Apparent Conflict Snares Watchdog Agency Director

The new director of the federal government’s lead watchdog agency for human medical experiments is himself embroiled in an ongoing investigation by that agency into a gene study that he supervised in his previous job.

Harvard professor Greg Koski was tapped two weeks ago to lead the Office for Human Research Protections, the agency the Clinton administration recently renamed, revamped and relocated to a top spot in the Department of Health and Human Services.

Until the new appointment, Koski was director of human research affairs at Partners HealthCare System Inc. in Boston, where he oversaw the protection of research volunteers in experiments carried out by a consortium of Harvard-affiliated hospitals.

“Greg Koski is the right person with the right experience at the right time to take on this challenge,” HHS Secretary Donna Shalala said in announcing his position.

Not said, however, was that the employees Koski is poised to supervise are already investigating a whistle-blower’s complaint about the adequacy of patient protection in a gene study by Brigham and Women’s Hospital, one of the consortium of hospitals in his charge.

An HHS spokesman called the apparent conflict of interest “routine” and said the new director would recuse himself from overseeing the agency’s Harvard investigation.

But patient protection experts inside and outside the government criticized that approach as inadequate because Koski still would oversee the investigative staff and have authority over staff members’ careers.

“It would certainly seem a smart thing for a person like Greg Koski not to walk into a situation where, if the outcome of the investigation is to exonerate Harvard, then you have people saying, ‘Well, of course. What else could those employees have done? Are they going to turn in their boss?’ ” said Alex Capron, a professor of law and medicine at USC and a member of the National Bioethics Advisory Commission.

“In ethics, what is so very important is not only the absence of a conflict but the absence of a perception of a conflict,” Capron said. “It’s an issue that anyone coming into the job has to be sensitive to, and if I were Greg Koski I wouldn’t want to get off on the wrong foot.”

Critics called for the Harvard investigation to be handed over to the independent HHS office of the inspector general.

Koski was not available for comment.

Formal complaints of patient abuses in medical research are relatively rare. The current investigation stems from a former Harvard faculty member’s complaint last September alleging regulatory violations in several related genetic studies in China run by Harvard researchers through various institutions, including Brigham and Women’s.