In response to suggestions from an external committee charged with evaluating clinical trials at the Institute for Human Gene Therapy, the University has rethought the way such trials are carried out and drastically reduced the IHGT's scope.
The committee was formed by President after the FDA put clinical trials at the IHGT on hold, following the death of an 18-year-old enrolled in one trial.
The measures taken by the University are certainly correct, but it is just as certain that these are measures that should have been in place from the beginning.
Virtually all involved now acknowledge that the University should have had regulated the human trials conducted at the institute more carefully.
The committee's report notes myriad concerns involved in conducting such trials, ranging from the sheer novelty of the field of gene therapy to the potential for conflicts of interest to large financial requirements.
While the University had begun making changes to its regulatory systems before the FDA's report, such changes should have been in place before any human research was carried out. Despite the great benefits gene therapy may hold, the utmost care must be exercised when dealing with human lives.
The issuing of committee's report also offers the opportunity for the University to review its overall research culture, to determine whether there is something inherent in the way research is conducted at the University that allowed for the work to go on with so little supervision.
As the report points out, "a culture that is both collegial and critical is essential" for conducting research. Researchers need the opportunity to have their work evaluated by knowledgeable outsiders who can check their claims and point out what may have been missed. The review of research by peers is just as essential to proper science as is institutional supervision.Comments powered by Disqus
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