STEPS TO STUDY ACTIVATION
Submit to the Institutional Biosafety Committee (IBC)
Your research activities may require that you submit a protocol to the Institutional Biosafety Committee (IBC). The IBC functions to ensure that all research activities are following federally mandated responsibilities and obligations, as described in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, the Centers for Disease Control and Prevention (CDC) select agent guidelines, and U.S. Department of Agriculture (USDA) select agent regulations.
The IBC consists of staff and community representatives who have responsibility for reviewing all research activities and teaching activities at IU Health and Indiana University involving recombinant DNA (rDNA) or synthetic nucleic acid molecules, and some non-recombinant biological materials. Activities involving the items previously mentioned must go through a review process before work can begin.
IU’s Institutional Biosafety Committees (IBC) and the IU Environmental Health and Safety Office’s Biological Safety Program review each protocol to ensure research is conducted with attention to the safety of laboratory personnel, the environment in which the research is conducted, and the community at large.
When is IBC Approval Required?
Principal investigators are responsible for submitting protocol applications in advance of any research or teaching activity that includes, but is not limited to:
All use of recombinant DNA (rDNA) or synthetic nucleic acid molecules, regardless of Biosafety Level (subject to the NIH Guidelines)
- Viral vectors or plasmid vectors
- Transfer of rDNA or synthetic nucleic acid molecules into human participants
- Transactive or infectious proteins
Use of the following non-recombinant biological materials requires biosafety level 2 or higher containment:
- Infectious agents
- Prion proteins
- Biohazards (e.g.: human or non-human primate tissues or fluids)
- Select agents or toxins
If your research involves any of the above, you must submit an Institutional Biosafety Committee protocol in addition to your IRB review. Should you have any questions, please contact IBC@iu.edu for assistance.
IBC Resources
- Training resources for IBC Kuali Protocols:
Biosafety: Quick Guides: Training & Workshops: RESEARCH: Indiana University (iu.edu) - To learn about the submission:
Institutional Biosafety Committee: Compliance: RESEARCH: Indiana University (iu.edu) - To learn about the process: https://research.iu.edu/compliance/biosafety/submissions/index.html
Contact
Should you have any questions, please contact IBC@iu.edu for assistance.
Submitting your study for IBC approval is only one component of study activation. Additional requirements should be reviewed using the Clinical Research Roadmap.