Western Michigan University
Institutional Biosafety Committee
Registration for Recombinant or Synthetic Nucleic Acid Molecules
Research – 2016
This form must be submitted for all research involving recombinant or synthetic DNA
molecules. Renewal of approval is required annually.
In this form, Guidelines means: NIH Guidelines for Research Involving Recombinant or Synthetic
Nucleic Acid Molecules (NIH Guidelines)
http://oba.od.nih.gov/rdna/nih_guidelines_oba.html
General Registration Information
Principal Investigator:
Office Phone:
Laboratory Phone:
Electronic Mail Address:
Office Address: Room
, Building:
Department:
Laboratory Where Research is to be Conducted:
Building: Haenicke Hall
Room:
Project Title:
Current status (check one):
Initiated
Date:
Will be initiated
Date:
Continuing (no changes)
2015 IBC Project Number: 15
Continuing (modifications) 2015 IBC Project Number: 15
Please provide a cover letter stating modifications.
Will not be initiated or will be discontinued
Completed
Date:
If Part of a Grant Proposal, List Agency/Agencies: None
WMU Proposal Tracking Number (if applicable):
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Class of Covered Experiments and Containment
1.
Which class of the Guidelines for covered experiments apply to the proposed experiments
(see section III of the Guidelines). Check only one:
III-A.
Experiments that require Institutional Biosafety Committee (IBC) approval,
Recombinant DNA Advisory Committee (RAC) review, and NIH Director
approval before initiation
III-B.
Experiments that require NIH/OBA (Office of Biotechnology Activities)
and IBC approval before initiation
III-C.
Experiments that require IBC and Human Subjects Institutional Review
Board (HSIRB) approvals and NIH/OBA registration before initiation.
III-D.
Experiments that require IBC approval before initiation (see items III-D-1
through III-D-6 in the Guidelines). Check all that apply to III-D:
a. Use of other than a risk group 1 agent as a host-vector system.
State risk group: Select one
b. Use of other than a risk group 1 agent as a DNA source.
State risk group: Select one
c. A viral vector (other than risk group 1) will be used:
1. Will less than 2/3 of a genome be used?
2. With helper virus?
Yes
Yes
No
No
3. May your experiment enhance pathogenicity (e.g. insertion
of oncogene, extend host range)?
Yes
No
d. Whole animals or plants will be used as host.
e. Experiments will involve more than 10 liters of culture.
All checks need to be explained on a separate page.
III-E.
Experiments that require IBC notification simultaneous with initiation
(experiments not included in III-A, III-B, III-C, III-D and III-F)
III-F.
Exempt experiments that require IBC notification simultaneous with
initiation (see items III-F-1 through III-F-7 in the Guidelines)
2.
Which physical containment level applies to this proposal (Appendix G, section II in the
Guidelines)?
Check one:
BL-1
BL-2
BL-3
3.
Briefly state justification for choosing class and containment level and cite appropriate
sections of the Guidelines.
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Description of Recombinant or Synthetic Nucleic Acid Molecules Experiments
1.
Summary of project (1 or 2 paragraphs). Include purpose and manner in which recombinant
DNA will be used in the project. Please define acronyms and abbreviations.
2.
Host strain(s) used, including genus, species, parent strains, and class of each agent.
3.
Source(s) and nature of inserted DNA sequences. Include size, gene name(s) and function
of gene(s), and sequence(s), and organism(s) if known.
4.
Vector(s) to be used. Include source.
5.
Will an attempt be made to obtain expression of a foreign gene?
If so, what protein will be produced?
Yes
No
Statements of Certification
I certify that I have read and understood the Western Michigan University Policy for Recombinant
and Synthetic DNA Biosafety including the description of my role and responsibilities as Principal
Investigator on this project. I agree to abide by the NIH Guidelines for Research Involving
Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) in conducting all work using
recombinant DNA molecules.
/________________________________________________________________
Principal Investigator Signature
Date
I have read the description of this proposed research involving Recombinant or Synthetic Nucleic
Acid Molecules. I have determined that the facilities and procedures proposed in this project
registration form are adequate for the safe conduct of this research and the safety of other
personnel – faculty, staff, and visitors – using the facilities within which this research is to be
conducted.
/________________________________________________________________
Department Chair/Unit Head Signature
Date
Submit the original plus 9 copies to the research compliance coordinator, 251W Walwood Hall, mailstop 5456. (Be
sure to make and keep another copy for your files.) Contact the research compliance coordinator at 387-8293 for
additional information.
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