4.2. The scientific rationale for the need to generate new hES cell lines, by whatever means, must be clearly presented, and the basis for the numbers of embryos and blastocysts needed should be justified.


4.3. Research teams should demonstrate appropriate expertise or training in derivation or culture of either human or nonhuman ES cells before permission to derive new lines is given.


4.4. When NT experiments involving either human or nonhuman oocytes are proposed as a route to generation of ES cells, the protocol must have a strong scientific rationale. Proposals that include studies to find alternatives to donated oocytes in this research should be encouraged.


4.5. Neither blastocysts made using NT (whether produced with human or nonhuman oocytes) nor parthenogenetic or androgenetic human embryos may be transferred to a human or nonhuman uterus or cultured as intact embryos in vitro for longer than 14 days or until formation of the primitive streak, whichever occurs first.


4.6. Investigators must document how they will characterize, validate, store, and distribute any new hES cell lines and how they will maintain the confidentiality of any coded or identifiable information associated with the lines (see Section 5.0 below).

5.0 BANKING AND DISTRIBUTION OF hES CELL LINES

There are several models for the banking of human biological materials, including hES cells. The most relevant is the U.K. Stem Cell Bank. The guidelines developed by this and other groups generally adhere to key ethical principles that focus on the need for consent of donors and a system for monitoring adherence to ethical, legal, and scientific requirements. As hES cell research advances, it will be increasingly important for institutions that are obtaining, storing, and using cell lines to have confidence in the value of stored cells—that is, that they were obtained ethically and with the informed consent of donors, that they are well characterized and screened for safety, and that the conditions under which they are maintained and stored meet the highest scientific standards. Institutions engaged in hES research should seek mechanisms for establishing central repositories for hES cell lines—through partnerships or augmentation of existing quality research cell line repositories and should adhere to high ethical, legal, and scientific standards. At a minimum, an institutional registry of stem cell lines should be maintained.


5.1 Institutions that are banking or plan to bank hES cell lines should establish uniform guidelines to ensure that donors of material give informed consent through



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