11/01/01
This website is designed to help faculty and students determine whether they need to apply for Administrative Review of their research or not apply at all, when their research is based solely on "existing data." In some cases human subjects protections are not required and therefore applications for either Administrative or IRB Review are not necessary. The cases are discussed in this website.
Research involving previously collected information about human subjects may be exempt from the policy under the provisions of 45 CFR 46.101 (b)(4), "Protection of Human Subjects," specifically:(4) Research, involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. (emphasis added to links)
Research which involves the production of and/or initial collection of data, records, information, specimens, etc. from the human subjects themselves requires application for formal review.
