AbstractKeywordsformal researchquality improvementinternal review boarddataresearch designGet full access to this articleView all access options for this article.Get accessReferences1.University of Iowa. (2013). Studies that are not human subjects research. Retrieved from http://hso.research.uiowa.edu/studies-are-not-human-subjects-research2.U.S. Department of Health and Human Services. (2013). Information on protection of human subjects in research funded or regulated by U.S. government. Retrieved from http://www.hhs.gov/1946inoculationstudy/protection.html