Empowering the Participant Voice (EPV) is an NCATS-funded six-CTSA collaboration to develop, demonstrate, and disseminate a low-cost infrastructure for collecting timely feedback from research participants, fostering trust, and providing data for improving clinical translational research. EPV leverages the validated Research Participant Perception Survey (RPPS) and the popular REDCap electronic data-capture platform. This report describes the development of infrastructure designed to overcome identified institutional barriers to routinely collecting participant feedback using RPPS and demonstration use cases. Sites engaged local stakeholders iteratively, incorporating feedback about anticipated value and potential concerns into project design. The team defined common standards and operations, developed software, and produced a detailed planning and implementation Guide. By May 2023, 2,575 participants diverse in age, race, ethnicity, and sex had responded to approximately 13,850 survey invitations (18.6%); 29% of responses included free-text comments. EPV infrastructure enabled sites to routinely access local and multi-site research participant experience data on an interactive analytics dashboard. The EPV learning collaborative continues to test initiatives to improve survey reach and optimize infrastructure and process. Broad uptake of EPV will expand the evidence base, enable hypothesis generation, and drive research-on-research locally and nationally to enhance the clinical research enterprise.

The Indiana Clinical and Translational Sciences Institute’s Community Engagement Partners-Purdue Extension collaborative model demonstrates tremendous potential for creating state-wide programmatic efforts and improvements in both the health culture and status of Indiana residents across the state. It can serve as a prototype not only for others interested in pursuing wide geographic health improvements through Clinical and Translational Sciences Award-Cooperative Extension partnerships but also for broader collaborations among United States Department of Agriculture, National Institutes of Health, Centers for Disease Control and Prevention, state and local health departments, and health foundation efforts to improve population health.

Electronic platforms provide an opportunity to improve the informed consent (IC) process by permitting elements shown to increase research participant understanding and satisfaction, such as graphics, self-pacing, meaningful engagement, and access to additional information on demand. However, including these elements can pose operational and regulatory challenges for study teams and institutional review boards (IRBs) responsible for the ethical conduct and oversight of research. We examined the experience of two study teams at Alzheimer’s Disease Research Centers who chose to move from a paper-based IC process to an electronic informed consent (eIC) process to highlight some of these complexities and explore how IRBs and study teams can navigate them. Here, we identify the key regulations that should be considered when developing and using an eIC process as well as some of the operational considerations eIC presents related to IRB review and how they can be addressed.

OBJECTIVES/SPECIFIC AIMS: Island communities face greater environmental risks creating challenges in their populations. A community and participatory qualitative research method aiming to understand community perspectives regarding the ecology and environmental risks of the island of Culebra was performed to develop a community-centered Information and Communications Technology (ICT) intervention (an app). The island of Culebra, a municipality from the archipelago of Puerto Rico is located 17 miles from the eastern coast of Puerto Rico’s main island. This ICT—termed mZAP (Zonas, Acción & Protección)—is part of a Translational Biomedical doctoral degree dissertation housed at the University of Rochester’s Clinical Translational Science Institute (CTSI) Informatics Core funded by an NIH Clinical Translational Science Award (CTSA). In September 2017, the island of Culebra faced 2 major category hurricanes 2 weeks apart. Hurricane Irma and Hurricane Maria devastated homes, schools, health clinics, and local businesses, disrupting an already-fragile ecological balance on the island. METHODS/STUDY POPULATION: These 2 storms catastrophically affected the archipelago of Puerto Rico. Culebra’s geographically isolated location, along with the inefficient response from authorities, exacerbated the stressors caused by these natural disasters, increasing the gap of social determinants of health, including the lack of potable water. Leveraging a community engagement partnership established before the hurricanes by the mZAP participatory research, which naturally halted once the hurricanes hit a new humanitarian objective formed to deliver aid. Along with another NIH funded RCMI Translational Research Network, or RTRN institution (University of Puerto Rico, Medical Science Campus) students and faculty, The Puerto Rico Testsite for Exploring Contamination Threats Program (PROTECT) an NIEHS Funded Grant, and the National Guard, a “people to people” approach was established to ascertain needs and an opportunity to meet those needs. A people-to-people approach brings humanitarian needs, identified directly by the community to the people who need it most; without intermediaries and bureaucratic delays that typically occur during catastrophes. RESULTS/ANTICIPATED RESULTS: The consumption of potable water in plastic bottles and subsequent accumulation of plastic material has proven to be collateral damage of a vulnerable water distribution system creating another environmental hazard on the island of Culebra. Therefore, this humanitarian partnership, worked to delivered community and family sized water filters, providing a safe environmental alternative to drinkable water for the island. The success of this approach, People to People for Puerto Rico (#p2p4PUR), demonstrated the power of genuine community engagement—arising from a previous clinical research partnership—and true established commitment with members of the community. DISCUSSION/SIGNIFICANCE OF IMPACT: Research partnerships can (and should, when needed) lead to humanitarian partnerships that extend beyond research objectives. Research may subsequently be adapted based on new realities associated with natural disasters and the altered nature of existing partnerships, allowing for a rapid response to communities need. Further, #p2p4PUR was not only able to channel a partnership humanitarian response but also created an opportunity to reflect on how the commitment between members of society and academia (researchers) can create beneficial bilateral relationships, always putting the community needs first. The resulting shared experience elevates community interest and engagement with researchers, and helps researchers see communities as true partners, rather than—simply—research subjects.

Explorations of workflow development within primary care allow us to understand initial steps in the pace of knowledge and practice acclimatization within clinics. This study describes use of practice facilitation as an implementation strategy to communicate shared project goals and monitor and support refinement of practice behavior. This study engaged eight health care organizations, including 55 primary care practices, ≈380 clinicians, and ≈620 nursing and support staff in a guideline implementation project regarding United States Preventive Services Task Force use of aspirin recommendations for primary prevention of cardiovascular events.

Contactless photoplethysmography (cPPG) is a method of physiological monitoring. It differs from conventional monitoring methods (e.g., saturation probe) by ensuring no contact with the subject by use of a camera. The majority of research on cPPG is conducted in a laboratory setting or in healthy populations. This review aims to evaluate the current literature on monitoring using cPPG in adults within a clinical setting. Adhering to the Preferred Items for Systematic Reviews and Meta-analysis (PRISMA, 2020) guidelines, OVID, Webofscience, Cochrane library, and clinicaltrials.org were systematically searched by two researchers. Research articles using cPPG for monitoring purposes in adults within a clinical setting were selected. Twelve studies with a total of 654 individuals were included. Heart rate (HR) was the most investigated vital sign (n = 8) followed by respiratory rate ((n = 2), Sp02 (n = 2), and HR variability (n = 2). Four studies were included in a meta-analysis of HR compared to ECG data which demonstrated a mean bias of –0.13 (95% CI, –1.22–0.96). This study demonstrates cPPG can be a useful tool in the remote monitoring of patients and has demonstrated accuracy for HR. However, further research is needed into the clinical applications of this method.

OBJECTIVES/SPECIFIC AIMS: Determine the effectiveness of a curriculum designed to teach doctoral students to use implementation science theories, models and frameworks in optimizing scientific, social, political, cultural and organizational impact METHODS/STUDY POPULATION: Analysis of Integrated Final Projects across three cohorts of doctoral students (N=30) to identify sub-disciplinary knowledge integration and application. RESULTS/ANTICIPATED RESULTS: Integrated Final Projects indicate that the integration of IS, Program Theory and Research design within semester two yields application of integrated, sub-disciplinary knowledge to research design, identification of mechanisms of action and the address of barriers and facilitators to implementation of findings. Future analysis will be conducted to determine the degree to which dissertations reflect a similar level of sub-disciplinary integration and focus on implementation within the appropriate service setting. DISCUSSION/SIGNIFICANCE OF IMPACT: Training future translational researchers to understand and use implementation science theories, models and frameworks can potentially result in narrowing the science-to-service gap.

Novel endometrial cancer (EC) early-detection approaches may reduce racial disparities in mortality. We conducted six community-based focus groups with White and Black women (N = 57 participants) in February-March 2020 to explore acceptability of a home-based tampon sampling approach for EC. Participants also completed a survey. Data were analyzed using qualitative content analysis. Awareness of EC and risk factors was low. Acceptability regarding home sampling was high, but participants expressed concerns about instruction complexity and potential risks. Black women reported lower comfort with tampons. Increasing EC awareness, self-efficacy, and familiarization with tampons would advance prospects for at-home sample collection for EC testing.

Telemedicine enables critical human communication and interaction between researchers and participants in decentralized research studies. There is a need to better understand the overall scope of telemedicine applications in clinical research as the basis for further research. This narrative, nonsystematic review of the literature sought to review and discuss applications of telemedicine, in the form of synchronous videoconferencing, in clinical research. We searched PubMed to identify relevant literature published between January 1, 2013, and June 30, 2023. Two independent screeners assessed titles and abstracts for inclusion, followed by single-reviewer full-text screening, and we organized the literature into core themes through consensus discussion. We screened 1044 publications for inclusion. Forty-eight publications met our inclusion and exclusion criteria. We identified six core themes to serve as the structure for the narrative review: infrastructure and training, recruitment, informed consent, assessment, monitoring, and engagement. Telemedicine applications span all stages of clinical research from initial planning and recruitment to informed consent and data collection. While the evidence base for using telemedicine in clinical research is not well-developed, existing evidence suggests that telemedicine is a potentially powerful tool in clinical research.

Revisions to the Common Rule and NIH policy require the use of a single Institutional Review Board (sIRB) for the review of most federally funded, multisite research, with the intent of streamlining the review process. However, since initial implementation in 2018, many IRBs and institutions continue to struggle with the logistics of implementing this requirement. In this paper, we report the findings of a workshop held in 2022 to examine why sIRB review remains problematic and propose possible solutions. Workshop participants identified several issues as major barriers, including new responsibilities for study teams, persistent duplicative review processes, the lack of harmonization of policies and practices across institutions, the absence of additional guidance from federal agencies, and the need for greater flexibility in policy requirements. Addressing these problems will require providing additional resources and training to research teams, the commitment of institutional leaders to harmonize practice, and policymakers to critically evaluate the requirement and provide flexibility in applicability.