RESEARCH INVOLVING PERSONS WITH MENTAL DISORDERS THAT MAY AFFECT DECISIONMAKING CAPACITY
DR. SHAPIRO: Let me just remind you of the steps. Jim will go over some of the recommendations that we approved yesterday. There are some that need to be changed from what are in the handout that we gave you before, and Jim will get to those, but most of them are as distributed.
But let me say the following regarding what your obligations are if you want to participate further in the finalizing of this report. One is that any textual comments that are outside the recommendations that you would like to see incorporated, examples, editorializing in any other way that you think is appropriate, that has to be in NBAC's offices no later than Monday morning. That's this coming Monday. I'm talking not about the recommendations now but about the changes in the text that you would like to see. And as I said before, we will certainly try very hard to accommodate that.
We will produce on the basis of those comments and those we receive during this meeting a clean text for the commissioners to consider in roughly two weeks. Then commissioners will have an opportunity, having seen a clear text with all the recommendations, etc., to decide if they wish to have any personal comments inserted in the report in cases where they differ in important ways with the recommendations we've approved or something else that you may object to in the report. But you will have really only a week following your receipt of this to submit those comments in writing to the staff, and we will incorporate them as they are submitted. Obviously, those are your comments and will not be altered in any way. And then we will go through the publication process.
So that takes us somewhere deep into December. I haven't made all the calculations, but it's roughly two weeks from Monday that you should receive the report, and three weeks from Monday we should be in receipt of any reaction you have if you wish to contribute anything further to it--again, we're not rewriting the report, I'm just saying if you feel importantly about something you want to be associated with, and then we will proceed to the publication itself.
PROF. CHARO: Question, Harold?
DR. SHAPIRO: Yes?
PROF. CHARO: Obviously, the recommendations and such are all on the public record, but the report is actually made to the President or to OSTP.
DR. SHAPIRO: NSTC.
PROF. CHARO: NSTC, thank you. I would just like to understand better how we describe it if we're asked about it, how free we should feel to write short pieces about the report in the near future if we're asked to by academic or semi-academic journals, etc.
DR. SHAPIRO: I think each commissioner will have to decide that for themselves. I think you can start writing things if you like, but I think we should really try to get the report published. That's not always been observed in this Commission, but I think it is preferable to get the report published. Now if there is some untoward delay, then we can review that issue. But if we can keep on this schedule, that means I'd prefer not to see things published before the report comes out so others have reasonable access to what it is you're talking about. It doesn't feel right to me the other way around. But if there is some unusual delay, then of course we can reconsider this. And I certainly do encourage commissioners to write about it or their reactions to it or whatever else they would like that they think is relevant. I think that informs the public debate and is a very positive thing.
So let me now turn directly to Jim. We are going to take about, we cannot afford a half an hour, that will be the outside maximum we're going to spend on this right now, because we do have to get to the comments on the President's letter and people are leaving at different spots almost minute by minute right now. Jim?
DR. CHILDRESS: After we met yesterday, Harold, Trish, and I spent some time going over what folks had proposed and that Eric and Emily had put down in text. We did discover in the materials that you have one major omission from 19 that Alta has worked on, and you'll be getting a revision in a few minutes or two of the pages or they will be made available overhead. There are three or four where there are wording changes that we need at least to look at and see whether they distort the meaning. We think they clarify the meaning and avoid misunderstandings, but we could be quite wrong about those. So we'll just go through them in order and note where changes have been made from what was discussed yesterday. Number One, no changes.
PROF. BACKLAR: Is it not possible to ask this one question before we start on this, Jim, about the legally authorized representative?
DR. SHAPIRO: We can't spend more than three to five minutes on it. I know it's important, Trish.
PROF. BACKLAR: All I'm asking, actually, Harold, is that we have Jack Schwartz clarify for certain commissioners that I've spoken to. As I understand it, an LAR may be appointed by a person who may become a potential subject, or an LAR may be in a sense imposed upon them by the researchers or someone else. Am I correct, Jack?
MR. SCHWARTZ: The recommendation reflects what I understood to be the following policy decisions by the Commission. First, a research subject who has the capacity to do so may, and indeed is encouraged to, designate his or her own LAR, and state law should reflect an entitlement to do so. But the recommendation goes on to recognize the fact, if clinical DPA is to be any guide, that relatively few research subjects will in fact designate their own LAR, and the recommendation goes on to answer what happens then if the subject does not designate an LAR. And the recommendation says the answer is to be found in state law, either state law that explicitly addresses research LARs or, in default of that, state law that addresses clinical LARs. That is the recommendation and I believe it reflects the prior decisions of the Commission.
DR. SHAPIRO: Thank you very much. That's very helpful. Thank you.
DR. CHILDRESS: All right, Recommendation 1. No changes were made from what we had talked about. Indeed, none were made, as I recall, during our discussion yesterday.
Recommendation 2, everything is the same until we get to the second page, the sentence beginning "RAPID panel...". That is a reduced version of what appeared on 129, so if you'll glance at that and make sure it represents the Commission's interpretation. It's to get away from the very wordy previous statement.
DR. SHAPIRO: That's the second-to-last paragraph on the second page.
DR. MIIKE: Just a comment: I recommend that we get rid of the word "RAPID." It sort of detracts from the seriousness of it all. We can still call the panel what it is but I would get rid of the word "RAPID."
The second part is that on the guidelines issue, the current guidelines are explicitly tied to the protocol-by-protocol approval. I think the panel should have more leeway; otherwise we're going to get into this delay about transferring responsibility back to the local IRBs. So I would like the Commission to consider that B section about guidelines, eliminating that thing based on protocol-by-protocol.
DR. SHAPIRO: Let me just refer back to the history of this without trying, again, to address this. The history of this was that we had, initially, "promulgating guidelines on the basis of protocol-by-protocol review or the development of new knowledge," or something like that so they could issue guidelines because new information from whatever source was available. There was some concern on the Commission that that was too broad. So I just reflect that. I don't have a strong feeling about it myself. I would be quite happy with adding the words "promulgating guidelines on the basis of protocol-by-protocol review or new knowledge development." But I just want the Commissioners to know. And if we took out "on the basis of protocol-by-protocol," that will of course include any reason that they would have. So let's just see if Commissioners want to restrict this or expand this. What is the sense? Bernie?
DR. LO: I agree with both of Larry's comments. Being more awake today, the RAPID acronym struck me as not being appropriate. And I actually would also agree with deleting from (b) on page 2 the "basis of protocol-by-protocol review." I would give this panel more discretion to base its guidelines on a whole variety of considerations.
DR. SHAPIRO: Let me try to settle it. We talked about this RAPID yesterday after the meeting. The reason we declined to change it was it would mean going into the text and changing lots of other things, because whatever else it may be or not be, it's a very convenient thing to use in the text. So if you will allow us to try to make that decision, we'll see--I don't mind whether we keep it or don't--but depending on how difficult it is to accommodate everywhere in the text, I wouldn't want to throw out that very useful--you may not like "RAPID," but it's a very useful thing to have an acronym to refer back to it. So why don't we just leave that particular thing to see if we can without too much effort change, but I'd like to leave that open.
On the basis of the second one, would it be satisfactory to those of you who want to go broader here to say "promulgating guidelines," as I said before, "on the basis of protocol-by-protocol review or new knowledge that would..."? On knowledge or protocol, do something like that? Alta?
PROF. CHARO: Personally, it's fine. I can't be sure that it's fine to every Commissioner who is not here. A simpler way to do it, actually, would simply be to delete the words "on the basis of protocol-by-protocol review."
DR. MIIKE: Yes.
PROF. CHARO: And in the text, when you finalize it this week, to mention that that along with new knowledge are the two bases that people expect will be used by the panel.
DR. SHAPIRO: Okay, why don't we do that? That's fine. Let's go on. That's a very helpful suggestion. Let's make a note and make sure that that gets added to the text. Very helpful. Thank you, Alta.
DR. CHILDRESS: And so the penultimate paragraph on that page, the one that begins "RAPID panel," I think we can in the text actually be able to use "review panel" and so forth to get away from "RAPID." That's my sense at this point but we'll check it out to make sure that captures in this abbreviated form what we had in the previous one. Any objection to that wording change? Okay.
Recommendation 3 remains the same. In Recommendation 4, and the original appears on page 133 in the text, there were two changes, let me just note: "a description of procedures designed to minimize risk to subjects," and then at the end of the second sentence, "to risk that may be inappropriate." That language replaces "similar risk."
DR. SHAPIRO: All right. Let's go on.
DR. CHILDRESS: Okay. Recommendation 5, no changes. Recommendation 6, the original is on page 137. Basically there was a feeling when Harold, Trish, and I went through this that the revision that we discussed yesterday and language to make it simpler probably went too far in this sense, that the decision to amend "subjects about their participation may not be overridden by any third party," because we do allow people to remove them from research protocols if they are being harmed. We thought the original language might be better in that regard, which looks more at the beginning of the participation rather than what happens within. That was the reason for that change. We just want to make sure that doesn't distort anything that the Commission agreed to.
PROF. CHARO: Jim, I want to simply say that the acceptance of this recommendation is conditional upon textual language that was offered yesterday. I want to make sure it's still there, to satisfy David Shore, that says that nothing in this recommendation is intended to supplant or overrule Federal regulations that allow for consent waivers under limited circumstances.
DR. CHILDRESS: Right. And that will be in the text.
PROF. CHARO: Right. Because it would appear to be....
DR. CHILDRESS: Thank you for implanting that now, though. Thank you. Anything else on Recommendation 6? Okay: Recommendation 7. Alex had objected to the language of "dissent." Upon further reflection, we thought that actually that probably was a good objection. He dissented to the language of "dissent" so we moved to "objection." We thought "objection" would capture everything without raising the larger question about whether the choice, which was other language being used, was autonomous or not. So that's the change. The other change that's present here is the use of language that [Frances Belet] suggested last week in Baltimore of rather than using "honor" or even "respect" to use the language of "heeded." And so those are the two changes in that particular recommendation. So it's from "dissent" to "objection" and from "respected" to "heeded."
DR. DUMAS: Where are you reading from?
DR. CHILDRESS: This is Recommendation 7. Any objection or dissent or whatever to this particular recommendation?
DR. MURRAY: What's the rationale for replacing "respect" with "heed"?
DR. CHILDRESS: Both "respect" and "honor" we tend to associate much more with respecting autonomous choices or honoring those.
DR. DUMAS: You might respect them but you might not do anything about it. "Heeded" implies that it's going to be a....
DR. CHILDRESS: We stop whatever we're doing with them is the logic of the point, yes.
DR. MURRAY: I worry that the word "heeded" might suggest the meaning that the people do not have full autonomy.
DR. CHILDRESS: I'm sorry?
DR. MURRAY: I just worry that the concept "heeded" here might actually diminish the respect for the important people who have diminished autonomy. I understand, I think, why the decision was made to introduce "heeded" instead of "respected," but I think it's a diminished form of acknowledgment of our respect for those persons. And I don't see any reason why we shouldn't continue to use the word "respect." I don't have a strong feeling about it. I just think it's less respectful, actually.
DR. CHILDRESS: How about both?
PROF. BACKLAR: Maybe one could say "respected and heeded."
DR. SHAPIRO: I actually far prefer "heeded." I think it's a very simple, straightforward idea: must be listened to, that's what "heeded" means. I think it's straightforward as it stands.
DR. MURRAY: Have a vote.
DR. SHAPIRO: All right. How many members would like to go with the word "heeded"? All right, "heeded" it is.
DR. CHILDRESS: Okay. Anything else about Recommendation 7 here? Recommendation 8 does involve a further attempt by the three of us who were working yesterday to capture what was involved in the discussion. Our attempt may not have succeeded. Please read this very carefully. It tries to build on both things--namely, identifying the independent qualified professional to do the assessment, but then also the protocol would not only describe who would do that but how the individual involved would do that, and then that would constitute one level; and then the IRB could permit investigators to use less formal procedures where the language of the seekers refers to both method and also the independent qualified professional and if there's good reason for doing so. So that was the attempt to capture what we talked about.
PROF. CHARO: Jim, I just want to make sure that in the text it's clear that the choice to use less formal procedures can include the choice to use no particular procedure but just to interact with these particular potential subjects the way you would with anybody else. For example, I would use bulimia as an example of a mental disorder where there seems to be no reason to assess capacity in any fashion, formal or informal, other than what we do every time a person is a potential subject. And, yes, I will write a sentence for you, Eric, to that point.
DR. MESLIN: Please.
DR. CHILDRESS: For these suggestions, please provide them if you would.
DR. MIIKE: A comment on the same line: perhaps instead of using "less formal," which is a little ambiguous, just say "alternative" procedures.
DR. CHILDRESS: Does everyone agree? Good. Very good. A small one.
DR. MURRAY: On the third line, the sentence beginning "The protocol should describe who will conduct the assessment," that's fine, "and how they propose to conduct it." That's kind of vague. In English, what do we mean by that? Should we say "the nature of that assessment;"
DR. CHILDRESS: That's fine.
MR. HOLTZMAN: Just a quick question, Jim, in terms of the independent. You may have discussed this yesterday. On page 153, in a lengthy footnote, we describe an ongoing assessment procedure that was used in a study and we sort of cite it as a good example. My question is, did it qualify as "independent" in a relevant sense? If we don't have time to talk about this, forget it.
DR. CHILDRESS: We did spend a fair amount of time talking about "independent" yesterday. But it's up to the chair.
MR. HOLTZMAN: That's okay.
DR. SHAPIRO: We'll take a look at it. I don't know.
DR. SCOTT-JONES: On the top of the next page, it says "if there are good reasons for doing so." We had a lot of discussion about saying "only if" and I thought we left "only" in. Was that wrong?
DR. CASSELL: I tried it with it and without it. The meaning is really the same.
DR. SHAPIRO: That's what I think.
DR. SCOTT-JONES: It is?
DR. SHAPIRO: That's what I believe. I'm totally neutral as to whether to put it in or out. It doesn't make any difference.
DR. SCOTT-JONES: It seems the difference is one of emphasis--whether you think it's going to be infrequent or quite frequent that there would be good reasons for doing it.
DR. SHAPIRO: All right, there's some disagreement here. How many of us would like to add the word "only" in here? Diane, I'm sorry.
DR. CHILDRESS: Okay with Recommendation 8, then? We turn to Recommendation 9 and here there is a correction.
DR. COX: I have a point on this thing we just went past. Just reading it, this is Recommendation 8, the second line down, it's really almost superfluous, the entire issue--to permit investigators to use alternative procedures to assess potential subjects' capacity if there's good reason for doing so. What we said up above is all we're asking is to say who is doing it and how they're doing it. I'm just trying to see what the extra content of that sentence is.
DR. MURRAY: But it may not be independent qualified professionals, for example.
DR. CHILDRESS: It may not be necessary.
DR. SCOTT-JONES: I would leave it out, too. I think when it had "only" in it, it tended to convey a different meaning. I think now it would be better to leave it out.
DR. CHILDRESS: Given the vote yesterday and what we have I guess to be cautious about, as the chair reminded us, is not to change the substance, as we did have kind of an approval process yesterday.
DR. COX: So I'm trying not to change the substance.
DR. CHILDRESS: And the question being whether, and this may be a recommendation, as Eric Meslin suggested, maybe go back to "less formal," not the most desirable formulation, but it at least indicates some kind of alternative that's being pursued relative to what was presented in the protocol.
DR. COX: I think we need to leave the sentence in, because otherwise....
DR. LO: I think we need to leave it in.
DR. CHILDRESS: But then I would suggest we just go back to "less formal."
DR. COX: Not ideal.
DR. CHILDRESS: Everyone has a new text at number 9. So if you will look at what you just received, a line had been omitted. So what you have in your version before you was not correct. But what you have now is correct. Let's see, the term "heeded" is used, but otherwise it's pretty much the same as it was.
DR. DUMAS: The term "as always" seems to me to be superfluous.
DR. CHILDRESS: How do you feel, remove "always"? All in favor of removing "as always"? Okay, looks like it carries. Now we need to move to an overhead because of one omission from this. Oh, I'm sorry, you do have it in your revised version. So look at what you just received, the update, on number 10. The difference from what you had a few minutes ago is that we had omitted (a). Okay. Does this capture everything that we wanted to say in 10? No problem with 10. Okay: Recommendation 11. There were no changes made beyond the addition of number 7. Anything on 11? On Recommendation 12, we need just to look to make sure we got the language right under (d), "is approved on the condition of its approval by the RAPID panel." I think that's the only change there. That was one we've made only one change on. What I was doing on those that we went through yesterday is just pointing to the changes. Anyone want more time or discussion of any part of 12? Recommendation 13 we discussed quite a bit yesterday, and we hope we got the change right: "authorization," on line 2, "to a particular class of research." And everything else remains. We got rid of "no general" and the changes that people had proposed. Yes, Diane?
DR. SCOTT-JONES: I have one change, and this is something that we agreed to do throughout, and that is to use the word "potential" whenever we use "benefits": "potential benefits." Recommendation 13. Line 2, line 3.
DR. CHILDRESS: That's fine.
DR. LO: If we do that, why don't we just say "potential benefits" and leave out the "direct and indirect;"
DR. SCOTT-JONES: Yes, leave out "direct and indirect."
DR. CHILDRESS: And then, just for purposes of this particular one, not worry about "direct and indirect"?
DR. SCOTT-JONES: Right.
DR. MESLIN: So just delete "direct," delete "indirect," and put "potential."
MR. HOLTZMAN: I wouldn't suggest that.
DR. CHILDRESS: In the text we go ahead and talk about all of those.
MR. HOLTZMAN: You could just say "potential direct and indirect benefits."
DR. DUMAS: Well, if you say "potential benefits," that takes in all kinds of benefits, doesn't it?
MR. HOLTZMAN: Yes, it does, except we go to great lengths elsewhere to make sure that we distinguish for these folks "direct" versus "indirect" so we don't have therapeutic misconceptions.
DR. CHILDRESS: We do emphasize in the text the importance of the distinction.
DR. DUMAS: Okay.
DR. CHILDRESS: So we'll go that direction, if everyone agrees?
DR. DUMAS: Okay.
MR. HOLTZMAN: So "potential direct and indirect benefits."
DR. CHILDRESS: "Potential direct and indirect benefits." Okay, anything else on 13 you want to talk about? Recommendation 14. We made in the first line a parenthetical addition: "within the limits set by the other recommendations," and in (a), "would have chosen" rather than "would have done." I think those are the only changes in 14.
DR. MURRAY: What about the "best interest"?
DR. CHILDRESS: We were talking about it in the text but not in the recommendation.
DR. MURRAY: I thought we decided yesterday to bring it up into the recommendation itself because there will be times when you just won't know what the subject wanted, and to give guidance to LARs about what standard they're to use. That was my recollection.
DR. CHILDRESS: Was someone delegated to provide language for us on that? We never received anything.
DR. MESLIN: No, I don't believe so.
DR. CHILDRESS: We can certainly go back and do that.
DR. MURRAY: I have a clear recollection we agreed that would be included in some notion. The issue is, if you don't have a clear read on what the person would have wanted you to do, then the thing you fall back on is the "best interest." We mention that expressly in the text that explicates this recommendation.
DR. CHILDRESS: One reason there's been a lot of resistance to go in that direction is that we've gone much more than the prospective authorization route here, and that even in cases where the LAR is enrolling someone in research we have stressed the way in which that should be tied to what the person would have wanted. One risk in going the direction you're going, though one can certainly make the case, perhaps, for some forms of research that involve greater than minimal risk with potential direct benefits, is that when we bring that under the therapeutic model. And so that's where the "best interest" standard would really fit. There's a lot of complicated stuff at work here. I don't have strong feelings about it, but I think if you do work it into the text of the recommendation it will have to be done very, very carefully.
DR. CASSELL: It would be awful hard to do that.
DR. MURRAY: Anyway, I remember the discussion very clearly from yesterday. I made this point. I've given my text over to Eric so I don't have my original text anymore. But in the bottom, in the explication of this recommendation, we say if there isn't a clear indication of the subject's wishes, the prospective subject's wishes, then the LAR may decide based on the judgment of the prospective subject's best interest. We said that. I don't have--fine. But we did say that very clearly.
DR. DUMAS: I don't understand how what you're saying is different from what's in (a) under 14: "The LAR bases the decision...".
DR. MURRAY: That's the so-called "substituted judgment" standard. That is, we try to figure out what the subject, if the person could have spoken for himself or herself, what he or she would have said. But there are some times we don't know that. When we don't know the answer to that, we move to a "best interest" standard. We say that in the material in which we discuss the recommendation. But I'm not going to waste people's time on this.
DR. CHILDRESS: Well, the problem with doing it in 14 in this way is that we have to be very clear about the research to which it's restricted. For example, in greater than minimal risk research, we have worked with prospective authorization where there's no potential direct medical benefit. I would just worry that without a great deal of care on this that we in effect will go back and we'll have some problems with what has been previously accepted as the structure.
DR. MURRAY: This will be inconsistent with the decision we reached yesterday, though.
DR. CHILDRESS: That could well be true on the basis of the discussion yesterday. The question, Harold, is whether we incorporate a "best interest" statement.
DR. SHAPIRO: I understand that, and Tom is right to point out the text where it describes that down below. I thought our decision was that there were more problems with changing it and incorporating it than leaving it.
DR. MURRAY: That may have been the decision in the revising of it. It was not what we decided in the discussions yesterday. But as I said, I'm not going to push it.
DR. CHILDRESS: We didn't have any textual things to work with on this, and so if it was the agreement as approved, it had certainly slipped from our consciousness in working on it because we had no text to work with. So, I don't know.
DR. CASSELL: You can do it by just putting, after the semicolon, "or an estimation of the best interest of the subject."
DR. DUMAS: Well, I thought it wasn't going to be right. I think if this is really unacceptable to the group, then I think we need to change it. But it's okay with me and I don't know how other people feel about it. I'm worried that we are beginning to rewrite the recommendations.
DR. CHILDRESS: Well, Tom is making the point that we agreed on this yesterday. And I'm sorry, I don't have a good recollection of exactly where we ended up on that.
DR. SHAPIRO: Well, let's leave it this way. We will have the transcript of yesterday's meeting before long. If it is agreed to there, we will change it to incorporate it. That seems to be a fair way to do it.
DR. MURRAY: That's fine with me.
DR. SHAPIRO: If it's in the transcript, we'll do it.
DR. CHILDRESS: And we will have to then circulate the set of recommendations to make sure of what is said here, then, and that if we include "best interest" it won't create problems for the other recommendations, some of which are tightly drawn in relation to prospective authorization. Anything else about 14? Okay. On Recommendation 15, which we discussed quite a bit yesterday, we need to determine whether it was a recommendation or guidance. This has been rewritten. Some of us are not happy with "incorporate" but didn't have a good alternative in the second line. But this is an effort to capture the discussion yesterday and then to move us to the point of deciding whether we want to keep it as a recommendation or put it in guidance.
DR. SHAPIRO: Let's just focus on that actual decision. I think this fairly represents what a lot of people were dealing with yesterday. We have two choices. I think it's in the wrong spot in the recommendations, but we need to either keep it as a recommendation--number X or whatever, we don't have to decide that now--or put it in the guidance. I think the people who felt most strongly about this were in favor of keeping it in the recommendations. But I think we just need to decide. We can put it in either section from my perspective. So let's just ask how many members of the Commission would like to keep this as a recommendation in the appropriate spot? Clearly, that's what we're going to do. Thank you.
DR. CHILDRESS: Anything about the wording you want to focus on?
DR. MURRAY: "Incorporate" isn't the right word, but it is hard to think of just what the best word is.
DR. CHILDRESS: We'll leave it open to a good editorial suggestion. If someone can come up on the plane with a....
DR. MURRAY: The other thing would be "rules about medical confidentiality." Should we say "respect for medical confidentiality"?
DR. CHILDRESS: How about "consistent with respect for the subject's autonomy and for medical confidentiality." Is that okay?
DR. MURRAY: Sure.
DR. SCOTT-JONES: And may I suggest "maintain" instead of "incorporate" ongoing communication? That's better, "maintain."
DR. DUMAS: That was the original language.
DR. CHILDRESS: That may have started it, though.
DR. LO: It was the allegation that researchers....
MS. KRAMER: "Establish"?
DR. SHAPIRO: Let's just put it this way. There might be better phrases in here, and if you have them, let us know, and if they don't change the meaning of this we will incorporate them. Because I'm a little bit afraid of doing it here on the fly with so little time.
DR. CHILDRESS: All right, 16 and 17 we went over yesterday. We'll do 16 first. It's exactly, I think, the same as yesterday. Any comments about 16? Okay, now 17 has been--and there should be a comma before "if" in the first line--this has been reworded. We ran it by Jack and this rewording, which seems a little clearer, doesn't distort what he had tried to capture in it. Any concerns about 17? Okay, 18. We revised this, as I recall, in response to direction the Commission had proposed. So we have a much fuller statement about what's involved in the educational materials and their purpose. Any comments here? Anything you want to say, Rhetaugh?
DR. DUMAS: I like it.
DR. CHILDRESS: Okay. Any other comments? We'll turn to 19. Here you need to look at the new one you received, because we had omitted some material inadvertently from that. So turn to the one you just received. We probably haven't proofed it very carefully because the material was added. But if you will look at that and read that carefully to make sure this captures....
DR. MESLIN: The omission was simply moving from the former Recommendation number 2, the "RAPID panels," and research activities, to this section. That's the addition.
DR. CHILDRESS: And, of course, it had to be reworded when (c) and (d) were brought over.
DR. DUMAS: Looks okay to me.
MR. HOLTZMAN: Why the choice of the word "comprehensive" in the second line?
DR. CASSELL: Change it to "best."
DR. DUMAS: "Best."
DR. CHILDRESS: Any objection to that? Anything else in this recommendation? Steve, were you raising your hand?
MR. HOLTZMAN: No, just reading.
DR. CHILDRESS: Okay.
DR. BRITO: The following sentence is just very wordy; I just thought we could tighten it up.
DR. DUMAS: How is that different from polishing the sentences?
[Tape changed; portion lost.]