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" ... short form. (c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: (1) That the only record linking the subject and the research would be the consent document and the... "
Code of Federal Regulations: Containing a Codification of Documents of ... - Page 253
2000
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Miltary Medical Ethics, Volume 2

...form written consent document stating that the elements of informed consent required by Sec. 219.116 have been presented orally to the subject or the subject's...which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research....
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The Gift of Participation: A Guide to Making Informed Decisions about ...

Kenneth Getz - Clinical trials - 2007 - 360 pages
...be potential harm resulting from a breach of confidentiality. Each subject will be asked whetherthe subject wants documentation linking the subject with...outside of the research context. In cases in which the documenta296 tion requirement is waived, the IRB may require the investigator to provide subjects with...
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