Which of the following studies would need IRB approval?

a. Studies that involve cadavers.
b. Studies that use publicly available census data from the years 1890-1910.
c. Studies that use data collected for internal department use only and the aim of the study is quality improvement for the department only.
d. Studies collecting identifiable information about living individuals.

Studies collecting identifiable information about living individuals needs IRB approval. An Institutional Review Board (IRB) is a body that has been explicitly authorized to review and oversee biomedical research involving humans in accordance with FDA standards.

An IRB has the power to approve, demand changes be made (to achieve approval), or reject research in keeping with FDA standards. The goal of IRB review is to ensure that sufficient measures are in place to protect the welfare of those who are participating as research subjects, both in advance and through periodic evaluation. All human subject research that is not exempt must be reviewed and approved by the IRB. The researcher might not be able to use the data and other material gathered via the research procedure if IRB permission is not obtained prior to doing the research.

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