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STUDY FINDS BIOMEDICAL RESEARCH REGULATIONS OUT-OF-DATE

Federal regulations governing the use of human subjects in biomedical research should be revamped, according to a study published in today's Journal of the American Medical Association (JAMA). The study, which was conducted by The Human Research Ethics Group over a two year period, recommends reform in three key areas: protecting subject populations with special needs and vulnerabilities, oversight by institutional review boards (IRBs) and regulatory policy.

The regulations governing the use of human subjects in biomedical research in the United States have not changed substantially in the past thirty years, said Jonathan Moreno, director of the Center for Biomedical Ethics at the University of Virginia and co-author of the study. Informed consent and review by local peer committees or IRBs has done much to protect the interests and welfare of human subjects, but regulations must evolve in order to keep pace with changes in practices.

Current regulations were designed to cover federally-funded research projects conducted by a single investigator at a single institution with a limited number of human subjects. The regulations also require that the institution's IRB provide oversight for research projects.

Today, biomedical research often involves multi-site trials with many researchers and a large number of human subjects. This creates unique logistical problems for the IRBs and their ability to monitor research activity, according to the study findings.

Moreover, in recent years there have been problems with some members of vulnerable populations, particularly the mentally ill, which raises concerns about the adequacy of the existing regulations, Moreno said.

Other complicating elements in today's research environment include the changing conception of informed consent requirements, the desire by those who are ill to have greater access to research drugs and the view that women and children are underrepresented in clinical studies.

Another significant development is the increase in privately funded research, which is not always covered under existing regulations, Moreno added.

As a result of the study, the Human Research Ethics Group recommends the following to update existing protections for human subjects:

  • Durable power of attorney and advance directives should be used more extensively to protect the rights of the mentally ill;

  • Special regulations, including tighter monitoring and surveillance of studies involving persons with cognitive impairment, should be enacted;

  • Existing protections for subjects in research should be extended to cover all forms of research in the United States, regardless of how they are funded or whether the research aims at producing commercial products;

  • Local IRBs should continue, but need to be bolstered with more resources and with a stronger mandate to directly monitor a sample or cross section of approved research studies as they progress;

  • IRBs should be directly informed of all potential conflicts of interest that exist for investigators and institutions;

  • The National Institutes of Health (NIH) Office for Protection from Research Risks (OPRR) should be moved outside the NIH and given appropriate authority to control the enforcement of regulations pertaining to human subjects research;

  • National review rather than local peer review should be considered for some categories of high risk or controversial research.
The Human Research Ethics Group is administered by the Center for Bioethics at the University of Pennsylvania Health System.

December 9, 1998