2013 Webinar: Key Decision Points

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Overview

This webinar focused on identifying whether activities are human subjects research and, if so, what level of review they require. Using case studies from both biomedical and social science/behavioral research, presenters discussed the process for determining when an activity constitutes research involving human subjects, and when such research is exempt, qualifies for expedited review, or must undergo full institutional review board (IRB) review.

  • What is considered human subjects research? During this part of the presentation, the speakers identified when an activity is considered “research” and when that activity involves “human subjects” as defined in the Department of Health and Human Services (DHHS) and U.S. Food and Drug Administration (FDA) regulations. They also briefly explored what it means to be “engaged in research” and therefore obligated to apply the regulations.
  • When is research exempt? This section featured an overview of the federally mandated exemption categories and the differences between DHHS and FDA regulations with regard to exempt research.
  • When is IRB review required? This section of the webinar focused on the criteria for expedited review, and the speakers compared this type of IRB review with full board review. 

Audience

This introductory-level webinar was of interest to individuals working with human research protections programs (HRPPs) and IRBs, especially those new to the field.

Faculty

Karen Hale RPh, MPH, CIP
Karen Hale is the director of the Office of Responsible Research Practices at The Ohio State University (Ohio State). Prior to serving in this role, Ms. Hale provided leadership for the development of content, review procedures, and education for Ohio State’s electronic institutional review board (IRB) submission process. Ms. Hale is a member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) Subcommittee on Harmonization for the Department of Health and Human Services, and serves as a consultant for the Office for Human Research Protections (OHRP). She is also a site visitor for the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Ms. Hale previously worked in Ohio State’s Wexner Medical Center department of pharmacy and served as vice chair of The Ohio State University Biomedical Sciences IRB. Ms. Hale received her Master’s degree in public health from Ohio State and is a Certified IRB Professional (CIP®). She has been a faculty member at PRIM&R’s regional and national meetings.

Daniel Nelson, MSc, CIP
Daniel Nelson is a professor of social medicine, an adjunct professor of pediatrics, and the director of the Office of Human Research Ethics at the University of North Carolina at Chapel Hill. Trained in medical physiology, Mr. Nelson previously held faculty appointments at the Mayo Clinic—with a sabbatical fellowship conducting human studies in Europe—and at the University of Rochester, where he was director of research in a clinical gastroenterology unit and chair of a hospital IRB. A national leader in the field of human research protections, Mr. Nelson has served as past-president of ARENA, PRIM&R’s former membership division; charter member of the AAHRPP Council for Accreditation; a former member of Council for Certification of IRB Professionals; founding co-chair of the IRB Sponsor Roundtable; consultant to OHRP; and liaison to the National Bioethics Advisory Commission. Since 2005, he has co-chaired a SACHRP subcommittee that advises the DHHS on the regulations that govern human research protections (the “Common Rule”). Mr. Nelson is also a co-investigator on several grants from the NIH concerning issues surrounding research ethics, and has frequently lectures on related topics.

Certificates of Attendance

Certificates of Attendance for the Key Decision Points: Is it Research Involving Human Subjects? Is it Exempt? Is IRB Review Required? webinar were made available at the conclusion of the webinar. To access the certificate, you must first complete the online evaluation. Such certificates are useful for obtaining continuing education (CE) credits (not Continuing Medical Education credits) from professional associations. Note that guidelines concerning CE credits may differ, and you should consult the appropriate professional association representative for further guidance.