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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
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?
NIH recently modified the forms used to report enrollment in accordance with the NIH Inclusion Policy. Learn more in our new podcast, “NIH’s Inclusion Policy: Understanding Race and Ethnicity” (mp3 and transcript), and on the NIH Inclusion of Women and Minority website.
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?
In this next installment of the NIH’s All About Grants podcast series, we delve into what you should know about certificates (MP3 / Transcript).
The latest NIH All About Grants podcast episode delves into just this issue (MP3 / Transcript). Lyndi Lahl, R.N., an NIH Human Subjects’ Officer, joins us (and her dog too!) in this final episode of this human subjects’ research mini-series.
A new “All About Grants” podcast is now available! In “Understanding the Definition of a Clinical Trial and What That Means for You”, Dr. Mike Lauer, NIH deputy director for extramural research, discusses the changes to clinical trial policies, addresses community questions, and speaks to how these changes will impact applicants and grantees.
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 have a promising research idea that may involve human participants to carry out the study. Do you know what to do next? Join us for the next NIH All About Grants podcast conversation about how you know you are doing human subjects’ research.
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.
