1. If the identities of the donors are retained (even if coded), a statement as to whether donors wish to be contacted in the future to receive information obtained through studies of the cell lines.

  2. An assurance that participants in research projects will follow applicable and appropriate best practices for donation, procurement, culture, and storage of cells and tissues to ensure, in particular, the traceability of stem cells. (Traceable information, however, must be secured to ensure confidentiality.)

  3. A statement that derived hES or hPS cells and/or cell lines might be kept for many years.

  4. A statement that the hES or hPS cells and/or cell lines might be used in research involving genetic manipulation of the cells or the mixing of human and nonhuman cells in animal models.

  5. Disclosure of the possibility that the results of study of the hES or hPS cells may have commercial potential and a statement that the donor will not receive financial or any other benefits from any future commercial development.

  6. A statement that the research is not intended to provide direct medical benefit to the donor(s) except in the case of autologous donation.

  7. A statement that embryos will be destroyed in the process of deriving hES cells.

  8. A statement that neither consenting nor refusing to donate embryos for research will affect the quality of any future care provided to potential donors.

  9. A statement of the risks involved to the donor.

In addition, donors could be offered the option of agreeing to some forms of hES cell research but not others. For example, donors might agree to have their materials used for deriving new hES cell lines but might not want their materials used, for example, for NT. The consent process should fully explore whether donors have objections to any specific forms of research to ensure that their wishes are honored. Investigators and stem cell banks are, of course, free to choose which cell lines to accept, and are not obligated to accept cell lines for which maintaining information about specific research use prohibitions would be unduly burdensome.


New derivations of stem cell lines from banked tissues obtained prior to the adoption of these guidelines are permissible provided that the original donations were made in accordance with the legal requirements in force at the place and time of donation. This includes gametes, morulae, blastocysts, adult stem cells, somatic cells, or other tissue. In the event that these banked



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