. "Appendix C: National Academies' Guidelines for Human Embryonic Stem Cell Research, Amended as of May 2010." Final Report of The National Academies' Human Embryonic Stem Cell Research Advisory Committee and 2010 Amendments to The National Academies' Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press, 2010.
The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
Final Report of the National Academies’ Human Embryonic Stem Cell Research Advisory Committee and 2010 Amendments to the National Academies’ Guidelines for Human Embryonic Stem Cell Research
1.5 Acceptability of research using hES cell lines imported from otherinstitutions or jurisdictions
1.5(a) Before approving use of hES and hPS cell lines imported from other institutions or jurisdictions, ESCRO committees should consider whether such cell lines have been “acceptably derived.”
1.5(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.
1.5(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.
2.0 ESTABLISHMENT OF AN INSTITUTIONAL EMBRYONICSTEM CELL RESEARCH OVERSIGHT COMMITTEE
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, eachmany institutions currently require that researchshould have activities involving hES cells should be overseen by an Embryonic Stem Cell Research Oversight (ESCRO) committee. Although not required under theNIH Guidelines on Human Stem Cell Research, institutions conducting federally funded stem cell research are nevertheless likely to decide to maintaintheir ESCRO committees and use them for consultation, training, and anyother functions appropriate to assist the institution and its researchers inevaluating and managing hES cell research. Institutions that conduct bothfederally funded and non-federally funded hES cell research, particularly if