DR. HAROLD T. SHAPIRO: Thank you all for coming here today. As you know, we have an extremely full agenda today, including the final drafting of our capacity report. In addition our agenda is, as you know, further and important discussion regarding human biological materials in research. However, there has been a particular development during this last week that occasioned a letter to me from the President asking us to take on another issue. One is very short-term, one somewhat longer-term, which we'll have to leave some time for discussion for also and that will occur at roughly 1:00 today. So at roughly 1:00, we will turn to the issue. This, of course, arises from the very well publicized and reported incidents not incidents, research results regarding stem cells and so on that we reported last week in just about all of the newspapers. And I just want to read the letter that I received from the President so that you'll know what the task is in front of us this afternoon. The letter is as follows: "Dear Dr. Shapiro," and so on ... "this week's report of the creation of an embryonic stem cell that is part human and part cow raises the most serious of ethical, medical and legal concerns. I am deeply troubled by this news of experiments involving the mingling of human and non-human species and am therefore requesting that the National Bioethics Advisory Commission consider the implications of such research at your meeting next week and report back to me as soon as possible. I recognize, however, that other kinds of stem cell research raise very different ethical issues while promising very significant medical benefits. Four years ago I issued a ban on the use of federal funds to create human embryos solely for research purposes. The ban was later broadened by Congress, which will prohibit any embryo research in the public sector. At that time, the benefits of human cell research were hypothetical, while the ethical concerns were immediate. Although the ethical issues have not diminished, it now appears that this research may have real potential for treating such devastating illnesses as cancer, heart disease, diabetes and Parkinson's disease. With this in mind, I am also requesting the Commission undertake a thorough review of the issues associated with such human stem cell research balancing all ethical and medical considerations. I look forward to receiving your report on these important issues."

What this request means for us is two things. One, in the very short term, today and tomorrow, we have to mobilize ourselves so I can write a letter to the President responding to the first aspect of what he raised here, that is, he referred to the embryonic stem cell, part human/part cow and so on the first part of that letter. That needs some type of immediate response from us. My proposal is that we, as I said before, turn to that at 1:00. We will try to have some briefing, perhaps by phone, from at least one scientist who is not on the Commission; we have some excellent scientists in this area and on the Commission. Then we will go to our own questions and try to evolve a I don't know if you want to call it a position at least a response. And then we will do some drafting of an actual response overnight in some way and then come back tomorrow and probably very quickly I hope by that time quickly approve it, because we don't have a lot of time for discussion here. I'd like to issue that response, as the President requested, as soon as possible.

There will then be a second part to our work. And although there is no deadline in this request, my ongoing assumption is that we should try to mobilize ourselves and give a response to the second issue within about six months. It is a very complex, extremely important issue. Some of you have served on panels that dealt with very similar issues before. But there's a lot more known now; there's a lot more to discuss than there was in 1994. For example, I think that was the year of the embryo panel in the Circuit Court. So we will have to think carefully about how we will mobilize ourselves for that effort how we will use other resources besides those sitting around this table and so on and so forth. But that we have a few days or weeks to do; we don't have to do that in the next day or so. So we will return to this overall issue later on this morning excuse me, early on this afternoon. This morning our primary and critical job is to finish our discussion regarding what we have shorthand referred to as a Capacity Report. That has to be accomplished between now and 11:30. This will be our final discussion on this report. I will take public testimony at 11:30.

Let me just indicate how I would propose we deal with the Capacity Report this morning. We will focus, as we did last time, only on Chapter 5, which are the recommendations themselves. And we will indeed focus only, so to speak, on the boldface recommendations that are there. Most of these we've already approved and are unchanged from when we did them, or at least, in some sense, only editorially changed. Some, however, reflect some considerable change because of the interaction that's taken place among us in the last month and because of the various public comments that we received regarding people's views of these particular items. In addition to which some members of the Commission Jim and I think Trish had an extensive set of discussions regarding Eric, well, a bunch of you were there and that has occasioned some better focus on some of these recommendations. I'll turn to Jim to present those. I don't think that they are in any way different than what was intended in the current one, which is the question of getting the language a little more accurate. So I don't think those will develop any problems. So I'm going to begin in just a moment, just to go through these one by one. Those of you who have editorial suggestions of which there have to be many because I have many regarding any part of this text, either in Chapter 5 or in the earlier chapters, please get those to us within the next three days. If we get them within the next three days in writing, then there's a very good chance they will be incorporated in the final text. We have tried to be as responsive as possible to the many thoughtful inputs that we have received from commissioners, and obviously you won't find your comments reflected in every case because obviously we all didn't have quite the same idea. But I think we made every attempt to be as responsive as possible. Now we will, of course, allow for if any commissioner feels well, let me just talk directly about differences that may be avoidable, where people just might disagree. We will adopt these recommendations by majority vote as we did last time. If anyone feels sufficiently strongly that they wish to have some type of statement added to the report that expresses their particular different perspective on an issue, they are, of course, welcome to do that within the same three- or four-day deadline. Now the benefits of this report obviously, this is an advisory report. A lot depends on how persuasive the report is. And while consensus is not the highest order of the day because we don't want to just keep changing things until we have consensus, there is some advantage to being together on an issue regarding the persuasiveness of the report. And so while you are certainly welcome to have statements included as your own thoughts and consciences dictate, I ask you to think carefully about it because it would be very unfortunate if the report, as I do not expect, would be littered with such comments. I think neither their comments nor our recommendations would be as effective. But that's something each of you can decide on your own and handle whatever way you like. So before I begin turning to the recommendations themselves, let me see if Jim has anything he would like to add.

DR. JAMES F. CHILDRESS: Just a warm thank you for all of you who participated in helping to revise and sharpen the recommendations, as well as the text itself. And so many contributed to that. I would like to single out just a couple of things that I thought were particularly important. Without slighting anyone's contribution, I thought the effort by Alta and Alex, among others, to get it together I thought that really helped move us forward. Then, the reordering of the recommendations, I thought and I think Alta and Eric and others were involved in that I thought that that helped a lot. And Kathy Hanna's role as an editor has been extremely vital. The discussion that several of us had in a public context with patients, subjects, families and researchers over the weekend did help us see when people were taking our report very seriously and they were areas where there were a few things to be sharpened and clarified, so a few points could come out of that discussion later.

DR. SHAPIRO: Thank you. Eric, do you have anything to add about this report itself right now?

DR. ERIC M. MESLIN: No, just to emphasize that written comments are far preferable to verbal ones. If you have marked up copies, commissioners, hand them to one of the staff who are here. It is much easier than trying to track it down later. We will be putting copies of the recommendations up on transparency for those who are here to help facilitate the discussion a little more. Plus there are some supplemental transparencies, all of which can be made available in hard copy to the public if they wish.

DR. SHAPIRO: Thank you very much. I think the reality is that whatever we receive in writing will be seriously incorporated if at all possible. What we receive as advice is likely to be forgotten, not because of any meanness of spirit, but just by the pressing time that we have to get this all accomplished. So let's just proceed directly to the first recommendation. I think we all have the same draft. In any case, it's on page 125 and we can put it up as a transparency just so members of the audience can see it. You're quite far back I don't know if it's going to help or not. I hope you have good eyesight.