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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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Code of Federal Regulations: Containing a Codification of Documents of ...

1986
...modifications in (to secure Approval), or disapprove all research activities covered by these regulations. (b) An IRB shall require that information given to...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 Use of Human Biological Materials in the Development of Biomedical ...

United States. Congress. House. Committee on Science and Technology. Subcommittee on Investigations and Oversight - 1986 - 278 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...activity, it shall include in its written notification 1 Reports should be filed with the Office for Protection from Research Risks. National Intutuiei of...
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Designer Drugs: Hearing Before the Subcommittee on Crime of the Committee on ...

United States. Congress. House. Committee on the Judiciary. Subcommittee on Crime - 1986 - 199 sider
...IRB's judgment the information would meaningfully add to the protection of the rights and welfare of ((c/ An IRB shall require documentation of informed...activity, it shall include in its written notification 1 Reports should be Tiled with rhc Office for Protection from Research Ritki. Nanonal Institutes of...
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The use of human biological materials in the development of biomedical ...

United States. Congress. House. Committee on Science and Technology. Subcommittee on Investigations and Oversight - 1986 - 278 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...activity, it shall include in its written notification ' Reports should be filed with the Office for Protection from Research Risks, Nation! Institutes of...
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The use of human biological materials in the development of biomedical ...

United States. Congress. House. Committee on Science and Technology. Subcommittee on Investigations and Oversight - 1986 - 278 sider
...require documentation of informed consent or may waive documentation in accordance with § 46. 1 17. «1) An IRB shall notify investigators and the institution...activity, it shall include in its written notification 1 Reponi should be tiled with the Office for Protection from Research Risks. National InttituWi of...
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Designer Drugs: Hearing Before the Subcommittee on Crime of the Committee on ...

United States. Congress. House. Committee on the Judiciary. Subcommittee on Crime - 1986 - 199 sider
...documentation of informed consent or may waive documentation in accordance with 5 46.117. (d) An lRB shall notify investigators and the institution in...research activity, or of modifications required to secure lRB approval of the research activity. lf the lRB decides to disapprove a research activity, it shall...
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Ethics and Regulation of Clinical Research

Robert J. Levine - 1988 - 452 sider
...investigators and the institution in writing of its decision to approve or disapprove the proposed research activity. If the IRB decides to disapprove...written notification a statement of the reasons for its decisions and give the investigator an opportunity to respond in person or in writing. (e) An IRB shall...
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The Code of Federal Regulations of the United States of America

1994
...activity, or of modiflcaioat required to secure IRB approval jf the research activity. If the ШВ de:ides to disapprove a research activity, It shall include...Investigator an opportunity to respond in person or In fitting. (e) An IRB shall conduct continuing review of research covered by this policy at Intervals...
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The Code of Federal Regulations of the United States of America

2004
...activity, or of modifications required to secure IBB approval of the research activity. If the IBB decides to disapprove a research activity, it shall...reasons for its decision and give the investigator an opportunitsr to respond in person or in writing. (e) An IBB shall conduct continuing review of research...
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The Code of Federal Regulations of the United States of America

1992
...with S 690.117. (d) An IRB shall notify investigators and the institution in writing of its de cision to approve or disapprove the proposed research activity,...statement of the reasons for its decision and give the investigs tor an opportunity to respond in person or in writing. (e) An IRB shall conduct continuing...
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