Categories of Research Review: Determining Which Category Best Fits the Researcher’s Inquiry
All research involving human subjects must be submitted to the IRB. There are three categories of review: Exempt, Expedited and Full. Principle investigators will be notified in writing about IRB decisions.
Exempt review determines whether or not the proposed research meets the requirements for Exempt status or whether the project should be submitted for review under another category. Exempt category does not apply to any research with children or other vulnerable subjects.
Expedited review may be used for certain types of research involving no more than minimal risk. The review may be carried out by the IRB Chair or by one or more IRB members designated by the IRB Chair. Expedited review can also be used for minor changes in previously approved research during the period for which approval has been authorized.
Research not covered under the Exempt or Expedited review categories will be referred to Full review. The investigator is welcome to attend the review in order to answer any questions that may arise, and may bring others if desired. The research is either approved, approved pending modifications that must be verified by committee members, or not approved. The IRB will be expeditious in its review and decision-making.
For reference: http://www.hhs.gov/ohrp/policy/protocol/index.html
The federal regulations require that IRBs give special consideration to protecting the welfare of particularly vulnerable subjects, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
Non-exhaustive list of vunerable subjects
Children as Subjects in Research
Research Involving Fetuses, Pregnant Women, or Human in Vitro Fertilization
Research Involving Prisoners
Fieldwork or Ethnographic Research
For reference: http://www.hhs.gov/ohrp/policy/populations/index.html