National Bioethics Advisory Commission
Thursday, September 18, 1997
9000 Rockville Pike Building 31 6th Floor, Conference Room 10 Bethesda, Maryland 20892
Eberlin Reporting Service
14208 Piccadilly Road Silver Spring, Maryland 20906
I N D E X
Update and Overview James Childress 1
The Importance of Placebo-Controlled (or Other Difference-Showing) Trials Robert Temple 10
Public Testimony on the Issue of the Cognitively Impaired as Research Subjects 54
Discussion: Protecting Cognitively Impaired Research Subjects 203
Report on Survey of Federal Agencies 270
Public Testimony on the Issue of the Cognitively Impaired as Research Subjects
DR. CHILDRESS: Thank you again. All right.
We turn now to our public hearing which is an indispensable part of our effort to chart our course, our direction or a report on decision impaired research subjects and possible guidelines or special protections for those subjects.
Several people have already indicated, and their names appear on the sheet, that they would like to present in this period. If there are others who wanted to present on this particular topic, that is decision impaired research subjects, do — I guess Pat Norris is at the desk? Pat Norris is here. — do indicate to her that you would like to so we can try to be aware of the time as we are moving along to be sure we get everyone in.
We will have subsequent public testimony on other topics relating to research involving human subjects. Today we are looking only at decisionally impaired research subjects.
We are grateful to those who have responded and their names appear on the list. We will go down the list in alphabetical order but we are treating the discussion of the New York case, T.D., as a separate matter and will hear from the different parties involved in that later this morning.
We are also grateful for the written testimony that several of you have provided. Several of you are planning to testify orally today, as well as others who could not testify and who also submitted written testimony.
We will ask each person, and we have indicated this in advance, to restrict his or her initial comments to five minutes and given the fact that we have already lost a lot of time and out of fairness and equity to others who will be wanting to speak I will try to be a stronger chair and enforce that.
We will want to have an opportunity to ask questions so it is really important to stick to the five minute limit so we will have a chance to engage you in discussion because there will be things that we would like to raise with you to again help us think through this project.
All right. If we are going now alphabetically is Mr. Robert Aller here?
All right. Thank you for joining us.
Note: Only portions of this NBAC transcript are available here. For a full version of this document in pdf format go to: http://bioethics.georgetown.edu/nbac/transcripts/sep97/human.pdf.