Republished by the LSU Medical Reseach Law Project

EXECUTIVE DIRECTOR’S REPORT

DR. MESLIN: Thanks very much. I’ll be very brief—I’m trying to make sure that the microphones are on and the folks in the audience hear us. Thanks, I’ll use Dr. Ellis as the test subject. I only have a very few brief remarks. One is to ensure that those who are here obtain copies of some additional handouts that we have provided. There are a number of materials that came in after we were able to put our two reports on the web site and circulate them to Commissioners. Those materials are on the table for Commissioners and are available for the public members of the audience who are here. Those items include, but are not limited to, the following. The first is a comprehensive analysis of the public comments that we received for our report on persons with mental disorders that affect decisionmaking capacity. There’s a memo and 16 pages of the text, much of which Commissioners have already seen but the bulk of those comments that arise have now been analyzed. We will obviously be able to refer to those comments for our discussion tomorrow. In addition, there is a very important supplemental memo for Commissioners and others regarding the report, the capacity report. This is a memo that Dr. Shapiro, Dr. Childress, and I have put together over the last few days. A memo that draws to Commissioners’ attention some unfortunate omissions in the text of the capacity report, which we wanted the Commissioners to have in their hands. You may want to refer to it over the course of today and this evening so that you are up to date in our discussion tomorrow. And thirdly, there is a paper from Professor Gunsalus, an earlier version of which had been sent to Commissioners. We wanted to not burden your briefing books with those additional papers. Professor Gunsalus will be here this afternoon to discuss her commissioned paper, and it is available for Commissioners now as well as the public. We do not expect every one to be able to read it thoroughly between now and the time she arrives. Apologies for coming when it did but Commissioners have seen the earlier draft and you will have an opportunity to discuss this with Professor Gunsalus this afternoon during that portion of our agenda. The last item that I would like to raise concerns meetings. The public in attendance here knows that we have had a regular schedule of meetings on a bimonthly basis. The Commission has decided to add an additional meeting next month on October the 20th. It will be held here in the Washington D.C. area. We will have the particulars of the location, etc. for the public as well as the Commissioners later on today. The express purpose of that meeting on the 20th of October will, we hope, be to finalize the report on research involving persons with mental disorders that may affect decisionmaking capacity and we hope that it will be an opportunity to begin an important discussion with Federal agency representatives that have been involved in our previous survey. If that meeting schedule is successful, we have also determined that it would be possible, if the Commission felt it necessary, to meet via teleconference in December, if necessary, should the Commission feel that they are in the same position to finalize the report on research use of human biological materials. So I’m simply indicating that staff has investigated the availability of the use of a teleconference mechanism which would be that not all of our Commissioners would physically have to be in the room. The public would be invited to the room where the Commission meeting would take place and we would ensure, hopefully, the highest quality telecommunications teleconference ability. We do not have a date. We have not established that as a meeting. I’m simply indicating it for the public record that that is a possibility should the Commission decide that it would wish to meet in December to finalize that report. That’s all I have for the moment. Mr. Chairman.