For Committee use only Investigator & Protocol no:
Version 4/15
Date rec’d:
Date approved:
Prior to beginning, make certain you are using the correct version of this form by downloading the latest version from fandm.edu/biosafety
Information must be provided in all boxes shaded yellow as well as in all other appropriate tables. All questions must be answered.
PI name and status (e.g., faculty, post-doc, student)
Table I. PI Information e-mail address Phone Office number
Previous hESC and iPSC protocol no.
(if a renewal/revision)
Pursuant to the Executive Order 13505: Removing the Barriers to Responsible Research involving Human Stem
Cells and the accompanying Presidential Signing Statement issued by President Obama effective March 9, 2009 and published in the Federal Register March 11, 2009, and recognizing Pennsylvania's prohibition on research using embryos or cell products derived from embryos (PA Code Title 18, Chapter 32; sec. 3203 and 3216) the following assurances regarding conduct of hESC and hiPSC research undertaken at Franklin and Marshall College are required from all faculty.
NOTE that if therapeutic cloning involving animal-derived materials is performed, it must be clear that no human tissue of any kind was used in such cloning. Therapeutic cloning using human material is prohibited by federal law.
Provide a brief title describing the work involving hESC and/or hiPSC and a short (usually less than 150 words) summary in lay terminology of 1) the overall goal of the research and 2) the planned research activities to assist
Committee members understand how the registered materials will be manipulated. This description must be written in lay scientific terms.
Table II. Project Title and Description of Work
II A: Project Title (maximum; 70 characters)
II B: Summary including overall goal(s) and description of research activities (in lay scientific terminology)
1. I have read, understand, and agree to abide by the National Institutes of Health Guidelines on Human Stem
Cell Research ( http://stemcells.nih.gov/policy/2009guidelines ).
(Put your initials in the box.)
2. I will use only those human embryonic cell lines eligible for federal funding and approved by the NIH for my research ( http://grants.nih.gov/stem_cells/registry/current.htm
).
(Put your initials in the box.)
Cell line(s) to be used (list all) Date Registry accessed
3. I will NOT perform any research in which hESCs or hiPSCs are introduced into non-human primate
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blastocysts
(Put your initials in the box.)
4. I will NOT perform any research involving breeding of animals where the introduction of hESCs or hiPSC may contribute to the germ line.
(Put your initials in the box.)
5. My research is NOT prohibited by the annual appropriations ban on funding of human embryo research
(Section 509, Omnibus Appropriations Act, 2009, Pub. L.118-8, 3/11/09), otherwise known as the Dickey
Amendment *.
(Put your initials in the box.)
6. My research does NOT use hESCs derived from other sources, including somatic cell nuclear transfer, parthenogenesis, and/or in vitro fertilized (IVF) embryos created for research purposes.
(Put your initials in the box.)
7. If any of the above conditions are not met, provide details of a) the type of cells that will be used, b) the e) f) b) c) d) source of the cells, c) manipulations of cells that are planned at Franklin and Marshall College (F&M), d) manipulations, if any, performed outside of F&M and the legal authority under which this work was done, e) the current PA state law that permits the use of the cells in the manner proposed, and f) other information that will assist in the review of the proposed work. a)
8. Has the Research Registration Form for this work been submitted to the Institutional Safety Committee
(IBC) for review? NOTE: IBC review and approval are required prior to initiation of work.
9. Has or will this protocol be submitted to the Institutional Review Board (IRB) for review?
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(number, pending, to be submitted)
10. Has or will this protocol be submitted to the Institutional Animal Care and Use Committee (IACUC) for review? (Review and approval by the IACUC are needed if cells will be put into animals. If already reviewed by the
IACUC, submit a copy of the review letter.)
(number, pending, to be submitted)
11. Do you have a Material Transfer Agreement (MTA) in effect for these cells?
(approval, pending, to be submitted)
I the undersigned Principal Investigator understand that I am responsible for insuring that all work with hESC or hiPSC in my laboratory and/or under my direction comply with the National Institutes of Health Guidelines on Human Stem
Cell Research and the stipulations on this form.
‘Electronic’ (typed) signature of PI Date
* Dickey Amendment a) None of the funds made available in this Act may be used for
1) the creation of a human embryo or embryos for research purposes; or
2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). b) For purposes of this section, the term "human embryo or embryos" includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.
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