Sharing is Caring: Are you ready for the NIH’s Data Management & Sharing Policy? Part 1
Regulatory
Posts about regulatory issues and interpretation
Five Questions with Meliha Rahmani: Post-Approval Monitoring
You open your email one morning to find a message from ORRP’s quality improvement staff that says your study has been selected for a post-approval monitoring check. What does that mean? Did you do something wrong?
Never fear! In this edition of Five Questions, Quality Improvement Specialist Meliha Rahmani breaks down post-approval monitoring: what it is, why we do it, and what it means for your research.
The Feds Want (to hear from) YOU!
When we think of practicing citizenship, we often think about exercising the right to vote and calling our representatives. But did you know the federal government regularly seeks public comments about specific topics and rules that are under consideration?
Both NIH and FDA currently are currently seeking comments on topics of interest to the human subjects research community. Share your thoughts on informed consent language that fosters participant data and specimen sharing, leveraging existing data to advance pediatric drug development, and more.
Continue reading The Feds Want (to hear from) YOU!Reliance Reflections: Summer Research Volunteers
Will non-Ohio State students, volunteers, or interns be helping with your IRB-approved human subjects research activities this summer? In this edition of Reliance Reflections, Jessica Mayercin-Johnson, ORRP’s program manager for reliance agreements and regulatory support, walks us through the nuts and bolts of ensuring your summer research collaborators are added to your study quickly and efficiently.
Continue reading Reliance Reflections: Summer Research Volunteers 
FDA-regulated Medical Device Research: Tools & webinar materials now available!
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.
What’s love got to do with it, FDA?
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.
Re-post: How should a “reasonable” person approach key information?
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 Re-post: How should a “reasonable” person approach key information? 
Webinar Follow-Up: FDA-Regulated Drug Research
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.
Re-post: Minding the (db)GaP: Age of Majority and the NIH’s GDS Policy
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?
Continue reading Re-post: Minding the (db)GaP: Age of Majority and the NIH’s GDS Policy