IRA FLATOW, host:

This is SCIENCE FRIDAY from NPR News. I'm Ira Flatow. Later in the hour, we'll be talking about concrete and climate change and the latest findings about Mars and celebrating the birthday of the SETI@home computing project.

But first in March, President Obama signed an executive order directing the government to change the rules for federal funding of embryonic stem cell research. Under the policy established by the Bush administration, federal funding was limited to a handful of stem cell lines that had been created prior to August 9, 2001. The hundreds of thousands of frozen embryos stored in fertility clinics were off-limits, even though they were waiting to be destroyed.

Well, when President Obama signed that order changing the rules, many people assumed that the president's order would make it easier to do research, opening up many more embryos, but according to my next guest, the new draft rules published by the NIH could have the reverse effect: further limiting the lines of stem cells available, including those allowed since the Bush limits, in effect the cure becoming worse than the disease is what the fear is.

Here to talk about it is Pat Taylor, deputy general counsel and chief counsel for research affairs at Children's Hospital Boston, and professor at Harvard Med School. He's also the author of a commentary about the proposed rules in stem cell. Welcome to SCIENCE FRIDAY.

Dr. PAT TAYLOR (Children's Hospital Boston): Hey, how are you?

FLATOW: Hey, is this - am I correct in summing it up that way?

Dr. TAYLOR: Well, I don't think it's a disaster exactly, and I hope that the cure isn't worse than the disease, but you're definitely right that there is some significant issues, which hopefully the NIH will fix. And maybe the best way to start it is just the way you did, with President Obama's really terrific executive order.

FLATOW: And tell us about the order.

Dr. TAYLOR: So that - you know, the title is great: Removing Barriers to Responsible Scientific Research. And what the order did is directed the NIH to actually look at other widely recognized guidelines, and there are a lot of them, and we'll get to that, on human stem cell research and then to come up with ways of funding responsibly derived stem cell lines to the maximum extent permitted by law.

FLATOW: And what were some of the key changes in that proposal, the NIH proposal?

Dr. TAYLOR: Well, I think the major issue with the NIH proposal is it lays out some informed-consent standards that are both different than some of those really intense self-regulatory standards and also different than the federal regulations that many institutions actually have been using to make sure these are ethical.

So that really has two kinds of implications. There's sort of a formal aspect to the guidance, which says everything's got to be documented in a certain way. So despite, say, global diversity, and there's at least maybe 800-plus lines around the world, things have got to be documented just our way.

FLATOW: And if they're not documented in the past, you can't use them.

Dr. TAYLOR: Exactly. That's exactly right. And some of the documentation relates to things like IVF clinics. You know, for example, that they have a certain policy on protecting people from the influence of researchers. There's no question that keeping people front and center, patient care first for IVF clinics, is what has to happen. But many of these clinics wouldn't have had occasion to put in their consent forms something like that because they're just separate.

FLATOW: So what you're saying is that all these embryos in these in-vitro fertilization clinics may be off-limits because the people who donated them never signed these consent forms.

Dr. TAYLOR: Well, they've signed, you know, a different and appropriate consent form, but this new, formal requirement with some of these new, additional elements would be problematic.

I want to emphasize that, you know, there's been a tremendous effort over the last eight years. It's involved self-regulatory bodies, it's involved institutional review boards, which are the ethical bodies designated, you know, under federal law to make sure that human protection, human subjects are protected in research, tremendous effort - and also, of course, a tremendous effort at public engagement.

You know, media involvement has been critical. So this is not an area where we're talking about, you know, grandfathering in or protecting unethical lines. We're talking about lines where they have met federal regulations, been extensively reviewed, but unfortunately, due to some new formal requirements and a couple new pretty debatable substantive ones, as well, they would not be eligible.

So it's as if the last eight years of, you know, science and ethics, self-regulation and public engagement in this, donor intentions, all that just disappears.

FLATOW: Wow, that's something that no one expected.

Dr. TAYLOR: I think you're right. You know, you mentioned it, as you introduced this, that it started with just some old lines, and the funny thing now is that it's probably going to be, almost certainly going to be, just new lines. So it's as if the last eight years just didn't exist.

FLATOW: Is there any chance - now this is open for public review, and I would imagine people like you and people who want to maybe change these guidelines now have a chance to comment on this.

Dr. TAYLOR: That's right. There's actually - the NIH has given 30 days to comment, and the 30 days actually ends next week. So they've made it very easy to comment through a Web site available that shows both the guidelines and a very easy-to-file comment form.

FLATOW: And what would you like to see in the comments? What would you like to see specifically change?

Dr. TAYLOR: Well, I think there are a few things. First of all, these ethically derived lines, where there's been ethical review and high standards according to core principles, those should be grandfathered to mean donor intentions and, you know, to respect the IRB and so-on regulatory process that has occurred, to make sure they don't go to waste. It's also critical, by the way, for the global nature of this research. We can't expect every country to have done things just our way. That's one thing.

The second is there's a couple elements - like directed donation, and people shouldn't benefit from any downstream patents - that are new and interesting ideas, but they're very debatable. And for those two, I think that it's really critical that they be subject to more examination in exactly the way that's occurred before.

That means media discussion of it, which has again been very critical to public engagement in this policy. They are not straightforward. There's arguments both ways. So that's - a couple of these really need more discussion.

You know, what's at stake there is really how we do ethics. Does ethics belong to somebody else, or does ethics belong, in a sense, to a combination of that kind of discipline and us, and those ones need some discussion.

FLATOW: And you're looking for that discussion now.

Dr. TAYLOR: Absolutely. I think with respect to those two, that really should happen. The third thing is there is this formulistic element that says everything in this certain form. We know - I think the president is reminding us constantly that we are citizens of the world, and so there needs to be some ability to look at the other ways that different countries document things and the different ways that people historically have done so very legitimately and very ethically.

FLATOW: Well, thank you very much for taking time to be with us today. And you say that period runs out when, next week?

Dr. TAYLOR: Next week. I think it's maybe May 26. I might have the date wrong, but I think that's correct.

FLATOW: And how can one comment on it?

Dr. TAYLOR: So the form is really easy to fill out. There's a link. I'm happy to send it to your show, and…

FLATOW: Tell us what it is.

Dr. TAYLOR: Let's see, just one second.

FLATOW: We have it on our Web site, so we can…

Dr. TAYLOR: Yeah, I think you have it on your Web site.

FLATOW: Yeah, we have it on our Web site. If you want to comment, go to sciencefriday.com, and we have the link up there to make a comment.

Dr. TAYLOR: Yeah, it's kind of a long link.

FLATOW: Yeah.

(Soundbite of laughter)

FLATOW: Just looking at it.

Dr. TAYLOR: But they've made it very easy to comment, and it's really critical.

FLATOW: Thank you very much for taking time to talk with us.

Dr. TAYLOR: My pleasure, and thank you for having me.

FLATOW: You're welcome. Pat Taylor is the deputy general counsel and chief counsel for research affairs at Children's Hospital Boston, and professor at Harvard Med School.

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