RESEARCH: Koski Takes Tough Stance on Ethical Practices
Dr. Greg Koski, director-designate of the Office for Human Research Protections, said yesterday at a conference on conflicts of interest in medical research that "he would use the information from the conference ... to start developing a new conflict-of-interest policy by the government" and impose "necessary" restrictions on researchers, the New York Times reports. Koski, the chief federal official overseeing the safety and ethics of human subject experiments, concluded at the conference that "the system may have gotten entirely out of control" and that "we must take steps to reestablish the public's trust in the goodness of our endeavors." The New York Times describes Koski's words as "particularly significant" because patient advocacy groups expected Koski "to take a softer line" than his predecessor, Gary Ellis, who was removed from office after terminating "human experimentation programs" at several major universities and medical centers for alleged violations of federal ethics rules. However, his speech yesterday indicated that he may crack down on ethics violations even more than Ellis had. Koski said he expects more than "mere compliance with the current standards," urging researchers to work at "the highest standard of ethical responsibility." Specifically, he advised that researchers refrain from conducting studies on products of companies in which they own stock (a practice currently allowed), and to avoid situations in which they "stand to profit if the tested product proves successful." Such practices, he said, show a lack of regard for patients. Koski praised the American Society of Gene Therapy for its new policy that researchers not be significantly financially involved with companies sponsoring their studies and urged other academic and industry research centers to follow in their footsteps (Hilts, 8/17).
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