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 and as such will have to go through the process for that particular 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 by contacting Gail Van Gorp(2-3689, gvangorp@anl.gov) . Documentation must also be filed in the ESAF system as well.

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. ALL Central nervous system human tissue will in additon to being reviewed by the IRB will also need to be reviewed by the Argonne Institutional Biosafety Committeee (IBC).

Process to work with Human Materials:

Chemically fixed or UV treated Human materials:

An ANL-955 form should be filled out to do a risk assessment on the biological material. Please contact APS Biosafety Officer Nena Moonier (2-8504 nmoonier@aps.anl.gov) for the ANL-955 Biological Materials Assessment form if you can not access the link or any of the links mentioned below. Please submit the ANL-955 form to the APS Biosfaety Officer (BSO). From there, the Argonne Institutional Biosafety Committee (IBC) Chair and or APS BSO will determine if the materials in the experiment consitute a biological hazard and or regulated by the federal goverment and requires a permit to transport and process. If the material is determined to be non hazardous nor non regulated then the PI will be informed in writting that a full IBC review is not needed and the materials can be handled at BSL1.

*Chemically fixed non-neuronal human tissue may still be required to be reviewed by the Institutional Review Board (IRB).

Non-fixed Human Materials:

The PI will be directed to seek full IBC review by completing form ANL-810 Registration Form for Recombinant DNA Experiments or ANL-812 Registration Form for Pathogens, Cells, Tissues, and OPIM. Please fill out a registration form for your samples through the Argonne IBC website. Please contact APS Biosafety Officer Nena Moonier (2-8504 nmoonier@aps.anl.gov) if you can not access any of the links mentioned above. Once reviewed and approved by the Argonne IBC you may then submit an ESAF to the APS. Please submit all information on the ESAF early enough (4 weeks in advance) to allow for this review and to avoid a delay in the start of your experiment.

.***ALL Central nervous system human tissue regardless of fixation process will, in additon to being reviewed by the IRB, will also need to be reviewed by the ANL Intitutional Biosafety Committee (IBC). Please fill out a registration form ANL-812 for your samples through the IBC website.

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.

Training –
  • To satisfy safety obligations, the Beamline Director shall provide experiment specific training to supplement the basic biosafety knowledge required by the Beamline Safety Policies and Procedures.
  • ESH 536 OSHA Blood Borne Pathogens training for Researchers MAY also be required.
  • Bio 200 Biosafety Training for Laboratory Researchers MAY be required
  • Bio 100 Introduction to the NIH Guidelines for Recombinant DNA (If needed)

Signs and Labeling –The work area must be posted for the appropriate hazard. Signs may be obtained from the AES ES&H Coordinator or the APS Biosafety Officer.

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

Biosafety in Microbiological and Biomedical Laboratories, 5TH edition, 2009.
World Health Organization Laboratory BioSafety Manual, Third edition, 2004
ANL ES&H Manual Section 4.9 Biosafety, ANL Biosafety Manual Rev 0,
Argonne National Laboratory Bloodborne Pathogens Occupational Exposure Contral Plan,
LMS-Proc-128 Working with Biological Materials,
ANL ES&H Manual Section 1.9 "Research Involving Human Subjects"

Reviewed and Updated: April 23, 2013