Forms

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Forms	Download Current Version	When to Submit	New or Revised
Protocol for Use of Recombinant or Synthetic Nucleic Acid Molecules, Infections Agents, Biological Toxins, or Human/NHP source materials in Research	2.0	Required for protocol submissions that involve the use of rDNA and/or synthetic nucleic acid molecules, infectious agents, biological toxins, or human/NHP source materials in research studies Any research under category I requires IBC approval and additional approvals prior to initiation. Contact OACIB. Any research under category II requires IBC approval prior to initiation. Any research under category III may be initiated simultaneous with submission.	New
Modification of Approved IBC Protocol	1.0	Required for all post-approval modifications of protocols	New
Protocol for Use of Recombinant DNA, Synthetic Nucleic Acid or Infectious Agent in Humans	1.0	Required for all research involving the transfer of rDNA or synthetic nucleic acids or DNA or RNA derived from these molecules or infectious agent (i.e., vaccine) deliberatively to humans Research of this type requires additional documentation. See below¹. Any research under category I in Protocol for Use of Recombinant or Synthetic Nucleic Acid Molecules, Infections Agents, or Biological Toxins in Research requires IBC approval and additional approvals prior to initiation. Contact OACIB.	New
Human rDNA or Synthetic Nucleic Acid Transfer Adverse Event Report¹	2.0	Required for all serious adverse events that are both related or possibly related to the use of the human gene transfer product and unanticipated in either in nature, severity, or frequency. Submit this form with IRB Form- Event Requiring Prompt Reporting to the IRB to the OACIB.
Accident/Exposure/Noncompliance Incident Report	2.0	Required for all laboratory accidents, exposures, or noncompliance with NIH Guidelines
BSL 1 Biosafety Manual	2.1	Required for all research when highest biosafety level for the project is BSL1	Revised
BSL 2 Biosafety Manual	3.1	Required for all research when highest biosafety level for the project is BSL2	Revised
BSL 3 Standard Operating Procedures (SOPs)	Contact OACIB for information on standard operating procedure requirements. BSL3 SOPs must be developed and updated with the Biosafety Office	Required for all research when highest biosafety level for the project is BSL3

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¹ In addition to the Human rDNA or Synthetic Nucleic Acid Transfer Adverse Event Report, investigators submitting Human rDNA or Synthetic Nucleic Acid Transfer Adverse Event Report protocols must submit the following documents:

Lay Summary (Same as submitted to IRB)
Scientific Summary (Same as submitted to IRB)
Clinical Protocol (Same as submitted to IRB)
Clinical Investigator’s Brochure (Same as submitted to IRB)
Pharmacy Manual (Same as submitted to IRB)
UIC Specific Study Informed Consent Document (Same as submitted to IRB)