• A field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process
• A key tenant of translational science is understanding common causes of inefficiency and failure in translational research projects
• Application of scientific and operational innovation and strategies to improve the efficiency and effectiveness of all research
• Examples of translational barriers may be found on the CCTS Pilot Program website. Examples in the context of pilot projects may be found on the Translational Science in Pilots website.

• Who can help with Human Subject Research training, ethics (IRB) review and related regulatory requirements?
  • CCTS Partner Institutions’ human subject research offices provide necessary training and review human subject research protocols to assure ethical conduct of research.
    • UAB’s Office of the IRB
    • Tuskegee University’s Human Participants Committee
    • Auburn’s Office of Human Research
    • University of Alabama at Tuscaloosa’s Institutional Review Board
    • University of South Alabama’s Research Compliance and Assurance
    • University of Mississippi’s Institutional Review Board
    • Louisiana State University Health Science Center New Orleans’ Institutional Review Board
    • Pennington Biomedical Research Campus’ Human Research Protection Program
    • Tulane University’s Human Research Protection Office and IRBs
  • Some Departments have Regulatory specialists as an administrative resource
  • The CCTS Clinical Regulatory Support Program may be leveraged to assist investigators with regulatory questions or needs.

• What are NIH-defined clinical trials?
  • The NIH’s definition of a clinical trial is a research study where one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. The NIH provides additional information and a decision tool to help determine if a study meets the definition.

• Will I need to register my study in ClinicalTrials.gov?
  • If your study meets the definition of an NIH-defined clinical trial, the study must be registered in ClinicalTrials.gov and results reported accordingly.
  • Note: If the study is an NIH-defined clinical trial, many institutions require investigators to submit to ClinicalTrials.gov before submitting a human subjects research protocol or before IRB approval will be granted.

• What are Investigational New Drug or Biologic (IND) and Investigational Device Exemptions (IDE) submissions?
  • The Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) website provides an excellent overview of IND and IDE submissions.
  • UAB’s Office of Research provides details about IND and IDE submissions

• Who can help with Vertebrate Animal training and regulatory requirements?
  • UAB’s Institutional Animal Care and Use Committee
  • Tuskegee University’s Institutional Animal Care and Use Committee
  • Auburn University’s Institutional Animal Care and Use Committee
  • University of Alabama at Tuscaloosa’s Institutional Animal Care and Use Committee
  • University of South Alabama’s Institutional Animal Care and Use Committee
  • University of Mississippi’s Institutional Animal Care and Use Committee
  • Louisiana State University Health Science Center New Orleans’ Institutional Animal Care and Use Committee
  • Tulane University’s Institutional Animal Care and Use Committee

• Where can I learn more about this program’s Just-in-Time Request?
  • Applicants receiving a Notice of Selection are asked to provide Just-in-Time information. Investigators are asked to provide relevant regulatory approval(s), related documents and programmatic information using a dynamic Just-in-Time Request form. *This example is hosted by a development instance of the live version. Users are not able to “Submit” this form. Data entered will not/cannot be saved.

• Tips on writing a research proposal
  • Address the Top 10 Problems Reviewers Cite in Applications
  • 23 Questions to Guide the Writing of a Quantitative Medical Education Research Proposal
  • Top ten strategies to enhance grant-writing success
  • Verify the novelty of your idea by searching publications (PubMed, dimensions.ai), awarded grants (NIH RePORTER, dimensions.ai, PIVOT) and registered trials (clinicaltrials.gov)
  • Read awarded grants in the CCTS Grant Library (spoiler alert: these are NOT pilot proposals)

The CCTS provides examples that may help you identify and/or frame your proposed work as translational science