This report summarizes federal regulations regarding protections of human subjects and describes the policies and procedures that the National Institute for Direct Instruction (NIFDI) will use when gathering data from subjects and analyzing data provided from other sources. The intention of the procedures is to minimize any risk to subjects that may occur from the research process and to maximize possible benefits. The document details the federal guidelines regarding the protection of human subjects, procedures to be used with intact data sets, and procedures to be used when data are gathered by NIFDI personnel. Additionally, appendices are included to provide details on categories of review used by the U.S. Department of Health and Human Services as well as a sample of a NIFDI informed consent letter.

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