UAB Guidelines for Conducting Human Xenograft Experiments in Mice
For human xenograft experiments in mice and administration of primary human material not suspected of harboring a human pathogen, standard ARP handling practices for housing and cage changing can be employed, with the exception that signage must be posted outside the door of the primary housing room to indicate the presence of human-xenografted animals. The sign is available here. Printing and posting of the sign is the responsibility of the investigator.
If the material to be administered is suspect of harboring a human pathogen or if the recipient animals have been modified to increase permissiveness for a human pathogen, the project must be registered with OH&S for approval, and ARP’s full ABSL-2 practices (autoclaving bedding and cages prior to disposal and cage washing, use of an AUSI for cage-level hazard identification) will be employed.
For human xenograft experiments using non-murine species, the project must be registered with OH&S for approval, and handling practices will be determined on a case-by-case basis.
BSL-2 practices must be employed during administration of any material of human origin to animals.
Click to download sign:
The complete guideline for handling animals administered material of human origin as endorsed by UAB’s IBC can be obtained here.
New Investigator Lab Set-up
It is always advised to contact OH&S at 4-2487 the moment a PI accepts an offer, even if the UAB start date is many months away. Getting all required approvals may take many months. The checklist provides a starting point for new researchers to obtain approval for research activities at UAB. OH&S will provide proper guidance on regulatory requirements and will meet with new Principal Investigators (PIs) if needed to introduce them to the safety policies and practices of the University.
Research involving the following requires approvals form OH&S:
- Biohazardous materials
- Radioactive materials
- Controlled substances (DEA regulated)
- Hazardous chemicals
- Select agents
Minors, Visiting Scientists, and Volunteers in UAB Research Laboratories
If the answer is yes:
- Employment of Minors describes the UAB policies that cover minors that want to be employees at UAB.
- Employing Minors Request for Clearance Form and Instructions has detailed instructions that must be followed to allow a minor to become a UAB employee.
If the answer is yes:
- UAB's policy can be found at Minors in Laboratories and Animal Facilities.
Do you want to have adult visitors/volunteers or visiting scholars work in your lab?
If the answer is yes:
- Download and fill out the UAB Occupational Health & Safety Request for Clearance/Consent for Volunteers in Labs form.
- The visitor must complete a UAB OH&S Occupational Medicine Enrollment Form.
- The visitor should then take a copy of the Request for Clearance form and the UAB OH&S Occupational Medicine Enrollment form to their Student Health or Primary Care Physician. The visitor's physician is asked to review the visitor's health information and the proposed work described in the Request for Clearance/Consent form, then issue a statement signed by the visitor's physician on the physician's office letterhead indicating that "The participant's medical history and proposed work/potential exposure at UAB has been reviewed and should not impact the volunteer's health status".
- Forward the physician's statement and all of the above forms to the UAB OHS& Occupational Medicine Program, 933 S 19th Street, Suite 445; Birmingham, AL 35294 at least 2 weeks prior to the start date for the volunteer/visiting scholar.
* A "minor" is defined for purposes of these policy guidelines as any individual less than 18 years of age.
- Minors less than 10 years of age and not enrolled in grade four or higher are not allowed in UAB laboratories or animal activity areas where there are physical hazards, where hazardous chemical, biological, or radiological agents are used or stored, or where laboratory animals are present.
- Minors who accompany UAB employees to the UAB workplace for reasons other than participation in UAB research-type activities are not permitted in UAB research laboratories or animal facilities. Admittance to other UAB areas is subject to approval by the appropriate dean, director, or department chair.
- There is an additional policy regarding protection of children on UAB premises and in UAB sponsored activities that applies to minors that are working/observing in UAB laboratories. All individuals that will have contact with minors or supervise minors in UAB laboratories should review this policy: UAB Protection of Children Policy. Any UAB employee, trainee, student, volunteer, or other representative that fails to follow this policy may have disciplinary action taken against them as described in the policy.
FAQ: Research Project Review
These are some commonly asked questions about UAB Occupational Health & Safety's role in grant submissions and project review.
1. Which projects require registration with UAB Occupational Health & Safety?
All research involving the use of radioisotopes, carcinogenic/mutagenic/teratogenic chemicals, highly toxic chemicals/drugs, toxins or toxic products, microbial agents or products, human blood/body fluids/tissues, human gene therapy (transfer), recombinant DNA/RNA molecules, and human or non-human primate primary cell/tissue culture must be registered with UAB Occupational Health & Safety (OH&S). This registration is accomplished by submitting a "Project Registration" form to UAB Occupational Health & Safety, CH19, Suite 445 (fax 934-7487).
2. Where can I get the most current version of the Project Registration and other OH&S forms?
The OH&S web site has information on many safety related topics. Look here for forms. They may be printed out and completed manually or filled out on line, printed and then sent via fax (934-7487) or campus mail to OHS. If you also have Acrobat Reader, you may save the document for your electronic files.
3. I have just received a "Notice of Receipt". What is this document and what does it mean?
This is your official confirmation of project registration (not to be confused with project approvals). OH&S sends a "NOTICE OF RECEIPT" by campus mail to the Principal Investigator indicated on the form acknowledging receipt of the document and registration of the project. If the project requires specific safety approval (as noted in Question 3) the form will automatically be forwarded to UAB safety divisions or committees for review. The notice and/or approval will be sent to the PI at the campus address listed in Section A of the form.
4. Which projects require approval before the work begins?
· Bacteria, viruses, fungi, parasites or their products which require biosafety level 2 or higher containment (see CDC BMBL http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm)
· Non-exempt recombinant DNA research
· Human gene transfer-IBC approval must be obtained from each institution at which recombinant DNA material will be administered to human subjects (see Appendix M of the NIH guidelines for recombinant DNA).
· Select agents (see 42 CFR Part 73) - these regulated agents also require additional facility registration with the Centers for Disease Control.
· Administration of any of the agents listed in question 1 to non-human primates and immunodeficient animals.
· Work involving Radioisotopes must be conducted in a licensed laboratory. Contact Radiation Safety for licensure information.
5. I have submitted a "Project Registration" form to OHS. What type of response(s) can I expect?
OHS will send a "NOTICE OF RECEIPT", by campus mail to the Principal Investigator indicated on the form, stating that the form has been received and the research is registered. If the project requires specific safety approval (as noted in Question 3) the form will automatically be forwarded to UAB safety divisions/committees for review. The notice and/or approval will be sent to the PI at the campus address listed in Section A of the form.
6. I did not receive an approval letter for the project I registered with OHS. Are approval letters automatically issued by OHS for every project registered?
No. Although all project information received by OHS is reviewed, certain projects require "Registration Only". Therefore, approval letters will be issued automatically for only the first four categories listed in the Question 3. Other approval letters are available upon request pending review of the project information and laboratory facilities.
7. The granting agency is requesting a copy of my approval letters. How do I get a formal approval letter for my project?
A Project Registration form must be on file with OHS for the specific project title and granting agency in question. If there are no outstanding requests for additional information about the project and it has been reviewed by the appropriate safety division/committee, you may request formal approval(s) via e-mail, fax, or phone. You must provide the OH&S Project # or project title, Principal Investigator's name, the name of the granting agency and the type of approvals the granting agency is requesting.
8. I attached the "Project Registration" form to my grant application. Will Grants & Contracts forward it to OH&S?
Although these groups both work to help you meet your granting agency requirements and deadlines, "Project Registration" forms must be sent directly to OH&S. Allow 4-6 weeks for review of projects involving agents listed in Question 3 especially if the agent or use of the agent is new to your laboratory.
9. I attached the "Project Registration" form to the Animal Use Review Form. Will the IACUC office forward it to OHS?
Although these groups both work to help you meet accrediting agency requirements and grant deadlines, "Project Registration" forms must be sent directly to OH&S. Allow 4-6 weeks for review of projects involving agents listed in Question 3 especially if the agent or use of the agent is new to your laboratory.
10. It seems that with every new grant application more paperwork is required. What's going on?
Even though the requirement to complete a "Hazardous Materials Reporting" form has been in place since 1989 (see the statement beside the signature line of the UAB Grants and Contracts application form), only in the last few years has Occupational Health & Safety been required to provide independent review and/or written assurance that the laboratory and principal investigator involved in the proposed project are following all federal, state, local, accrediting agency, and/or granting agency safety requirements. In order to provide this assurance, information about the project and laboratory is reviewed by OH&S. OH&S is making every attempt to use existing paperwork systems and condense or combine paperwork from other review groups to minimize duplication of effort for the investigator. Check the Forms page of our website for the most recent forms and submission instructions. The paperwork reduction activities are ongoing. You help this effort by using the most recent version of the OH&S forms.