Regulatory Webinar Series


How to Develop an Effective Schedule of Events for a Research Protocol

So Many Procedures, So Little Time - How to Develop an Effective Schedule of Events for a Research Protocol. Presented by: Mike Fusakio, PhD; Nathan Hawk, BSPS; Samantha Sonoda, MS, CCRA; Lisa M. Tully, MA, CCRP, all affiliated with Cincinnati Children's Hospital Medical Center. Originally aired Dec. 2, 2020.

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Single IRB (Institutional Review Board) Presentation & Panel Discussion

Single Institutional Review Board (IRB): Presentation & Panel Discussion. Features Nichelle Cobb, PhD, Smart IRB Director at University of Wisconsin-Madison. Panelists include James Cnota MD (Cincinnati Children's), Jeremy Corsmo, MPH (Cincinnati Children's), Pooja Khatri, MD, MSC (University of Cincinnati) and Mike Linke, PhD (University of Cincinnati). Originally aired Sept. 16, 2020.

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Human Subject Research Protocols: If you write it (well), they will come

Helpful Tips and Tricks for Developing and Amending Protocols for the Rare Disease Clinical Research Network, presented By: Mike Fusakio PhD, Cincinnati Children's Hospital Medical Center. Originally aired June 30, 2020.

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For Early Career Researchers


NIH Mentored Research (K) Career Development Awards for Clinician Researchers

NIH Mentored Research (K) Career Development Awards for Clinician Researchers, featuring Paula Gregory, PhD, Associate Dean for Faculty & Educational Development, UNTHSC Graduate School of Biomedical Sciences, with Debra Regier, MD, PHD, of Children's National Hospital, Principal Investigator of the Rare Disease Scholar's Program.

Diversity in Rare Disease Research


Race, ethnicity and racism in the nutrition literature: an update for 2020 image
Race, ethnicity and racism in the nutrition literature: an update for 2020.

Reviews the limitations of classifying research participants by race, and recommends a series of steps for authors, researchers and policymakers to consider.


Enhancing Diversity of Clinical Trial Populations Image
The U.S. Food and Drug Administration has published guidance on “Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry.” This guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of underrepresented populations in their clinical trials.

Additional Resources


NIH Data Management image
The The NIH has released a Data Management and Sharing policy, which goes into effect January 25, 2023 and replaces the existing 2003 NIH Data Sharing Policy. The policy is updated to keep pace with scientific and technological advancements and emphasizes the NIH’s commitment to data management and sharing, which is seen as an integral piece to the conduct of research. A summary of the new policy can be found here.

COVID-19 image
The NIH has shared Resources for Research Impacted by COVID-19. Please see this page for a variety of guidance and informational resources provided by the National Institutes of Health for recipients of NIH research funds.