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 be evaluated to determine their biosafety level and as such will have to follow the process and protocols for the applicable biosafety level.

IMPORTANT NOTE:  For non-Argonne employees, all experimental protocols involving human tissue are required to be either reviewed or declared exempt from the experimenter's Institutional Review Board (IRB) at the experimenter's home institution.  Documentation of the review must be attached to the Description Tab of the ESAF and filed with the APS BioSafety Officer Nena Moonier (630-252-8504).  Argonne employees who will be involved in an experiment using human materials must submit an IRB application to the UofC IRB.  This is in addition to submission of an ESAF.  The UofC IRB will determine if a full review is needed or if the samples are exempt from review.  Argonne employees may obtain the Uof C application by contacting Dan Schabacker.

Experimenters must plan for additional time (up to four weeks) for review of experiments involving human tissue/material.  Refer to a summary of information on human tissue/materials research from an NIH guide for further information.

In addition to an IRB review, human tissues may require approval from the Argonne Institutional Biosafety Committee.  Please see below for further information.

*Chemically fixed non-neuronal human tissue is required to be reviewed by the IRB and the APS Biosafety Officer but not the Argonne Instutional Biosafety Committee (IBC) as the samples will be devoid of any infectious agents.

*All non-fixed human tissues must go through a full review by the Argonne IBC.  Please see below for the application process.

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

An ANL-955 form must be submitted in order to complete a risk assessment on the biological material.  Contact the APS Biosafety Officer Nena Moonier (630-252-8504) for the ANL-955 Biological Materials Assessment form if the internal link is not working properly.  Sumbit the completed ANL-955 form to the APS Biosfaety Officer.  Once the completed form is submitted, the Argonne Institutional Biosafety Committee (IBC) Chair and/or the APS Biosafety Officer will determine if the materials in the experiment constitute a biological hazard and/or are regulated by the federal government and require a permit to transport and process.  If the material is determined to be nonhazardous nor non-regulated, the PI will be informed in writing that a full IBC review is not needed and the materials can be handled at BSL-1.

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

The PI must seek full Argonne IBC review by completing form ANL-810 Registration Form for Recombinant DNA Experiments or ANL-812 Registration Form for Pathogens, Cells, Tissues, and OPIM.  Complete the registration form for the samples through the Argonne IBC website.  Once the samples are reviewed and approved by the Argonne IBC, the experimenter must submit an ESAF to the APS.  Submit all information on the ESAF early enough (4 weeks in advance of the experiment start date) to allow for sufficient time for experimental review and to avoid a delay in the start of the experiment.

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

Address any questions to the APS Biosafety Officer, Nena Moonier (630-252-8504).

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

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 BSL-2 or higher.

Design Reviews and Equipment Inspections – All experimental protocols involving human tissue (even if there is no biohazard) are required to be either reviewed or declared exempt from review by the experimenter's Institutional Review Board (IRB) at their home institution.  Contact Nena Moonier (630-252-8504) for further information.  Experimenters must provide a copy of the review by the Institutional Review Board (IRB) from their home institution as well as a letter of exempt status and proof of anonymity regarding the samples.  Experimenters must attach the Institutional Review Board (IRB) letter from their home institution and associated sample documents to the Description Tab of the ESAF.

Additionally, non fixed human tissue will require Argonne IBC approval before work may begin.

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 biosafety level.  Signs may be obtained from the APS Biosafety Officer.

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

Unless otherwise noted in the approved experiment safety plan, the PSC Deputy Associate Laboratory Director of Operations delegates the authority to authorize an experiment in this hazard class to the Argonne Institutional Biosafety Committee, the APS Experiment Safety Review Board, the APS Biosafety Officer, and resident beamline personnel having the authority to authorize experiments as listed in the ESAF system.  Approval by both the host beamline and APS Experiment Safety Review Board are mandatory prerequisites for experiment authorization.

The PSC Deputy Associate Laboratory Director of Operations delegates responsibility for verifying that required controls are in place to the experiment On-Site Spokesperson and Beamline Management.

Biosafety in Microbiological and Biomedical Laboratories, 5TH edition, 2009

World Health Organization Laboratory BioSafety Manual

Argonne Biosafety Manual 4/16/2020 (Internal link)

LMS-MNL-8: Research Using Human Subjects or Their Data 3/6/2020 (Internal link)

Argonne Blood Borne Pathogens Occupational Exposure Control Plan 4/27/2018 (Internal link)

LMS-PROC-128: Working with Biological Materials 3/26/2018 (Internal link)

IRB Review Flowchart 6/2/2023

HRSPP PI Guidance 6/2/2023

Contact the APS User Safety Program with any questions or if the internal links are not working properly.