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US government calls for tighter regulation of clinical trials

Deborah Josefson, San Francisco

The US Department of Health and Human Services is calling for tighter regulation of clinical trials.

The current system is outdated and unwieldy and leaves hundreds of thousands of research participants inadequately protected, according to the department in a recent report. In a meeting with a congressional subcommittee, George Grob, deputy inspector general for evaluations and inspections, said: "The long established system for protecting human research subjects has vulnerabilities that threaten its effectiveness. This is the time for reform."

One concern is that the institutional review boards--the committees that oversee and approve experiments--are too overworked to do a competent job and often lack expertise in the areas that they are supervising.

The review boards were federally mandated in 1974, in the wake of the infamous Tuskegee experiments, to assist the Food and Drug Administration and the National Institutes of Health in ensuring the safety and the ethical protection of experimental subjects. The boards are instrumental in educating study participants about the risks and benefits of participating in a study. But technology has advanced beyond the knowledge of many supervising committees, and it has also been difficult to recruit dedicated and knowledgeable members, as traditionally they are unpaid.

Moreover, when the system was devised, most clinical research took place at universities and hospitals, and oversight was thus centralised. With research now frequently taking place in large trials in a variety of settings, such as clinics, health maintenance organisations, hospitals, and industry, it is more difficult to monitor and control.

The report by the Department of Health and Human Services also found that competition for research money may compromise the protection of patients. It also criticised the recruitment of experimental subjects through newspaper and subway advertisements. These advertisements typically play down the risks of being in an experiment and emphasise the potential benefits, such as free health check ups. Participants may not appreciate that their health is not the primary concern of the investigators and that they might be in a placebo group. Many potential participants therefore do not give true "informed consent."

The report called for greater governmental oversight of the review boards, with the appointment of independent, non-
institutional monitoring committees to review the safety of experimental treatments.
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