Federal Official Returns To HMS

The director of the federal office that protects human research subjects announced last week that he will resign from his government position and return to the faculty of Harvard Medical School (HMS) and staff of Mass. General Hospital (MGH).

Greg Koski ’71 will return at the end of November to a faculty position as a professor of anesthesiology through MGH, an HMS-affiliated teaching hospital.

Two years ago, Koski was appointed the first director of the Office for Human Research Protections (OHRP), which was created within the federal Department of Health and Human Services in response to growing governmental concerns about the safety of human research subjects—concerns underscored by the death of a participant in a gene therapy study at the University of Pennsylvania.

Under Koski’s leadership, the OHRP commissioned a study by the Institute of Medicine to assess the current systems for protecting human research subjects and to make recommendations for improvements. Koski cited the completion of that report as motivation in his decision to step down.

“The past two years of public service have placed heavy burdens on my family, and I believe that having this report in hand affords an opportune and appropriate time for me to pass the baton to the next director of the Office for Human Research Protections,” Koski wrote in an Oct. 9 letter to Secretary of Health and Human Services Tommy Thompson.

Koski could not be reached for further comment.

In his letter, Koski outlined the accomplishments made during his tenure and said that he believes that, for personal reasons, the time is right for him to step down.

“We have conveyed to all in a clear, strong and consistent voice, a philosophy that to preserve public trust in research, the scientific community must go beyond a culture of compliance—it must strive for a culture of conscience—one in which we do the right thing not because we are required to, but because it is the right thing to do, a refrain now echoed frequently throughout the research community,” Koski wrote in his letter to Thompson.

Vera Hassner Sharav, the president and founder of the Alliance for Human Research Protection (AHRP), gave Koski credit for his willingness to hear differing points of view in his role at OHRP. AHRP is a non-profit group that works to raise public awareness about the use of human subjects in research.

“He tried to reach out to all the warring parties—not equally, certainly, but at least he tried to include the voice of dissidents such as myself. But he tried to be liked by everyone, and you can’t do that in such a tough job,” Sharav said.

“His leaving the post is unfortunate because the work has just begun,” she said.

Many areas of concern have still not been addressed, due in part to resistance from the research community, according to Sharav.

She said a lack of consistent requirements, of enforcement of these regulations and of a system of informed consent are the biggest problems facing scientific researchers and their use of human subjects.

But Sharav said that Koski did make some real progress during his tenure.

“More responsible members of the research community have come to the conclusion which we said in 1997 and Dr. Koski said when he took the position in 2000—that the system in fact is totally and completely dysfunctional and in need of overhaul,” she said.

Before taking on the leadership of the OHRP, Koski spent 30 years at Harvard and was involved in research, teaching and patient care. In 1989 he joined the Subcommittee on Human Studies at MGH and he later served as director of Human Research Affairs at Partners HealthCare, an organization which oversees major Boston-area hospitals including MGH and Brigham and Women’s Hospital.

His role as director of the OHRP gave Koski the opportunity to advocate for the rights of human research subjects on a national level.

Upon his return to Boston in November, Koski will serve as a full-time cardiac anesthesiologist at MGH.

Warren Zapol, chief of anesthesia and critical care at MGH and Koski’s department head, said he expects Koski will also take on administrative work in the future, while continuing to advocate for patients’ rights.

“I’m delighted to have him back. He’s a wonderful physician,” Zapol said.