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!)
Read the full article, How the FDA regulates ‘love,’ at FDA Today and follow @AlecGaffney for the latest on FDA regulation of medical products.
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.Continue reading
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.Continue reading
The Revised Common Rule requires informed consent documents to begin with a concise summary of information that a “reasonable” person would want to know when deciding to participate or not participant in a research study. At the 2018 Advancing Ethical Research conference, panelists from the Office of Human Research Protections (OHRP), National Institutes of Health (NIH), and two research institutions discussed considerations for implementing the key information requirement.Continue reading
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.
The National Institutes of Health Genomic Data Sharing (GDS) Policy recognizes participants’ informed consent as integral to responsible sharing of genomic data, stating that consent processes must “explicitly discuss future research use and broad data sharing, even if the data are generated from specimens that are de-identified” before such information may be deposited in publicly available databases. Minors are unable to legally consent, however, and parental permission is valid only until the child turns 18. Do researchers have an ethical obligation to re-contact of-age participants to obtain consent, perhaps years after their genetic data was collected?
After 12 years as a Quality Improvement Specialist for Education and Outreach in the Office of Responsible Research Practices, Joni Barnard retired in April 2020. In this edition of Five Questions, Joni reflects on her time supporting the Social and Behavioral Sciences research community.