according to The Scientist magazine:

Will new ESC rules hurt research?
Posted by Elie Dolgin
[Entry posted at 14th May 2009 05:21 PM GMT]

The retroactive nature of the NIH's proposed guidelines on human stem cell 
research will exclude funding for many existing stem cell lines that were 
ethically created yet don't meet the stringent criteria of the proposal's 
technical requirements, according to a new report published online today 
(May 14) in Cell Stem Cell.

The proposed regulations outline nine distinct elements to be documented in 
written informed consent forms for embryo donors, including prohibiting 
directed donation, barring financial compensation, and requiring that donors 
of unused IVF embryos sign at least two separate consent forms, one of which 
must avoid mention of stem cell research. All these rules apply 
retroactively.

Image: Patrick Taylor
Ahead of the NIH's May 26th deadline for comments on the draft guidelines, 
the paper's author, Patrick Taylor, a lecturer at Harvard Medical School and 
deputy general counsel at Children's Hospital Boston, who co-chairs the 
International Society for Stem Cell Research's standards committee and has 
sat on many of its task forces, spoke with The Scientist about why he takes 
issue with the new NIH rulebook.

The Scientist: Two months ago, President Barack Obama pledged to lift 
restrictions on funding human embryonic stem cell research. Do you think 
that the NIH guidelines live up to that promise?

Patrick Taylor: If you go back to the very wonderful Obama executive order, 
it talked about maximizing funding. In the context of doing that, it 
retroactively imposes new restrictions. A lot of people who want stem cell 
research funded would actually be surprised to learn that under the proposed 
guidelines a lot of existing stem cell lines aren't eligible [for federal 
funding].

TS: Like some of the 21 cell lines approved by President Bush?

PT: This goes beyond the [Bush] Presidential lines and includes many, many 
stem cell lines created as a result of institutional funding. These lines 
were created under very rigorous IRB [Institutional Review Board] and ESCRO 
[Embryonic Stem Cell Research Oversight] processes, and under a set of 
standards that have really evolved through not just scientific 
self-regulation but very heavy public involvement and engagement.

TS: Beyond the logistical argument, what do you see as the main problem with 
the NIH guidelines?

PT: The broader, deeper argument is: Should retroactive ethics be 
permissible? The answer to that is, 'Look, we actually ought to evaluate 
stem cell lines based on the sound prevailing ethics of the time that led to 
them.'

TS: But some past informed consent forms don't live up to current best 
standards, right? Don't we need clear guidelines moving forward?

PT: Of course, it's vitally important that participants be fully informed 
and one actually know that they are informed. But an informed consent form 
is not the same thing as an informed consent process. There are a bunch of 
different ways of showing and establishing good processes for really 
informed consent [from embryo donors].

TS: Where do you draw the line? Isn't that a slippery slope to, say, 
accepting the stem cell lines collected by discredited Korean scientist 
Hwang Woo-suk, who violated some ethical principles in creating them?

PT: No. There are certain ethically core principles. And there are years of 
literature and practical human experience for informed consent in the 
context of respect for people's knowledge and choices. With the Hwang lines, 
people were actually being paid or being solicited under the authority of 
the principal investigator, so they couldn't make free choices. If you look 
at what scientists and ethicists said at the time, universally they 
recognized that those stem cell lines crossed a very important ethical line. 
We're not talking about approving the Hwang lines.

TS: So what are we talking about? Can you give me an example of when the NIH 
guidelines might not make sense?

PT: The NIH guidelines call for two separate IVF consents: one which says 
you will actually donate for research -- it doesn't say anything about 
embryonic stem cell research -- and then a second one once someone has 
decided to donate for research saying, 'would you be interesting in donating 
for hESC [human embryonic stem cell research]'? At the time, people thought 
that was a really important idea, but what we find now in real life is that 
some people already know what they want to happen. They believe so strongly 
in embryonic stem cell research. They say, 'I know what I want I don't need 
two consents.' [And they don't sign the first, non-specific consent, which 
invalidates the line.] In that context -- and that is what has happened for 
some of these existing cell lines -- why exactly should that line be 
invalidated? Why shouldn't there be a federal investment in the research 
that arises out of that line? Do you want to leave that line just to 
industry funding?

TS: What would be the scientific impact if cell lines like that weren't 
eligible for federal funding?

PT: Existing stem cell lines are things that have acquired tremendous 
scientific value as a result of their being the centerpiece of a lot of 
scientific research. That's all that knowledge lost. It's as if the last 
eight years of science and ethics and regulation and so on have just 
vanished -- literally. It's just snap your fingers. It's gone.

TS: On Tuesday (May 12) the International Society for Stem Cell Research and 
the California Institute for Regenerative Medicine published comments on 
their Web sites about changes that they'd like to see made to the NIH's 
proposals. How would you amend the guidelines?

PT: I think there should be specific grandfathering with respect to some of 
the [Bush] Presidential lines, and also with respect to things that have 
actually been approved by IRBs and ESCROs as meeting the ethical standards 
that are core and prevailing. I think there also should be a process of 
continuous discussion, and there ought to be some openness to establishing 
the ethical fundamentals in a way other than just the informed consent 
forms. Real life is more complicated than just a single form traveling 
through administrative space.

TS: Do these issues go beyond human embryonic stem cell research?

PT: Yes, the issue of retroactivity versus prospectively isn't one that's 
unique to stem cells. I think that the impact [of the NIH guidelines] is 
really important, not only for stem cell science but for self-regulation in 
science generally. How do we make science policy? Do we make it based on new 
decisions retroactively applied from government or do we take into 
account -- and in effect recognize -- the role of scientists, the public, 
and the media in actually creating that policy? I think we have to. That's 
the best way to achieve public benefit.

TS: Isn't the NIH consulting the scientific community and the greater public 
right now?

PT: It's great to do notice and comment. But notice and 30 days comment 
looking forward is no substitute for eight years of close and careful 
development beforehand. The views of the scientific self-regulation and a 
lot of public input into the development of guidelines are being discounted. 
And I think that's a mistake.

Rayilyn Brown
Director AZNPF
Arizona Chapter National Parkinson Foundation
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