Is The Research Exempt From Federal Regulations? Who may determine that research is exempt? The regulations do not specify who at an institution may determine that research is exempt under 45 CFR 46.101(b). Can federally funded research be exempt? Research regulated by the Food and Drug Administration (FDA): With the exception of Category 6, FDA-regulated
Is My Research IRB Exempt? Research can be approved as “exempt” if it is no more than “minimal risk” and fits one of the exempt review categories as defined by federal regulation 45 CFR 46. Studies that may qualify for “Exempt” must be submitted to the IRB for review. Exempt reviews are conducted by a
What IRB Exempt? Education research. Surveys, interviews, educational tests, public observations (that do not involve children) Benign behavioral interventions. Analysis of previously-collected, identifiable info/specimens. Federal research/demonstration projects. Taste and food evaluation studies. What makes a research study exempt? Research can be approved as “exempt” if it is no more than “minimal risk” and fits one
What Is Considered Exempt Research? Research can be approved as “exempt” if it is no more than “minimal risk” and fits one of the exempt review categories as defined by federal regulation 45 CFR 46. Studies that may qualify for “Exempt” must be submitted to the IRB for review. Exempt reviews are conducted by a