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 |
From inside the book
Results 1-5 of 59
Page 4
... written rules , the arts as we know them would be annihilated and ... could never be resurrected because ... this law [ would put ] an embargo on all research . The result would be that life which is hard enough as it is , would be ...
... written rules , the arts as we know them would be annihilated and ... could never be resurrected because ... this law [ would put ] an embargo on all research . The result would be that life which is hard enough as it is , would be ...
Page 26
... written , may include any exculpa- tory language " through which the subject is made to waive or appear to waive any legal rights or release the investiga- tor , the sponsor , the institution or its agents from liability for negligence ...
... written , may include any exculpa- tory language " through which the subject is made to waive or appear to waive any legal rights or release the investiga- tor , the sponsor , the institution or its agents from liability for negligence ...
Page 36
... written tellingly of the cost to an IRB's " local credibility " if it identifies the source of its authority and responsibility as resting outside the institution . Robert J. Levine , Ethics and Regulation of Clinical Research , Urban ...
... written tellingly of the cost to an IRB's " local credibility " if it identifies the source of its authority and responsibility as resting outside the institution . Robert J. Levine , Ethics and Regulation of Clinical Research , Urban ...
Page 37
... written assurance that they will comply with the HHS regulations to protect human subjects . An institution's assurance of compliance must be approved by the Office for Protection from Research Risks ( OPRR ) within the Office of the ...
... written assurance that they will comply with the HHS regulations to protect human subjects . An institution's assurance of compliance must be approved by the Office for Protection from Research Risks ( OPRR ) within the Office of the ...
Page 47
... written procedures which the IRB will follow " for " conducting its ... continuing re- view of research . . . " and for " determining which projects require review more often than annually ... " 45 CFR §46.109 ( e ) states that an IRB ...
... written procedures which the IRB will follow " for " conducting its ... continuing re- view of research . . . " and for " determining which projects require review more often than annually ... " 45 CFR §46.109 ( e ) states that an IRB ...
Other editions - View all
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.