Generally, an IRB protocol is required for use of potentially identifiable individual-level data, documents or records about living individuals, or biospecimens . In some situations (e.g. when data is publically available, or has been irreversibly de-identified) the IRB may determine that their use does not involve 'human subjects'.

If information to be used is available to the general public, without restriction or limitation, a protocol is not required. This would include public newspapers, journal articles, and public websites. Researchers should be aware, however, that some websites or online communities have privacy expectations or limitations to use of their information and postings; use of this type of information would require IRB approval.

Also, some human specimens are available through commercial sources, and/or have been obtained from deceased individuals; these may not require a protocol to the IRB; however, if an FDA regulated device or drug is being tested, an IRB protocol is required.

When in question, please contact the IRB office for more information.