Tips to Complete rDNA and Biosafety Forms
General but important tips before you begin your new rDNA and/or Biosafety registration forms:
- For security reasons, you will be timed-out of the database after 20 minutes of inactivity and all unsaved entries will be lost. SAVE OFTEN.
- Once a form has been saved the first time, it is issued a protocol or study number. Other forms may ask for this number. The Biosafety form asks for the rDNA study number and the rDNA forms asks for the Biosafety study number. Make note of the numbers.
- Text boxes have very limited space on the forms. Pay attention and plan for this. Text box space limitations require succinct wording. To save space, leave off opening statements such as: we would like to, this project will, and we will. If your project really cannot be described in about 30 words, contact the IBC Coordinator about possible options.
- Do not use the copy/paste function when completing the forms, formatting is not compatible and the text will appear truncated on the final protocol form.
- To re-enter the rDNA or Biosafety database and access a saved rDNA or Biosafety protocol that has not been submitted, go to the Registration and Forms page on the IBC website (make forms page a link) and log in by selecting the Form link to the relevant database. This will give you a blank form. Using the Navigation Menu located in the upper left hand corner, select the “go to listing page” or the “xx database”. You will only be able to open your own protocol from those listed by selecting the “view/update” button. If can’t find your protocol on that page, you may be able to locate it by entering your UTeid in the box at the top right box of the page titled “PI EID:” The boxes below should be set at “Search by PI” and “Choose Status (Optional)” click on the “see next page” button and your protocol(s) will be displayed for you. Select the “view/update” button to open the form for access. Be sure to save often and before you submit. If you don’t find your protocol after the search, it may not have been saved or it was deleted.
- You can navigate between the rDNA and Biosafety databases through the Navigation Menu found in the upper left hand corner of the form by clicking on recombinant DNA or Biosafety listing page.
Registration of “Exempt” BSL-1 or ABSL-1 recombinant or synthetic nucleic acids research
If you are registering recombinant or synthetic nucleic acid molecules research that is BSL-1 or ABSL-1 work and “exempt from the NIH Guidelines” you can use either the Exempt BLS-1/ABSL-1 recombinant DNA registration form or the Non-Exempt recombinant DNA registration form. Both forms are equally short with one important difference: exempt protocols submitted using the Non-Exempt rDNA registration form are maintained, searchable, and accessible on the rDNA database by you and other University Offices such as OSP. Protocols submitted using the Exempt BSL-1/ABSL-1 rDNA registrations are maintained as a paper file in ORS and are not searchable or accessible on the rDNA database.
- Most Non-Exempt recombinant or synthetic nucleic acids research also requires Biosafety registration describing the study, but Exempt BSL-1 or ABSL-1 protocols may not need a Biosafety protocol. If you are unsure, contact the IBC Coordinator.
Registration of “Exempt” and Non-Exempt recombinant or synthetic nucleic acids research
If you are registering recombinant or synthetic nucleic acid molecules research using the rDNA registration form, you may also need to complete a Biosafety form. If you are unsure, contact the IBC Coordinator.
Detailed directions for completing the rDNA registration (protocol) form:
- To register a new rDNA protocol, use this direct link for the rDNA database. https://utdirect.utexas.edu/vr/recom_dna.WBX you will need to enter your UT EID and password.
- The protocol form can be a challenge to fill out with the space limitations and avoiding truncated text. The text boxes on the rDNA protocol form allows about 6 to 8 words/line with 2 to 5 lines allowed depending on the question. The Biosafety protocol form allows around 9 words/line and 5 to10 lines allowed depending on the question. Since the rDNA and Biosafety protocols are reviewed together, each protocol must reference the other. The Biosafety protocol was designed with larger text boxes and the additional space allows for more information on the Biosafety form can be used by the PI (and reviewers) to fill in details for the rDNA protocol. Do not use the copy/paste function when completing the forms, formatting is not compatible and text will appear truncated on final form.
- If your work involves any infectious agents including viral vectors, human or primate tissue, fluids, or cell lines, or animals a Biosafety protocol is usually needed. The Biosafety and rDNA protocols need to reference each other. The Biosafety form asks for the rDNA study number and the rDNA forms asks for the Biosafety study number. Once a form has been saved the first time, it is issued a protocol or study number. Make note of the issued protocol numbers for reference. Both forms asks for this number and you will need to enter it when completing each of the forms. Use the Navigation Menu to move between the databases to access and refer to your protocols.
- Include all applicable hosts including E. coli, mice/rats, transgenic mice, C. elegans, and packaging cell lines to the text box for Host for recombinant DNA.
- Identify the plasmid (e.g., pCDNA3) and viral vectors (e.g., pLKO) used in the work in the text box for Cloning Vectors Reviewers may ask your to provide additional information on the plasmid or viral vectors used such as safety features, source, and packaging system.
- Will foreign gene be expressed? If yes what protein or RNA will be produced? The reviewers are interested in genes expressed or manipulated. The text box should include a listing of the genes expressed or manipulated (e.g., shRNA for X gene).
- If the insert DNA sequence is from a >RG-2 agent or the host is a >RG-2 agent and/or viral vector, check box to Question #1 and identify the agent(e.g. Adenovirus Type5 RG-2) in the text box.
- If the vector is amphotropic, the virus (e.g., lentivirus) and envelope protein (e.g., VSV-g), check box to Question #3 and identify the virus (e.g., lentivirus) and envelope protein (e.g., VSV-g) in the text box.
- If animals will be exposed to genetically modified microorganisms including viral vectors, toxins, or cells, check box to Question #6 and add IACUC (AUP) Protocol number and include description of animal work.
- Be sure check the box for Question #10 and add BSL you will use for the work and check boxes to all physical manipulations that will be used.
- If you have any questions or need assistance with the rDNA registration form, contact the IBC at (512) 232-9674 or email: email@example.com
Biosafety Registration for recombinant or synthetic nucleic acids research and biohazardous materials, agents, and toxins
Use this registration form to register research and teaching activities that involve the collection, testing or use of human fluids, tissue, and cells including cell lines in addition to infectious agents, toxins and recombinant or synthetic nucleic acid molecules research.
Detailed directions for completing the Biosafety registration (protocol) form:
- To register a new Biosafety protocol, use this direct link for the Biosafety database. https://utdirect.utexas.edu/vr/biosafety_list.WBX you will need to enter your UT EID and password.
- Check box to: Infectious Agents if using pathogens, opportunistic pathogens, or infectious agents including viral particles and vectors. Identify the agents in the text box.
- Check box to: Human Cells, Blood, or Tissue if collecting, testing, or using human or primate fluids, tissue, or cells: As applicable, provide description of type of human/primate fluids, tissue or cells and a list of cell lines used including packaging cell lines.
- Use of human/primate fluids tissue and cell lines and biotoxins require BSL-2 containment.
- Section I: located just below the text box for rDNA Study Number, select Biosafety Level Group (Risk Group) BSL-2
- Section II: located just below the text boxes for Project Indicate laboratory containment conditions for these experiments, e.g., Biosafety Level enter BSL-2.
- Selecting BSL-2 triggers the requirement to complete a Risk Group form. This form is a supplemental form within the Biosafety form and must be completed to submit the Biosafety form. The link is located in Section I just under the designation of BSL-2. To complete the RG form so that it makes sense for human tissue, below are examples of responses to first three questions:
- Q#1 Description of the virulence, pathogenicity,…etc.
- Response: Untested human skin tissue from …
- Q#2 Estimated infectious dose for humans
- Response: n/a
- Q#3 If the agent is bacterial or fungal,…..etc.
- Response: no
- Q#4 Is immunization recommended by CDC
- Response: yes
- Q#1 Description of the virulence, pathogenicity,…etc.
- FYI: Hepatitis B immunization is recommended for all personnel working with human fluids, tissue, and cells. Occupational Health on campus will provide the hepB vaccination to lab personnel that have not been immunized free of charge.
- Answer the remaining procedure and lab related questions as they apply to your work.
- Be sure to save the RG form before you submit it.
- Include description of the proposed research to the text box: Briefly describe the proposed research located just below the question for CDC/HHS/USDA select agent.
- If animals including transgenic will be used and exposed genetically modified microorganisms including viral vectors, toxins, or cells, check box to Agents or Toxins will be used in whole animals or primary animal cells and add IACUC (AUP) Protocol number and include description of animal work.
- If you have any questions or need assistance with the Biosafety registration form, contact the IBC at (512) 232-9674 or email: firstname.lastname@example.org