Submitting a Biosafety Protocol

Investigators who conduct research involving potential biological risks to University faculty, staff, or students are required to submit biosafety protocols to the Institutional Biosafety Committee (IBC). Once a protocol has been submitted to the committee, it is pre-reviewed by a subcommittee of the IBC. Reviewer comments and requests for revision are returned to the investigator with sufficient time to complete the revisions and submit a revised protocol for review at the next IBC meeting.

Once a project has been approved, an approval letter is prepared and sent to the investigator. The approval letter will include the approval date, protocol expiration date, project title, and IBC protocol number.

Biosafety Protocols:

Use the following guide to choose the proper forms for completing and submitting your biosafety protocol.

These forms can also be located in the
ORI Document Catalog - Category: Biosafety

Form A: General Biohazard Form [DOCX]

• Complete this form for all biosafety protocols.
• If your research includes the use of pathogenic organisms or human/primate samples but does not involve recombinant DNA (rDNA), hazardous chemicals, or animals, then this is the only form required to submit your protocol for approval.
• If you require more space on Form A for additional personnel, please use Form A: Additional Personnel Addendum [DOCX]

Form B: Recombinant DNA Registration Addendum [DOCX]

• Complete for the use of:
  • Recombinant DNA or synthetic nucleic acid molecules, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules
  • cells, organisms, and viruses containing such molecules
  • research involving gene drive modified organisms (GDMOs)

Form C: Hazardous Substance Addendum [DOCX]

• Complete for each chemical carcinogen, cytotoxic agent, mutagen, acute toxin, or teratogen used.

Form D: Animal Use Addendum [DOCX]

• Complete for each biohazardous agent used in animals.

Biosafety protocols are reviewed at the monthly IBC meeting. Completed protocols must be submitted in advance of the monthly meeting with sufficient time for pre-review and revision prior to the meeting. For specific deadline and meeting dates, please see the Meeting Deadlines and Calendar page.

Low Risk Research Involving Human Specimen Collection:

Human Specimen Collection IBC Checklist [DOCX]

• The Human Specimen Collection IBC Checklist can be used to help determine what type of IBC review is required and what forms need to be completed.

Form F: Low Risk Human Specimens Review Form [DOCX]

• Complete if you are performing low-risk research that involves the collection of human cells, tissues, fluids, or other patient-derived samples.