Human Radiation Experiments: Hearing Before the Committee on Governmental Affairs, U. S. Senate
DIANE Publishing, 1998 - 434 pages
Examines progress that the U.S. government has made to identify and catalog the many radiation experiments carried out in the U.S. involving human subjects and to establish an effective set of policies and procedures to protect citizens from dangerous and unethical research practices. Presents testimony from representatives from the Republic of the Marshall Islands, the State of Alaska, the Task Force on Radiation and Human Rights, Concerned Relatives of Cancer Study Patients, the National Institute of Health (Office for Protection from Research Risks), the Dept. of Energy, the General Accounting Office, and the Dept. of Defense.
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ACHRE ACHRE's activities Air Force atolls Atomic Bikini Bioethics biomedical brain cancer Chairman Stevens Committee on Human Committee's Common Rule compliance conducted Department of Energy documents drug ensure environmental ethical exposure facilities fda's federal agencies Final Report funding harm Health Human Experiments Human Radiation Experiments human research subjects human subject protection human subjects research identified implementation individuals informed consent inspections Institutional Review Board institutions investigation involving human subjects IRB review issue Laboratory March Marshall Islands Marshallese medical follow-up monitoring Nasal Radium Irradiation National North Slope Borough nuclear Nuremberg Code Office OPRR OPRR's oversight participants patients Point Hope potential President procedures Project Chariot Protecting Human Research protection of human questions radioactive Radiological records releases research involving response RMI Government Senator Glenn staff statement Task Force Testimony tests treatment U.S. Government victims
Page 283 - A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information...
Page 404 - March 26, 1996 The Honorable Ted Stevens Chairman Committee on Governmental Affairs United States Senate 340 Dirksen Senate Office Building Washington, DC 20510-8250 Dear Mr.
Page 283 - When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
Page 283 - It is a local review, by individuals who are in the best position to know the resources of the institution, the capabilities and reputations of the investigators and staff, and the prevailing values and ethics of the community and likely subject population. Once research is underway, the IRB must conduct continuing review of the research, at intervals appropriate to the degree of risk-in any event, at least once per year. I will return to the responsibilities of the IRB in a moment An additional...
Page 282 - Subpart B— Additional Protections Pertaining to Research, Development, and Related Activities Involving Fetuses, Pregnant Women, and Human In Vitro Fertilization SOURCE: 40 FR 33528.
Page 283 - ... (2) A description of any reasonably foreseeable risks or discomforts to the subject. (3) A description of any benefits to the subject or to others which may reasonably be expected from the research. (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food...
Page 158 - Laboratory were also forthcoming about the experimentation aspect of their research: Bikini may be the only global source of data on humans where intake via ingestion is thought to contribute the major fraction of plutonium body burden.. .It is possibly the best available data for evaluating the transfer of plutonium across the gut wall after being incorporated into biological systems.2 As a result of the weapons testing...
Page 283 - A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental; (2) A description of any reasonably foreseeable risks or discomforts to the subject; (3) A description of any benefits to the subject or to others which may reasonably be expected from the research...
Page 283 - A fair explanation of the procedures to be followed, and their purposes, including identification of any procedures which are experimental; (2) A description of any attendant discomforts and risks reasonably to 'be expected; (3) A description of any benefits reasonably to be expected; (4) A disclosure of any appropriate...