In Brief

The new NIH biosketch

The National Institutes of Health (NIH) has issued a new biosketch format, which should be used for all NIH grant applications and Research Performance Progress Reports due on or after May 25, 2021. On Jan. 25, 2022, the NIH will require use of the new format and may reject or delay applications using the old format. All changes listed below pertain to the Non-Fellowship Biographical Sketch:

• In Section A “Personal Statement,” mention ongoing and completed research projects from the past three years that you want to highlight. This information previously went in Section D “Research Support.”
• The title of Section B has changed from “Positions and Honors” to “Positions, Scientific Appointments and Honors.”
• Section D “Research Support” has been removed. To easily update your biosketch, you can use SciENcv on the NCBI website. You can copy and paste your information into the relevant text fields on SciENcv, which will create a properly formatted biosketch that you can download as a PDF or Microsoft Word file.

For assistance with your biosketch, please contact Courtney Bricker-Anthony, PhD, CFRI scientific editor, at courtney.bricker-anthony@lebonheur.org.

FDA issues notice of noncompliance with ClinicalTrials.gov requirements

Under current federal law, researchers are required to register clinical trials of drug products, biological products and device products on ClinicalTrials.gov within 21 days after the first human subject is enrolled. The summary results for these trials must also be submitted no later than one year after the study’s completion date. The FDA recently issued the first Notice of Noncompliance for failure to submit summary results to ClinicalTrials.gov. The FDA has the ability to issue monetary fines and pursue criminal litigation for failure to comply.

If you are running a clinical trial or plan to conduct a clinical trial, please ensure that you are in compliance with all federal laws regarding ClinicalTrials.gov, as the FDA is currently conducting an audit. Please also note that clinical trials cannot be published in peer-reviewed journals if they are not registered on ClinicalTrials.gov.

For assistance with clinical research and regulatory matters, please contact Kerry Moore, CFRI director of clinical research, at kerry.moore@lebonheur.org.