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In this episode of the NIH All About Grants podcast, Deysi Duque, a Senior Clinical Trials Analyst within the NIH Office of Extramural Research, talks us through the clinical trials dissemination policy, its purpose, resources (like this decision tree (PDF)), exceptions, and what recipient organizations and researchers should know
ClinicalTrials.gov is the world’s largest repository of clinical trial information. The site allows the public to easily find and learn about the myriad of research studies in human participants. Users can determine which studies are recruiting, when they will be completed, and can even find trial results. But what should researchers and recipients be aware of regarding this system as it relates to reporting NIH grant-funded trials?
NIH expects that sex as a biological variable (SABV) will be factored into research designs, analyses, and reporting in pre-clinical and clinical studies. Accounting for SABV helps interpret and validate research findings, as well as enhances the rigor, reproducibility, and applicability of biomedical research. But how exactly do you account for SABV?
For decades, NIH has required valid analysis, also known as stratified analysis, to explore how well interventions work across sex/gender and race/ethnicity for all applicable clinical trials. After revising the policy last year, NIH now requires the findings from these stratified analyses to be reported on ClinicalTrials.gov after an applicable NIH-Defined Phase III clinical trial has completed. Wondering about how this impacts your research?
Starting January 29, 2019, NIH will begin implementing the Inclusion Across the Lifespan policy, which requires the consideration of age, along with sex/gender and race/ethnicity, in applications that involve human participants. What does this policy mean for you and your study?
You’ve done your homework: read the requisite materials on human subjects, spoken with program staff at NIH, even listened to Part 1 of this podcast mini-series for some insights on how you know you are actually doing human subjects research. Now you’re ready to explain in your NIH grant application how research participants will be protected and monitored.
