Depending on the nature of your study, the IRB may require other approvals:
Clinical Research Center Advisory Committee: Research involving the use of services at the Clinical Research Center (CRC) for any reason, including the use of personnel as back up to the research team or plans to use personnel in the event of an emergency, need to be reviewed by the CRC Advisory Committee. CRC Advisory Committee approval is not required before the IRB will approve the study.
Conflict of Interest Committee (Individual): Research studies in which a member of the study staff has a financial interest as defined by PSU policies must be reviewed by the Conflict of Interest Review Committee (CIRC-HY). IRB approval will not be granted until the IRB has reviewed the recommended management plan.
Conflict of Interest Committee (Institutional): Research studies in which an institutional conflict may exist as defined by PSU policies must be reviewed by the Institutional Conflict of Interest Review Committee. IRB approval will not be granted until the IRB has reviewed the recommended management plan.
Institutional Animal Care and Use Committee: Research involving vertebrate animals must receive approval from the Institutional Animal Care and Use Committee. Investigators will need to complete an IACUC application. The IACUC approval is required before IRB approval will be issued.
IND/IDE Audit Ancillary Review: Research in which a Penn State researcher holds the IND or IDE or intends to hold the IND or IDE must be reviewed by the Office for Research Protections Quality Management Program to ensure sponsor-investigator is compliant with FDA sponsor requirements (including GMP when applicable). The IND/IDE audit must be completed before IRB approval will be issued.
See the IRB Investigator Manual for a complete list of other approvals required before initiating human subject research.