FOR IBC
USE ONLY
Not exempt
EXEMPT per Section III-F
IBC ID:
Review Date:
Does not require IBC
review
INSTITUTIONAL BIOSAFETY COMMITTEE
EXEMPT STUDY REVIEW FORM
FOR RESEARCH INVOLVING RECOMBINANT
OR SYNTHETIC NUCLEIC ACID MOLECULES
SECTION I: GENERAL INFORMATION
Principal Investigator (PI):
Degrees:
Department:
Center/Institute:
PI Level:
Faculty
Staff
Alternate Contact Person:
Correspondence Address:
Title of Project:
Phone:
Fax:
Correspondence Address:
Email Address:
College:
Postdoctoral
Email Address:
Phone:
Key Personnel
List all members and relevant experience of the project personnel. This information is intended to inform the committee of
the training and background related to the specific procedures that each person will perform on the project.
NAME & DEGREE(S)
SPECIFIC DUTIES ON PROJECT
TRAINING & EXPERIENCE
RELATED TO PROCEDURES
PERFORMED, DATE OF
TRAINING
Funding Information
If internally funded, please provide account number:
If externally funded, please provide funding source and account number:
If funding is pending, please provide OSPA GoldSheet ID:
Title on GoldSheet if different from above:
Other: (e.g., funding will be applied for later, project not funded)
Assurance



I certify that the information provided in this application is complete and accurate and consistent with any
proposal(s) submitted to external funding agencies.
I agree to provide proper surveillance of this project to ensure that the rights and welfare of the human subjects or
welfare of animal subjects are protected. I will report any problems to the appropriate assurance review
committee(s).
I agree that I will not begin this project until receipt of official approval from the appropriate committee(s).
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
I agree that modifications to the originally approved project will not take place without prior review and approval
by the appropriate committee(s), and that all activities will be performed in accordance with all applicable federal,
state, local, and Iowa State University policies.
SIGNATURES
Signature of Principal Investigator
Date
Signature of Department Chair
Date
For IBC Use Only
Project is exempt.
Project is not exempt.
Project does not require IBC review because:
Signature of IBC Chair
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SECTION II: EXEMPTION CATEGORY
PLEASE NOTE:
All procedures for all subjects in a project must be exempt in order for the project to be reviewed for exemption (i.e.,
all of the research activities must be found in one or more of the following categories).
This form is to be used only for research that is found in Section III-F: Exempt Experiments and Appendix C:
Generation of B11 Transgenic Rodents via Breeding of the NIH Guidelines for Research Involving Recombinant or
Synthetic Nucleic Acid Molecules. If your research involves human, plant or animal pathogens, biological toxins, or
administration of experimental biological products, you must complete either an “IBC Application Form” or a
“Protocol Review Form – Research (combined IACUC and IBC application).”
Investigators who complete the exempt form and whose research project involves procedures which do not fit within
an exempt category will be asked to complete one of the forms noted above.
If you have any question about the exempt categories and whether your study falls within the exempt category, we
encourage you to contact the IBC Administrator for assistance (4-5412).
If your study is declared exempt, you will not be required to submit the annual continuing review document.
If any changes are made to the research project, you must submit a modification for a determination by the IBC as to
whether the research remains exempt according to the NIH Guidelines.
1. Please explain why your study is exempt from the NIH Guidelines.
2. The following categories are eligible for exempt status review. Check all categories and sub-parts applicable
to your research. To select a category box, double-click on the check box.
Section III-F-1: Those synthetic nucleic acids that: (1) can neither replicate nor generate nucleic acids that
can replicate in any living cell (e.g., oligonucleotides or other synthetic nucleic acids that do not contain an
origin of replication or contain elements known to interact with either DNA or RNA polymerase), and (2) are
not designed to integrate into DNA, and (3) do not produce a toxin that is lethal for vertebrates at an LD50 of
less than 100 nanograms per kilogram body weight. If a synthetic nucleic acid is deliberately transferred into
one or more human research participants and meets the criteria of Section III-C, it is not exempt under this
Section. This form does not need to be filled out for synthetic nucleotides that are PCR primers or PCR
products.
Section III-F-2: Those that are not in organisms, cells, or viruses and that have not been modified or
manipulated (e.g., encapsulated into synthetic or natural vehicles) to render them capable of penetrating
cellular membranes.
Section III-F-3: Those that consist solely of the exact recombinant or synthetic nucleic acid sequence from a
single source that exists comtemporaneously in nature.
Section III-F-4: Those that consist entirely of nucleic acids from a prokaryotic host, including its indigenous
plasmids or viruses when propagated only in that host (or a closely related strain of the same species), or
when transferred to another host by well established physiological means.
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Section III-F-5: Those that consist entirely of nucleic acids from a eukaryotic host including its chloroplasts,
mitochondria, or plasmids (but excluding viruses) when propagated only in that host (or a closely related
strain of the same species).
Section III-F-6: Those that consist entirely of DNA segments from different species that exchange DNA by
known physiological processes, though one or more of the segments may be a synthetic equivalent. A list of
such exchangers will be prepared and periodically revised by the NIH Director with advice of the RAC after
appropriate notice and opportunity for public comment (see Section IV-C-1-b-(1)-(c), Major Actions). See
Appendices A-I through A-VI, Exemptions under Section III-F-6—Sublists of Natural Exchangers, for a list
of natural exchangers that are exempt from the NIH Guidelines.
Section III-F-7: Those genomic DNA molecules that have acquired a transposable element, provided the
transposable element does not contain any recombinant and/or synthetic DNA.
Section III-F-8: Those that do not present a significant risk to health or the environment (see Section IV-C-1b-(1)-(c), Major Actions), as determined by the NIH Director, with the advice of the RAC, and following
appropriate notice and opportunity for public comment. See Appendix C, Exemptions under Section III-F-8
for other classes of experiments which are exempt from the NIH Guidelines.
Appendix C-I, Recombinant or Synthetic Nucleic Acid Molecules in Tissue Culture—Introduction
into tissue culture cells of any recombinant or synthetic nucleic acid molecules containing less than
half of any eukaryotic viral genome
Appendix C-II, Escherichia coli K-12 Host-Vector Systems—Cloning of DNA in E. coli
Appendix C-III, Saccharomyces Host-Vector Systems—Cloning of DNA S. cerevisiae host-vector
systems
Appendix C-IV, Kluyveromyces Host-Vector Systems—Experiments involving Klyuveromyces lactis
host-vector systems
Appendix C-V, Bacillus subtilis or Bacillus licheniformis Host-Vector Systems—Cloning of DNA in
B. subtilis or B. licheniformis host-vector
Appendix C-VI, Extrachromosomal Elements of Gram Positive Organisms—Recombinant or
synthetic nucleic acid molecules derived entirely from extrachromosomal elements of the organisms
listed
Note: The exemptions listed above do not apply to DNA from Risk Groups 3 and 4 pathogens.
Appendix C-VII, The Purchase or Transfer of Transgenic Rodents—The purchase or transfer of transgenic
rodents for experiments that require BL1 containment
Will the animals be purchased from a commercial source?
Yes
No
If “No,” how will the animals be obtained?
Appendix C-VIII, Generation of BL1 Transgenic Rodents via Breeding—The breeding of two different
transgenic rodents or the breeding of a transgenic rodent and a non-transgenic rodent with the intent of
creating a new strain of transgenic rodent that can be housed at BL1 containment will be exempt if:
Both parental rodents can be housed under BL1 containment, and
Neither parental transgenic rodent contains the following genetic modifications:
Incorporation of more than one-half of the genome of an exogenous eukaryotic virus from a single
family of viruses;
Yes
No
Or
Incorporation of a transgene that is under the control of a gammaretroviral long terminal repeat
(LTR);
Yes
No
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and
The transgenic rodent that results from this breeding is not expected to contain more than one-half of
an exogenous viral genome from a single family of viruses.
Note: The exemptions listed above do not apply to DNA from Risk Groups 3 and 4 pathogens.
SECTION III: PROTOCOL INFORMATION
Study Objectives
1.
Provide an overall summary of the project and briefly explain in language understandable to a high school
student the specific aim(s) of the study.
2.
Briefly explain the experimental design. Please describe the project with respect to use of recombinant DNA.
3.
Please describe the source of the DNA, including the type of organism, species, strain, cultivar/cell line.
4.
Please describe the nature of the inserted DNA sequences, including regulatory or coding region, entire genome,
synthetic antisense sequences, etc.
5.
Please describe the recipient organism(s) for the DNA. Specify the type of organism, species, strain, cultivar/cell
line, origin, etc.
6.
List vectors to be used, such as expression vectors, and briefly specify their purpose.
7.
Yes
No
Will there be a deliberate attempt to express a foreign gene?
If “Yes,” describe how expression of the inserted DNA sequences will result in differences from the non-modified
parental organism (for example, morphological or structural characteristics, physiological activities and processes,
growth characteristics). Indicate possible toxicity or other hazards, if any:
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SECTION IV: ENVIRONMENTAL HEALTH AND SAFETY
Yes
No Will this project involve any of the following: human cell or tissue cultures (primary OR immortalized),
or human blood components, body fluids or tissues? If the answer is “Yes,” please proceed to Part A:
Human Cell or Tissue Cultures.
Part A: Human Cell or Tissue Cultures
Yes
No Will this project involve human cell or tissue cultures (primary OR immortalized cell lines/strains)?
1. Please list the specific cell lines/strains to be used, their source, and description of use.
CELL LINE
SOURCE
DESCRIPTION OF USE
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Yes
No Have the human cell or tissue cultures been documented to be free of bloodborne pathogens? If “Yes,”
please fax or attach copies of the documentation. If “No,” please complete this section.
2. Please refer to the ISU Bloodborne Pathogens Manual, which contains the requirements of the OSHA
Bloodborne Pathogens Standard. Please list the specific precautions to be used for this project below (e.g.,
retractable needles will be used for blood draws):
Anyone working with human cell lines/strains that have not been documented to be free of bloodborne pathogens is
required to have Bloodborne Pathogen Training annually. Current Bloodborne Pathogen Training dates must be
listed in Section I for all Key Personnel. Please contact Environmental Health and Safety (294-5359) if you need to
sign up for training and/or to get a copy of the Bloodborne Pathogens Manual.
Part B: Human Blood Components, Body Fluids or Tissues
Yes
No Will this project involve human blood components, body fluids or tissues? If “Yes,” please answer all
of the questions in the Human Blood Components, Body Fluids or Tissues section.
1. Please list the specific human substances used, their source, amount, and description of use.
SUBSTANCE
E.g., Blood
SOURCE
Normal healthy
volunteers
AMOUNT
2 ml
DESCRIPTION OF USE
Approximate quantity, assays to be done.
Add New Row
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