Earlier this year, the Office of Responsible Research Practices held a two-part webinar series for researchers titled FDA-Regulated Research: Myth vs. Reality – Medical Devices. In this follow-up blog post, we cover where to find session materials and answer questions that we weren’t able to address during the session or that fell outside the scope of the learning objectives.
As a service to our research community, we periodically share upcoming non-Ohio State events, webinars, and workshops that may be of interest to human subjects researchers, research staff, and IRB members. This month’s events cover a range of topics, from the ethics of using left-over clinical samples to implementation science research on improving care in underserved populations. All events are free or low-cost and open to the public but may require pre-registration.
The ORRP education team is putting the final touches on our investigator tools and materials from our recent webinar on FDA-regulated device research. In the meantime, we invite you to check out this delightful Valentine’s Day-themed article recounting “all the ways in which the FDA has sent Warning Letters to companies for using the word love” from Alec Gaffney at POLITICO’s AgencyIQ. (Pro tip: Don’t list “love” as an ingredient in a food product!)As a service to our research community, we periodically share upcoming non-Ohio State events, webinars, and workshops that may be of interest to human subjects researchers, research staff, and IRB members. This month’s round-up includes virtual events on real world data/real world evidence, impacts of the new Administration on the life sciences, the ethics of artificial intelligence, and implications of deep phenotyping in psychiatry research. All events are free and open to the public but may require pre-registration.
As announced in OnCampus yesterday, the Wexner Medical Center Compliance and Integrity office is proposing a new Protected Health Information and HIPAA Policy. Once in effect, “research” will be designated as a non-covered function and fall outside of HIPAA regulations, regardless of the unit employing the researchers. Procedure IV concerns the disclosure of PHI for research purposes. ORRP encourages the research community to review and comment on the proposed policy during the public comment period, which closes January 25, 2021.
On September 10, 2020, the Office of Responsible Research Practices held a webinar for researchers titled FDA-Regulated Research: Myth vs. Reality – Part 1: Drugs. In this follow-up blog post, we cover where to find session materials, introduce a “Test your knowledge” exercise, and answer questions that we weren’t able to address during the session or that fell outside the scope of the learning objectives.