After heading efforts to beef up patient safety in clinical trials for 2 years, the director of the federal Office for Human Research Protections (OHRP) is returning to academia in December. Greg Koski, a Harvard University anesthesiologist, came in to head the newly promoted OHRP within the Department of Health and Human Services (HHS) after a death in a gene therapy trial brought increased scrutiny of patient safety in research.
Since Koski's arrival, OHRP has cracked down on several institutions for violating patient safety protections and has cleared a backlog of investigations. Koski also developed what he calls a "proactive, performance-based system" for helping institutions do a better job. The idea is to have institutions grade themselves on their patient protections programs, just as factories strive to achieve gold stars for quality control, Koski says. A report earlier this month from the Institute of Medicine helps complete the "road map" on where to go next, he notes, partly by calling for voluntary accreditation of human subjects protection programs.
University of Kansas bioethicist Mary Faith Marshall calls the quality-assurance program "fantastic" and says Koski was a "tireless ambassador," traveling the country to win over "the hearts of many people in the research community" with his message of "shared goals." Some patient advocates, however, are pushing for mandatory standards instead of the voluntary approach that Koski has supported.
Koski, who will serve through the end of November, insists that his departure "is not a political decision in any way" and notes that he was on a 2-year leave from Harvard in Massachusetts, where his family still lives. However, some observers suggest that a lack of support at HHS might have helped speed his return to academe. Recently, HHS abruptly decided to let the charter of OHRP's advisory committee lapse, a decision that Marshall, the panel's chair, says "shocked and dismayed" members and surprised Koski as well. HHS is now reforming the group and is said to be expanding its charter to include protection of fetuses and embryos, in line with the antiabortion views of the Bush Administration.