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.
1. 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.
2. 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.
3. Are gametes, morulae, blastocysts, or somatic cells being prospectively obtained from donors
for this research?
Yes
No
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.)
4. Will banked tissues be used to derive new stem cell lines?
Yes
No
Page 1 of 2
Rev. 7.11.2014
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 reconsent 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.)
5. Does the research involve derivation of new hESC or iPSC lines?
Yes
No
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 embryos made using somatic cell nuclear transfer of 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.
6. Will hESC or iPSC lines be stored in a repository at OHSU for future research uses?
Yes
No
Page 2 of 2
Rev. 7.11.2014