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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 ..., Utgave 24,Deler 0-199

1993
...shall require documentation of informed consent or may waive documentation in accordance with i 60.117. (d) An IRB shall notify investigators and the Institution...decides to disapprove a research activity, it shall " 24 CFR Subtitle A (4-1-93 Edition) notification a statement of the reasons for its decision and give...
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Children As Research Subjects : Science, Ethics, and Law: Science, Ethics ...

Program in Medical Ethics Michael A. Grodin Director, Leonard H. Glantz Associate Director and Professor of Health Law both at the Boston University Schools of Medicine and Public Health - 1994 - 272 sider
...to that available on the IRB. These individuals may not vote with 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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Code of Federal Regulations: Containing a Codification of Documents of ...

1994
...the information would meaningfully add to the protection of the rights and welfare of subjects. (0) An IRB shall require documentation of informed consent...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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Radiation Experiments Conducted by the University of Cincinnati Medical ...

United States, United States. Congress. House. Committee on the Judiciary. Subcommittee on Administrative Law and Governmental Relations - 1994 - 389 sider
...require documentation of informed consent or may waive documentation in accordance with 5 219.117. (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

1995
...§46.110), review proposed research at convened meetings at which a majority of the members of the ГОВ are present, including at least one member whose primary...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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Validation Compliance Annual: 1995

International Validation Forum - 1995 - 1200 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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The Code of Federal Regulations of the United States of America

1997
...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 M.D. - 1997 - 454 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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The Ethics of Biomedical Research: An International Perspective

Baruch A. Brody, Leon Jaworski Professor of Biomedical Ethics Director of the Center for Medical Ethics and Health Policy Baruch A Brody - 1998 - 386 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 - 640 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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