Which of the following are forms of exempt review research?
Types of IRB ReviewExempt ResearchAlthough the category is called "exempt," this type of research does require IRB review and the determination of exemption must be made by the IRB. Show
The exempt determination process is much less rigorous than an expedited or full-committee review. To qualify, research must fall into one or more of eight federally defined exempt categories. These categories present the lowest amount of risk to potential subjects because, generally speaking, they involve either collection of anonymous or public data, or conduct of the least potentially harmful research experiments. Some examples of exempt research are:
Research involving minor children may be exempt only as it applies to categories 1, 4, 5, 6, 7 and 8. Research involving minors which falls under category 2 may be exempt for educational tests and observation (when the investigator does not participate in the activities being observed). Research involving survey or interview procedures may not be exempted for minors. Research activities in which the only involvement of human subjects will be in one or more of the following categories will qualify for an exempt review. Research involving prisoners may not be exempted. Expedited ResearchTo qualify for expedited review, research must fall into one or more nine federally defined expedited categories. These categories involve collection of samples and data in a manner that is not anonymous and involves no more than minimal risk to subjects. Some examples of expedited research are:
Expedited review as defined by federal regulations allows the IRB chairperson or one or more experienced reviewers designated by the chairperson from among members of the IRB to evaluate and approve specific types of research. Reviewers conducting an expedited review may exercise all of the authority of the IRB except that they may not disapprove a study. When reviewers cannot approve the research under expedited review, the study is referred to the committee for full board review. Applicability of Expedited Review:
Full Committee ResearchProposed human subject research that does not fall into either the exempt or expedited review categories must be submitted for full committee review. This is the most rigorous level of review and, accordingly, is reserved for research projects that present more than minimal risks to subjects. To be classified as exempt, the research:
Currently, MSU does not plan to use the Revised Common Rule (2018 Requirements) Exempt Category 7 or 8. Submission to the MSU Human Research Protection Program for an exempt determination is required. See What & How to Submit: Exemptions and Review Process: Exemptions for submission help. Also see HRPP Manual 8-1, Exemptions. Revised Common Rule (2018 Requirements) Exempt CategoriesUnless otherwise required by federal department/agency, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt:
Pre-Common Rule Exempt CategoriesUnless otherwise required by federal department/agency, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt:
Exempt Category Flexibility InitiativesWhen certain criteria are met (e.g. project does not include use of federal funds), a research project that would not otherwise qualify for exempt review through the DHHS or FDA exempt categories may be granted exempt status through HRPP flexibility initiatives.
U.S. Food and Drug Administration (FDA) Exempt CategoriesThe following exempt categories apply to research subject to FDA regulations (i.e., clinical investigations). 21 CFR 56.104 sub-categories (a), (b), and (c) cannot be applied to activities that are regulated by the U.S. Department of Health and Human Services (DHHS).
What is exempt review in research?Exempt research applications are reviewed by Office for Protection of Human Subjects (OPHS) staff, and involve a shorter application form and generally a faster review process than non-exempt studies. Individual investigators do not have the authority to determine that a research project qualifies as exempt.
What research is exempt from IRB review?Exempt human subjects research is a specific sub-set of “research involving human subjects” that does not require ongoing IRB oversight.
What are the three types of IRB review?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.
Which type of IRB review does not require?“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.
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