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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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The Code of Federal Regulations of the United States of America

2000 - 682 sider
...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 - 268 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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Risk Management Handbook for Health Care Organizations

Roberta Carroll - 2001 - 971 sider
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Clinical Research Coordinator Handbook: GCP Tools and Techniques, Second Edition

Deborah Rosenbaum, Michelle Dresser - 2001 - 358 sider
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Lessons in Law and Aging: A Tool for Educators and Students

Marshall B. Kapp - 2001 - 248 sider
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Institutional Review Board: Management and Function

Robert J. Amdur, Elizabeth A. Bankert - 2002 - 630 sider
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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 - 184 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 - 756 sider
...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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Baldrige Award Winning Quality -- 18th Edition: How to Interpret the ...

Mark Graham Brown - 2013 - 244 sider
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