Human Products Registration
Registration of Human Products Experiments
NO RECOMBINANT OR SYNTHETIC NUCLEIC ACID MOLECULES WILL BE INVOLVED IN THESE PROCEDURES
SECTION A Principal Investigator and Personnel Information (please type)P.I. Name: / Title: / Dept:
Phone No: / Fax: / Mail code:
Building and Lab Room No(s): / E-mail:
Please provide name, PeopleSoft ID number, title and insurance carrier for all laboratory personnel (including students or volunteers). All persons handling human products must have medical insurance.
Title of the protocol:
Principal Investigator Acknowledgement:
I accept responsibility for:
o The safe use of human products
o All personnel have been informed of potential risks, and proper laboratory practices for working safely with human products and have had or have been given the opportunity for the Hepatitis B vaccination.
o Verification of medical insurance for laboratory personnel handling human products.
The University’s Biosafety Manual is located at http://www.uh.edu/ehls/ . This manual must be supplemented with the laboratory’s safety plan and must include special practices when working with human products. Also, all laboratory personnel must be familiar with safe handling practices (e.g., training with proof of training).
______
Principal Investigator (Signature) Date
______
Environmental Health and Life Safety Date
Please send Registration to: Biological Safety Manager, Environmental Health and Life Safety, Mail Code 1005; ; (713) 743-5858.
Human Products Standard Operating Procedures
Registration of Human Products Experiments
Special precautions must be taken when handling human products. Experiments using human products should follow the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) Guidelines (5th Edition-2009). Below are the recommendations for handling human products and necessary paperwork needed in order to use the samples in the laboratory.
Brief Safety Overview:
o The Principal Investigator (PI) is responsible for training laboratory personnel how to correctly work with human products. The training should include a discussion of the known and potential hazards and an explanation of the relevant policies, techniques and procedures including the proper use of personal protective equipment, containment equipment, decontamination and spill clean-up procedures. Employees should be trained initially and then annually thereafter. Their knowledge, competence and practices should be evaluated and documented.
o Laboratory personnel handling human products must have a completed Hepatitis B Vaccination form on file with Environmental Health and Life Safety.
o Implement a safety program and include this information in the biological safety plan.
o Limit access to authorized users.
o Minimize the possibility of inadvertent ingestion or inhalation and direct skin,
eye contact or accidental inoculation with the human products.
o Notifying EHLS when work with human products is terminated or when other significant changes occur, such as changes in protocol, personnel or relocation of the laboratory.
o
Section B Experimental DesignBriefly describe experimental design:
Types of Manipulations:
¨ Centrifugation ¨ Bleeding/Mixing ¨ Dissection ¨ Sonication ¨ Pipetting ¨ Other ______
Type of human products manipulated:
¨ Cell lines ¨ Blood ¨ Tissues ¨ Urine ¨ Feces ¨ Other ______
Origin of samples: ______
How long will samples be maintained?______How much sample will be maintained at any given time?______
Are samples infected with a pathogen?
¨ No ¨ Yes If yes, please list ______
Is the project registered with the Institutional Review Board (IRB)? ¨ No ¨ Yes
IRB protocol# ______IRB date of approval:______
Section C Safety Plan
Training Plan:
Personal Protective Equipment (PPE) Required:
¨ Lab coat Gloves ¨ Goggles ¨ Safety glasses ¨ Closed-toe shoes ¨ Long pants
¨ Respirator (specify) ______¨ Face mask
¨ Other ______
Containment Equipment:
Is containment equipment available in the laboratory? ¨ No ¨ Yes
Containment equipment used for this project: ¨ Biological Safety Cabinet Location:______Last Certified:______
¨ Fume Hood ¨ Containment Centrifuge ¨ Other ______
Handling of Biohazardous Waste:
Liquid-
Solid-
Spill Cleanup Procedures:
Will the samples be shipped? ¨ No ¨ Yes
Will samples be transported between laboratories or outside University? ¨ No ¨ Yes
Hepatitis B vaccination offered to laboratory personnel (if applicable)? ¨ No ¨ Yes
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