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

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

  1. experiments on individuals involving intentional exposure to ionizing radiation. This category does not include common and routine clinical practices.

  2. 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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