Training
IBC’s training requirements vary widely and depend largely on the type of research being conducted. All members of the research team must complete the Research Integrity training module. Most researchers must also complete the Chemical Hygiene Training module and will need to complete an Agent Registration Workbook. If you will work with animals, you must complete all training required by IACUC for your project as well. Note that even if IACUC approves your protocol, you will not be able to proceed without IBC approval. If you work with human cell lines, you must complete the Bloodborne Pathogen Training module. If your work requires laboratory space that is classified as biosafety level 2 (BSL-2) or higher, you must contact the Regional Biocontainment Laboratory (RBL) to complete additional forms and training requirements.
Submitting the protocol
All new protocol applications should be submitted to the IBC via e-mail. An initial screening is done to ensure that applications are complete. Protocols are processed according to the committee calendar. Complete protocols are entered into the IBC database, and a receipt e-mail is sent to the investigator.
The committee first reviews applications electronically and recommends one of the following possible actions: full approval, approval pending IBC-directed changes, reconsideration, or discussion. Recommendations and/or concerns are then sent to the investigator.
Once the investigator’s responses are received, the IBC again reviews the application and takes one of the following possible actions: full approval, approval pending IBC-directed changes, reconsideration, or disapproval. Following the meeting, the investigator is notified of the outcome.
For clinical trials, the IBC will review the application and supporting documents to ensure the following: compliance with Appendix M of the NIH Guidelines; consideration of issues and recommendations made by the Recombinant DNA Advisory Committee (RAC); the investigator’s or sponsor’s response to the RAC’s recommendations (when applicable); and compliance with data reporting, adverse event reporting, and surveillance.
