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©2021 by The International Society for Stem Cell Research. All rights reserved.

No part of this document may be produced in any form without written permission of The International Society for Stem Cell Research.

Appendices

Appendix 3. Informed Consent Considerations for Procurement of Cells and Tissues for Stem Cell Research and Translation

The informed consent process for the procurement of cells and tissues for stem cell research and translation should cover the following statements, adapted to the particular project:

  1. That the cells and tissues may be used in the derivation of continuously growing cell cultures, including production of embryonic or pluripotent stem cell lines.
  2. That the embryos or tissues will be destroyed, or isolated cells altered, during the process of deriving totipotent or pluripotent cells for research.
  3. That derived cells and/or cell lines might be deposited and stored in a repository many years and used internationally for future studies, many of which may not be anticipated at this time.
  4. That cells and/or cell lines might be used in research involving genetic alteration of the cells, the generation of organoids (small organ models) or animal research (resulting from the transfer of human stem cells or their direct derivatives into animal models, or the introduction of human stem cells into animal embryos).
  5. That the donation is made without any restriction or direction regarding who may be the recipient of transplants of the cells derived, except in the case of autologous transplantation or directed altruistic donation.
  6. Whether the donation is limited to specific research purposes or is for broadly stated purposes, including research and/or clinical application not presently anticipated, in which case the consent shall notify donors, if applicable under governing law, of the possibility that permission for broader uses may later be granted and consent waived under appropriate circumstances by a human subjects review committee. The consent process should explore and document whether donors have objections to the specific forms of research and/or clinical application outlined in the research protocol.
  7. Whether the donor may be approached in the future to seek additional consent for new uses or to request additional materials (such as blood or other clinical samples) or information.
  8. Disclosure of what donor medical or other information and what donor identifiers will be retained, specific steps taken to protect donor privacy and the confidentiality of retained information, and whether the identity of the donor will be readily ascertainable to those who derive or work with the resulting stem cell lines, or any other entity or person, including specifically any oversight bodies and government agencies.
  9. Disclosure of the possibility that any resulting cells or cell lines may have commercial potential, and whether the donor will or will not receive financial benefits from any future commercial development.
  10. Disclosure of any present or potential future financial benefits to the investigator and the institution related to or arising from proposed research.
  11. That the research is not intended to provide direct medical benefit to anyone including the donor, except in the sense that research advances may benefit the community.
  12. That neither consenting nor refusing to donate biomaterials for research will affect the quality of care provided to potential donors.
  13. That there are alternatives to donating human biomaterials for research, and an explanation of what these alternatives are.
  14. For donation or creation of embryos for research, that the embryos will not be used to attempt to produce a pregnancy.
  15. For donation of gametes, that they will not be used to create embryos unless explicit consent is obtained and the resulting embryos will not be used for reproductive purposes.
  16. For experiments in embryonic stem cell derivation, somatic cell nuclear transfer, somatic cell reprogramming, parthenogenesis, or androgenesis, that the resulting cells or stem cell lines derived would carry some or all of the DNA of the donor and therefore be partially or completely genetically matched to the donor.
  17. That nucleic acid sequencing of the resulting stem cell line is likely to be performed and this data may be stored in databases available to the public or to qualified researchers with confidentiality provisions, and that this may compromise the capacity for donation to remain anonymous and/or de-identified.
  18. That the donor and/or biomaterials will be screened for infectious and possibly genetic diseases or markers of disease.
  19. Whether there is a plan to share with the biomaterials donor any clinically relevant health information discovered incidentally during the course of research, and if so, what those plans are, including the right not to receive such results.

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