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ACHRE Report
Preface
Introduction
Why the Committee Was Created
The President's Charge
The Committee's Approach
Lessons from History: Looking to the Future
How this Report is Organized
A Final Note
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The President's Charge
The Advisory Committee was created under the Federal Advisory Committee Act of
1972, which provides that committee meetings and basic decision making be
conducted in the open. The Committee's charter[4] defined human radiation experiments to
include
- experiments on individuals involving intentional exposure to ionizing
radiation. This category does not include common and routine clinical
practices.
- experiments involving intentional environmental releases of radiation that
(A) were designed to test human health effects of ionizing radiation; or (B)
were designed to test the extent of human exposure to ionizing radiation.
The Committee was mandated to review experiments conducted between 1944 and
1974, the latter being the year that the U.S. Department of Health, Education,
and Welfare issued rules for the protection of human subjects of federally
sponsored research. The Committee was asked to determine the ethical and
scientific standards by which to evaluate the pre-1974 experiments and the
extent to which these experiments were consistent with such standards. We were
also to "consider whether (A) there was a clear medical or scientific purpose
for the experiments; (B) appropriate medical follow-up was conducted; and (C)
the experiments' design and administration adequately met the ethical and
scientific criteria, including standards of informed consent, that prevailed at
the time of the experiments and that exists today." The charter also directed
that, upon completing our review, the Committee may recommend that subjects (or
families) be notified of potential health risks and the need for medical
follow-up and also that we "may recommend further policies, as needed, to
ensure compliance with recommended ethical and scientific standards for human
radiation experiments."
In order to inform the public about the conduct of research involving human
subjects taking place today, we were authorized to sample and consider examples
of research with human subjects currently under way.
In essence, we were to answer several fundamental questions: (l) What was the
federal government's role in human radiation experiments conducted from 1944 to
1974? (2) By what standards should the ethics of these experiments be
evaluated? and (3) What lessons learned from studying past and present research
standards and practices should be applied to the future?
In addition, while the Committee was not expressly charged with considering
issues relating to remedies, including financial compensation, we have felt
obliged to address the type of remedies that we believe the government, as an
ethical matter, should provide to subjects of experiments where the
circumstances warranted such a response.
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