Human Embryonic Stem Cell Research: An Argument for National Research Review

Abstract

The US National Academy of Sciences (NAS) recently published voluntary guidelines for human embryonic stem (hES) cell research. The NAS guidelines propose two levels of oversight. At the local level, research institutions are to create Embryonic Stem Cell Research Oversight (ESCRO) committees with a mandate to assess the scientific merit and ethical acceptability of hES cell research. At the national level, a new committee is to be created, not to review specific research proposals, but rather to periodically assess, and as needed revise, the NAS guidelines. In this article, we critically assess this proposal. In particular, we review the benefits and limitations of local research review. On this basis, we argue that local review is insufficient for hES cell research and that while there are obvious pragmatic and political reasons for the NAS to favor local research review, there are more compelling reasons for the NAS to have recommended national review of hES cell research proposals.

Keywords:

• research ethics
• research ethics committees
• stem cells
• IRB
• public policy

Acknowledgment

Thanks to members of the Novel Tech Ethics research team (especially Jocelyn Downie, Michael Hadsksis and Tim Krahn) <www.noveltechethics.ca> as well as Lee Zwanziger for discussion of previous versions of this article. We also thank an anonymous reviewer for helpful comments.

Notes

¹In the U.S., ethics and science review of federally funded research is the responsibility of IRBs, as specified in federal regulations (45 CFR 46.103, 21 CFR 56.103). Research to derive hES cells is not federally funded, however, and thus not subject to IRB review. In 2001, President Bush prohibited the use of federal funds to derive hES cell lines (Bush, 2001). Further, IRB review of research involving existing hES cell lines is not required because this is not human subjects research as specified in the regulations (Office for Human Research Protections, 2002).

²45 CFR Part 46, Subpart D §407 (2005). The “panel of experts” refers to an ad-hoc national committee of experts organized by the DHHS (Lahl, Personal Communication).

45 C.F.R. 46 (2005).