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Publicly available data do not require IRB review. Examples: census data, labor statistics. Note: Investigators should contact the IRB if they are uncertain as to whether the data qualifies as \u201cpublicly available.\u201d
Human subjects research that is classified as \u201cexempt\u201d 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.
There are three (3) types of review paths for an IRB application: Full Board, Expedited, and Exempt. The review path is determined by: Level of risk to subjects associated with the project. The type of research being conducted (e.g., an educational intervention, a survey, an ethnographic observation, etc.)
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.
Projects not eligible for an exempt review may be eligible for an expedited review. Expedited does not mean that the review is less rigorous or happens more quickly than convened review. It refers, instead, to certain types of research considered to involve minimal risk.
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IRB must review all projects that meet the definition of research and that involve human participants prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major levels of human subjects' research review: Exempt, Expedited, and Full.
There are five types of IRB review: (a) exempt, (b) expedited, (c) full, (d) continuing, and (e) limited. An exempt review doesn't require monitoring by the IRB. Exempt categories are outlined by the Department of Health and Human Services in 45 CFR 46.101(b).
IRB must review all projects that meet the definition of research and that involve human subjects prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major types of review: Exempt, Expedited, and Full.
Exempt Research Although the category is called "exempt," this type of research does require IRB review and the determination of exemption must be made by the IRB. The exempt determination process is much less rigorous than an expedited or full-committee review.
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.

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