Journal of Research Administration最新文献

A major pre-award administrative challenge research universities face is turnaround time for generation of high-quality NIH Data Training Tables for NIH training grants (e.g., T32, K12, TL1, KL2, R25s) which are required for training grant submission proposals to the National Institutes of Health (NIH). Universities with dedicated training grant submission offices generally require data preparation following a structured timeline of several months in advance of the grant submission due date, while other universities with less or no dedicated support for training grant submissions use an ad hoc approach. In these cases, department or program administrators may collect the data manually, in Excel or REDCap, or similar manually maintained methods for those tables requested by the specific NIH grant announcement for the relevant participating graduate predoctoral and/or postdoctoral (including clinical) training programs across the university, depending on the training focus and the "participating faculty" provided by the proposed program director (PD/PI) for the grant. We describe an efficient "federated" method of data collection and construction for NIH Tables (2, 4, 5A/B, 6A/B & -8A part III/8C part III) for new and renewal applications by combining the use of REDCap and NIH xTRACT, leveraging the strengths of each.

Background: Pilot project programs offer early-stage and other investigators support to pursue emerging research areas, explore new methodologies, gain experience as principal investigators, and collect pilot data needed to pursue larger extramural research funding, such as from the National Institutes of Health. Pilot project programs may be particularly important to early-stage investigators from underrepresented backgrounds, who must overcome unique challenges to launching careers in community-based participatory research. This paper describes the structure, function, and impact of the Native Center for Alcohol Research and Education (NCARE) Pilot Project Core.

Methods: During four calls for applications from 2018 to 2021, research investigators interested in conducting alcohol use disorder research in partnership with Tribal communities were recruited, with a focus on early-stage and American Indian and Alaska Native investigators. Eligible investigators were required to submit letters of intent prior to preparing full applications, which underwent a rigorous review process.

Results: Eight pilot projects were awarded. Of the eight pilot project investigators, seven were early-stage scholars, seven were female, and four identified as American Indian or Alaska Native. The funded projects included two primary areas of research, epidemiological studies and intervention projects. Once funded, the Pilot Project Core assisted pilot project investigators with securing approvals for their research studies, responding to methodological and analysis questions, and mentoring and monitoring of their progress. At the time of writing this paper, three pilot project investigators have completed their pilot projects, three investigators are currently collecting data, and one is in the analysis phase. One pilot project investigator did not complete their project due to COVID-19 restrictions early in the pandemic. The pilot project investigators submitted 36 grant proposals for independent external funding and received 25 grants after funding of their pilot project; four were directly related to pilot project grants. Additionally, four peer-reviewed manuscripts resulting from Pilot Project Core support were published.

Conclusions: Despite challenges related to COVID-19 pandemic the pilot project funding through NCARE provided eight pilot grants, half of which identified as AI/AN and most of which led directly to multiple grants and papers. The NCARE pilot program provides a model for other similar programs seeking to support early-stage investigators who identify as AI/AN or other groups underrepresented in science.

To successfully and efficiently initiate clinical research studies, it is critical to develop a strong, feasible, and well-written study protocol early in the start-up phase. The University of Minnesota's Clinical Research Support Center designed and implemented a structured Feasibility Review process in 2018 that addresses common start-up challenges such as poor study design, inappropriate outcomes, and limited resources. This process has been shown to turn an unfeasible study into a well-designed protocol that is IRB-approved with few protocol-related stipulations and well prepared for execution. It has also educated study teams on how to write better quality and more robust protocols for subsequent studies. Once a draft protocol is available, the entire process takes just six working days and is free of charge to investigators, study teams, and departments. From 2018-2021, one hundred sixteen Feasibility Reviews (n=116) have been completed across eight schools or colleges. Mean satisfaction scores for study team members who responded were high (N=126, M=4.71 ± 0.5) on a 5-point Likert-type scale. Most respondents (96%) indicated that they planned to modify their protocol based on reviewer feedback. Open ended/qualitative feedback was highly positive with most responses centered around the helpfulness of feasibility review, the high level of expertise, and fast turnaround time. The Feasibility Review is a valuable and multifunctional program providing timely expert guidance to study teams to efficiently and successfully launch and execute clinical research studies. It can be easily replicated, adapted, and implemented at other institutions to increase the quality and efficacy of academic research.

The National Institutes of Health (NIH) established the Building University Infrastructure Leading to Diversity (BUILD) initiative to increase engagement and retention of undergraduates from diverse backgrounds in biomedical research. Portland State University, in partnership with ten other academic institutions, received a BUILD award and developed the BUILD EXITO (Enhancing Cross-Disciplinary Infrastructure and Training at Oregon) project. The EXITO program offers a three-year research and mentorship experience for undergraduates in biomedical, behavioral, social science, clinical, and bioengineering disciplines. The BUILD initiative also emphasizes enhancing research capacity and infrastructure through institutional change and faculty development. A key piece of EXITO's program to enhance research capacity is offering faculty an opportunity to apply for up to $50,000 of funding to carry out a one-year pilot study. We conducted two separate RFAs for this purpose, closely modeled on NIH's Small Grant Program (R03), over two years. Principal Investigators of pilot projects were encouraged to include EXITO students, or other undergraduate students, on their research teams. Students then worked on these research projects as part of EXITO's intensive mentored research program. This paper reports on methods to conduct and implement a pilot project program intended to train primarily junior faculty members to write and submit an NIH proposal and fund successful applicants to gather pilot project data to aid in applying for future proposals. We provided a step-by-step rigorous submission and review process. We provided proposal writing and revising workshops, technical support, and helped pilot project Principal Investigators (PIs) with biosketches, IRB applications, IUCUC documents, budgets, and other proposal sections. We secured at least three external (not at any BUILD EXITO institution) reviewers for each proposal. PIs revised proposals before resubmitting and receiving their final scores. Across two RFAs, we provided funds twenty PIs to conduct pilot projects; these projects included at least 21 students working on them who received mentoring in research methods and in disseminating results. This paper describes important lessons learned, including the importance of: allotting sufficient time to recruit reviewers; recruiting reviewers through a variety of sources and methods; and assisting PIs in engaging with research administration staff at Portland State University and partner institutions. Challenges included: finding an optimal timeline that was neither too compressed nor too stretched out; encouraging applicants from distant partner institutions to apply and keeping them engaged and retained through the entire process; and assisting PIs from partner institutions to efficiently utilize Portland State University's sponsored projects department if similar resources were not available at their home institutions. Our goal is to provide gui

While Elizabeth Barrett Browning counted 25 ways in which she loves her husband in her poem, "How Do I Love Thee? Let me Count the Ways," we identified only eight ways to evaluate the potential for success of a federal research grant proposal. This may be surprising, as it seems upon initial glance of the review criteria used by various federal funding agencies that each has its own distinct set of "rules" regarding the review of grant proposals for research and scholarship. Much of the grantsmanship process is dependent upon the review criteria, which represent the funders' desired impact of the research. But since most funders that offer research grants share the overarching goals of supporting research that (1) fits within its mission and (2) will bring a strong return on its financial investment, the review criteria used to evaluate research grant proposals are based on a similar set of fundamental questions. In this article, we compare the review criteria of 10 US federal agencies that support research through grant programs, and demonstrate that there are actually only a small and finite number of ways that a grant proposal can be evaluated. Though each funding agency may use slightly different wording, we found that the majority of the agencies' criteria address eight key questions. Within the highly competitive landscape of research grant funding, new researchers must find support for their research agendas and established investigators and research development offices must consider ways to diversify their funding portfolios, yet all may be discouraged by the apparent myriad of differences in review criteria used by various funding agencies. Guided by research administrators and research development professionals, recognizing that grant proposal review criteria are similar across funding agencies may help lower the barrier to applying for federal funding for new and early career researchers, or facilitate funding portfolio diversification for experienced researchers. Grantmakers are furthermore provided valuable guidance to develop and refine their own proposal review criteria.

In an effort to foster research integrity, the National Institutes of Health and the National Science Foundation mandate education of all trainees in the responsible conduct of research (RCR). Nevertheless, recent studies suggest that rates of questionable research practices and scientific misconduct are both high and considerably underreported. In part, this may be due to the fact that some ethical norms (e.g., authorship assignment) are far from clear and researchers are unsure how to respond to perceived misconduct. With funding from the U.S. Office of Research Integrity (ORI), we convened four panels of experts to develop a consensus on the overarching goals and teaching content of RCR instruction. Our panelists recommended nine overarching objectives for RCR instruction that require us to rethink common modes of instruction, and they identified issues and standards that should be covered within controversial areas such as authorship assignment and whistle-blowing. Additionally, our experts recommended two new core areas for RCR instruction: The social responsibilities of scientists and current topics in RCR.