meetings

DR. WAGNER:  Our next session is on protection of private and public genomic databases.  And if Dr. Chahine and -- Drs. Chahine and Rodriguez would come forward.  Wonderful.

                             We'll be hearing first from Dr. Ken Chahine.  He is the senior vice president of Ancestry.com, well known online resource for family history and general manager for Ancestry DNA where he leads the development and commercialization of population genetics at the website which is the same name, AncestryDNA.com. 

DR. GUTMANN:  Good morning, everybody.  I'm Amy Gutmann.  I'm president of the University of Pennsylvania and chair of the Presidential Commission for the Study of Bioethical Issues.  On behalf of my vice chair Jim Wagner who is president of Emory University and myself I welcome you all to this our tenth meeting.

                             Before we continue and in order for us to continue officially I want to recognize our designated federal officer, Dr. Lisa Lee.  Lisa, would you please stand up?  Lisa is the executive director of our Commission.  Thank you.

               DR. GUTMANN:  Thank you all for giving us such stimulating presentations.  And this is an opportunity for us to pick your brains one more time, and it's become a tradition to begin with a question of asking you to pinpoint one single issue that you think is most important, but I want to refine that question somewhat in light of your excellent presentations.

                             DR. WAGNER:  Gentlemen, welcome. To our panelists, we have been eager ‑‑ I was going to say "agonizing" (laughter) ‑‑ but we have been eager to have more facts, more information, and to zero-in on what is the key information needed for decision-making regarding pediatric medical countermeasures research.  And we are hoping these speakers are going to help inch us ‑‑ in fact, feel free to move more than inch ‑‑ in this conversation, gentlemen.

DR. GUTMANN:  I am going to get started because we have a wonderful guest.

                             Please take seats.

                             Our next session will focus on national-level review of certain types of pediatric research.  Initially contemplated in the late 1970s by one of our predecessor bioethics commissions, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, this type of national-level review is also codified in federal regulations.

DR. GUTMANN:  Welcome back, everyone.  If you would please take a seat we will get started.  This is the beginning of a series of sessions in which we as members of the Commission will discuss in real potential form possible draft -- well, these are draft recommendations and we'll discuss them as a Commission. 

DR. WAGNER:  But don't go anywhere. No, please don't go anywhere.  In fact, what we want to do is invite back now all of our other morning's guests and speakers, if they would join us.  And I think we've got name tags up here to remind you who you are.

DR. GUTMANN:  Commission members, please be seated.  Welcome back, everybody.  We are about to welcome Dr. Bartha Knoppers.  And Dr. Knoppers will speak with us about consent and return of research results.

                             Dr. Knoppers is the director of the Center of Genomics and Policy at McGill University in Canada.  She has served as the chair of the International Ethics Committee of the Human Genome Organization and as a member of the UNESCO International Bioethics Committee which drafted the Universal Declaration on the Human Genome and Human Rights. 

DR. GUTMANN:  Okay.  We are going to jump right into our first session.

                             So, yesterday we began with some of our recommendations and had a very, I thought, productive discussion of them.  Today we are going to continue with them.

                             They clump into two big categories.  One is consent to hold genome sequencing and to the possible findings and how they will be treated, and the other is oversight of them.