To qualify for two-year approval studies must
- Must not include any of the following:
New or renewing applications meeting the criteria cited above will be reviewed by the IRBMED to determine that subject protections comply with federal regulations. If appropriate protections are in place, and there are no additional extenuating circumstances, IRBMED may issue a two year approval. All other regulatory requirements, including amendments, adverse event, and ORIO reporting, remain unchanged.
Examples of qualifying research may include, but are not necessarily limited to, the following:
- Secondary use of identifiable data/specimens (both prospective and retrospective), not otherwise exempt
- Survey, focus group, or interview projects not otherwise exempt