Human Radiation and Other Scientific Experiments: The Federal Government's Role : Hearing Before the Committee on Governmental Affairs, United States Senate, One Hundred Third Congress, Second Session, January 25, 1994 |
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Page 1
... do with radiation are being conducted , and do these experiments have the proper consent of the people involved ? A large number of Federal agencies are or were involved in such ( 1 ) research ; for example , FDA , NIH , CDC.
... do with radiation are being conducted , and do these experiments have the proper consent of the people involved ? A large number of Federal agencies are or were involved in such ( 1 ) research ; for example , FDA , NIH , CDC.
Page 3
... agencies and ask that they investigate the allegations . There are also privacy concerns for the records of those people involved in the tests . It would set a very poor precedent for the U.S. Government to release privileged medical ...
... agencies and ask that they investigate the allegations . There are also privacy concerns for the records of those people involved in the tests . It would set a very poor precedent for the U.S. Government to release privileged medical ...
Page 6
... agencies no doubt were carried on - if I may borrow a phrase from network television - with an eye on America . But the protection of future generations cannot come at the expense of the most vulnerable members of the present ...
... agencies no doubt were carried on - if I may borrow a phrase from network television - with an eye on America . But the protection of future generations cannot come at the expense of the most vulnerable members of the present ...
Page 7
... agencies no doubt were carried on , if I can borrow a phrase from one of our networks , with an eye on America , but the protection of future generations cannot come at the expense of the most vulnerable members of the present ...
... agencies no doubt were carried on , if I can borrow a phrase from one of our networks , with an eye on America , but the protection of future generations cannot come at the expense of the most vulnerable members of the present ...
Page 13
... own Presidential memorandum to each Cabinet agency directing that will be done . That has been done in the case of the Department of Energy and I am clear that it has been done with my sister departments and agencies as well 13.
... own Presidential memorandum to each Cabinet agency directing that will be done . That has been done in the case of the Department of Energy and I am clear that it has been done with my sister departments and agencies as well 13.
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Common terms and phrases
agencies Answer approval assure Bacillus subtilis benefits cancer Chairman GLENN classified compliance concerned conducted CONGRESS THE LIBRARY CRAFT Defense Department of Energy documents dose drug effects ethical experimentation facility Fernald School followup funded going Government Health and Human HSRRB human radiation experiments human research Human Services individuals informed consent institutional review board Interagency Working Group investigations involving human subjects ionizing radiation iron isotope issues LIBRARY OF CONGRESS MASSÉ medical research ment monitoring NTPR nuclear medicine nuclear test Nuremberg Code OPRR participants patients personnel plutonium pregnancy procedures protection of human question radi radiation exposure radioactive radioisotopes records regulations release research protocols research subjects risk scientific Secretary BROWN Secretary O'LEARY Senator COHEN Senator SASSER standards studies subjects of research Thank things tion tracer treatment U.S. Army Vanderbilt veterans volunteers
Popular passages
Page 174 - Agency head determines to be appropriate. This evaluation will take into consideration the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained.
Page 118 - 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 163 - Memorandum for Secretaries of the Military Departments, Chairman of the Joint Chiefs of Staff, Under Secretaries of Defense Director, Defense Research and Engineering. Assistant Secretaries of Defense, General Counsel of the Department of Defense, Inspector General of the Department of Defense.
Page 118 - An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject...
Page 118 - IRB's use of the expedited review procedure. §46.111 Criteria for IRB approval of research. (a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied: (1) Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or...
Page 118 - 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...
Page 118 - ... (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 118 - ... (d) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. (e) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
Page 118 - Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. (d) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
Page 109 - ... obtain the consent of such human beings or their representatives, except where they deem it not feasible or, in their professional judgment, contrary to the best interests of such human beings.