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" Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm... "
Code of Federal Regulations: Containing a Codification of Documents of ... - Page 107
1982
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Code of Federal Regulations: Containing a Codification of Documents of ...

1988 - 584 pages
...expedited review procedure, if the research involves no more than minimal risk. The IRB may also use the expedited review procedure to review minor changes...investigator, appropriate institutional officials, and the Secretary.1 [46 PR 8386, Jan. 26, 1981; 46 PR 19195. Mar. 27. 1981] § 46.114 Cooperative research....
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The Code of Federal Regulations of the United States of America

1983 - 458 pages
...45— Public Welfare dure, if the research involves no more than minimal risk. The IRB may also use the expedited review procedure to review minor changes...IRB's action and shall be reported promptly to the investiga§46.111 §46.116 tor, appropriate institutional officials, and the Secretary. ' [46 FR 8386,...
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The Code of Federal Regulations of the United States of America

1993 - 592 pages
...rights and welfare of these subjects. § 46.112 Review by institution. Research covered by this policy that has been approved by an IRB may be subject to...investigator, appropriate institutional officials, and the department or agency head. (Approved by the Office of Management and Budget under control number 99990020)...
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The Code of Federal Regulations of the United States of America

1997 - 652 pages
...rights and welfare of these subjects. §46.112 Review by institution. Research covered by this policy that has been approved by an IRB may be subject to...statement of the reasons for the IRB's action and shall be 45 CFR Subtitle A (10-1-97 Edition) reported promptly to the investigator, appropriate institutional...
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Code of Federal Regulations: Containing a Codification of Documents of ...

2000 - 688 pages
...However, those officials may not approve the research if it has not been approved by an IRB. N•690.113 Suspension or termination of IRB approval of research....investigator, appropriate institutional officials, and the department or agency head. (Approved by the Office of Management and Budget under control number 9999-0020)...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1996 - 624 pages
...However, those officials may not approve the research if it has not been approved by an IRB. §lc.H3 Suspension or termination of IRB approval of research....and shall be reported promptly to the investigator. /trtm/li conducted shall be retained iat 3 years after completion of rch. All records shall be accesinspection...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1994 - 492 pages
...approve the research if it has not been approved by an IRB. §27.113 Suspension or termination of 1KB approval of research. An IRB shall have authority...investigator, appropriate institutional officials, and the department or agency head. (Approved by the Office of Management and Budget under Control Number 999SHJ020)...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1997 - 788 pages
...an IRB. 106 ill. Ill §11.116 §11.113 Suspension or termination of IRB approval of research. An IBB shall have authority to suspend or terminate approval...investigator, appropriate institutional officials, and the department or agency head. (Approved by the Office of Management and Budget under control number 9999-0020)...
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The Code of Federal Regulations of the United States of America

1998 - 956 pages
...However, those officials may not approve the research if it has not been approved by an IRB. i 745. 113 Suspension or termination of IRB approval of research....statement of the reasons for the IRB's action and shall be §745.114 reported promptly to the investigator, appropriate institutional officials, and the department...
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The Code of Federal Regulations of the United States of America

1991 - 424 pages
...However, those officials may not approve the research if it has not been approved by an IRB. § 56.113 Suspension or termination of IRB approval of research....termination of approval shall include a statement of the §56.111 Food and Drug Administration, HHS reasons for the IRB's action and shall be reported promptly...
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