 | Roger B. Dworkin - Medical - 1996 - 234 pages
...regulations require IRBs to conduct at least annual reviews of ongoing research and authorize them "to suspend or terminate approval of research that...has been associated with unexpected serious harm to subjects."36 However, as a practical matter, it is hard to expect an IRB to do more by way of monitoring... | |
 | Administrative law - 1998 - 656 pages
...approve the research if it has not been approved by an IRB. §690.113 Suspension or termination of ГОВ approval of research. An IRB shall have authority...and shall be reported promptly to the investigator, §690.116 appropriate Institutional officials, and the department or agency head. (Approved by the... | |
 | Albert R. Jonsen, Robert M. Veatch, LeRoy Walters - Medical - 1999 - 524 pages
...However, those officials may not approve the research if it has not been approved by an IRB. § 46.113— Suspension or termination of IRB approval of research...has been associated with unexpected serious harm to sub)ects. Any suspension or termination of approval shall include a statement of the reasons for the... | |
 | Nancy M. P. King, Gail Henderson, Jane Stein - Medical - 1999 - 300 pages
...safeguards have been included in the study to protect the rights and welfare of these subjects. -.113 Suspension or Termination of IRB Approval of Research...that is not being conducted in accordance with the IRB s requirements or that has been associated with unexpected serious harm to subjects. Any suspension... | |
 | James E. Mitchell, Ross D. Crosby, Stephen A. Wonderlich, David E. Adson - Medical - 2008 - 224 pages
...proposed investigations" ("Guidelines" 1993). Getting Into Trouble The text of 45 CFR 46. 1 13 reads: "An IRB shall have authority to suspend or terminate...associated with unexpected serious harm to subjects." The regulation goes on to state the necessity for the IRB to mention the causes for action and also... | |
 | David A. Gettman, Dean Arneson - Medical - 2003 - 452 pages
...of data Terminate ongoing studies subject to this part when doing so would not endanger the subjects Suspension or termination of IRB approval of research:...promptly to the investigator, appropriate institutional officials, and the FDA. Disqualification of an IRB or an institution: The commissioner may disqualify... | |
 | Daniel Farb, Bruce Gordon - Medical - 2005 - 337 pages
...However, those officials may not approve the research if it has not been approved by an IRB. §46.113 Suspension or termination of IRB approval of research....serious harm to subjects. Any suspension or termination or approval shall include a statement of the reasons for the IRB's action and shall be reported promptly... | |
 | Dorothea Magnus - Children - 2006 - 356 pages
...However, those officials may not approve the research if it has not been approved by an IRB. §46.1 13 Suspension or termination of IRB approval of research....or that has been associated with unexpected serious härm to subjects. Any Suspension or termination of approval shall include a Statement of the reasons... | |
 | Elizabeth A. Bankert, Robert J. Amdur - Institutional review boards (Medicine) - 2006 - 568 pages
...However, those officials may not approve the research if it has not been approved by an IRB. §46.113 Suspension or termination of IRB approval of research...serious harm to subjects. Any suspension or termination or approval shall include a statement of the reasons for the IRB's action and shall be reported promptly... | |
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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... 
