Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: SATURDAY, June 24, 1995 TAG: 9506260067
SECTION: NATL/INTL PAGE: A-7 EDITION: METRO
SOURCE: GARY LEE THE WASHINGTON POST
DATELINE: WASHINGTON LENGTH: Medium
The White House-appointed Advisory Committee on Human Radiation asked 1,800 randomly selected patients in waiting rooms at 16 hospitals and clinics whether they were involved in a medical research project. A total of 412 turned out to be research subjects, including 99 who had said they were not and had never been participants in research.
About one-fifth of the unwitting participants were involved in experiments that posed more than a minimal health risk, and 16 people in that group had even signed consent forms. A handful of respondents mistakenly said they were participants when they were not. Twenty-one patients in all had signed consent forms.
The survey, which panel members called the most comprehensive probe of current medical research practices in 20 years, raises serious questions about research ethics and the extent to which the rights of participants are respected, some members of the radiation committee said.
The panel is weighing recommendations for major changes in the process under which subjects are recruited for and informed about medical experiments.
Most of the ethical standards for conducting human experimentation in the United States were established in the 1960s and early '70s and have remained unchanged since then.
The radiation committee, appointed last year by President Clinton, has focused most of its attention on the ethics of experiments conducted during the Cold War. It will conclude its work in September.
Some 90 percent of respondents to the survey said they favored medical research involving human beings. ``People appear to be very understanding and accepting of the research enterprise,'' said Jeremy Sugarman, a senior research official for the panel. ``They think that research is a good thing.''
Public views on human involvement in medical projects seem to depend on the terms used to describe it, a panel spokesman said. When asked their opinions about human participation in ``medical experimentation'' - as opposed to research - many of the respondents were more critical. Some said they would participate in ``an experiment'' only if they were terminally ill.
The hospitals and clinics surveyed were chosen in part according to the levels of federal aid they receive. A wide range of institutions, from Walter Reed Army Medical Center in the District of Columbia to the Seattle Veterans Affairs Medical Center, was included. Three Baltimore hospitals, including Johns Hopkins Hospital, also took part.
The patients were involved in three types of research: medical oncology, radiation oncology and cardiology. The majority were undergoing treatment. Some were subjects of clinical trials. In all, 23 percent of the patients randomly approached for the survey were actually involved in experiments.
The profile of individuals who had signed consent forms and were involved in risky experiments without knowing it was diverse. They were patients at various types of hospitals, including some community institutions and some serving veterans. They ranged in age from 21 to 91.
``What that means to us is that almost anyone could wake up one day and find out that they were a participant in medical research,'' one panel member said. ``That clearly should not be.''
by CNB