The Code of Federal Regulations of the United States of America

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U.S. Government Printing Office, 1991
The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.
 

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Common terms and phrases

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Էջ 325 - Subject an individual to segregation or separate treatment in any matter related to his receipt of any service, financial aid, or other benefit under the program...
Էջ 124 - IRB's use of the expedited review procedure. §690.111 Criteria for IRB approval of research. (a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied: (1) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or...
Էջ 46 - The Government shall obtain the entire domestic right, title and interest in and to all inventions made by any Government employee (i) during working hours, or (ii) with a contribution by the Government of facilities, equipment, materials, funds, or information, or of time or services of other Government employees on official duty, or (iii) which bear a direct relation to or are made in consequence of the official duties of the inventor.
Էջ 126 - An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above...
Էջ 337 - ... other entity, or any individual, in any State, to whom Federal financial assistance is extended, directly or through another recipient, for any program, including any successor, assign, or transferee thereof, but such term does not include any ultimate beneficiary under any such program. (i) The term "primary recipient...
Էջ 120 - Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.
Էջ 258 - Secretary or his delegate, under any of the following methods: (1) the straight line method, (2) the declining balance method, using a rate not exceeding twice the rate which would have been used had the annual allowance been computed under the method described in paragraph (1).
Էջ 125 - ... (1) 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; (3) A description of any benefits to the subject or to others which may reasonably be expected from the research; (4) A disclosure of appropriate alternative...
Էջ 124 - Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in...
Էջ 67 - An individual or family that has a primary nighttime residence that is: (i) A supervised publicly or privately operated shelter designed to provide temporary living accommodations (including welfare hotels, congregate shelters, and transitional housing for the mentally ill); (ii) An institution that provides a temporary residence for individuals intended to be institutionalized; or (ill) A public or private place not designed for, or ordinarily used as, a regular sleeping accommodation for human...

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