Biomedical Research Ethics and the Protection of Human Research Subjects: Hearings Before the Subcommittee on Public Health and Environment of the Committee on Interstate and Foreign Commerce, House of Representatives, Ninety-third Congress, First Session ... September 27 and 28, 1973 |
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Common terms and phrases
administrative agency application appointed appropriate approved assurance behavioral research bill biomedical and behavioral biomedical research brain CARTER Chairman clinical investigation clinical research Code Commission concern conduct CONGRESS THE LIBRARY Cooper DHEW policy Director drug EDWARDS established ethical experiments facility family planning Federal fetus funds grant guidelines Health Service Hjornevik hospital human experimentation individual informed consent Institutional Review Boards involving human subjects issues KELSEY LAMONT-HAVERS legislation Leon Cooper LIBRARY OF CONGRESS ment mental National Board Nuremberg Code Office patient Paul O'Neill performance person physician PREYER problems procedures project or activity proposed protection of human psychosurgery question recommendations record regulations RELF responsibility review committees risk ROGERS scientific Secretary Senator KENNEDY social statement sterilization study group Subcommittee surgery thalidomide Thank therapy tion treatment United United States Code Warren Hern Welfare World Medical Association
Popular passages
Page 257 - The names of the subjects need not be divulged unless the records of the particular subjects require a more detailed study of the cases, or unless there is reason to believe that the records do not represent actual studies or do not represent actual results obtained.
Page 176 - ... representative and by an auditor witness to the oral presentation and to the subject's signature. A copy of the approved summary, annotated to show any additions, is to be signed by the persons officially obtaining the consent and by the auditor witness. Sample copies of the consent form and of the summaries as approved by the committee are to be retained in its records.
Page 250 - If the First Amendment means anything, it means that a State has no business telling a man, sitting alone in his own house, what books he may read or what films he may watch. Our whole constitutional heritage rebels at the thought of giving government the power to control men's minds.
Page 242 - In addition, the agreement, written or oral, entered into by the subject, should include no exculpatory language through which the subject is made to waive, or to appear to waive, any of his legal rights, or to release the institution or its agents from liability for negligence (the use of exculpatory clauses is contrary to public policy [Tunkl v.
Page 90 - STATEMENT OF HON. EDWARD M. KENNEDY, A US SENATOR FROM THE STATE OF MASSACHUSETTS Senator KENNEDY.
Page 261 - If at all possible, consistent with patient psychology, the doctor should obtain the patient's freely given consent after the patient has been given a full explanation.
Page 261 - ... 9. 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.
Page 59 - States information necessary to enable it to carry out this Act. Upon request of the Chairperson of the Commission, the head of such department or agency shall furnish such information to the Commission.
Page 29 - Chairman shall have the power to — (1) appoint and fix the compensation of an executive director, and such additional staff personnel as he deems necessary, without regard to the provisions of title 5, United States Code, governing appointments in the competitive service, and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates...
Page 162 - Subject at risk" means any individual who may be exposed to the possibility of injury, including physical, psychological, or social injury, as a consequence of participation as a subject in any research, development, or related activity which departs from the application of those established and accepted methods necessary to meet his needs...