Protecting Human Subjects: First Biennial Report on the Adequacy and Uniformity of Federal Rules and Policies, and Their Implementation for the Protection of Human Subjects in Biomedical and Behavioral ResearchPresident's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 1981 - Government publications - 271 pages |
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... Human Subjects in Biomedical and Behavioral Research United States. President's Commission for the Study of Ethical ... Human Subjects . " The Commission is directed by $ 1802 ( c ) of the Public Health Service Act to report every two ...
... Human Subjects in Biomedical and Behavioral Research United States. President's Commission for the Study of Ethical ... Human Subjects . " The Commission is directed by $ 1802 ( c ) of the Public Health Service Act to report every two ...
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... Human Subjects in Biomedical and Behavioral Research United States. President's Commission for the Study of Ethical ... Human Subjects . " The Commission is directed by $ 1802 ( c ) of the Public Health Service Act to report every two ...
... Human Subjects in Biomedical and Behavioral Research United States. President's Commission for the Study of Ethical ... Human Subjects . " The Commission is directed by $ 1802 ( c ) of the Public Health Service Act to report every two ...
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... Research Involving Human Subjects Conducted or Supported by Agencies with Statutory Liaisons to the Com- mission 13 2. Agencies Excluded from Review and Analysis in This Report 16 3. Agencies Included in This Report's Review and ...
... Research Involving Human Subjects Conducted or Supported by Agencies with Statutory Liaisons to the Com- mission 13 2. Agencies Excluded from Review and Analysis in This Report 16 3. Agencies Included in This Report's Review and ...
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... involved in some fashion in research involving human subjects . It is impressed that the officials of these agencies are for the most part concerned about the careful execution of their responsibilities and concludes that the rules and ...
... involved in some fashion in research involving human subjects . It is impressed that the officials of these agencies are for the most part concerned about the careful execution of their responsibilities and concludes that the rules and ...
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... in Medicine and Biomedical and Behavioral Research. The second major area of Commission recommenda- tions centers on improving the present handling of reports of harm or misconduct involving human subjects . Although such reports are not ...
... in Medicine and Biomedical and Behavioral Research. The second major area of Commission recommenda- tions centers on improving the present handling of reports of harm or misconduct involving human subjects . Although such reports are not ...
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Common terms and phrases
addition Air Force appropriate award Behavioral Research Biomedical and Behavioral Boston University Central Intelligence Agency Commission's Committee compliance conducted or supported consent form Consent Provisions contracts debarment Department of Defense Department of Health determine Development Director documents Ethical evaluation Federal agencies Federal Register fetus financial assistance funds grant Health and Human hearing HHS regulations 45 human research Human Services identified implementation individual informed consent Injuries and Complaints Institutional Review Board involving human subjects IRB members IRB review letter Memorandum misconduct NASA NHTSA Office OPRR participation Patricia Roberts Harris policies President's Commission principal investigator programs protection of human protocol recommendations records regulations 45 CFR Reporting of Injuries research conducted research involving human research projects research with human responsible review and approval Review Procedures Review Standards risks to subjects Secretary staff submitted subpart support research suspension termination tion vitro fertilization
Popular passages
Page 25 - 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; and (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, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
Page 95 - A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable; (2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent; (3) Any additional costs to the subject that may result from participation in the research; (4) The consequences of a subject's decision to withdraw from the research...
Page 95 - A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained...
Page 109 - Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available, or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
Page 113 - 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...
Page 88 - 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 96 - IRB finds and documents that: (1) The research involves no more than minimal risk to the subjects; (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects; (3) The research could not practicably be carried out without the waiver or alteration; and (4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Page 16 - Private information" includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be...
Page 102 - ... and the purpose of the activity is the development of important biomedical knowledge, which cannot be obtained by other means, or 2.
Page 25 - ... medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; 7. 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; and 8.