(a) Before approving use of hES cell lines imported from other institutions or jurisdictions, ESCRO committees should consider whether such cell lines have been “acceptably derived.”
(b) “Acceptably derived” means that the cell lines were derived from gametes or embryos for which
The donation protocol was reviewed and approved by an IRB or, in the case of donations taking place outside the United States, a substantially equivalent oversight body;
Consent to donate was voluntary and informed;
Donation was made with reimbursement policies consistent with these Guidelines; and
Donation and derivation complied with the extant legal requirements of the relevant jurisdiction.
(c) ESCRO committees should include on their registry a list of cell lines that have been imported from other institutions or jurisdictions and information on the specific guidelines, regulations, or statutes under which the derivation of the imported cell lines was conducted. This is in accord with the requirement in Section 2.0 of the Guidelines that calls for ESCRO committees to maintain registries listing the cell lines in use at their institutions.
To provide oversight of all issues related to derivation and use of hES cell lines and to facilitate education of investigators involved in hES cell research, each institution should have activities involving hES cells overseen by an Embryonic Stem Cell Research Oversight (ESCRO) committee. This committee could be internal to a single institution or established jointly with one or more other institutions. Alternatively, an institution may have its proposals reviewed by an ESCRO committee of another institution, or by an independent ESCRO committee. An ESCRO committee should include independent representatives of the lay public as well as persons with expertise in developmental biology, stem cell research, molecular biology, assisted reproduction, and ethical and legal issues in hES cell research. It must have suitable scientific, medical, and ethical expertise to conduct its own review