review / IBC ID:
EXEMPT per Section III-F / Review Date:
INSTITUTIONAL BIOSAFETY COMMITTEE
EXEMPT STUDY REVIEW FORM
FOR RESEARCH INVOLVING rDNA
SECTION I: GENERAL INFORMATION
Principal Investigator (PI): / Phone: / Fax:Degrees: / Correspondence Address:
Department: / Email Address:
Center/Institute: / College:
PI Level: Faculty Staff Postdoctoral
Alternate Contact Person: / Email Address:
Correspondence Address: / Phone:
Title of Project:
Project Period (Include Start and End Date): [mm/dd/yy][] to [mm/dd/yy][]
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 TRAININGFunding 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).
· 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.
Conflict of Interest
ISU’s Conflict of Interest Policy requires that investigators and key personnel disclose any significant financial interests or relationships that may present an actual or potential conflict of interest. A conflict of interest can be defined as a set of conditions in which an investigator’s or key personnel’s judgment regarding a project (including human or animal subject welfare, integrity of the research) may be influenced by a secondary interest (e.g., the proposed project and/or a relationship with the sponsor). By signing this form below, you are certifying that all members of the research team, including yourself, have read and understand ISU’s Conflict of Interest policy as addressed by the ISU Faculty Handbook (www.provost.iastate.edu/faculty) and have made all required disclosures.
Yes No Do you or any member of your research team have an actual or potential conflict of interest?
Yes No If “Yes,” have the appropriate disclosure form(s) been completed?
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 Date
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-VII: Generation of B11 Transgenic Rodents via Breeding of the NIH Guidelines for Research Involving Recombinant DNA 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 that are not organisms or viruses.
Section III-F-2: Those that consist entirely of DNA segments from a single nonchromosomal or viral DNA source, though one or more of the segments may be a synthetic equivalent.
Section III-F-3: Those that consist entirely of DNA 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.
Section III-F-4: Those that consist entirely of DNA 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-5: 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. See Appendices A-I through A-VI, “Exemptions” under Section III-F-5—Sublists of Natural Exchanges, for a list of natural exchanges that are exempt from the NIH Guidelines.
Section III-F-6: Those that do not present a significant risk to health or the environment. See Appendix C, “Exemptions” under Section III-F-6 for other classes of experiments which are exempt.
Appendix C-I-A, Recombinant DNA in Tissue Culture—Introduction into culture cells of any recombinant DNA containing less than half of a 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, Bacillus subtilis or Bacillus licheniformis Host-Vector Systems—Cloning of DNA in B. subtilis or B. licheniformis host-vector
Note: The exemptions listed above do not apply to DNA from Risk Groups 3 and 4 pathogens.
Appendix C-VI, Purchase or Transfer of Transgenic Rodents—The purchase or transfer of transgenic rodents 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-VII, 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
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:
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 USEow
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 / SOURCE / AMOUNT / DESCRIPTION OF USEE.g., Blood / Normal healthy volunteers / 2 ml / Approximate quantity, assays to be done.
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Office for Responsible Research
Revised: 1/31/11