STUDY-SPECIFIC REPORTABLE EVENTS
Federal regulations and LSUHSC policies require timely reporting of incidents that occur during research and teaching activities and any instances of non-compliance with regulations and policies.
Institutional procedures for reporting incidents and non-compliance are described here. If the incident or non-compliance occurs during an activity on a protocol approved
by the IBC, additional study-specific reporting is required as described below.
What to Report
According to the NIH Guidelines, incidents that must be reported include "any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses." Thus, incidents, from research or teaching activities that involve potentially hazardous biological agents subject to IBC purview must be reported.
Examples of incidents involving recombinant or synthetic nucleic acids or other potentially hazardous biological agent:
- Spill of a culture outside a biosafety cabinet
- Injury with a needle
- Aerosol exposure
- Illness from an infectious agent used in your lab
- Breach of containment
- Escape or improper disposition of a transgenic animal
- a research activity not approved by the IBC prior to initiation
How to Report
Study team members who become aware of any incidents associated with a specific IBC-approved protocol must promptly report the incident as described below:
Does Incident Require Medical Services? |
Reporting Method |
|
YES |
|
|
NO |
|
Resources
- Kuali Quickguide: Creating and Submitting IBC Protocols in Kuali (including submission of reportable events). Download from the Resources page.