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It is the policy of the Mayo Clinic Office for Human Research Protection, Institutional Review Board (IRB), that all research activities under its jurisdiction involving human subjects be reviewed to determine whether the research meets one or more exemption categories, as defined by Federal regulations.
Exempt Categories: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.
Human subjects research that is classified as exempt means that the research qualifies as no risk or minimal risk to subjects and is exempt from most of the requirements of the Federal Policy for the Protection of Human Subjects, but is still considered research requiring an IRB review for an exemption determination.
Exempt research are human subjects studies that present no greater than minimal risk to subjects and fit into one or more exempt categories (as described below).
Human subjects research that is classified as exempt means that the research qualifies as no risk or minimal risk to subjects and is exempt from most of the requirements of the Federal Policy for the Protection of Human Subjects, but is still considered research requiring an IRB review for an exemption determination.
Research involving children can be classified as exempt under this category if the research involves only educational tests and / or observation of public behavior where the investigator does not participate in the activities being observed and meets the other conditions of the exempt category.
To qualify as an exempt study, the research must fall within one of the specific federal regulatory categories. A determination of exemption must be made by the JHM IRBs and principal investigators must submit all such studies for their review.
Human subjects research studies that do not qualify for an exemption are referred to as non- exempt human subjects research. Unless there is a Secretarial waiver, they must comply with the Common Rule requirements, including IRB review and approval, before the research can begin.
Exempt Categories: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.