The Interstate Alliance on Stem Cell Research, meeting in Baltimore, MD, Tuesday and Wednesday, moved into new territory, opting to develop a model form to be used by states to help certify stem cells have been ethically derived.
It was a good decision and exactly the sort of thing the Alliance should do. Adding credibility to the process is the fact that it all happened in sessions completely open to the public.
I sat at the table and had the opportunity as a member of the public to say I thought the decision was a good idea. Thankfully the days when I got kicked out of the organization’s meeting in Irvine, CA., appear to be long passed.
Some background is necessary:
One of the big ethical issues in research that involves human subjects is "informed consent." People need to be fully informed about and understand the possible benefits and risks of the procedures and research in which they are involved.
The choice to participate must be made freely, without any coercion or pressure.
This ethical concern for informed consent extends to experiments involving donation of human tissues and organs. And in the realm of stem cell research, fraught with moral questions and political controversies, the issue of informed consent rises to the highest level.
To ensure human subject research is held to ethical standards, researchers must have their experiments reviewed by Institutional Review Boards that include non-scientists and experts in ethics. In California stem cell research regulations require an additional level of scrutiny by a Stem Cell Research Oversight (or SCRO) Committee. Such committees are also sometimes known as ESCRO Committees — Embryonic Stem Cell Research Oversight Committees.
Though some states don’t have the specific regulations or laws that are on the books in California, virtually all researchers involved in stem cell research in the United States follow guidelines developed by the National Academies. The NAS guidelines call for ESCRO Committee review.
One of the issues that has emerged as more states have begun to fund stem cell research is that regulations in one state may differ enough from those in another that a stem cell line derived in one state might not meet the standards of the other.
The idea behind IASCR’s Model Oversight Committee Certification Form is to provide a standardized format so that SCRO and ESCRO committees can easily see if their required ethical and criteria have been met by a particular cell line. It doesn’t mandate what those criteria are.
To me, once the form is developed, it will be like different states’ driving licenses. They may look a little different, but there is general agreement state-to-state about the data that should appear on each state’s license.
Since its inception IASCR has been reluctant to advocate polices. Most attendees are state employees — essentially bureaucrats, if you will — who are charged with overseeing policies crafted and enacted by elected and appointed officials.
It was for this reason that the name of the organization was changed at the outset. It started out known as the Interstate Alliance FOR Stem Cell Research, but quickly its monicker morphed to the Interstate Alliance ON Stem Cell Research.
The fear was that FOR implied advocacy on the part of the members. ON is supposed to mean a focus on programs enacted by duly elected or appointed policy-makers; with no suggestion that IASCR members advocate for or make that policy.
A hair-splitting sensitivity, perhaps? Yes, but in the controversial world of publicly funded stem cell research a sensible one.
What’s this has meant in the past is that most of IASCR’s work product has been reports listing states differing policies and approaches — information that could be used by the decision-makers at home to make policy.
The proposed model certification form goes beyond merely gathering information and it’s good Co-Chairman Warren Wollschlager stressed that point to the group before it moved into new territory.
Standardizing the format in which information appears will help all jurisdictions. It won’t mandate how the information is used. That’s up to the individual states. It will simply provide clearly access to data for decision making.
So, it was a good — albeit small — step into new territory for IASCR in Baltimore. And, it was done with the essential safeguard: it happened in public.