Experiment Hazard Class 7.5 – Human Tissue/Materials

Applicability

This hazard classification applies to all experiments involving biohazards requiring the use of human tissue/materials. Other hazard classifications and their associated hazard controls may also apply to experiments in this hazard class. Human tissue/materials must also be evaluated for their biosafety level.

IMPORTANT NOTE: For non-Argonne employees, all experiment protocols involving human tissue are required to be either reviewed or declared exempt from review by their home institution's Institutional Review Board (IRB). Documentation of the review should be filed in the ESAF system and with the APS BioSafety Officer (BSO) (Nena Moonier 2-8504, nmoonier@aps.anl.gov) For Argonne employees who will be involved in an experiment dealing with human materials an IRB application to the Uof C IRB must be submitted, The Uof C IRB will then determine if a full review is needed or declare it exempt from review. Argonne employees may obtain the Uof C application here. Documentation must also be filed in the ESAF system and the APS BSO (Nena Moonier 2-8504, nmoonier@aps.anl.gov).

You must allow additional time (up to four weeks) for this review. Please review a summary of information on human tissue/materials research from an NIH guide if you have questions.

In addition at an IRB review, human tissues may require approval from the Argonne Institutional Biosafety Committe: Please see note below.

*Chemically fixed non-neuronal human tissue is still required to be reviewed by the IRB and the APS BSO but not by the ANL IBC. Central nervous system human tissue will in additon to being reviewed by the IRB will also need to be reviewed by the ANL Intitutional Biosafety Committee (IBC) and the ANL BSO. Approval for this work is a two step process. Please fill out a registration form for your samples through the IBC website. Once reviewed and approved by the Argonne IBC you may submit an ESAF. Please allow additional time (up to four weeks) for this review.*

Any questions please contact the APS Biosafety Officer, Nena Moonier at 2-8504 or nmoonier@aps.anl.gov

Experiment Category

Experiments involving non fixed human tissue/materials are considered high risk.

Experiment Hazard Control Verification Statements

Engineered Controls – As determined in the safety review of the experiment..

Procedural Controls – An SOP describing the handling of the samples will be needed for samples classified as BSL2 or higher.

Design Reviews and Equipment Inspections –All experiment protocols involving human tissue (even if there is no biohazard) are required to be either reviewed or declared exempt from review by Institutional Review Board. Please contact Nena Moonier (2-8504, nmoonier@aps.anl.gov) for details. The User must provide a copy of the review by the Institutional Review Board of their home institution. A letter of exempt status and proof of anonymity is required for the samples. The home Institutional Review Board letter and associated sample documents may be attached to the "Description" page of the ESAF.

Signs and Labeling – None.

Personal Protective Equipment – As specified in the written SOP for the experiment.

Experiment Authorization

Unless otherwise noted in the approved experiment safety plan, the Director of the APS Engineering Support Division delegates the authority to authorize an experiment in this hazard class to the Argonne Institutional Review Board, a member of the APS Experiment Safety Review Board and resident Beamline Management personnel appearing in the Director of the AES's list of personnel having the authority to authorize experiments.

Hazard Control Verification

The Director of the APS Engineering Support Division delegates responsibility for verifying that required controls are in place to personnel delegated the authority to perform this task to AES ES&H Coordinator, the experiment On-site Spokesperson, and Beamline Management personnel having experiment safety responsibilities. .

References

ANL East ESH Manual Chapter 1-9, "Research Involving Human Subjects".

Reviewed and Updated: May 18, 2011