ASGCT Press Release

Statement from the ASGT President in Response to Announcement from the Department of Health and Human Services

Milwaukee, WI - The American Society of Gene Therapy (ASGT) applauds the efforts of the Department of Health and Human Services to strengthen protection of human research subjects in all clinical trials, including those involving gene transfer. When it comes to protecting patient safety in clinical trials, the ASGT firmly believes that the same set of high standards should be applied in all fields of medicine. The Society's reactions to the five initiatives described in Secretary Shalala's statement on May 23,2000 are the following:

EDUCATION AND TRAINING. The ASGT embraces this initiative, which is very much in line with the ASGT intention of providing intensive training courses for clinical investigators and their team members conducting clinical gene transfer studies. Making the receiving of federally sponsored training program being a pre-requisite to receiving NIH clinical research grant awards and of the OPRR assurance process will ensure a high success rate of educating the clinical investigators.

INFORMED CONSENT. The ASGT supports the notion that the NIH and FDA will issue specific guidance on informed consent, which will help to achieve a certain level of uniformity between different institutions in ensuring patient's awareness of the research nature and potential risks in the clinical studies that they are volunteering for.

IMPROVED MONITORING. The ASGT supports improved monitoring of all clinical trials including those involving gene transfer. While independent monitoring in large trials (Phase III) that enroll many patients should be the responsibility of the Data and Safety Monitoring Boards, it is important for a simpler but sound process be identified to monitor pilot-scale Phase I/II trials sponsored by physicain investigators, such that the objective of ensuring patient safety can be achieved without incurring excessive costs that will stifle academic research. In addition to the requirement of including such monitoring plans at the time of NIH grant submission, it should also cover non-NIH funded clinical trials conducted in instituions that receive HHS funding.

CONFLICT OF INTEREST. The ASGT has recently adopted a policy on this issue and all members have been notified of it. The policy calls for investigators and team members directly involved for patient selection, the informed consent process and/or clinical management in a trial not to have equity, stock options or comparable arrangements in companies sponsoring the trial. We look forward to working with the NIH to further develop federal guidelines on financial conflict of interest.

CIVIL MONETARY PENALTIES. The ASGT has taken the position that investigators and their institutions be held accountable for willful non-compliance of federal regulations and guidelines in the conduct of clinical research involving patients.

The American Society of Gene & Cell Therapy (ASGCT) is a professional non-profit medical and scientific organization dedicated to the understanding, development and application of genetic and cellular therapies and the promotion of professional and public education in the field. For more information on ASGCT, visit its website, www.asgct.org.

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