From: Vera Hassner Sharav President, CIRCARE: Citizens for Responsible Care & Research, a Human Rights organization Tel. 212-595-8974 FAX: 212-595-9086 [EMAIL PROTECTED] FYI An essential ingredient for any oversight agency is independence. A boost in administrative status does not necessarily confer independence. We are concerned about unreported adverse incidents & widespread abuse of the dignitary rights of individual subjects --i.e., the right to be fully informed in writing of the known & potential risks prior to obtaining informed consent. Those concerns will be allayed when the new Office of Human Research Protections headed by Dr. Greg Koski demonstrates to the American public & the research community that those who violate ethical standards in research involving human beings--no matter how powerful the institution may be-- will be held accountable & will be penalized. ~~~~~~~~~~~~~ Science June 16, 2000 CLINICAL TRIALS: Harvard's Koski to Lead Human Subjects Office Eliot Marshall As Congress steps up oversight of human clinical trials, the Administration is getting a high-level manager of its own to watch out for the interests of volunteers in U.S.-financed research. As expected, Secretary of Health and Human Services (HHS) Donna Shalala last week named anesthesiologist E. Greg Koski, 50, to run a new HHS Office for Human Research Protections (Science, 26 May, p. 1315). One of Koski's first jobs when he takes over in September will be to conclude more than 170 pending investigations into alleged infractions of regulations governing human experimentation. Koski may also be swept into a debate on the adequacy of those regulations. Last week a bill, H.R. 4605, was introduced by Representatives Diana DeGette (D-CO), Henry Waxman (D-CA), and John Mica (R-FL) that would extend HHS's authority over patients in federally funded studies and certain private studies that are not now subject to federal monitoring. Arguing for a "comprehensive reform," the sponsors propose to bring all human research under a single standard, "independent of setting and funding source." They also would like to create a "nonprofit entity" to accredit the local Institutional Review Boards that examine and approve clinical trials. Koski, an M.D.-Ph.D. associate professor at Harvard Medical School in Boston, has spent 30 years in the Harvard community, most recently as director of human research affairs for Partners HealthCare System Inc., which oversees the Massachusetts General Hospital in Boston and other Harvard-affiliated hospitals. As chief U.S. protector of research subjects, Koski will report directly to the assistant secretary of health, Surgeon General David Satcher. An agency reorganization that created his job at HHS also created a 12-person advisory panel--not yet named--that will give outsiders a chance to drive policy from the back seat. Koski could not be reached for comment, but scientific leaders say they welcome him to Washington. Jordan Cohen, president of the Association of American Medical Colleges, said last week that Koski "is highly respected within the academic medical community and brings to the new office a strong track record in the area of human subject protections." The administration, he added, "is to be applauded for attracting a person of Dr. Koski's caliber." Cohen also supports H.R. 4605. But Vera Hassner Sharav, a leader of one of the patient advocacy groups that has faulted the government for weak enforcement of regulations, Citizens for Responsible Care and Research in New York City, offers a more wary endorsement of HHS's new scheme. Sharav says she is concerned that a boost in the status of the human subjects office, formerly headed by Gary Ellis, does not necessarily confer independence. "The new office," she says, "should be judged on its actions--on how vigorously and expeditiously it investigates allegations of research violations." _______ The Washington Post Tuesday, June 20, 2000 Head of Watchdog Agency Faces Questions By Rick Weiss and Deborah Nelson Washington Post Staff Writers Tuesday, June 20, 2000; A02 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," Secretary of Health and Human Services Donna E. Shalala said in announcing his position. Not said, however, was that the employees Koski is poised to supervise are already investigating a whistleblower'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 the University of Southern California 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 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. Most of the studies involved drawing blood from Chinese participants to search their DNA for genetic links to various diseases. The complaint alleged that the researchers and their sponsoring institutions did not adequately weigh, among other things, the risk that the Chinese government would discriminate against those participants found to have a genetic "defect." Koski chaired the Harvard-affiliated science and ethics oversight committee that was responsible for approving the China experiment repeatedly in annual reviews. An HHS official said Koski never "personally gave his approval" of the China study because a subcommittee handled those annual reviews--a delegation of authority the HHS official acknowledged may not have been "in full compliance" with federal regulations. A Brigham and Women's spokeswoman disagreed, saying Koski personally read and "ratified" the subcommittee's recommendations. In either case, both officials agreed, Koski was ultimately responsible for the China study's ongoing approval. The complaint was filed initially with the federal Office for Protection from Research Risks (OPRR)--the predecessor to Koski's new Office for Human Research Protections, which came into formal existence yesterday and has inherited the OPRR's investigative caseload. Sources said the investigation of the Harvard study could take months or even years to complete, because the office has a limited staff. A Harvard spokeswoman said an internal oversight committee visited China last April and found adequate protections in place to ensure that participants were well-informed about the study and that any genetic information about them would be kept confidential. The controversy comes at a time of heightened public and congressional interest in the protection of human subjects in medical experiments--interest that reached critical mass last September following the death of a mostly healthy teenage patient in a University of Pennsylvania gene therapy study. In April the HHS inspector general released a report concluding that the federal government had made "minimal progress" in the past two years toward implementing suitable protections for people in medical experiments. Three weeks later, Shalala introduced several initiatives to enhance protections for human research subjects. But the cornerstone of Shalala's plan has been the long-awaited upgrading of the OPRR--a relatively low-ranking office in the National Institutes of Health--to the newly renamed Office for Human Research Protections, which has the prestige of being located within Shalala's office. Koski was chosen to lead that office after a nationwide search and was hailed by department officials as someone who would reinvigorate federal patient protection programs. 2000 The Washington Post Company __________________________________ ____________________________________________________________________ Get free email and a permanent address at http://www.netaddress.com/?N=1 <A HREF="http://www.ctrl.org/">www.ctrl.org</A> DECLARATION & DISCLAIMER ========== CTRL is a discussion & informational exchange list. Proselytizing propagandic screeds are unwelcomed. Substance—not soap-boxing—please! 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