Gene Therapy: Are Patients Any Safer? : Hearing Before the Subcommittee on Public Health of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Sixth Congress, Second Session ... May 25, 2000, Volume 4 |
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adenoviral adverse event reporting agencies ASGT Bill Frist Bioethics Biotechnology CF Foundation Chairman civil monetary penalties clinical gene transfer clinical investigators clinical research compliance conduct conflict of interest Director disease DNA Advisory Committee DSMB ensure patient safety ethical FDA and NIH FDA's Federal gene therapy clinical gene therapy product gene therapy research gene therapy trials gene transfer research gene transfer trials Health and Human Human Gene Therapy human gene transfer human research subjects human subjects protection informed consent initiative inspection Institutional Review Board issues Jesse Gelsinger Johns Hopkins Johns Hopkins Hospital Murray NIH and FDA NIH Guidelines NIH's OPRR patient protection Ph.D Pilaro potential Preclinical protocols Raub Recombinant DNA Advisory recommendations regulations regulatory reporting requirements response risks Senator DODD Senator FRIST Senator KENNEDY serious adverse events Skirboll Society of Gene Subcommittee Thank therapy clinical trials tion vectors Zeitlin Zoon
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Page 8 - ... 1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental; 2.
Page 1 - COMMITTEE ON LABOR AND HUMAN RESOURCES, Washington, DC. The Committee met, pursuant to notice, at 9:38 am, in room SD-430, Dirksen Senate Office Building, Senator Edward M.
Page 39 - . . . investigators and team members directly responsible for patient selection, the informed consent process and/or clinical management in a trial must not have equity, stock options or comparable arrangements in companies sponsoring the...
Page 37 - Medicine at the Mount Sinai School of Medicine in New York City.
Page 67 - If you have further questions, please let us know. Sincerely, Melinda K. Plaisier Associate Commissioner for Legislation Enclosure cc: The Honorable Edward M.
Page 14 - Guidelines in light of advances in the knowledge about the science and safety of gene transfer research. It conducts public review and discussion of the scientific, safety, and ethical issues of novel gene transfer protocols. It explores in-depth complex scientific and ethical issues raised by the continuing progress of the research by convening Gene Therapy Policy Conferences, which can also yield important consensus recommendations that guide the field.
Page 5 - CENTER FOR BIOLOGICS EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATION, BETHESDA, MD Mr.
Page 1 - ... SUBCOMMITTEE ON PUBLIC HEALTH, OF THE COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS, Washington, DC.
Page 1 - Genetic Therapy Apparently Cures 2," The Washington Post Al (April 28, 2000). 6 Testimony of Bill Frist United States Senator Tennessee Before the Senate Committee on Health, Education, Labor and Pensions Subcommittee on Public Health, Gene Therapy: Is there Oversight for Patient Safety?
Page 35 - Institute for Gene Therapy and Molecular Medicine Mount Sinai School of Medicine New York...