What qualifies for exempt IRB?
To qualify for expedited review, an activity must: (1) involve no more than minimal risk AND be found on this list, OR (2) be a minor change in previously approved research during the period of 1 year or less for which approval is authorized by the IRB.
What types of studies are exempt from IRB?
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.
What type of research is exempt from IRB review?
“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.
What is considered exempt research?
“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).
What is exempt category?
To be classified as exempt, the research: Must involve only procedures or be a type of research study listed in one or more of the exempt categories (see exempt categories sections below); The study cannot involve prisoners as research subjects. Cannot be greater than minimal risk.
What is an exemption category?
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.
Are qualitative studies exempt from IRB review?
All non-exempt research involving human subjects must have advance IRB approval. Qualitative research often does not need IRB, Meyer said.
Which research proposal would most likely be classified as a Category I proposal by the IRB?
proposal by the IRB? A research proposal fits in Category I (Exempt Review) if the research presents no possible risk to adult participants. Examples of Category I proposals include anonymous, mailed surveys on innocuous topics and anonymous observation of public behavior.
Do I not need IRB approval?
Studies that fit any of the categories below typically do not need IRB review. Data collection for internal departmental, school, or other University administrative purposes. Examples: teaching evaluations, customer service surveys. This would include surveys by professional societies or University consortia.
What is the difference between exempt and expedited IRB?
Research that is classified as Expedited only needs to be reviewed by the chair or by a qualified member of the IRB that has been designated by the chair. A research project is appropriate for Expedited review if it involves only minimal risk, but is not classified as Exempt.