IOM Report Offers Recommendations To Improve Oversight of Clinical Trials
Federal regulators need to improve oversight of public and private clinical trials involving human participants, according to an Institute of Medicine report released yesterday, the Wall Street Journal reports. The report, which was commissioned by HHS after the 1999 death of gene therapy trial subject Jesse Gelsinger, says that federal patient protection standards should apply to all research on human subjects, not just subjects participating in federally funded studies. The IOM also recommends establishing a compensation system for participants injured during a study and an independent federal body to oversee patient protections during such trials. In addition, the report says that consent forms given to human trial participants should focus primarily on communicating risks associated with studies and says that informed consent should be "an ongoing process" (Lueck, Wall Street Journal, 10/4). The report also recommends that the National Library of Medicine's registry of publicly funded clinical studies be expanded to include private trials (Schmid, AP/Contra Costa Times, 10/4). Dr. Daniel Federman, a Harvard Medical School dean and head of the IOM committee that produced the report, said that currently the United States does not keep track of how many human research trials are conducted each year, how many people participate in such studies or how many deaths or illnesses occur during the trials (Bor, Baltimore Sun, 10/4).
The IOM also recommends that institutional review boards, which are currently "strained by too many responsibilities," should focus only on ethical reviews and not on scientific issues or potential conflicts of interest (Wall Street Journal, 10/4). "There is no single cause for the errors and mishaps that unfortunately have resulted in the deaths of some research participants in recent years," Federman said, adding, "Rather a combination of stresses, weaknesses and lack of accountability have strained the current hodgepodge of protections to the point that fundamental changes are needed to protect all participants and keep public trust from being irrevocably eroded" (AP/Contra Costa Times, 10/4). The report also recommends that Congress pass a law requiring all research -- federally and privately funded -- to abide by the Common Rule, a set of patient-protection principles that currently only govern federal trials. Sen. Edward Kennedy (D-Mass.) yesterday introduced a bill that includes changes to standards for human trials similar to those recommended in the report, but Congress will likely not address the issue until next year, the Journal reports (Wall Street Journal, 10/4).
Some critics of the IOM report said the committee failed to address what they say is "the fundamental conflict of interest inherent" in medical research -- that universities and hospitals establish committees to review their own experiments. Although the report suggested that universities and hospitals conduct separate reviews on ethics and patient safety, conflict of interest and scientific merit, the proposed changes "did not satisfy some longtime observers" of the system. Vera Hassner Sharav, president of the Alliance for Human Research Protection, said, "The IOM committee, headed by a Harvard University dean, disingenuously recommended entrusting the responsibility of ensuring that protective rules are followed to the leadership of the organization doing the study. That is an example of conflicts of interest." George Annas, chair of the health law department at the Boston University School of Public Health, said that "a lot more reform" than what the report suggested is needed to improve human research trials. However, Dr. Michael Kagel, who oversees institutional review boards at Johns Hopkins University, said the recommendations outlined in the report were "reasonable," adding that a board of outside reviewers "may not understand the special needs and concerns of the community where the research is done" (Kranish/Dembner, Boston Globe, 10/4).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.