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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 20
2004
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Beyond Regulations: Ethics in Human Subjects Research

Nancy M. P. King, Gail Henderson, Jane Stein - 1999 - 279 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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The Code of Federal Regulations of the United States of America

2000
...approved, it shall receive the approval of a majority of those members present at the meeting. §46.109 1KB review of research. (a) An IRB shall review and have...an opportunity to respond in person or in writing. (e) An IBB shall conduct continuing review of research covered by this policy at intervals appropriate...
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Suspension of Medical Research at West Los Angeles and Sepulveda VA Medical ...

United States. Congress. House. Committee on Veterans' Affairs. Subcommittee on Oversight and Investigations - 2000 - 253 sider
...approval of the research activity. (2) lf the lRB decides to disapprove a research activity, it will include in its written notification a statement of...an opportunity to respond in person or in writing. c. Maintaining Written Procedures for Operations. An lRB will follow written procedures: (1) For conducting...
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Ownership of Human Tissues and Cells: New Developments in Biotechnology

Office of Technology Assessment United S, United States. Congress. Office of Technology Assessment - 2002 - 180 sider
...rights and welfare of subjects. (c) An IRB shall require documentation of informed consent or may have documentation in accordance with §46.117. (d) An...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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The Code of Federal Regulations of the United States of America

2003
...policy each IRB shall: (a) Follow written procedures in the same detail as described in §46.103(b)(4t and, to the extent required by. §46.103(b)(5). (b)...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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Agent GCP and the Bloody Consent Form Guidebook

Daniel Farb, Bruce Gordon - 2005 - 332 sider
...a conflicting interest, except to provide information requested by the IRB. §46.108 IRB functions and operations. In order to fulfill the requirements...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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Medizinische Forschung an Kindern: rechtliche, ethische und ...

Dorothea Magnus - 2006 - 321 sider
...require documentation of informed consent or may waive documentation in accordance with §46.1 17. (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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The Code of Federal Regulations of the United States of America

2004
...shall require documentation of informed consent or may waive documentation in accordance with §11.117. (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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The Code of Federal Regulations of the United States of America

2006
...approved, it shall receive the approval of a majority of those members present at the meeting. 546.109 IRB review of research. (a) An IRB shall review and...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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Institutional Review Board: Management and Function

Elizabeth A. Bankert, Robert J. Amdur - 2006 - 530 sider
...16. The IRB may require that information, in addition to that specifically mentioned in §46. 1 1 6, be given to the subjects when in the IRB's judgment...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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