FAQ's

Frequently Asked Questions

What is the purpose of the EHS Risk Assessment?

• The EHS Risk Assessment helps the Principal Investigator conveny potential hazards and risks associated with a proposed research project. This tool helps EHS staff and the IRSC evaluate the associated risks involved and how to help mitigate any potential problems.

When is an IRSR form required?

• With all research proposals submitted to Sponsored Programs Administration
• With all Animal Care and Use Proposals submitted to the Institutional Animal Care and Use Committee (IACUC) for animal research.
• With all human subjects applications submitted to the Human Subjects Committee (HSC) except those that are classified as "exempt" by federal regulations. Classification for excempt categories can be found at here

Why do the specific vectors and agents need to be identified for Recombinant DNA and other human studies?

• The specific vector or agent used can determine the risk classification and potential level of risk.

What are the Biological Safety Levels (BLs)?

• BL1 Not known to consistently cause disease in healthy adults
• BL2 Associated with human disease, hazard = percutaneous injury, ingestion, mucous membrane exposure
• BL3 Indigenous or exotic agents with potential for aerosol transmission; disease may have serious or lethal consequences
• BL4 Dangerous/exotic agents which pose high risk of life-threatening disease, aerosol-transmitted lab infections; or related agents with unknown risk of transmission.

What are the Recombinant DNA Risk Group Levels (RGs)?

• RG1 Agents are not associated with disease in healthy adult humans
• RG2 Agents are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available
• RG3 Agents are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available
• RG4 Agents are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available.

What happens to the IRSR form after it is submitted?

• All forms indicating a RC 3 level risk are reviewed at time of submission for funding in order to assure that adequate facilities and resources are available to support the research. Forms for RC 2 level or lower that are submitted with human subject and animal protocols are reviewed at time of the protocol submission. Similar forms for basic science research are reviewed at the time of funding.

What is the review process?

• Forms are initially screened by the Office of Compliance staff. Forms that indicate research of an RC 2 level may also be reviewed by the Chair of the Institutional Research Safety Committee (IRSC.) Forms listing an RC3 level are reviewed by the Chair and the full IRSC at a convened meeting.

When is supporting documentation required with the IRSR form?

• If the Risk Classification is listed as an RC2, the researcher must submit the purpose of the project, project summary, a description of hazards with associated safety procedures to be implemented, and a description of personnel training
• If the study is a RC3, the complete protocol and the "IRSC Risk Class 3 or 4 Additional Information Form" must be submitted. This two page form follows the IRSR form here.

If the only items making a study a RC2 is the collection of routine blood draws under item #4 Human Tissues/Body Fluids, do I need to submit the documentation listed for an RC2 project?

• No, not if the blood is collected by routine blood collection procedures using universal precautions.