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 (AKA Appendix G http://www.healthsafe.uab.edu/pages/home/manuals.html) to UAB Occupational Health & Safety, CH19, Suite 445 (FAX 934-7487).

Additional information may be required for work involving recombinant DNA. See Appendix G, Section D7.



2. Where can I get the most current version of the Appendix G and other OH&S forms?

The OH&S web site has information on lots of safety related topics. Look here for forms. http://www.healthsafe.uab.edu/pages/home/manuals.html. They may be printed out and completed manually or filled out on line, printed and then sent via FAX (4-7487) or campus mail to OH&S. If you also have Acrobat Reader, you may save the document for your electronic files. The OH&S website is always changing, so check it often for the latest information.



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 Appendix G form acknowledging receipt of the document and registration of the project. If the project requires specific safety approval (as noted in Question 3) the Appendix G 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 Appendix G.



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 http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html).
· Select agents (see 42CFR72 http://www.healthsafe.uab.edu/pages/biosafety/selectagentregistration.html) - 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 (AKA Appendix G) to OH&S. What type of response(s) can I expect?

OH&S will send a "NOTICE OF RECEIPT", by campus mail to the Principal Investigator indicated on the form, stating that the Appendix G has been received and the research is registered. If the project requires specific safety approval (as noted in Question 3) the Appendix G 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 Appendix G.



6. I did not receive an approval letter for the project I registered with OH&S. Are approval letters automatically issued by OH&S for every project registered with an Appendix G?

No. Although all project information received by OH&S 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?

An Appendix G must be on file with OH&S 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 and Contracts forward it to OH&S?

Although these groups both work to help you meet your granting agency requirements and deadlines, "Project Registration" forms (App G) 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 OH&S?

Although these groups both work to help you meet accrediting agency requirements and grant deadlines, "Project Registration" forms (App G) 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 (App G) 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 ( http://www.healthsafe.uab.edu/pages/home/manuals.html) 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.

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