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" That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. "
Code of Federal Regulations: Containing a Codification of Documents of ... - Page 199
1994
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The Code of Federal Regulations of the United States of America

Administrative law - 1992 - 680 pages
...potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research,...subjects with a written statement regarding the research. 49 CFR Subtitle A (10-1-92 Edition) (Approved by the Office of Management and Budget under control...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 2001 - 812 pages
...potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research,...which the documentation requirement is waived, the IRE may require the investigator to provide subjects with a written statement regarding the research....
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The Code of Federal Regulations of the United States of America

Administrative law - 1983 - 458 pages
...potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research,...required outside of the research context. In cases where the documentation requirement is waived, the IRB may require the investigator to provide subjects...
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The Code of Federal Regulations of the United States of America

Administrative law - 2004 - 556 pages
...potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research,...of harm to subjects and involves no procedures for 7 CFR Subtitle A (1-1-04 Edition) which written consent is normally required outside of the research...
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The Code of Federal Regulations of the United States of America

Administrative law - 2002 - 774 pages
...potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research,...of harm to subjects and involves no procedures for §11.117 Office of the Secretary of Transportation which written consent is normally required outside...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 2002 - 780 pages
...potential harm resultinc from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research,...risk of harm to subjects and involves no procedures foi which written consent is normally required outside of the research context. In cases in which the...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 2000 - 544 pages
...subject, or the subject's legally authorized representative, sign a written consent form if it finds that the research presents no more than minimal risk...which written consent is normally required outside the research context; or (2) The IRB may, for some or all subjects, find that the requirements in §50.24...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1999 - 508 pages
...subject, or the subject's legally authorized representative, sign a written consent form if it finds that the research presents no more than minimal risk...which written consent is normally required outside the research context; or (2) The IBB may, for some or all subjects, find that the requirements in §50.24...
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The Code of Federal Regulations of the United States of America

Administrative law - 1992 - 434 pages
...subject or the subject's legally authorized representative sign a written consent form if it finds that the research presents no more than minimal risk...harm to subjects and involves no procedures for which 21 CFR Ch. I (4-1-92 Edition) written consent is normally required outside the research context. In...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1997 - 468 pages
...consent form if it finds that the research presents no more than minimal risk of §56.108 §56.111 harm to subjects and involves no procedures for which written consent is normally required outside the research context; or (2) The I RB may, for some or all subjects, find that the requirements in...
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