Ethical questions around human experiments was brought forcefully to the public last fall, with the death of Jesse Gelsinger, an 18-year-old who died while taking part in experimental gene therapy. If the public was unsettled by his death, the medical community was more so, and last week a group of nearly 700 researchers convened in Maryland to examine, as the conference was called, “Human Subject Protection and Financial Conflicts of Interest.” The final speaker at the conference and the nation’s chief official overseeing these experiments was commendably blunt in pointing out the shortcomings of the current protections.

Greg Koski, a cardiac anesthesiologist at Harvard University and Massachusetts General Hospital, will next month become the nation’s first director of the Office of Human Research Protection, but he hasn’t waited until receiving his title officially to discuss the issue with colleagues. “One may rightly conclude,” he said last week, “that our well-intentioned efforts to promote biomedical research, research from which all of society realizes benefit, have lead to the evolution of a system out of control, a system in which financial incentives have become the principle drivers and in which conflicts that may threaten the well-being of research subjects and the integrity of the science abound.”

In brief, Dr. Koski concludes, investigators who have a financial stake in the outcome of research should not be involved in conducting that research. This may sound like a commonsense guideline, but as universities and other major research institutions compete for the billions of dollars available to do cutting edge genetic research, conflicts – sometimes deep and alarming – are inevitable. One of Dr. Koski’s jobs will be to reduce or at the very least expose them.

He offered some sound ideas for to form a policy on what is likely to be a growing problem:

. Effective policies and management procedures should be established for all research sites and applied uniformly to all sponsors and investigators.

. Whenever possible, independent review committees established specifically to consider conflicts of interest should be the primary line to ensure that conflicts are minimized.

. Simple disclosure is not enough, openness is essential. If unavoidable conflicts remain, they should be justified and disclosed.

The very newness of many of the fields of genetic research currently being explored and the possibility of large paybacks for the researchers who get it right first make these guidelines an important part of the dialog around human gene therapy. They not only provide greater protections for patients/subjects, but help build public confidence in an area of medicine that holds the promise to improve or save countless lives in the coming decades.