This webinar focuses 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 discuss 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.

Objectives

• Identify what is considered human subjects research.
• Identify when research is considered exempt.
• Identify when IRB review is required.

Speakers

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.