Will new ESC rules hurt research?

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 linkurl:report;http://www.cell.com/cell-stem-cell/fulltext/S1934-5909(09)00210-0 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 TaylorAhead of the NIH's linkurl:May 26th deadline;http://nihoerextra.nih.gov/stem_cells/add.htm 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 linkurl:standards committee;http://www.isscr.org/committees/committeeResults.cfm?CommitteeName=COMMITTEE/STANDARDS 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 linkurl:International Society for Stem Cell Research;http://www.isscr.org/press_releases/NIHletter.html and the linkurl:California Institute for Regenerative Medicine;http://www.cirm.ca.gov/sites/default/files/PDFs/NIH%20Comments%20NIH_guidelines%20v8_accepted_eb_clean.doc%20%5BCompatibility%20Mode%5D.pdf 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. **__Related stories:__***NIH, stem cells: IVF ok, not SCNT[17th April 2009]*linkurl:Obama good for science, experts say;http://www.the-scientist.com/blog/display/55167/ [5th November 2008]*linkurl:The Future of U.S. Science Policy;http://www.the-scientist.com/2008/9/1/30/1/ [September 2008]

Will new ESC rules hurt research?

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