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Implementing Rigor and Transparency in NIH Grant and Career Development Applications

 
Effective January 2016, NIH established critical changes to grant applications that are intended to enhance the reproducibility of research findings (Notice Numbers: NOT-OD-16-011NOT-OD-16-012 and NOT-OD-17-068). These new instructions and revised review criteria focus on the following four areas deemed important for enhancing rigor and transparency: 

Scientific premise of the proposed research
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Rigorous experimental design for robust & unbiased results
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Consideration of relevant biological variables     
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Authentication of key biologicals and/or chemicals
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How will this affect the scoring (and ultimate fundability) of your grant?

 
Scored Criteria – Help NIH reviewers easily find the answers to these questions in your grant application:
  1. Significance: Is there a strong scientific premise for the project? (required for fundability)
  2. Robust Approach: Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? (required for fundability)
  3. Relevant biological variables: Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? (required for fundability)
Additional Considerations – Authentication of Key Biological and/or Chemical Resources: For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources (a plan or explanation as to why one is unnecessary is required before funding will be released).

Work with our experts to sharpen your science and meet NIH rigor, responsibility, and transparency requirements:

 
CCTS Biostatistics, Epidemiology & Research Design (BERD)
Our BERD experts partner with investigators in support of rigorous design, data management, and biostatistical analysis. Experts are available at standing walk-in clinics and by appointment every day. 
 
CCTS Project Panels
We are here to help you brainstorm ideas, generate research questions, meet possible collaborators, fine-tune study design and sharpen your proposals. Whether you want a multidisciplinary panel for your proposal or a quick, more tailored group, we assemble whatever expertise is needed to work with you to strengthen your project. Meet with a team of scientific experts who have perused your application as a first level of peer review.
 
CCTS Informatics
Work with experts to optimize data management, version control, and archiving.

Contact CCTS Research Commons to schedule an appointment or to learn more:
ccts@uab.edu or 205-934-7442


Additional CCTS Rigor, Reproducibility, and Transparency Resources

 
                                   
Kaizen-based R2T Game
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Have fun while you learn about rigor, reproducibility, and transparency! Our online R2T game, built on a Kaizen web-based platform developed by CCTS Informatics, helps investigators meet an NIH policy requiring formal training in R2T. Kaizen has been successfully used by the UAB Schools of Medicine, Nursing, Dentistry, and Public Health to enhance learner engagement and increase retention. R2T gamers can play alone or compete on teams. Learn more and get added to the Kaizen waitlist for upcoming R2T games.

Help us spread the word about Kaizen by downloading our flyer.

   
             
CCTS YouTube Rigor and Transparency Playlist

NIH Expectations: Are You Ready? (Dec. 2015 Forum presentation)

Rigor & Transparency: Tips from Study Section Reviewers (June 2016 Forum presentation)

Rigor, Reproducibility, and Transparency (slide deck from the December 2016 presentation at Auburn University)

   
 
CCTS Grant Library

See examples of successful grant applications, including a new section showing how fellow investigators are tackling the NIH requirement for “Authentication of Key Biological and/or Chemical Resources.”

Note: Samples provided are currently pending study section review.


Programs in Formal Instruction of Rigor and Transparency

Mastering the Art of Reproducible Science (Yoder, Brooks, Lorenz, Patel, Redden; Fall 2016)

The problem of non-reproducible outcomes in the scientific literature is rapidly eroding the credibility of biomedical research. The goal of the Mastering the Art of Reproducible Science course is to advance the visibility and awareness of this critical issue and to equip students to better recognize and eliminate sources of irreproducibility. The course will explore the fundamental causes and consequence of data irreproducibility, discuss best-practice procedures to minimize data irreproducibility, and discuss the responsibility of the scientific community to confront the irreproducibility crisis. The course is structured around four one-month long modules using a team based learning strategy.

The course will cover:


  • Emergenetics Profiling and Established Working Groups
  • Module 1 Reproducibility issues related to research tools and reagents.
  • Module 2 Reproducibility issues related to pressure, bias, data analysis, and presentation
  • Module 3 Reproducibility issues relate to preclinical testing and failures in clinical studies
  • Module 4 Reproducibility issues involving gender, race, age and health disparities.
  • Panel Discussion

Each module will consist of four one-week long blocks that will involve independent reading and assessment, literature based research, and team preparation for in class presentations that will facilitate active debate on major issues of reproducibly of scientific findings. A final class will consist of a panel forum consisting of researchers, journal editors, peer reviewers, clinicians, academic and industry scientists who will discuss their roles in addressing the reproducibility crisis in scientific and clinical research. 

Questions? Contact Research Commons at ccts@uab.edu or 205.934.7442


Additional External Resources

 
NIH – Rigor and Reproducibility Scientific rigor and transparency in conducting biomedical research is key to the successful application of knowledge toward improving health outcomes. The information provided on this website is designed to assist the extramural community in addressing rigor and transparency in NIH grant applications and progress reports.
 
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Biologic Variables Statistical Methodology
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Historical Perspective – How did we get here?