For Immediate Release     April 13, 2000

Contact: Elizabeth Dooley Ph. 414/278-1341

American Society of Gene Therapy establishes ethical policy to guide clinical trials

MILWAUKEE-The Board of Directors of the American Society of Gene Therapy (ASGT) has approved a policy for ethical standards involving gene therapy clinical studies. The policy, which was developed by the Ethics Committee of ASGT, will help ensure the safety of all patients participating in gene transfer studies and that researchers involved in clinical studies are free from financial conflicts of interest. Members of the Society have been notified of the new policy.

According to ASGT president, Savio L. C. Woo, Ph.D., "This policy is a significant step forward in addressing the safety and interests of the many patients who volunteer in such trials. Patients should know that investigators have their best interest in mind, are practicing in an objective manner and are not in any way influenced by financial incentives."

Potential conflicts of interest may arise in the course of all clinical research, including gene therapy. In principle, the ethical standards for clinical research in gene therapy should be the same as those demanded in all areas of medicine. Therapeutic agents used in clinical trials are often produced by for-profit companies, which can give rise to circumstances that present a financial conflict of interest to the investigators. An extreme case would be that a clinical reagent, be it a small molecule, a protein or a gene transfer vector, that is manufactured by a company wholly or partly owned by the Principal Investigator conducting the clinical trial. The guiding principle is clear: clinical investigators must be able to design and carry out clinical research studies in an objective and unbiased manner, free from conflicts caused by significant financial involvement with the commercial sponsors of the study.

Clinical trials are often sponsored by industry, where legitimate costs in conducting the research are covered. The Regulations on Objectivity in Research and the Investigator Financial Disclosure Policy adopted by the National Institutes of Health and the National Science Foundation on July 3, 1996 have established that: "Investigators are required to disclose to the institution a listing of Significant Financial Interests (and those of his/her spouse and dependent children) that would reasonably appear to be affected by the research proposed for funding by the Public Health Services. The institution will review those disclosures and determine whether any of the reported financial interests could directly and significantly affect the design, conduct, or reporting of the research and if so, the institution must report the existence of such conflicting interests to the PHS Awarding Component and act to protect PHS-funded research from bias due to the conflict of interest." The same documents also established significant financial interests as equity ownership in companies exceeding 5%, and/or aggregate payments received from companies in excess of $10,000/year. Academic institutions have also established policies governing investigators' financial conflicts of interest that are consistent with these federal regulations.

The American Society of Gene Therapy is not a regulatory body and it should beware of becoming one. However, in order to pursue its mission to promote gene therapy research and development, the following is the statement approved by the Board of Directors: "In Gene Therapy trials, as in all other clinical trials, the best interest of the patients must be always primary. International, national and institutional guidelines on standards of care must be rigorously followed, approved protocols strictly adhered to, serious adverse events promptly reported to all appropriate regulatory and review bodies. Relevant federally and institutionally established regulations and guidelines in financial conflicts must also be abided by. In addition, all 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 trial. The American Society of Gene Therapy requests its members to abstain from or to discontinue any arrangement that is not consonant with this policy."

Gene therapy is a revolutionary approach to fight and prevent disease. The ASGT is the largest medical professional organization representing researchers and scientists dedicated to discovering new gene therapies. ASGT was established in 1996, and has grown to more than 2,000 members. It is committed to promoting and fostering the exchange and dissemination of information and ideas related to gene therapy, to encouraging the general field of research involving gene therapy and to promoting professional and public education in all areas of gene therapy.

Editor's Note: The Policy of the American Society of Gene Therapy on Financial Conflict of Interest in Clinical Research can be viewed on the society's Web site at www.asgt.org/policy .

 ###