Radiation Experiments Conducted by the University of Cincinnati Medical School with Department of Defense Funding: Hearing Before the Subcommittee on Administrative Law and Governmental Relations of the Committee on the Judiciary, House of Representatives, One Hundred Third Congress, Second Session, April 11, 1994
United States, United States. Congress. House. Committee on the Judiciary. Subcommittee on Administrative Law and Governmental Relations
U.S. Government Printing Office, 1994 - Government publications - 389 pages
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addition agency American APPLICATION appropriate approved asked believe benefit Board bone marrow BRYANT cancer Chairman changes clinical College Committee concerning conducted considered continue contract death Department of Defense developed died disease doctors documents doses effects EGILMAN evaluation experiments exposure fact father Federal funding give given Government Health Hospital human indicated informed consent institution involved issue Journal Kereiakes letter lived MANN means ment mother never Nuclear Medicine Office Oncology pain partial body participation patients period physicians PORTMAN possible present procedures proposal question Radiology rads reason received records response risks Saenger selection Senator Society standards statement subcommittee subjects tests Thank therapy told total body irradiation treated treatment tumor understand University of Cincinnati whole body radiation
Page 94 - During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible. 10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment...
Page 64 - 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...
Page 63 - Informed consent will be appropriately documented, in accordance with, and to the extent required by § 219.117. (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
Page 63 - Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
Page 59 - Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Page 64 - No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.
Page 65 - A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and (6) The approximate number of subjects involved in the study.
Page 62 - HHS, has established, and published as a Notice in the FEDERAL REGISTER, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The list will be amended, as appropriate after consultation •with other departments and agencies, through periodic republication by the Secretary, HHS, in the FEDERAL REGISTER.
Page 94 - ... 7 Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability or death. 8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment 9.