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" IRB shall require documentation of informed consent or may waive documentation in accordance with §46.117. (d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or... "
The Code of Federal Regulations of the United States of America - Side 18
2004
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Ethical Decision Making in Physical Activity Research

John N. Drowatzky - 1996 - 118 sider
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Clinical Research in Pharmaceutical Development

Barry Bleidt, Michael Montagne - 1996 - 392 sider
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The Code of Federal Regulations of the United States of America

1997 - 656 sider
...approved, it shall receive the approval of a majority of those members present at the meeting. § 46. 109 IRB review of research. (a) An IRB shall review and...secure IRB approval of the research activity. If the ERB decides to disapprove a research activity, it shall include in its written notification a statement...
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The Handbook of Psychopharmacology Trials: An Overview of Scientific ...

Marc Hertzman, Douglas E. Feltner - 1997 - 492 sider
...IRB may require the investigator to provide subjects with a written statement regarding the research. (d) An IRB shall notify investigators and the institution...an opportunity to respond in person or in writing. (e) An IRB shall conduct continuing review of research covered by these regulations at intervals appropriate...
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Clinical Research Monitor Handbook: GCP Tools and Techniques, Second Edition

Deborah Rosenbaum, Fred Smith - 1998 - 544 sider
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The Ethics of Biomedical Research: An International Perspective

Baruch A. Brody - 1998 - 412 sider
...require that information given to subjects as part of informed consent is in accordance with §46.1 16. The IRB may require that information, in addition...an opportunity to respond in person or in writing. (e) An IRB shall conduct continuing review of research covered by this policy at intervals appropriate...
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Source Book in Bioethics: A Documentary History

Albert R. Jonsen, Robert M. Veatch, LeRoy Walters - 1999 - 524 sider
...require documentation of informed consent or may waive documentation in accordance with § 46.117. )dl An IRB shall notify investigators and the institution...an opportunity to respond in person or in writing. )e) An IRB shall conduct continuing review of research covered by these regulations at intervals appropriate...
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Ethics in Psychiatric Research: A Resource Manual for Human Subjects Protection

Harold Alan Pincus, Jeffrey A. Lieberman, Sandy Ferris - 1999 - 376 sider
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Ethics in Psychiatric Research: A Resource Manual for Human Subjects Protection

Harold Alan Pincus, Jeffrey A. Lieberman, Sandy Ferris - 1999 - 366 sider
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Beyond Regulations: Ethics in Human Subjects Research

Nancy M. P. King, Gail Henderson, Jane Stein - 1999 - 300 sider
...shall require documentation of informed consent or may waive documentation in accordance with § 117. (d) An IRB shall notify investigators and the institution...an opportunity to respond in person or in writing. (e) An IRB shall conduct continuing review of research covered by this policy at intervals appropriate...
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