Section I: General Information (all applicants must complete this section)
1. Program Director or Department Head:
2. Principal Investigator(s):
3. Grant or Project Title:
4. MURC Grant # (six digits beginning with 2):
5. rDNA Registration Title (leave blank):
6. Description of Project: (in layman's terms):
7. Department: Laboratory room #:
8. PI Telephone #: Emergency Tel. no.:
Laboratory Staff: (Please list)
________________________________
________________________________
________________________________
________________________________
________________________________
________________________________
________________________________
Section II: Recombinant DNA (rDNA) use application
7. Does your project involve use of rDNA? Yes____ No___. If yes, please complete questions 8-16.
8. Is there large Scale ( > OR = 10 liters) production of rDNA? Yes____ No___.
9. Is an rDNA gene expressed in cells, tissues or animals?
10. If yes, describe expression system:
11. Host-Vector-Donor-Detailed System: (attach list if necessary)
12. Federal Register Reference 1999 NIH Guidelines:
The current Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) were originally published in the Federal Register on July 5, 1994 with later amendments. The most recent version of the document can be read or obtained at http://www4.od.nih.gov/oba/guidelines.html. You will need to read sections I, II and III and some appendices to complete 12A, B, C and D. For your research, please list the appropriate subsection, appendix and containment level(s) for your research.
12A. Subsection: ____________ Select from subsections IIIA - IIIF.
12B. Does your rDNA work fall into exempt category: Yes [ ] No [ ]
12C. Appendix: ___________________ Select from Appendices A, B and C
12D. Containment Levels: ____________ Select from Appendix G, I, P or Q
III. Marshall University rDNA Lab Safety Form
If you checked “yes” on question 7 in section 2, please provide the following information
13. Recombinant DNA approval is only valid for the PI(s) listed on the registration application. This title is not transferable. Have you ever been approved for rDNA Research as Principal Investigator at Marshall University?
Yes _____ No____
14. Recombinant DNA approval is given by title only. If for grant purposes you wish to change the title of an rDNA application that has been approved previously you may do so if:
A. Containment levels remain the same as previously approved.
B. Probes are the same.
C. Host-Vector-Donor System is unchanged.
Under the above conditions if you wish to make a change of title(s).
A. Give approval # of referred registration.
B. List new title(s)
_______________________________________
_______________________________________
_______________________________________
15. As directed under the NIH Guidelines Section IV_B_1_I, should you (PI) and your staff undergo medical surveillance?
Yes ______ No ______
If yes, contact IBC Chairman's Office 304- 696-7338
16. I have read the Recombinant DNA Guidelines (including Sections G, H and I) and I agree to adhere to its rules and regulations regarding safe laboratory practices.
___________________________ _______________________
Principal Investigator's Name Signature
_______________________
Date
Section IV: Infectious Agents/Select Agents
17. Will you be working with any pathogens or toxins on the USDA Select Agent List? Yes [ ] No [ ]. http://www.selectagents.gov/agentToxinList.htm
If yes, you must notify the IBC Chair and complete a Select Agent Registration form before obtaining the Agent. You must also complete sections 19 and 20.
18. Does this project involve human, animal, or plant microbial pathogens that are not Select Agents? Yes [ ] No [ ] If yes, please complete sections 19 and 20.
19. List the pathogens to be used:
20. Provide the appropriate biosafety level for each pathogen listed? (See online ABSA pathogen listing at http://www.absa.org/)
Section V: Human Sera or Tissue
21. Does this project involve human sera or tissue? Yes [ ] No [ ]. If yes, please complete sections 18-21.
22. Describe the human tissue or sera to be used:
23. Do these materials have an increased risk of containing pathogens? Yes [ ] No [ ]
(e.g. derived from persons known to be infected with a microorganism)
24. What is the increased risk due to?
25. Under which biosafety level will this work be conducted?
26. Have you read our recommendation for handling human cell lines? Yes [ ] No [ ]
Section VI: Human Cell Lines
26. Does this project involve human cell lines Yes [ ] No [ ]. If yes, please complete sections 27- 29
27. List all cell lines that will be used.
28. Please list any known infectious agents associated with these cell lines.
29. Under which biosafety level will this work be conducted?