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.
Applying for a Grant?
If your work involves the use of:
- Microbial agents or products
- Human blood/body fluids
- Human gene transfer (therapy)
- Carcinogenic, mutagenic or teratogenic chemicals
- Highly toxic chemicals/drugs
- Toxins or toxic products
- Human or non-human primate primary cell/tissue culture
- Recombinant DNA/RNA
or your granting/funding agency, UAB collaborator or service provider requires a formal safety compliance letter from UAB Occupational Health and Safety, then you must register the project and send a summary of the work to UAB OHS.
All projects that require OHS or Institutional Biosafety Committee authorization or compliance letters must be received by OHS by the last working day of the month in order to enter them into the review cycle for the subsequent month (e.g. project received by May 31 are reviewed in the June review cycle).
Projects involving human gene transfer, Select Agents, HIV, BSL-3 agents, or novel recombinants may have additional requirements.
Contact OHS early in the process. Incomplete packages (missing documents or information) will be deferred until the missing information is received by OH&S. Project types that require written approvals or authorization for use include, but are not limited to:
- Bacteria, viruses, fungi, parasites or their products which require biosafety level 2 or higher containment (see 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)
- Select agents (see 42CFR73)
- Introduction of any of this material into animals (including the administration of transfected cells).
- Requirement specified by the granting agency, collaborator, or service provider (check your grant application packet for requirements)
- Project Registration Form
- Select Agent Registration
- FAQs Research Project Review
- UAB Laboratory Safety Plan and Laboratory Self Audit - under Laboratory Safety Audit Forms, Stickers & Signs