award (e.g., K12, K23, etc.) or a foundation-supported career development award may subsume the effort devoted to the project under the career development award if the project proposed is consistent with the career development award.

Any salary support requested in a submitted budget should reflect University of Pittsburgh’s fringe benefit rates for non-federally funded projects (https://www.osp.pitt.edu/about/data-proposal-preparation-general). If an award is made, a budget meeting will be held between principal investigators, their respective research administrators, and financial administrators from CTSI. If necessary, minor adjustments to the requested budget will be made at that meeting.

Proposal Timeline (one 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.

Human and/or Animal Subjects (no page limit): 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 project funding may begin. Although animal research is expected to be rare in this program, the Institutional Animal Care and Use Committee (IACUC) must approve any projects involving animal subjects prior to final funding approval.

In this section, 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.

NIH Biosketches (no page limit): Include biosketches of no more than 5 pages each for the Principal Investigators and for any other investigator whose expertise will be critical for successful completion of the project. The personal statement in any biographical sketch should be appropriate for the project proposed in the application.

Review of the pilot proposals will use the NIH review criteria and Program-specific criteria to evaluate the scientific merit and transdisciplinary nature of the project. 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: Scientific Merit

• Overall Impact: The likelihood for the project to exert a sustained, powerful influence on the research field.
• Significance: Does the project address an important problem or a critical barrier to progress in the field?
• Investigators: Are the PD/PIs, collaborators, and other researchers well suited, sufficient, and able to conduct the project?
• Innovation: Does the project shift current research or clinical practice paradigms, use novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?
• Approach: Are the strategies, methods, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?
• Environment: Are the personnel, equipment, and other physical resources available to the investigators to perform the proposed research within the time frame allotted?

Program-Specific Criteria:

• New Insights: Will the project provide new insight into the barriers and facilitators for people choosing to participate in clinical trials, research studies or other parts of the investigative enterprise?

• Solutions: Will the project test potential methods to increase participation, recruitment or retention of persons from specific groups in research studies?

Agrawal M, Grady C, Fairclough DL, Meropol NJ, Maynard K, Emanuel EJ. Patients' decision-making process regarding participation in phase I oncology research. J Clin Oncol. 2006 Sep 20;24(27):4479-84. doi: 10.1200/JCO.2006.06.0269. PMID: 16983117.

Clark LT, Watkins L, Piña IL, Elmer M, Akinboboye O, Gorham M, Jamerson B, McCullough C, Pierre C, Polis AB, Puckrein G, Regnante JM. Increasing Diversity in Clinical Trials: Overcoming Critical Barriers. Curr Probl Cardiol. 2019 May;44(5):148-172. doi: 10.1016/j.cpcardiol.2018.11.002. Epub 2018 Nov 9. Erratum in: Curr Probl Cardiol. 2021 Mar;46(3):100647. PMID: 30545650.

Ding EL, Powe NR, Manson JE, Sherber NS, Braunstein JB. Sex differences in perceived risks, distrust, and willingness to participate in clinical trials: a randomized study of cardiovascular prevention trials. Arch Intern Med. 2007 May 14;167(9):905-12. DOI: 10.1001/archinte.167.9.905. PMID: 17502531.

Donovan JL, Rooshenas L, Jepson M, Elliott D, Wade J, Avery K, Mills N, Wilson C, Paramasivan S, Blazeby JM. Optimizing recruitment and informed consent in randomized controlled trials: the development and implementation of the Quintet Recruitment Intervention (QRI). Trials. 2016 Jun 8;17(1):283. DOI: 10.1186/s13063-016-1391-4. PMID: 27278130; PMCID: PMC4898358.

Flythe JE, Narendra JH, Dorough A, Oberlander J, Ordish A, Wilkie C, Dember LM. Perspectives on Research Participation and Facilitation Among Dialysis Patients, Clinic Personnel, and Medical Providers: A Focus Group Study. Am J Kidney Dis. 2018 Jul;72(1):93-103. doi: 10.1053/j.ajkd.2017.10.011. Epub 2017 Dec 27. PMID: 29289476; PMCID: PMC6421569.

Jacobsen PB, Wells KJ, Meade CD, Quinn GP, Lee JH, Fulp WJ, Gray JE, Baz RC, Springett GM, Levine RM, Markham MJ, Schreiber FJ, Cartwright TH, Burke JM, Siegel RD, Malafa MP, Sullivan D. Effects of a brief multimedia psychoeducational intervention on the attitudes and interest of patients with cancer regarding clinical trial participation: a multicenter randomized controlled trial. J Clin Oncol. 2012 Jul 10;30(20):2516-21. doi: 10.1200/JCO.2011.39.5186. Epub 2012 May 21. PMID: 22614993; PMCID: PMC4577714.

Jansen LA, Mahadevan D, Appelbaum PS, Klein WM, Weinstein ND, Mori M, Daffé R, Sulmasy DP. Dispositional optimism and therapeutic expectations in early-phase oncology trials. Cancer. 2016 Apr 15;122(8):1238-46. doi: 10.1002/cncr.29908. Epub 2016 Feb 16. PMID: 26882017; PMCID: PMC4828311.