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 - 271 sider |
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Side 4
... tion and incentive . 1 Plato , Statesman * 229e ( J.B. Skemp trans . ) , Yale University Press , New Haven ( 1952 ) at 208 . Introduction 1 The Mandate The Commission's mandate regarding the protection 4 Protecting Human Subjects.
... tion and incentive . 1 Plato , Statesman * 229e ( J.B. Skemp trans . ) , Yale University Press , New Haven ( 1952 ) at 208 . Introduction 1 The Mandate The Commission's mandate regarding the protection 4 Protecting Human Subjects.
Side 11
... tion From Research Risks , Office of the Director , NIH , assisted by Richard Riseberg , Chief , NIH Branch , Office of General Counsel , John C. Petricciani , M.D. , Assistant Director for Clinical Research , Bureau of Biologics , FDA ...
... tion From Research Risks , Office of the Director , NIH , assisted by Richard Riseberg , Chief , NIH Branch , Office of General Counsel , John C. Petricciani , M.D. , Assistant Director for Clinical Research , Bureau of Biologics , FDA ...
Side 12
... tion and will be released early in 1982 . Extent of Federal Involvement in Research with Human Subjects Annual expenditures for health - related research are now about $ 8 billion , of which the Federal government con- tributes more ...
... tion and will be released early in 1982 . Extent of Federal Involvement in Research with Human Subjects Annual expenditures for health - related research are now about $ 8 billion , of which the Federal government con- tributes more ...
Side 15
... tion of human subjects of Federally funded and regulated research was conducted by the Commission in 1980-81 in response to the legislative mandate that the Commission re- port biennially to the President , the Congress and the heads of ...
... tion of human subjects of Federally funded and regulated research was conducted by the Commission in 1980-81 in response to the legislative mandate that the Commission re- port biennially to the President , the Congress and the heads of ...
Side 19
... tion of research involving human subjects supplied to the Federal agencies was compatible with the scope of the then existing HHS regulations which applied to , among other things , the administration of surveys or questionnaires and ...
... tion of research involving human subjects supplied to the Federal agencies was compatible with the scope of the then existing HHS regulations which applied to , among other things , the administration of surveys or questionnaires and ...
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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
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Side 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.
Side 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...
Side 95 - A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained...
Side 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.
Side 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...
Side 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.
Side 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.
Side 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...
Side 102 - ... and the purpose of the activity is the development of important biomedical knowledge, which cannot be obtained by other means, or 2.
Side 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.