Advisory Committee on Human Radiation Experiments

                              FACT SHEET

                       AND QUESTIONS AND ANSWERS

The Advisory Committee on Human Radiation Experiments is a 14-
member committee of nationally recognized experts in the areas of
bioethics, epidemiology, law and nuclear medicine.  The Committee
also includes a public representative.  Appointed by the
President in April 1994, the members are to prepare a report, due
in April 1995, about the use of human beings as subjects of
federally funded research using ionizing radiation.  Ruth Faden,
Ph.D., M.P.H., a bioethicist at Johns Hopkins University, chairs
the Advisory Committee.

The Committee's report will be issued to an Interagency Working
Group composed of the secretaries of the departments of Defense,
Energy, Health and Human Services, Justice, and Veterans Affairs,
and the directors of the Central Intelligence Agency and the
Office of Management and Budget, and the administrator of the
National Aeronautics and Space Administration.

The Committee's charter includes the investigation of experiments
conducted since 1942 with ionizing radiation, the investigation
of specific intentional releases of radiation into the
environment, and the recommendation to the working group of
remedies for abused of human subjects in past experiments, and of
policies to improve ethical practices in today's research.

The Committee held its first meeting in April 1994 and has met
approximately monthly since.  A staff of professionals in
history, bioethics, nuclear medicine and epidemiology works in
Washington, D. C., under the Committee's direction.  The staff is
headed by Executive Director Dan Guttman.  Stephen Klaidman is
spokesman for the Committee and can be reached by telephone at
202/254-9795.

The Advisory Committee's meetings are public and material
presented to members of the Committee at its meetings become
public record.  The Committee's schedule includes at least one
meeting on the West Coast and also includes meetings of panels to
hear testimony at other sites in the United States.

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                         QUESTIONS AND ANSWERS

                                   
Why was the Advisory Committee formed?

    The President of the United States appointed the Committee
to analyze these questions: What is the federal government's
responsibility for wrongs and harms to human subjects as a result
of experiments with ionizing radiation? What remedies are
appropriate for those wronged or harmed? And what lessons learned
from studying research standards and practices in the past and
present can be applied to the future?

Who are members of the Advisory Committee?

     The 14 members are nationally recognized experts in
bioethics, epidemiology, radiation oncology and biology, history
of science, law and nuclear medicine. The Committee also includes
a citizen representative. Ruth Faden, a bioethicist at Johns
Hopkins University, chairs the Advisory Committee.

What is the Committee authorized to review?

    The Committee's charter includes the review of experiments
conducted since the 1940s with ionizing radiation and the
investigation of specific intentional releases of radiation into
the environment.
    The Committee's mandate does not include common and routine
clinical practices, such as established diagnosis and treatment
methods. An important question is how to define the difference
between ordinary practice and experimental procedures.
    Another important question is whether accidental exposures
gave agencies or researchers a chance to conduct "experiments of
opportunity."

What will the Advisory Committee do?

    The members will prepare a report designed to answer the
three questions posed above.  The report will be issued in 1995
to an Interagency Working Group composed of the secretaries of
the departments of Defense, Energy, Health and Human Services,
Justice, and Veterans Affairs, and the directors of the Central
Intelligence Agency and the Office of Management and Budget, and
the administrator of the National Aeronautics and Space
Administration.

How will the Advisory Committee evaluate today's practices?

    A sample of research protocols funded by federal agencies in
fiscal year 1993 is being used to assess ethical standards and
procedures in today's environment. Researchers and subjects of
research will be interviewed.

How has the Committee looked into past practices?

    The President directed federal agencies to search their
files for information about research on human subjects in the
past. This process has been revised and expanded under the
Committee's direction. Literally thousands of documents, many
previously unreported and some of them only declassified this
year, have been made available to the public as a result of this
effort.
    Many documents are, of course, fragmentary accounts of
experiments. Recreating the ethics policies, standards and
practices of 40 or 50 years ago is difficult, much less
recreating the conversations between subjects and researchers.
    The Advisory Committee has reviewed many private collections
left by subjects of experiments and by researchers.

How has the Committee responded to public concern about these
experiments?

    The Committee recognizes the importance of hearing directly
from people throughout the country and including them in its
activities. The Committee seeks out participants in past
experiments to hear about their experiences and use their
recollections to guide its research and inform its judgments.
    In addition to soliciting the views of subjects and other
interested parties at its Washington meetings, the Committee has
scheduled public meetings around the country to hear first-hand
from persons involved in research. The Committee has gained
valuable documents and insights from working with subjects or
their families, as well as researchers, and that process will
continue throughout the life of the Committee's work.

What are key questions about experimentation?

    The Committee must define the boundaries of experimentation.
What is an experiment? How does it differ from innovative
treatment? How does it differ from training, as in the case of
military units participating in atomic weapons tests in the
1950s? When is an experiment over? Each question bears on the
scope of the Committee's endeavors and the way it evaluates the
evidence before it.

What are the ethical questions in research?

    The issues to be weighed by the Committee are many and
complex. These include the risks or harm to the subject, and the
benefit to the subject or to society as a whole; whether subject
populations have been chosen fairly and appropriately; whether
subjects have been fully informed and have fully consented to
participate in research.
    The Committee has discovered more extensive ethical codes
and policies in the government than had previously been known.
It's not always clear whether they were applied, or how they were
interpreted in different circumstances. These codes and policies,
however, are critical to the determination of whether experiment
subjects were appropriately informed of risks or harms, and
selected fairly for the purposes of experimentation.

How can people contact the Committee?

    The Committee staff can be reached by telephone at 202/254-
9795 or in writing at 1726 M Street NW, Suite 600, Washington,
D.C. 20036.