Use of Human blood, body fluids, tissues, cell lines. Review OSHA Bloodborne Pathogen guidelines. (If clinical blood draw or fingerstick procedure you may obtain approval through the Medical Institutional Review Board in lieu of IBC approval)
Exotic plants, animals and microbes (e.g., nonindigenous plant or insect pathogens, or biological control agent); provide a copy of any required federal permit http://www.aphis.usda.gov/.
Toxins on the Select Agent list, when administered in vivo or in vitro to induce a biological outcome.
The application must be signed by the investigator and the researchers supervisor
If the investigator is a student, the students must sign the cover page, and the protocol must be reviewed and signed by the faculty adviser to provide evidence of the faculty adviser’s approval for the research.
Faculty investigators must obtain their department chairs signature to provide evidence of review of scientific merit within the discipline.
All applications must include applicable supporting materials including required federal or agency permits for research material access.
IBC Determination Options
Approval – When an acceptable risk/benefit ratio exists and the criteria required for approval are deemed acceptable, protocol is approved as submitted or corrected.
Conditional/Withheld Approval (Pending Changes) – The IBC determines that the protocol will meet the regulatory criteria for approval provided the investigator agrees to make specific changes to the IBC application including the informed consent document. Research may not be initiated until a letter of IBC approval is received and other applicable committee reviews are satisfied.
Tabled/Re-submission – The IBC requires substantive changes that are directly relevant to the determinations required by the IBC under federal guidelines, the IBC will table the approval of the protocol or remand the protocol for re-submission pending subsequent review by the convened IBC of the responsive material.
Disapproved – The IBC determines that the research does not meet the regulatory criteria for approval and cannot provide modifications that may allow the protocol to be approved or determines that Georgia Southern does not possess the appropriate containment facilities or ability to assure personnel safety and/or environmental control to conduct the study.
Report of Non-Compliance
Any report of non-compliance will be investigated by the chair of the IBC and the Biosafety Officer with support of the IBC administrative staff.
If the chair determines that the report is creditable, the chair will report the non-compliance to the full committee for action.
Examples of IBC Noncompliance by Principal Investigators include, but are not limited to, the following:
Failure of the Principal Investigator (PI) to adhere to the responsibilities outlined in Section IV-B-7 of the NIH Guidelines
Working with an infectious agent, viral vector, or host system that is not documented in an approved IBC protocol
Deviating from approved SOPs in a way that could increase the exposure risk of employees or the environment to biohazardous materials and/or non-exempt recombinant/synthetic nucleic acid molecules
Conduct of procedures by personnel not adequately trained and/or not listed on an approved IBC protocol
Improper disposal of medical waste
Conducting procedures involving biohazardous materials and/or recombinant/synthetic nucleic acid molecules in a facility(ies) not approved by EH&S Biosafety for such use
Failure to provide appropriate personal protective equipment (PPE) to personnel who are at risk of exposure to biohazardous materials and/or recombinant/synthetic nucleic acid molecules
Failure to report an overt exposure to biohazardous materials and/or recombinant/synthetic nucleic acid molecules
The IBC has the authority to address noncompliance with the NIH Guidelines, the BMBL, University policies and other regulatory requirements. Findings of noncompliance may result in one or more of the following actions:
Suspending the use of recombinant/synthetic nucleic acid molecules and/or biohazardous materials pending completion and acceptance by the IBC of a written plan by the PI for the correction and/or prevention of recurrence.
Termination of approval for use of recombinant/synthetic nucleic acid molecules and/or biohazardous materials.
Confiscation and destruction of the recombinant/synthetic nucleic acid molecules and/or biohazardous materials.
Any other action necessary to protect employees, the environment, the public and/or University, including restricting access to the laboratory in order to suspend activities.
Confidentiality — Details pertaining to an investigation in progress remain confidential to the extent possible to protect all concerned; however, when the IBC releases the final report of its findings to federal regulatory agencies, those reports may become accessible to the public under the Freedom of Information Act.