When SBER Involves Drugs and Devices: Cases to Clarify FDA Oversight


Increasingly, social, behavioral, and educational research (SBER) incorporates techniques and devices that are more traditionally found in biomedical research, creating challenges for IRBs in determining whether a study falls under US Food and Drug Administration (FDA) oversight. The FDA’s authority includes drugs, biologics, and medical devices. FDA oversight may also extend to mobile medical applications and other innovations, which can create challenging regulatory questions as to whether a study falls under FDA jurisdiction.

During this 90-minute webinar, speakers will pair key regulatory concepts with illustrative scenarios to provide a broad overview of essential FDA issues for IRBs reviewing relevant SBER. Speakers will:

  • Define several fundamental regulatory concepts present in the FDA regulations—including drug, Investigational New Drug (IND), Investigational Device Exemption (IDE), significant risk (SR), non-significant risk (NSR), dietary supplement, medical device, and mobile medical app—and explore application of these definitions to SBER
  • Discuss factors to consider when determining whether an SBER protocol involves FDA-regulated drugs or devices and is therefore subject to FDA oversight
  • Examine a diverse set of SBER cases in areas such as mobile apps, exploratory devices, food and dietary supplements, and transcranial magnetic stimulation
  • Explore other relevant IRB issues, including the application of different levels of review that can be applied to FDA-regulated SBER and considerations for informed consent

This webinar will review basic FDA definitions and terminology.

What will I learn?

After attending this webinar, you will be able to:

  • Define some key FDA regulatory concepts and recognize their potential application to SBER
  • Determine whether an SBER protocol involves FDA-regulated drugs or devices
  • Apply appropriate IRB review levels to studies with FDA-regulated drugs or devices

Who should attend?

This webinar will review basic FDA definitions and terminology. IRB professionals and members as well as researchers who review and conduct SBER will benefit from this webinar.

Continuing Education

CIP Credit label Webinar participants holding the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP recertification.


Patrick McNeilly, PhD is a senior health policy analyst with the Office of Good Clinical Practice in the FDA’s Office of the Commissioner. He is involved in a variety of policy issues related to human subject protections and good clinical practice. He joined FDA in May 2011 with FDA’s Center for Drug Evaluation and Research overseeing compliance programs related to IRB and Radioactive Drug Research Committees. Prior to working at FDA, Dr. McNeilly was the human protections administrator for the Agency for Healthcare Research and Quality. He has also served as a compliance oversight coordinator for the HHS Office for Human Research Protections. He is a registered pharmacist and was originally trained at the Rutgers University College of Pharmacy and received his doctoral degree in medicinal chemistry from the University of Maryland School of Pharmacy.

Robin Tyndall serves as director for the Office of Research Protections at Appalachian State University. Her small but mighty office supports regulatory compliance with human subjects, animals, biosafety, intellectual property, export controls, conflicts of interest, and responsible conduct of research-- as well as compliance and ethics training for faculty and students. Prior to joining Appalachian State in 2009, Ms. Tyndall worked for 14 years in a global technology company as an Operations Director and ISO Program Manager for multiple sites and business functions. Ms. Tyndall graduated from UNC-Chapel Hill with a degree in English. She is pursuing her MS in Bioethics from Clarkson University/Icahn School of Medicine at Mount Sinai.

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HRP Consulting Group provides expert advice to institutions seeking to develop or improve all aspects of their human research protection program. For more information, please visit www.thehrpconsultinggroup.com.

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