Discussion: Part III
1. Committee's Official Designation
Advisory Committee on Human Radiation Experiments (the "Advisory Committee" or "Committee").
Executive Order No. 12891.
3. Objectives and Scope of Activities
There has been established a Human Radiation Interagency Working Group (the "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 section 4 of this Charter, the Advisory Committee shall provide to the 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:
Consistent with the provisions set forth in section 4 of this Charter, the Advisory Committee also shall provide advice, information and recommendations on the following experiments:
- 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.
- 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 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 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 Interagency Working Group, that such inquiry is warranted.
- 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 in Hanford, Washington;
- 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;
- Six tests conducted during 1949-1952 of radiation warfare ballistic dispersal devices containing radioactive agents at the U.S. Army's Dugway, Utah site;
- Four atmospheric radiation-tracking tests in 1950 at Los Alamos, New Mexico; and
- Any other similar experiments which may later be identified by the Interagency Working Group.
4. Description of Duties for Which Committee is Responsible
The duties of the Advisory Committee are solely advisory and shall be:
- The Advisory Committee shall determine the ethical and scientific standards and criteria by which it shall evaluate human radiation experiments, as set forth in section 3 of this Charter. 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.
- 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 (a) of this section. If deemed necessary for such an assessment, the Advisory Committee may carry out a detailed review of experiments and associated records to the extent permitted by law.
- 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 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.
- The Advisory Committee may recommend further policies, as needed, to ensure compliance with recommended ethical and scientific standards for human radiation experiments.
- The Advisory Committee may carry out such additional functions as the Interagency Working Group may from time to time request.
5. To Whom the Advisory Committee Reports
The Advisory Committee shall report to the Interagency Working Group.
The Advisory Committee shall submit its final report to the Interagency Working Group within one year of the date of the first meeting of the Advisory Committee, unless such period is extended by the Interagency Working Group. The Advisory Committee shall issue an interim report not more than six months after the date of the first meeting of the Advisory Committee. That interim report shall advise the Interagency Working Group on the status of the Advisory Committee's proceedings and the likelihood that the Committee will be able to complete its duties within one year of the date of the first meeting of the Advisory Committee.
6. Duration and Termination Date
The Advisory Committee shall terminate thirty days after submission of its final report to the Interagency Working Group. This Charter shall expire one year plus thirty days after the first meeting of the Advisory Committee, subject to renewal and extension by the President.
7. Agency responsible for providing financial and administrative support to the Advisory Committee
Financial and administrative support shall be provided by the Department of Energy.
8. Estimated Annual Operating Costs
9. Estimated Number And Frequency of Meetings
The Advisory Committee shall meet as it deems necessary to complete its functions.
To facilitate functioning of the Advisory Committee, subcommittee(s) may be formed. The objectives of the subcommittee(s) are to make recommendations to the Advisory Committee with respect to matters related to the responsibilities of the Advisory Committee. Subcommittees shall meet as the Advisory Committee deems appropriate.
Up to a maximum of fifteen Advisory Committee members shall be appointed by the President for a term of one year, which may be extended by the President. Committee members 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).
The President shall designate a Chairperson from among the members of the Advisory Committee.