Washington Editor

WASHINGTON - A government advisory panel said that broader federal oversight of both publicly and privately funded clinical trials could help prevent deaths and injuries sometimes associated with poorly run biologics and drug studies.

The Institute of Medicine (IOM) of the National Academies early this month released a report, "Responsible Research," calling on Congress to require all human research organizations to abide by federal protections laws. The report, submitted to the Department of Health and Human Services, was commissioned following the 1999 death of Jesse Gelsinger, an 18-year-old patient participating in a gene therapy study at the University of Pennsylvania.

As the law stands now, most researchers must abide by either the Common Rule (a set of principles designed to protect research participants in federally funded studies) or by FDA guidelines. However, some private research exists that does not fall under either set of guidelines and to that, the IOM recommends universal standards under the authority of its newly termed group called the "Human Research Participant Protection Program" (HRPPP). For example, the program would require ethics education and a "transparency," that is, open communication between researchers, investigators and stakeholders.

The Gelsinger case, and later the death of 24-year-old Ellen Roche, a healthy volunteer participating in an asthma trial at Johns Hopkins University, brought to light the growing problems faced by research centers, such as conflicts of interest, inadequate monitoring and oversight and insufficient communication with participants, the report observes.

"In the last 24 months we've seen a dramatic increase in the number of complaints against investigators and against ethical review boards. There have been a lot of reports that have come out from a variety of different agencies looking at the way IRBs [institutional review boards] operate and the sense that they are operating over capacity," Kenneth Getz, CEO of Boston-based CenterWatch, a publishing company that focuses on clinical trials, told BioWorld Today. "You've had a lot of traffic accidents that have occurred because of protocol, noncompliance, potential conflicts of interest - there's just so many things that have happened that have made the regulation of clinical research and the safe and ethical treatment of human subjects a focal point for policymakers, researchers, health providers and even the public."

Chief among the issues within the IOM report is the expanding responsibilities of institutional review boards. "As the demands on the research oversight system have grown, so has the reliance on IRBs to accomplish all protection tasks," Getz said. "This is a disservice to research participants, because IRBs find it exceedingly difficult to both manage the increasing volume of protocol actions and to ensure the safety of research volunteers."

The authors of the report said IRBs should return to the focused role they were originally intended to serve - reviewing the ethical issues of proposed protocols - because the boards do not necessarily have the expertise, authority or resources to handle all of the additional tasks. Organizational responsibilities such as compliance issues should be assigned to other boards or units that likely already exist. (The committee also recommends changing the IRB name to Research Ethics Review Board or Research ERB.)

Furthermore, the IOM suggests that informed consent should be a series of conversations between the participant and enrollment staff, as well as in written form. However, the writing should not be "obscured by language designed mainly to insulate the institution from liability."

Getz said the report does a good job of recommending sweeping changes that target a number of key areas, including better communication with potential volunteers. "There's also more discussion and debate that needs to take place," he said. "Some of these recommendations are very insightful, but we really need to understand the impact, from a financial and practical standpoint, that these changes might have on the development of medical interventions and scientific innovation."

Among the recommendations is a suggestion that research organizations compensate trial participants who are injured as a direct result of the research. Compensation should include at least the costs of medical care and rehabilitation, the report said.

Also, the report includes a recommendation to establish a centralized, comprehensive clinical trials registry giving patients and their health care providers information about ongoing trials.