CLINICAL STUDIES: Ethical Dilemmas ‘Surprisingly Common’

      The "unprecedented" federal directive last week to end clinical and animal research at the West Los Angeles Veterans Affairs Medical Center points to deeper ethical problems with clinical studies that appear to be "surprisingly common," the Los Angeles Times reports. The most common deficiencies are informed-consent documents that "overstate the potential benefits of studies -- and understate the potential risks." The article cites ample evidence of widespread shortcomings:

• A 1997 FDA analysis of 194 hospital ethics review committees found that 38% had "deficiencies" in informed consent procedures.
• Between 1980 and 1995, the FDA issued 84 enforcement letters to drug researchers, and the GAO identified "serious misconduct" in an analysis of 69 of those notices.
• An NIH-sponsored survey of 632 researchers showed they spent on average only 30 minutes explaining research to prospective subjects, with a third of researchers spending 10 minutes or less.
• Participants in clinical studies often "are recruited from society's poorest and least-educated people"; in a recent study of 1,760 patients, roughly half did not understand standard informed-consent documents.

Calling for Reform
      Scholars and officials are calling for reforms to close "troubling gaps" in federal consent regulations:

• The National Bioethics Advisory Commission is advocating regulations to safeguard "people with mental disorders that may affect decision-making capacity."
• A coalition of academics called the Human Research Ethics Group has called for regulations covering consent in research not overseen by the FDA.
• Public Citizen's Health Research Group is advocating "closer adherence to regulations requiring local review boards to include outside scientists, tighter regulation of advertisements that recruit patients for clinical studies, and a centralized national registry of clinical studies to facilitate monitoring of practices and results" (Monmaney, 3/29).

A Little Bit Louder Now
      An editorial in the Los Angeles Times argues that violations of informed consent are a national problem, and urges federal officials to crackdown on "errant researchers" and focus on "beefing up" enforcement of ethical guidelines. The editorial concludes, "Washington needs to recognize that it's not likely to solve widespread medical ethics problems simply by punishing indiscriminate research at a particular hospital. Federal officials should aim for something sharper: a reexamination of principles for safeguarding patients, and of its mechanisms for ensuring that those principles are put into practice" (3/30).