Harold Edgar

The institutional review board and beyond : future challenges to the ethics of human experimentation

Over the past two decades, institutional review boards (IRBs) have transformed the conduct of clinical research, in the process protecting human subjects and setting an admirable standard for monitoring the ethics of science. Nevertheless, the very proliferation of these committees, in addition to changing the character and sponsorship of new research, suggests that a ¿one size fits all¿ approach to the governance of human experimentation may have outlived its usefulness. It may be time to remove the ¿I¿ from the IRB and create a system with greater national oversight. Whether such a change can be accomplished within the current political climate is debatable. But the need for such a shift is becoming increasingly apparent.

New Rules for New Drugs: The Challenge of AIDS to the Regulatory Process

AIDS is systematically changing attitudes and practices regarding the regulation and use of drugs. The complex framework and rigorous research protocols developed by the Food and Drug Administration prior to the 1980s to minimize risk to subjects is shifting in the epidemics wake to maximize innovation. The FDA has adopted new procedures hastening access to investigational drugs and easing drug importation for personal use, which, in effect, transfers decisions about the benefits and risks of drugs from the agencys staff to patients and their physicians. While the FDAs tilt toward embracing consumer rights may continue in the near future, disappointing results could prompt the agency to reassert its authority in controlling drug policy more restrictively.

Patients Beware: Commercialized Stem Cell Treatments on the Web

A report by the International Society for Stem Cell Research (ISSCR)s Task Force on Unproven Stem Cell Treatments outlines development of resources for patients, their families, and physicians seeking information on stem cell treatments.

AIDS, activism, and ethics.

From the treatment IND to drug importation, to the parallel track and beyond, AIDS advocates have largely succeeded in doing what earlier FDA critics were unable to do: take more decisions out of the hands of government and the research establishment and cede them to patients and their physicians. The profound ethical and clinical implications are discussed.