Scientific Integrity Trumps Stem Cell Research?

May 18th, 2009

Posted by: admin

That’s an interpretation of this analysis in Cell Stem Cell (no, that’s not a stutter, but a journal title).  In short, there is a significant concern that the consent standards required by the new NIH guidelines (currently under public comment) would preclude using most existing stem cell lines, including those that were accepted under President Bush’s stem cell research guidelines.  Of course, we are talking about federal funding for these stem cell lines; private entities will be free to continue to fund stem cell research.  The new guidelines were drafted in response to President Obama’s Executive Order removing the guidelines of the previous administration.

The issue is the retroactive application of informed consent standards.  For reasons listed in the piece that are primarily legal/judicial in nature, the authors of the analysis consider retroactive regulations to be an unfair infringement, equivalent to an ex post facto law which is specifically proscribed in the Bill of Rights.  From a research perspective, such retroactive regulations are problematic where consent procedures are concerned because it is usually difficult, if not impossible, to conform old consent actions to new consent procedures without violating subject confidentiality (or anonymity), or the validity of the experiments in the research.  As a result, most current NIH grants in this area would have to be stopped.

Given that President Obama’s actions on stem cell research and scientific integrity were issued on the same day, I find it ironic that an effort to preserve one could serve to undercut change in another.  The comment period on the stem cell guidelines should close soon, and we will see whether or not the final regulations will manage to have a chilling effect on stem cell research that could rival the effect following President Bush’s 2001 limitations.  If this is the case, some comfort could be taken in the Obama Executive Order, which allows for the NIH to review and update the guidelines as appropriate.  This ought to be a lesson to those who thought the issue was resolved with the March Executive Order.

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