The ACHRE Final Report on deliberate non medical exposures of the public to ionising radiation
Quick reference: http://www.hss.doe.gov/healthsafety/ohre/roadmap/achre/index.html
Although I have the complete volume of the Final Report, I will not bore the reader with vast tracts of text. Instead I will concentrate on salient quotes the reader can easily confirm by consulting the Department of Energy links which exist as a result of a US Presidential Executive Order which mandates that the Department of Energy and other involved agencies be open with the public.
quote: “In chapter 2 we turn from a consideration of government standards to an exploration of the norms and practices of physicians and medical scientists who conducted research with human subjects during this (Cold War) period. We include here an analysis of the significance of the Nuremberg Code, which arose out of the international war crimes trial of German physicians in 1947. Using the results of our Ethics Oral History Project, and other sources, we also examine how scientists of the time viewed their moral responsibilities to human subjects as well as how this translated into the manner in which they conducted their research. Of particular interest are the differences in professional norms and practices between research in which patients are used as subjects and research involving so-called healthy volunteers.
In chapter 3 we return to the question of government standards, focusing now on the 1960s and 1970s. In the first part of this chapter, we review the well-documented developments that influenced and led up to two landmark events in the history of government policy on research involving human subjects: the promulgation by DHEW of comprehensive regulations for oversight of human subjects research and passage by Congress of the National Research Act. In the latter part of the chapter we review developments and policies governing human research in agencies other than DHEW, a history that has received comparatively little scholarly attention. We also discuss scandals in human research conducted by the DOD and the CIA that came to light in the 1970s and that influenced subsequent agency policies.
With the historical context established in chapters 1 through 3, we turn in chapter 4 to the core of our charge. Here we put forward and defend three kinds of ethical standards for evaluating human radiation experiments conducted from 1944 to 1974. We embed these standards in a moral framework intended to clarify and facilitate the difficult task of making judgments about the past.” end quote.
The Committee then selected for particular consideration, in chapter 7, radioisotope research that used children as subjects. We determined to focus on children for several reasons. First, at low levels of radiation exposure, children are at greater risk of harm than adults. Second, children were the most appropriate group in which to pursue the Committee’s mandate with respect to notifica tion of former subjects for medical reasons. They are the group most likely to have been harmed by their participation in research, and they are more likely than other former subjects still to be alive. Third, when the Committee considered how best to study subject populations that were most likely to be exploited because of their relative dependency or powerlessness, children were the only subjects who could readily be identified in the meager documenta tion available. By contrast, characteristics such as gender, ethnicity, and social class were rarely noted in research reports of the day.”
In chapter 9 we examine experimentation on healthy subjects, specifically prisoners, for the purpose of learning the effects of external irradiation on the testes, such as might be experienced by astronauts in space. The prisoner experiments were studied because they received significant public attention and because a literally captive population was chosen to bear risks to which no other group of experimental subjects had been exposed or has been exposed since. This research took place during a period in which the once commonly accepted practice of nontherapeutic experimen tation on prisoners was increasingly subject to public criticism and moral outrage.
Chapter 10 also explores research involving healthy subjects: human experimentation conducted in connection with atomic bomb tests. More than 200,000 service personnel–now known as atomic veterans–participated at atomic bomb test sites, mostly for training and test-management purposes. A small number also were used as subjects of experimentation. The Committee heard from many atomic veterans and their family members who were concerned about both the long-term health effects of these exposures and the government’s conduct. In seeking to reconstruct the story of human experimentation in connection with bomb tests, we found need and opportunity to examine the meaning of human experimentation in an occupational setting where risk is the norm.
In chapter 11 we address the thirteen intentional releases of radiation into the environment specified in the Committee’s charter, as well as additional releases identified during the life of the Committee. In contrast with biomedical experimentation, individu als and communities were not typically the subject of study in these intentional releases. The secret releases were to test intelligence equipment, the potential of radiological warfare, and the mecha nism of the atomic bomb. While the risk posed by intentional releases was relatively small, the releases often took place in secret and remained secret for years.
The final case study, in chapter 12, looks at two groups that were put at risk by nuclear weapons development and testing programs and as a consequence became the subjects of observa tional research: workers who mined uranium for the Atomic Energy Commission in the western United States from the 1940s to 1960s and residents of the Marshall Islands, whose Pacific homeland was irradiated as a consequence of a hydrogen bomb test in 1954. While these observational studies do not fit the classic definition of an experiment, in which the investigator controls the variable under study (in this case radiation exposure), they are instances of research involving human subjects. The Committee elected to examine the experiences of the uranium miners and the Marshallese because they raise important issues in the ethics of human research not illustrated in the previous case studies and because numerous public witnesses impressed on the Committee the significance of the lessons to be learned from their histories.
Part II concludes with an exploration of an important theme common to many of the case studies–openness and secrecy in the government’s conduct concerning human radiation research and intentional releases. In chapter 13 we step back and look at what rules governed what the public was told about the topics under the Committee’s purview, whether these rules were publicly known, and whether they were followed…….
Finally, our examination of the history of the past half century has helped us understand that the revision of regulations that govern human research, the creation of new oversight mechanisms, and even a scrupulous professional ethics are necessary, but are not sufficient, means to needed reform. Of at least equal import is the development of a more common understanding among the public of research involving human subjects, its purposes, and its limitations. Furthermore, if the conduct of the government and of the professional community is to be improved, that conduct must be available for scrutiny by the American people so that they can make more informed decisions about the protection and promotion of their own health and that of the members of their family. It is toward that end that we close our report with recommendations for continued openness in government and in biomedical research. It is also toward that end that this report is dedicated. Some of what is regrettable about the past happened, at least in part, because we as citizens let it happen. Let the lessons of history remind us all that the best safeguard for the future is an informed and active citizenry.
Presidential Executive Order 12891 of January 15, 1994
Advisory Committee on Human Radiation Experiments By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows: Section 1. Establishment. (a) There shall be established an Advisory Committee on Human Radiation Experiments (the ``Advisory Committee'' or ``Committee''). The Advisory Committee shall be composed of not more than 15 members to be appointed or designated by the President. The Advisory Committee shall comply with the Federal Advisory Committee Act, as amended, 5 U.S.C. App. 2. (b) The President shall designate a Chairperson from among the members of the Advisory Committee. Sec. 2. Functions. (a) There has been established a Human Radiation Interagency Working Group, the members of which include the Secretary of Energy, the Secretary of Defense, the Secretary of Health and Human Services, the Secretary of Veterans Affairs, the Attorney General, the Administrator of the National Aeronautics and Space Administration, the Director of Central Intelligence, and the Director of the Office of Management and Budget. As set forth in paragraph (b) of this section, the Advisory Committee shall provide to the Human Radiation Interagency Working Group advice and recommendations on the ethical and scientific standards applicable to human radiation experiments carried out or sponsored by the United States Government. As used herein, ``human radiation experiments'' means: (1) experiments on individuals involving intentional exposure to ionizing radiation. This category does not include common and routine clinical practices, such as established diagnosis and treatment methods, involving incidental exposures to ionizing radiation; (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. Consistent with the provisions set forth in paragraph (b) of this section, the Advisory Committee shall also provide advice, information, and recommendations on the following experiments: (1) the experiment into the atmospheric diffusion of radioactive gases and test of detectability, commonly referred to as ``the Green Run test,'' by the former Atomic Energy Commission (AEC) and the Air Force in December 1949 at the Hanford Reservation in Richland, Washington; (2) two radiation warfare field experiments conducted at the AEC's Oak Ridge office in 1948 involving gamma radiation released from non-bomb point sources at or near ground level; (3) six tests conducted during 1949-1952 of radiation warfare ballistic dispersal devices containing radioactive agents at the U.S. Army's Dugway, Utah, site; (4) four atmospheric radiation-tracking tests in 1950 at Los Alamos, New Mexico; and (5) any other similar experiment that may later be identified by the Human Radiation Interagency Working Group. The Advisory Committee shall review experiments conducted from 1944 to May 30, 1974. Human radiation experiments undertaken after May 30, 1974, the date of issuance of the Department of Health, Education, and Welfare (``DHEW'') Regulations for the Protection of Human Subjects (45 C.F.R. 46), may be sampled to determine whether further inquiry into experiments is warranted. Further inquiry into experiments conducted after May 30, 1974, may be pursued if the Advisory Committee determines, with the concurrence of the Human Radiation Interagency Working Group, that such inquiry is warranted. (b)(1) The Advisory Committee shall determine the ethical and scientific standards and criteria by which it shall evaluate human radiation experiments, as set forth in paragraph (a) of this section. The Advisory Committee shall 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 standards, including standards of informed consent, that prevailed at the time of the experiments and that exist today. (2) The Advisory Committee shall evaluate the extent to which human radiation experiments were consistent with applicable ethical and scientific standards as determined by the Committee pursuant to paragraph (b)(1) of this section. If deemed necessary for such an assessment, the Committee may carry out a detailed review of experiments and associated records to the extent permitted by law. (3) If required to protect the health of individuals who were subjects of a human radiation experiment, or their descendants, the Advisory Committee may recommend to the Human Radiation Interagency Working Group that an agency notify particular subjects of an experiment, or their descendants, of any potential health risk or the need for medical follow-up. (4) The Advisory Committee may recommend further policies, as needed, to ensure compliance with recommended ethical and scientific standards for human radiation experiments. (5) The Advisory Committee may carry out such additional functions as the Human Radiation Interagency Working Group may from time to time request. Sec. 3. Administration. (a) The heads of executive departments and agencies shall, to the extent permitted by law, provide the Advisory Committee with such information as it may require for purposes of carrying out its functions. (b) Members of the Advisory Committee shall be compensated in accordance with Federal law. Committee members may be allowed travel expenses, including per diem in lieu of subsistence, to the extent permitted by law for persons serving intermittently in the government service (5 U.S.C. 5701-5707). (c) To the extent permitted by law, and subject to the availability of appropriations, the Department of Energy shall provide the Advisory Committee with such funds as may be necessary for the performance of its functions. Sec. 4. General Provisions. (a) Notwithstanding the provisions of any other Executive order, the functions of the President under the Federal Advisory Committee Act that are applicable to the Advisory Committee, except that of reporting annually to the Congress, shall be performed by the Human Radiation Interagency Working Group, in accordance with the guidelines and procedures established by the Administrator of General Services. (b) The Advisory Committee shall terminate 30 days after submitting its final report to the Human Radiation Interagency Working Group. (c) This order is intended only to improve the internal management of the executive branch and it is not intended to create any right, benefit, trust, or responsibility, substantive or procedural, enforceable at law or equity by a party against the United States, its agencies, its officers, or any person. (Presidential Signature.) THE WHITE HOUSE, January 15, 1994.