Supplemental Questionnaire for Research Involving Human Pluripotent Stem Cells – IRB
eIRB Number:
Principal Investigator:Phone:
Study Title:
Funding Source:
Instructions: Please complete the questions below, referencing other documents included in your submission when applicable.
- Confirm that one of the following is true:
The proposed project will not use any federal funding, including federally funded resources and facilities.
The proposed project will use federal funding, but is limited to research on pre-existing stem cell lines that are listed on the NIH stem cell registry.
- Identify and provide a brief description of any pre-existing human stem cell lines to be used in this study, including the origin of the cell line and whether it is listed on the NIH registry.
- Are gametes, morulae, blastocysts, or somatic cells being prospectively obtained from donors for this research?
YesNo
If yes, will the donors receive any payment for donating materials for this research? If so, describe these payments and provide justification for the amount(s). (Note: Payments may not be made to donors of excess materials originally created for clinical [IVF] purposes.)
- Will banked tissues be used to derive new stem cell lines?
YesNo
If yes, describe the circumstances of the original donations, the original consent process, and any planned re-consent process: (Note: The original consent process must have included specific consent for stem cell research or re-consent of the donors must be obtained. If re-consent will be obtained, specifically address who will contact the original donors, who will obtain re-consent, and discuss whether this re-contact raises concerns about invasion of the donors’ privacy.)
- Does the research involve derivation of new hESC or iPSC lines?
YesNo
If Yes, describe the following(you may reference your protocol where applicable):
Scientific rationale for the need to generate new cell lines:
Estimation of and justification for the numbers of embryos, morulae, and/or blastocysts to be used in deriving the cell lines:
Training and experience of the research team in derivation and culture of stem cell lines:
Procedures for characterizing, validating, storing, expanding, maintaining, and distributing any new cell lines, including how confidentiality of the associated donors will be maintained:
Confirm that embryosmade using somatic cell nuclear transferof human nuclei(whether produced with human or nonhuman oocytes) nor parthenogenetic or androgenetic human embryos will be transferred to a human or nonhuman uterus.
Confirm that no intact human embryo, regardless of derivation method, will be cultured in vitro for longer than 14 days or until formation of the primitive streak begins, whichever occurs first.
- Will hESC or iPSC lines be stored in a repository at OHSU for future research uses?
YesNo
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Rev. 7.11.2014