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" IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy. (b) An IRB shall require that information given to subjects as... "
The Code of Federal Regulations of the United States of America - Page 18
1998
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The Code of Federal Regulations of the United States of America

1996 - 590 pages
...addition to that specifically mentioned in §97.116, be given to 34 CFR Subtitle A (7-1-96 Edition) the subjects when in the IRB's judgment the information...consent or may waive documentation in accordance with §97.117. (d) An IRB shall notify investigators and the institution in writing of its decision to approve...
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Code of Federal Regulations: Containing a Codification of Documents of ...

2001 - 524 pages
...50.25. The IRB may require that information, in addition to that specifically mentioned in §50.25, be given to the subjects when in the IRB's judgment...IRB shall require documentation of informed consent in accordance with §50.27 of this chapter, except as follows: (1) The IRB may, for some or all subjects,...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1996 - 460 pages
...§50.25. The IRB may require that inforroation, in addition to that specifically mentioned in §50.25, be given to the subjects when in the IRB's judgment...IRB shall require documentation of informed consent in accordance with §50.27, except that the IRB may, for some or all subjects, waive the requirement...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1994 - 738 pages
...in addition to that specifically mentioned in §1028.116, be given to the subjects when in the IRB s judgment the information would meaningfully add to...consent or may waive documentation in accordance with S 1028.117. (d) An IRB shall notify investigators and the institution in writing of its decision to...
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Protecting Human Subjects: First Biennial Report on the Adequacy and ...

United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research - 1981 - 286 pages
...in addition to that specifically mentioned in § 46.116, be given to the subjects when in the IRB 's judgment the information would meaningfully add to...documentation in accordance with § 46.117. (d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1983 - 456 pages
...modifications in (to secure approval), or disapprove all research activities covered by these regulations. (b) An IRB shall require that information given to...documentation in accordance with §46.117. (d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1986 - 486 pages
...modifications in (to secure Approval), or disapprove all research activities covered by these regulations. (b) An IRB shall require that information given to...documentation in accordance with § 46.117. (d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove...
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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 - 288 pages
...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...documentation in accordance with § 46.117. (d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove...
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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 - 288 pages
...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...consent or may waive documentation in accordance with § 46. 1 17. «1) An IRB shall notify investigators and the institution in writing of its decision...
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Ethics and Regulation of Clinical Research

Robert J. Levine - 1988 - 484 pages
...46.116. The IRB may require that information, in addition to that specifically mentioned in § 46. 1 16, be given to the subjects when in the IRB's judgment...documentation in accordance with § 46.117. (d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove...
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