IBC and IRB Protocols
Summary
Occasionally, researchers will need to submit their research to more than one research committee. This guidance addresses when submitting to the IBC and IRB is required.
Full Description
An IRB and IBC Protocol is needed when....
- it involves the transfer of recombinant DNA or DNA/RNA derived from recombinant DNA (human gene transfer). Recombinant and synthetic nucleic acids are defined as:
- molecules that are constructed by joining nucleic acid molecules and that can replicate in a living cell, i.e. recombinant nucleic acids,
- molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e. synthetic nucleic acids,
- molecules that result from the replication of those described in (i) or (ii) above.
- using infectious agents with research participants
- the IBC protocol involves the use of human research participants or identifiable human biospecimens
- the researcher(s) are collecting, storing, or shipping biological specimens. (This includes: saliva, blood, or any other BIOLOGICAL sample from participants.)
Personnel Responsibilities
The Principal Investigator must ensure that:
- Both an IRB and IBC protocol are in place (when necessary)
- All team members have taken BOTH IRB and IBC CITI trainings
- All team members handling biohazards have taken the relevant EH&S trainings. Students do not have access to Cornerstone. PIs should contact Crystal Taylor for access to the training outside of Cornerstone.
- Team members who are employees of the university and are handling human blood, must complete the Hepatitis B Declination Form. Please contact Crystal Taylor for further instructions.
- MOST individuals born after 1990 have already had three doses of the hep B vaccine as a part of the regular childhood vaccine schedule. Please check your personal records, but receiving this again will not be detrimental if you do not know. This is a series of 3 shots over 6 months . If you request it, we will give more information on receiving the vaccine.
- Proof of completion of the EH&S Training is uploaded to the protocol. Certification from Cornerstone should be attached. For students, the linked spreadsheet can be downloaded and attached.
Student Documentation of EH&S Training