Gulf War Veterans' Illnesses: The Research Agenda : Hearing Before the Subcommittee on Human Resources of the Committee on Government Reform and Oversight, House of Representatives, One Hundred Fifth Congress, Second Session, February 24, 1998

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Стр. 45 - ... (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled...
Стр. 44 - 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...
Стр. 129 - The Department of Defense is responsible for providing the military forces needed to deter war and protect the security of our country. The major elements of these forces are the Army, Navy, Marine Corps, and Air Force, consisting of about 1.5 million men and women on active duty.
Стр. 129 - The chain of command runs from the President to the Secretary of Defense and through the Joint Chiefs of Staff to the commanders of unified and specified commands.
Стр. 42 - Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information shall be provided to each subject: (1) 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...
Стр. 129 - Organization of the Joint Chiefs of Staff, constitute the immediate military staff of the Secretary of Defense. The Joint Chiefs of Staff are the principal military advisers to the President, the National Security Council, and the Secretary of Defense.
Стр. 87 - It is important to distinguish between biomedical and behavioral research, on the one hand, and the practice of accepted therapy on the other, in order to know what activities ought to undergo review for the protection of human subjects of research. The distinction between research and practice is blurred partly because both often occur together (as in research designed to evaluate a therapy) and partly because notable departures from standard practice are often called "experimental...
Стр. 84 - ... investigational new drug application (IND) sponsored by the Department of Defense (DOD). DOD's request for a determination that obtaining informed consent from military personnel is not feasible must be limited to a specific military operation involving combat or the immediate threat of combat. The request must also include a written justification supporting the conclusions of the physician(s) responsible for the medical care of the military personnel involved and the investigator(s) identified...
Стр. 44 - 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.
Стр. 44 - ... 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...

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