Code of Federal Regulations: 2000-, Parts 1-199

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U.S. General Services Administration, National Archives and Records Service, Office of the Federal Register, 1993 - Administrative law
Special edition of the Federal register, containing a codification of documents of general applicability and future effect as of ... with ancillaries.

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Page 116 - ... short form. (c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: (1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or (2) That the research...
Page 46 - Government of the entire domestic right, title and interest in and to such invention, or in any case where the Government has insufficient interest in an invention to obtain the entire domestic right, title, and interest therein (although the Government could obtain same under paragraph (a...
Page 113 - IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB, except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth in 46.108(b).
Page 114 - IRB in the same detail as described in 46.103(b)(4) and 46.103(b)(5). (7) Statements of significant new findings provided to subjects, as required by 46.116(b)(5). (b) The records required by this policy shall be retained for at least 3 years, and records relating to research which is conducted shall be retained for at least 3 years after completion of the research. All records shall be accessible for inspection and copying by authorized representatives of the department or agency at reasonable...
Page 39 - ... (6) to the National Archives of the United States as a record which has sufficient historical or other value to warrant its continued preservation by the United States Government, or for evaluation by the Administrator of General Services or his designee to determine whether the record has such value...
Page 231 - ... are allowable to the extent such charges do not exceed the normal costs of ownership such as depreciation, taxes, insurance, and maintenance, provided that no part of such costs shall duplicate any other allowed costs. c. Unless otherwise specifically provided in the...
Page 121 - Purpose. Inasmuch as prisoners may be under constraints because of their incarceration which could affect their ability to make a truly voluntary and uncoerced decision whether or not to participate as subjects in research, it is the purpose of this subpart to provide additional safeguards for the protection of prisoners involved in activities to which this subpart is applicable. 46.303 Definitions. As used in this subpart: a. Secretary...
Page 118 - Boards. (a) One or more Ethical Advisory Boards shall be established by the Secretary. Members of these board(s) shall be so selected that the board(s) will be competent to deal with medical, legal, social, ethical, and related issues and may include, for example, research scientists, physicians, psychologists, sociologists, educators, lawyers, and ethicists, as well as representatives of the general public. No board member may be a regular, full-time employee of the Department of Health and Human...
Page 178 - ... family members, favors or benefits under circumstances which might be construed by reasonable persons as influencing the performance of governmental duties. VI. Make no private promises of any kind binding upon the duties of office, since a Government employee has no private word which can be binding on public duty. VII. Engage in no business with the Government, either directly or indirectly, which is inconsistent with the conscientious performance of governmental duties. VIII. Never use any...
Page 275 - Federally assisted programs for the provision of health or welfare services, discrimination in the selection or eligibility of individuals to receive the services, and segregation or other discriminatory practices in the manner of providing them, are prohibited. This prohibition extends to all facilities and services provided by the grantee under the program or, if the grantee is a State, by a political subdivision of the State. It extends also to services purchased or otherwise obtained by the grantee...

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