Time: 11:00am to 12:15pm
Content level: Intermediate
In a follow up review of a 1998 study of challenges facing institutional review boards (IRBs), Brown, Varmus and Friedman (U.S. Department of Health and Human Services, Office of Inspector General, oei-01-97-00194) further assessed these risk factors for low volume IRBs – IRBs that conduct less than 125 annual reviews and are typically housed in community-focused organizations lacking a research culture. Identified IRB risks included:
- Review too much, too quickly, with too little expertise
- Minimal continuing review of approved research
- Conflicts that threaten their independence
- Little training for investigators and board members
- Little attention to evaluating IRB effectiveness
Many community college and primarily undergraduate institution IRBs fall into the low-volume category – some falling into what we have termed a “lower than low”-volume category – IRBs that review a handful of limited-methodology proposals on campuses, where most personnel serve dual roles, in a culture that is not compliance literate – all of which further exacerbate the challenges identified in the 1998 study. This session focuses on a case study of a community college’s overarching process improvement effort – stimulated by the impending deadline for the Common Rule – to update their IRB materials and processes. In order to meet the needs of multiple stakeholders (research subjects, researchers, institutional offices, and regulators), the project was approached through the frameworks of the low-volume IRB challenge study, the Nuffield Council on Bioethics Public Health Policy Processes, and existing campus Higher Learning Commission continuous process improvement and risk management efforts.
Learning objectives:
- Understand the risks faced by Low-Volume IRBs and their applicability to campus processes and practices.
- Develop an understanding of frameworks that can be used when implementing IRB process improvements.
Prerequisites:None
Speaker(s):
Victoria Steel, PhD, Director, Sponsored Awards and Compliance, Maramie County Community College; Janice Putnam PhD, RN Chair, The Missouri Nurse Editorial Advisory Board Professor of Nursing in the Health Studies Program, University of Central Missouri