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Institutional leadership from across the partner network met in Birmingham this week to explore opportunities presented by the unique capacities and synergies for high-impact science that exist within the Center. CCTS Executive Council members were joined by leadership from Auburn University, Louisiana State University Health Sciences Center, Pennington Biomedical Research Center, Southern Research, Tulane University, University of Alabama Tuscaloosa, UAB, and University of South Alabama. Other partners, including Southern Research and Tuskegee University, were representing the CCTS at international meetings.

Discussion centered around several initiatives that could be further leveraged to advance scientific discovery and to support the development of the research workforce across the network. Brief highlights are offered below.

Rigor and Transparency
The CCTS offers numerous resources to help principal investigators meet the new NIH requirements on rigor and transparency, which apply to the majority of research and training grant applications. Resources include consultations with Biostatistics, Epidemiology and Research Design (BERD) experts, who offer methodologic guidance at every stage of research development, from design, implementation, and analysis to reporting and data archival. Likewise, the CCTS offers advanced peer review via Project Panels. Notably, CCTS Panels have a demonstrated impact on extramural grant success, exceeding the national average for funding success by five-fold.

Multi-site Clinical Trials
Opportunities exist to accelerate clinical and translational research toward improved health and health care delivery by taking advantage of the efficiencies offered by multi-site clinical investigation. Adoption of best practices and standards in clinical research management will improve feasibility assessments, contracting, time to trial activation, regulatory processes and data management. Modeled after the Midwest Area Research Consortium for Health (MARCH), the nascent Southeastern Health Alliance for Research (SHARE) provides an infrastructure for CCTS investigators and external federal and industry sponsors who want to conduct collaborative clinical research at academic institutions in the Southeast.

The CCTS Partner Network, working in collaboration with institutional review boards (IRBs), is also developing the capacity to support the IRB reliance model established by NCATS’ Streamlined, Multi-site, Accelerated Reliance for Trials (SMART) IRB. This flexible platform is based on the successful experiences of NIH’s single IRB initiatives and on CTSA Program demonstration projects using a model called IRBrely. The effort aims to harmonize and streamline processes to support the protection of human subjects in research.

Disease Cohorts and Biospecimen Repositories
The CCTS is presently developing the capacity for federated specimen collections connected by ‘query-able’ informatics strategies. Instances of i2b2 (Informatics for Integrating Biology & the Bedside) have been established at multiple CCTS Partners and plans are in place to link them together. CCTS Informatics leaders have established approaches to automate IRB processes and to enable investigator self-service access to data. They are developing ontologies to further enhance the integration of these systems. In addition, work is underway to develop strategies to incorporate clinical research forms, patient-reported outcomes, biospecimen availability, and registry information into i2b2. In collaboration with other southeast CTSAs, the CCTS is also exploring how to use i2b2 to leverage existing research cohorts and to enable sample capture to create a “living biorepository.”

Training and Career Development
The CCTS Training Academy promotes the continuous development of skills and knowledge for learners at all career stages in support of a vibrant, innovative, and multidisciplinary research workforce to improve human health and health care. To this end, the CCTS supports training opportunities that foster the next generation of translational researchers through formal curricula (the TL1 8-week training program, TL1 Yearlong Clinical Research Training program, and the KL2). These opportunities will be promoted more broadly throughout the partner network to reach promising doctoral students and junior faculty and data encourage them to apply.

Drug Discovery and Device Development Programs
The discussion point for both of these programs was to identify research projects with potential biologic targets or clinical observations that may benefit from the Academic Drug Discovery/Device Development Alliance (ADDA). All projects supported by the CCTS engage a multidisciplinary team of experts, which meets quarterly to guide the project’s progress and to troubleshoot obstacles. This project development team assembles members with expertise in the scientific content space, medicinal chemistry, high-throughput assay development, and clinical application. Additionally, the projects are advised of intellectual property and commercialization opportunities very early in the process.

Genomics and Precision Medicine
The sequencing of the human genome has created an unprecedented opportunity to apply new knowledge and technology to improve human health. The goal of the CCTS Genomics Special Module is to connect clinical and translational researchers to expertise and capacity to undertake genetic and genomic investigation. In this way, the network will accelerate discoveries in genomics and will propel those discoveries into clinical practice.

Building on the state-of-the-art technologic capacities and expertise at the HudsonAlpha Institute for Biotechnology and other CCTS Partners, the Genomics Module catalyzes rigorous genomic research and innovation through consultation with CCTS investigators in the design and implementation of studies, including advice regarding scientific strategy, appropriate use of technologies as well as data analysis. These experts also spearhead cutting-edge assay development, including single cell genomics and advanced next-generation sequencing of nucleic acid species (e.g., miRNA), techniques. Opportunities exist to connect investigators across the network with experts in genetic/genomic study design, assay and analysis through consultation and provide access to high-throughput & state-of-the-art technology.

Community Engagement
Efforts are underway to learn from CCTS Partner community engagement (CE) experiences and to share CE strategies across the network.

For instance, in 2012 the Community Engagement arm of the CCTS, One Great Community (OGC), launched the Community Health Innovation Awards (CHIA), a competitive program supporting grants ranging from $5,000 to $25,000 to local organizations with ideas that creatively and innovatively address community issues. The awards are envisioned as a way for participants to think boldly and creatively about solutions to "on the ground" health challenges and to partner with local businesses and experts to complete a project. How to nurture similar mission-relevant collaborations with community stakeholders across the CCTS region was discussed. To support greater networking, the CCTS is planning to catalog regional CE activities using the Elsevier PURE database tool.

Building on the success of the CHIA program, OGC has established the Community Engagement Institute, an education and networking opportunity for academic and community partners to explore, to discuss, and to gain practical skills related to collaborative research and service, especially to address locally identified needs and to connect key stakeholders and change agents to one another for action. This regional event draws on organizers and participants from across the southeast, including the CCTS Partner Network. The 3rd Annual Community Engagement Institute is scheduled for October 14, 2016.

To learn more about the recent IAC meeting, please contact CCTS Research Commons via email This email address is being protected from spambots. You need JavaScript enabled to view it. or 205-934-7442.

The National Institutes of Health (NIH) recently provided guidance to its study section volunteers regarding how they should apply the new rigor and transparency requirements during the upcoming June 5th cycle of grant reviews. The CCTS gathered several reviewers based at UAB to discuss what they had learned from their training with the audience of investigators at its monthly Forum. An overflow room was required to accommodate the number of attendees. Still others participated via GoToMeeting.

Panelists included Yabing Chen, PhD, professor, and Jianhua Zhang, PhD, associate professor, both Division of Molecular & Cellular Pathology; Rita Cowell, PhD, associate professor, Department of Psychiatry & Behavioral Neurobiology; and Mohammad Athar, PhD, professor, Department of Dermatology.

Four areas that the NIH states “require more explicit attention by applicants” were discussed, including (1) scientific premise, (2) scientific rigor, (3) consideration of relevant biological variables, and (4) authentication of key biological/chemical resources. Panelists clarified that only the first three will be scored, but that the fourth requires a new form that must be downloaded and attached to grants for submission.

The panelists helped attendees understand how NIH is defining scientific “premise” and “rigor” and where each needs to be addressed in grant applications. Scientific premise addresses the underlying scientific foundation of a project. Applicants must show sufficient justification for the proposed work, cite appropriate work or preliminary data, identify the strengths and weaknesses of prior work, and describe how they propose to fill a significant gap in the field. It should be addressed under the Significance section.

Rigor pertains to the application of scientific methods to ensure a robust and unbiased design, analysis, interpretation, and reporting of results and that sufficient information about the study is provided for it to be assessed and reproduced. Plans for determining group size, ensuring blinded and independent measurements, improving precision and reducing variability, excluding/including subjects, and managing missing data must be addressed under the Approach section.

Research studies that involve vertebrate animals or humans need to account for relevant biological variables such as sex, age, weight, genetic strain, and race/ethnicity. Applicants must justify the use of only one sex in a study. If little is known about sex differences in the given topic, the applicant must include both, with sufficient numbers to inform the presence or absence of sex differences.

Reviewers will comment on the new Authentication of Key Biological and/or Chemical Resources attachment, rating it acceptable or unacceptable. The goal is to help researchers avoid misidentifying or contaminating resources. Panelists stressed that applicants should not put experimental methods or preliminary data in this section. They also informed investigators that “even applications scored in the fundable range will not receive a Notice of Grant Award in the absence of this document.”

Page limits for NIH grants have not changed. The NIH told reviewers that “page limits, cost, and time are not valid reasons to disregard attention to these issues.”

To learn more and stay up to date on rigor and transparency issues, visit the CCTS Rigor and Transparency web page.