Report Cites Concerns About Safety, Ethics;
Calls for Oversight of Inheritable Genetic Research

Should researchers be allowed to test genetic therapies that might eventually rid a family of an inherited disease, or even change the way one's children might look, or how well they perform in school or in sports? The answer for now is a resounding "no," according to a report issued this week by AAAS.

"Human trials of inheritable genetic changes should not be initiated until techniques are developed that meet agreed upon standards for safety and efficacy," according to the authors of the report, Human Inheritable Genetic Modifications: Assessing Scientific, Ethical, Religious, and Policy Issues. The report also concludes that "IGM cannot presently be carried out safely and responsibly on human beings," and that ethical concerns about IGM have not yet been adequately addressed.

To address these and other concerns, the report recommends the immediate creation of an independent body to monitor and oversee research into human inheritable genetic modification (IGM), and warns that even now, genetic damage could result inadvertently from somatic cell therapies, which target nonreproductive cells and are intended to treat only the individual affected by the disease.

Citing the public "furor" that accompanied the release of news that somatic cell nuclear transfer technology had created a cloned sheep — and could make possible the cloning of human beings — the report notes the importance of public discussion about IGM, in advance of major technical innovations.

"It is important to plan ahead, to decide whether and how to proceed with its development, and to give direction to this technology through rigorous analysis and public dialogue," the report said.

The AAAS report was prepared by a working group, composed of scientists, lawyers, ethicists and representatives from several religious faiths, who considered the issues over a two-and-a-half year period. The study was funded by the Greenwall Foundation.

According to Mark S. Frankel, director of AAAS's Scientific Freedom, Responsibility and Law Program and co-author of the report, technical obstacles in applying current gene transfer methods raise concerns about the safety and efficacy of such genetic interventions, and will continue to do so in the foreseeable future. "The report recommends that human trials of inheritable genetic changes should not be initiated until reliable techniques for gene correction or replacement are developed that meet agreed upon standards for safety and efficacy," said Frankel, who co-authored the report with Audrey R.Chapman, director of AAAS's Science and Human Rights and its Program of Dialogue on Science, Ethics, and Religion

Chapman notes that serious ethical and religious issues were addressed by the group in the course of their work. "IGM for enhancement, meaning applications to produce improvements in human form or function, would be particularly problematic," said Chapman, who co-authored the report. "Even if the techniques are intended only for therapy and not for enhancement purposes, it would be very difficult to draw the line."

The IGM report is available on the AAAS Science and Policy Programs Web site.