No animal into which hES cells have been introduced at any stage of development should be allowed to breed.
Through its Embryonic Stem Cell Research Oversight (ESCRO) committee, each research institution should establish and maintain a registry of investigators conducting hES cell research and record descriptive information about the types of research being performed and the hES cells in use.
Investigators who collaborate across national boundaries should respect the ethical standards and procedural protections applicable in all the relevant jurisdictions.
If a U.S.-based investigator collaborates with an investigator in another country, the Embryonic Stem Cell Research Oversight (ESCRO) committee may determine that the procedures prescribed by the foreign institution afford protections equivalent with these guidelines and may approve the substitution of some or all of the foreign procedures for its own.
The committee hesitates to recommend another bureaucratic entity to oversee the biomedical research system, but in this case it believes the burden to be justified because of the special issues involved in hES cell research and the diverse entities that might have a role in the review process in a research institution. A coordination function is crucial. In some cases, smaller institutions may wish to avail themselves of the services of larger facilities that have ESCRO committees.
The creation of an ESCRO committee to perform functions unique to hES cell oversight does not relieve institutions or scientific investigators, regardless of their field, of the ultimate responsibility to ensure that they conduct themselves in accordance with professional standards and integrity. In particular, people whose research involves hES cells should work closely with oversight bodies, demonstrate respect for the autonomy and privacy of those who donate gametes and embryos, and be sensitive to public concerns about research involving human embryos.
As individual states and private entities move into the field of hES cell research, it is important to initiate a national effort to provide a formal context in which the complex moral and oversight questions associated with this work can be addressed. The state of the science of hES cell research and the clinical practice and public policy surrounding these topics are in a state of flux and are likely to be so for several years. Therefore, the committee believes that some entity needs to be estab-