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An examination of minimal risk human subjects research: Federal regulation and institutional practice

Norman O Braaten, University of Nebraska - Lincoln


There are ethical imperatives and regulations to protect people who participate in research activities. Some of these activities may carry a great amount of risk to participants, while others may be classified as "minimal risk." At the same time there has been a call for more empirical research into human subjects research: "considerable additional research would be valuable in informing the future structure and organization, processes and outcomes of IRBs in the U.S." (Abbott & Grady, 2011). The dissertation study examined institutional practices in the review of "not human subjects research," of minimal risk human subjects research that may qualify as exempt or be eligible for expedited review, and collaborative human subjects research. According to Speers, "Some institutions make a conscious decision not to exempt research or not to use the expedited review procedure. This is not what the regulations require, and it doesn't necessarily result in stronger protections" (AAHRPP, 2008). Institutions were surveyed to discover how they make a determination of not human subjects research and how reviews of collaborative human subjects research activities are conducted. Survey questions presented exempt scenarios to determine the extent to which a higher level of review than the regulations call for was used in surveys, interviews, and in research involving existing data. Variations in the review of minimal risk research were discovered. Data indicated that institutions may have opportunities to become more efficient in their review of minimal risk research, with approximately 4 percent of institutions choosing not to use any exemptions or expedited procedures. Another 10 percent of institutions surveyed did not use the exemption for existing data, and 15 percent chose not to exempt surveys, interviews, and observational research. The use of a level of review higher than the regulations would call for in some exempt scenarios ranged from 40 to 66 percent. Qualitative interviews confirmed that caution/risk aversion and an incomplete understanding of the regulations were possible reasons for reviews beyond what the regulations specified.

Subject Area

Occupational health|School administration

Recommended Citation

Braaten, Norman O, "An examination of minimal risk human subjects research: Federal regulation and institutional practice" (2014). ETD collection for University of Nebraska - Lincoln. AAI3618651.