Policy/Position Statement

ASGT Position Statement on Informed Consent
August 2008

The American Society of gene Therapy (ASGT) is dedicated to the understanding, development and application of gene and related cell and nucleic acid therapies. In their work, ASGT members have an ethical obligation to promote high standards of patient safety and autonomy.

Any communication by investigators conducting clinical trials should reflect genuine concern for the safety of subjects and should be open, honest, and understandable. Information about the clinical procedure, short and long-term follow-up testing and procedures, anticipated risks and benefits (including adverse effects in preclinical studies), commercial interests involved with the trial, and the importance of patient choice, should be directly addressed.

ASGT members conducting clinical trials are expected to abide by applicable regulations in the states and countries where trials take place. In the United States, that includes conformance with relevant provisions of Titles 21 and 45 of the Code of Federal Regulations. As thinking on informed consent is an evolving area, ASGT members should consider current information on the content and conduct of the consent process. In conducting informed consent, members should also consider the ethical issues related to the treatment of genetic diseases and the consent of special populations, including the enrollment of children in clinical trials.

Consistent with the mission of ASGT to promote education among professionals and the public about gene therapy, the ASGT will provide introductory information on the ASGT website regarding conduct of clinical trials and informed consent.