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 |
Inni boken
Resultat 1-5 av 66
Side
... Staff Alexander M. Capron , LL.B. , Executive Director Deputy Director Administrative Officer Barbara Mishkin , M.A. , J.D. Anne Wilburn Support Staff Assistant Directors Florence Chertok Joanne Lynn , M.D. Ruth Morris Alan J. Weisbard ...
... Staff Alexander M. Capron , LL.B. , Executive Director Deputy Director Administrative Officer Barbara Mishkin , M.A. , J.D. Anne Wilburn Support Staff Assistant Directors Florence Chertok Joanne Lynn , M.D. Ruth Morris Alan J. Weisbard ...
Side 6
... staff was also in touch with the Commission on the Federal Drug Approval Process , sponsored by Representatives Scheuer and Gore . That body is now reported to have decided not to disturb the status quo regarding the responsibilities of ...
... staff was also in touch with the Commission on the Federal Drug Approval Process , sponsored by Representatives Scheuer and Gore . That body is now reported to have decided not to disturb the status quo regarding the responsibilities of ...
Side 9
... staff , for more than a year has been , and continues to be , engaged in correspondence and meetings with officials at the Department of Health and Human Services in an attempt to clarify current Departmen- tal policies and procedures ...
... staff , for more than a year has been , and continues to be , engaged in correspondence and meetings with officials at the Department of Health and Human Services in an attempt to clarify current Departmen- tal policies and procedures ...
Side 10
... staff particpated in a number of conferences on the role and re- sponsibilities of IRBS , the need for improved education of investigators and members of IRBS , and the effect that the revised HHS regulations will have on IRB procedures ...
... staff particpated in a number of conferences on the role and re- sponsibilities of IRBS , the need for improved education of investigators and members of IRBS , and the effect that the revised HHS regulations will have on IRB procedures ...
Side 11
... staff of the sponsoring organizations . ( See Appendix J. ) The conclusions and recommendations of the Workshop were transmitted to members of the Commission and were taken into consideration in developing recom- mendations on this ...
... staff of the sponsoring organizations . ( See Appendix J. ) The conclusions and recommendations of the Workshop were transmitted to members of the Commission and were taken into consideration in developing recom- mendations on this ...
Andre utgaver - Vis alle
Vanlige uttrykk og setninger
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
Populære avsnitt
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.