Michigan Exempt Survey
Description
How to fill out Exempt Survey?
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FAQ
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.
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.
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).
According to the Federal regulations (45 CFR 46.101(b)), survey research may be exempt from the regulations unless "the information obtained is recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects" or if "federal statute(s) require(s) without
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 human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.
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.
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.
Educational tests, surveys, interviews, or observations research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observations of public behavior meets the definition of human subjects research and requires IRB review.
