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Introduction........... 1
Applicability of the Guidelines to Non-Embryonic Human Pluripotent Stem Cells........... 4
From Section 1........... 6
From Section 3........... 7
From Section 4 ...........9
From Section 5........... 10
Section 7 ...........10
Clarification of the Meaning of “Proper Notification” ...........13
1.3(a) hES Cell Research Permissible after Currently Mandated Reviews........... 14
Sections 6.1 and 6.2........... 15
Public Openness and ESCRO Committee Audits........... 15
2.0 Establishment of an Institutional Embryonic Stem Cell Research Oversight Committee..... 16
Clarification of Policy Regarding Reimbursement for Oocyte Donors........... 17
Section 3.4(b)........... 19
References........... 20

Appendixes
A National Academies’ Guidelines for Human Embryonic Stem Cell Research, Amended as of September 2008 ...........21
B Glossary ...........39
C Committee Biographical Sketches........... 47

 

 

The National Academies’ report Guidelines for Human Embryonic Stem Cell Research (NRC and IOM, 2005) was developed by the Committee on Guidelines for Human Embryonic Stem Cell Research and released in April 2005. The body of the report provided the background and rationale for the choices involved in formulating the Guidelines, which were compiled in its final chapter. Because human embryonic stem (hES) cell research touches on many ethical, legal, scientific, and policy issues, the Guidelines are intended to make explicit how research with hES cells can be pursued most responsibly.

The Guidelines are intended to address researchers primarily in the United States, but they may be applicable internationally as well. The 2005 publication of the Guidelines offered a common set of ethical standards for a field that, because of the absence of comprehensive
federal funding, was lacking national standards for research. Although the Guidelines have proved useful since 2005, it was recognized soon after their initial issuance that some aspects of them needed clarification in light of experience and that they must be kept up to date given the rapid pace of scientific developments in the field of stem cell research. The National Academies established the Human Embryonic Stem Cell Research Advisory Committee for that purpose in 2006 with support from the Ellison Medical Foundation, the Greenwall Foundation, and the Howard Hughes Medical Institute. It issued its first set of amendments to the Guidelines in 2007 (NRC and IOM, 2007).