Regulation of Genetic Testing

Aug 31, 2009

National Academy of Sciences

The National Research Council and Institute of Medicine held a symposium to explore the health, policy, and ethical implications of direct-to-consumer genetic testing. In the second of four parts, participants focused on regulation of genetic and genome testing. Among the issues they addressed were monitoring and oversight of laboratory and .. Read More
The National Research Council and Institute of Medicine held a symposium to explore the health, policy, and ethical implications of direct-to-consumer genetic testing. In the second of four parts, participants focused on regulation of genetic and genome testing. Among the issues they addressed were monitoring and oversight of laboratory and direct-to-consumer procedures, possible roles for federal and state agencies in regulating testing, quality assurance methods, and providing room for future market growth. They also responded to questions from the audience.

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TRANSCRIPT

TIME SPEAKER TEXT
00:00:39 Anderson, FrederickAttorney
00:02:30 Ferreira-Gonzalez, AndreaDirector
00:19:57 Aitman, TimothyProfessor
00:42:40 Q&A
00:42:50 Anderson, FrederickAttorney
00:44:19 Aitman, TimothyProfessor
00:45:28 Khoury, MuinDirector
00:47:03 Aitman, TimothyProfessor
00:50:00 Korn, DavidVice Provost
00:50:42 Ferreira-Gonzalez, AndreaDirector
00:53:21 Bierer, BarbaraSenior Vice President
00:53:38 Ferreira-Gonzalez, AndreaDirector
00:55:47 Anderson, FrederickAttorney
00:57:57 Lee, Sandra Soo-JinSenior Research Scholar
00:58:30 Ferreira-Gonzalez, AndreaDirector
00:59:23 Becker, K. DavidChief Science Officer
01:01:06 Aitman, TimothyProfessor
01:02:27 Ganz, PatriciaVice Chair
01:03:39 Korn, DavidVice Provost
01:06:01 Anderson, FrederickAttorney
01:06:51 Khoury, MuinDirector
01:12:24 Aitman, TimothyProfessor AND THEY EITHER DO OR DON'T TAKE THE ADVICE AND THAT'S NOT GOING TO PARTICULARLY HELP. IT COULD EVEN...
01:15:34 Anderson, FrederickAttorney HE HAVE EFFCASIOUS. I WOULDN'T WANT TO PREDICT WHEN. WE'RE GOING TO MOVE ON AT THIS POINT BEFORE WE...
01:16:20 Kutz, Gregory D.Managing Director GREG? OKAY. THANK YOU VERY MUCH FOR INVITING ME TODAY. I THINK THIS IS GOING TO BE A LITTLE DIFFERENT...
01:26:01 Anderson, FrederickAttorney THAT WAS NEVER OUR INTENT. BUT AGAIN, IT WAS TO HOPEFULLY INFORM AND I HOPE IT HELPED INFORM YOUR...
01:26:34 Lee, Sandra Soo-JinSenior Research Scholar CENTER OF BIOMEDICAL ETHICS. OKAY. CAN YOU HEAR ME? YES. ALL RIGHT. FIRST I'D LIKE TO THANK THE ORGANIZERS...
01:44:31 Anderson, FrederickAttorney ELSE THAT'S RECREATIONAL. THOSE KINDS OF BOUNDARIES DO NOT SERVE US WELL IN THE REGULATORY OVERSIGHT...
01:45:02 Q&A FROM STANFORD, I STARTED TO THINK ONLY IN CALIFORNIA BUT ON THE OTHER HAND THIS IS A GLOBAL PHENOMENON...
01:46:44 Levin, ElissaCounselor TOWARDS IN THE AFTERNOON. BUT I HAVE TO SAY THAT AS YOU -- ONE OF THE THINGS THAT WE CONSTANTLY HEAR...
01:47:24 Lee, Sandra Soo-JinSenior Research Scholar BE ABLE TO BETTER LEARN HOW TO REFINE ALL OF THESE RISK ASSOCIATIONS, WHETHER IT BE FOR ANCESTRAL...
01:48:22 Anderson, FrederickAttorney WE HAVE THREE OR FOUR PEOPLE WHO ARE LOOKING TO SPEAK. TRISHA AND DAVID AND SOMEONE STANDING BACK...
01:48:34 Korn, DavidVice Provost TO SPEAK? [LAUGHTER] AND LET ME -- DAVID, I THINK -- HE'S VERY EAGER TO SPEAK. I'M VERY INTERESTED...
01:50:13 Khoury, MuinDirector KNOWING IT, LET ALONE CONSENTING TO IT AND I'M WONDERING IF ANYBODY IS THINKING ABOUT THAT. I'M GLAD...
01:52:31 Lee, Sandra Soo-JinSenior Research Scholar AROUND SAME GENETIC TRAITS AND WE CREATE, YOU KNOW, NEW RACIAL ETHNIC OR OTHER ETHIC CLASSIFICATION...
01:53:18 Ganz, PatriciaVice Chair SUDDEN THAT CHALLENGES HOW THEY SEE THEMSELVES AND SO I THINK IT'S IMPORTANT TO DO EMPIRICAL WORK...
01:55:28 Q&A ON ONE HAND, THE MEDICAL COMMUNITY IS BEING CUT OUT AND UNWILLING -- POTENTIALLY UNWILLING MEMBERS...
01:56:11 Lee, Sandra Soo-JinSenior Research Scholar COMMUNICATING BETWEEN THE MOLECULAR BIOLOGISTS AND GENOMISTS. IT HAS BECOME VERY, VERY HARD TO COMMUNICATE...
01:59:40 Anderson, FrederickAttorney VERY EASY TO DO. SO I JUST WANTED TO BRING THAT POINT UP WHICH I THINK YOUR TALK RAISED. I'D LIKE...
02:02:38 Lee, Sandra Soo-JinSenior Research Scholar TO PRECLUDE AN INDIVIDUAL'S PARTICIPATION IN ONE OF THE EXERCISES THAT SANDRA DESCRIBED? I MEAN, THAT...
02:03:44 Woodward, ScottDirector THAT'S ONE OF THEIR INDIVIDUAL RIGHTS? HAVE YOU HEARD OF ANY INSTANCES OF THIS OR ANYONE? I HAVEN'T....
02:04:30 Bierer, BarbaraSenior Vice President BECAUSE THEY FELT IT WAS UP TO THE INDIVIDUAL TO MAKE THAT DECISION IN THESE CASES. BUT THIS ISwac...
02:05:14 Anderson, FrederickAttorney DOESN'T ADDRESS IT. SO THIS IS SOMETHING THAT I THINK WE HAVE TO TAKE ON PROACTIVELY AS AN ISSUE WELL...
02:06:25 Aitman, TimothyProfessor OR A MUST -- MUST WAIT UNTIL THEY'RE AT AN AGE OF CONSENT. AND THAT ITSELF IS A PROTECTION WE WOULD...
02:09:45 Levin, ElissaCounselor MIND. I HAVE TWO COMMENTS. THE FIRST IS AROUND THE TESTING OF MINORS. I THINK ONE OF THE THINGS THAT...
02:12:14 Anderson, FrederickAttorney THAT MEANS FOR YOUR CHILDREN. IT REALLY DOES BECOME MORE OF THAT INDIVIDUAL NEEDS TO TEST THEMSELVES...
02:13:34 Korn, DavidVice Provost CAN I ASK ONE QUESTION AND MAKE ONE COMMENT? COMMENT IS AKIN TO OTHERS THAT I'VE MADE THAT MY UNDERSTANDING...
02:15:13 Aitman, TimothyProfessor BE FOUND IN MY KIN IS THAT THE CODE -- COSEGREGATION OR WHAT IS IT -- IS IT LIKELY THAT THE ARRAY...
02:16:24 Moreno, Jonathan D.Professor SNIPS IN THE FIRST PLACE THEN YOU COULDN'T IDENTIFY THEM IN THE DATABASE. BUT IF YOU HAVE A SMALL...
02:17:04 Bierer, BarbaraSenior Vice President GIVEN THE FACT THAT THEY ARE COMMITTING A LOT OF DATA THAT ISN'T GOING TO BE COMMITTED BY THEIR ENTITIES....
02:17:18 Kutz, Gregory D.Managing Director TO BE MADE THAT THEY SHOULD. WE CAN'T LEAVE THIS SESSION WITHOUT KNOWING WHAT'S HAPPENED SINCE 2006...
02:19:00 Aitman, TimothyProfessor TAKE THESE YOU REDUCE YOUR RISK OF GETTING CANCER AND THESE OTHER TYPES OF CONDITIONS. THE FEDERAL...
02:19:32 Ferreira-Gonzalez, AndreaDirector BY ONE OF THE GENE WATCH UK, AND AS A RESULT OF THAT, THE COMPANY DECIDED TO STOP MARKETING THAT PARTICULAR...
02:19:49 Q&A CONCERN ABOUT THE TESTING IN WHERE THERE ARE REGULATION LIKE THE FDA AND FTC THAT THEY NEED TO STEP...
02:20:57 Anderson, FrederickAttorney I'M FINDING MORE THAT ARE EMERGING, BUT JUST AS A NOTE OFF OF THAT.

NOTE: The transcript for this program was compiled from uncorrected Closed Captioning.

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PEOPLE GRID LIST

  • Aitman, Timothy
  • Lee, Sandra Soo-Jin
  • Ferreira-Gonzalez, Andrea
  • Kutz, Gregory D.
  • Anderson, Frederick
  • Khoury, Muin
  • Korn, David
  • Ganz, Patricia
  • Levin, Elissa
  • Becker, K. David
  • Bierer, Barbara
  • Woodward, Scott
  • Moreno, Jonathan D.

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