Here’s my question:
Barack Obama issued an executive order for removing barriers to responsible scientific research involving human stem cells. How effective do you believe that the NIH’s 2009 Guidelines on Stem Cell Research are in removing these barriers?
Please see the poll at the end of this post to cast your vote.
Here’s some background:
Yesterday I vented my frustration with the recent decision by the NIH to deny approval for the use of 47 human embryonic stem cell lines in NIH funded research. More specifically, I was frustrated by the fact that the denial was linked to the use of exculpatory language (unacceptable legal language) in the consent form used by the RGI to obtain the embryonic stem cells rather than a more conventional medical ethics question.
What struck me as even more interesting is the story behind this whole fiasco. According to the NIH, on March 9, 2009, President Barack H. Obama issued Executive Order 13505: Removing Barriers to Responsible Scientific Research Involving Human Stem Cells. The order was meant to help establish policy and procedures under which the NIH will fund such research, and to ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law. Since the procedures for receiving NIH approval of human Embryonic Stem Cells may be complicated and lengthy the NIH established a stem cell registry which would avoid burdensome and repetitive assurances from multiple funding applicants.
Now for an explanation on NIH policy and my take on how RGI ended up in this precarious position. Most of what I’m about to tell you can be found in full in the NIH document National Institutes of Health Guidelines on Human Stem Cell Research. If you want to read the story from the primary source feel free to visit the website. If you want the “version in a nutshell” peppered with some of my commentary please read on.
The NIH policy is primarily concerned with the official definition of stem cells, ethical issues such as financial gain and informed consent, pre-existing stem cell populations, “extra” embryos leftover from Pre-Implantation Genetic Diagnosis (i.e. the source of RGI’s embryos) and monitoring and enforcement of the NIH stem cell policies.
The first challenge for the NIH was to define the scope of its policy vis-a-vis stem cell types. (For a great review on the various types of stem cells be sure to download Bio-Rad’s Stem Cell Basics for Life Science Researchers.) In the end, the NIH pretty much restricted its policy to the use of human embryonic stem cells proper, which encompass “cells that are derived from the inner cell mass of blastocyst stage human embryos, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers.”
Financial gain really deals with 2 main issues. One issue concerns the fact that the stem cell recipient (i.e. the scientist) might derive profit from developing the hESCs without the knowledge of the hESC donor which might lead to exploitative practices. The other financial concern is that scientists may use their intellectual property rights to impose conditions that significantly restrict the use of these cells in biomedical research and therefore hold back scientific progress.
The big issue that really served as the backbone to the RGI story was that of informed consent and the specific language used to obtain such consent. I believe that the standard practice of informed consent is to uphold the right of any individual to not have their biological material used in a fashion that they don’t agree with and to ensure that individuals are not coerced into participating an a research study. These policies make sense and are widely accepted by the scientific community. The problem that arises in this specific case is that the use of stem cells in scientific research has been around for over decade and numerous regulatory bodies have differed in their approach to obtaining informed consent for the use of stem cells. As such, informed consent policies and procedures vary and may lead to confusion regarding the acceptable use of stem cells that pre-exsited the NIH policy in NIH-funded research. In dealing with this problem, the NIH has declared that “applicant institutions wishing to use hESCs derived from embryos donated (in the United States) prior to the effective date of the Guidelines may either comply with Section II (A) of the Guidelines or undergo review by a Working Group of the Advisory Committee to the Director (ACD).” The “patchwork of standards” referred to in the NIH document may very well have precipitated the poorly written informed consent form used by RGI thereby rendering 47 of their cell lines ineligible for NIH funded research. Furthermore, the policy also states that informed consent needs to be obtained during the time of donation and that there needs to be a degree of separation between the physician obtaining the embryo and the scientist. This further exacerbated RGI’s predicament and made it next to impossible for them to rectify the situation ipso facto.
When looking at the number of cell lines approved by the NIH, it is striking that only 75 cell lines from a handful of scientific researcher have been approved for the registry since its implementation in December 2009. Furthermore, 48 cell lines are currently pending approval 232 are in draft status, and 48 have been rejected. While it might seem like 232 stem cell lines are a significant number to have in the pipeline, it is telling to note that the huge majority of these applications were submitted by RGI followed in large part by Harvard University. Furthermore, 47 out of the 48 stem cell lines rejected by the NIH came from RGI.
If stem cell research has been around for a decade and several other regulatory bodies such as the International Society for Stem Cell Research (ISSCR) and the National Academy of Sciences (NAS) have long been involved in regulating their use, why is the NIH’s current list so short? Furthermore, why are there only a handful of institutions submitting applications for NIH approval? This seems a bit concerning to me especially considering that the NIH is the largest funding institution in the United States.
Well…now’s your chance to vote.