MEDICAL TRIALS: Panel Criticizes Human Safety Standards
The 17-year-old guidelines that regulate human safety in medical experimentation are outdated and do not adequately assure that patients are well-informed and protected from risks, a panel of experts report in today's Journal of the American Medical Association (12/9). The Human Research Ethics Group, based at the University of Pennsylvania, also concludes that institutional review boards are generally "undertrained, overburdened and swamped with paperwork," and thus limited in their ability to ensure "sound execution" of the research conducted at their medical centers. The panel offers the following suggestions for a system-wide overhaul of the medical review process:
- Patient-focused information: The role of the patient consent form should be refocused on informing the patient, rather than protecting researchers from liability. The panel advocates "clear language that discourages unrealistic expectations in research," and also indicates the need to create provisions for "special" consent protocols in the case of cognitively or otherwise impaired patients.
- Improved Institutional Review Board (IRB) monitoring: Bureaucratic responsibilities should be streamlined, so that IRBs can concentrate on monitoring "the actual conduct of research," and protocols for multisite research should be re-evaluated. IRBs must also be alert to potential conflicts of interest among researchers.
- Increased federal oversight of private research: Federal restrictions on research methodology, currently applicable only toward government-funded research, must be extended to include sensitive research funded by pharmaceuticals and other for- profits (Moreno et al., JAMA, 12/9 issue).