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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 130
1996
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Ownership of Human Tissues and Cells: New Developments in Biotechnology

Office of Technology Assessment United S, United States. Congress. Office of Technology Assessment - Science - 2002 - 180 pages
..."short form" written consent document stating that the elements of informed consent required by §46.116 have been presented orally to the subject or the subject's...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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Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and ...

National Research Council, Policy and Global Affairs, Science, Technology, and Law Program, Committee on the Use of Third Party Toxicity Research with Human Research Participants - Science - 2004 - 226 pages
...because the limited regulatory detail provided is written in the context of clinical research (ie, "that the research presents no more than minimal risk...normally required outside of the research context" (40 CFR 117(c) (2)). As discussed in Chapter 4, the committee finds the concept of "minimal risk" to...
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Agent GCP and the Bloody Consent Form Guidebook

Daniel Farb, Bruce Gordon - Medical - 2005 - 332 pages
...short form written consent document stating that the elements of informed consent required by §46.116 have been presented orally to the subject or the subject's...research. (Approved by the Office of Management and Budget under Control Number 9999-0020.) §46.118 Applications and proposals lacking definite plans...
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The Code of Federal Regulations of the United States of America

Administrative law - 2004
...short form written consent document stating that the elements of informed consent required by §11.116 have been presented orally to the subject or the subject's...research. (Approved by the Office of Management and Budget under control number 9999-0020) §11.118 Applications and proposals lacking definite plans for...
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Medizinische Forschung an Kindern: rechtliche, ethische und ...

Dorothea Magnus - Law - 2006 - 321 pages
...subject's wishes will govern; or (2) That the research presents no more than minimal risk of härm to subjects and involves no procedures for which written...research. (Approved by the Office of Management and Budget under control number 9999-0020) §46.1 18 Applications and proposals lacking definite plans...
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The Code of Federal Regulations of the United States of America

Administrative law - 2006
...only record linking the subject and the research would be the consent document and the principal nsk would be potential harm resulting from a breach of...research. (Approved by the Office of Management and Budget under Control Number 0990-0260) [56 FR 28012, 28022. June 18, 1991, as amended at 70 FR 36328,...
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Institutional Review Board: Management and Function

Elizabeth A. Bankert, Robert J. Amdur - Medical - 2006 - 530 pages
...process most readily permitted. Documentation of informed consent may be waived when the IRB finds (1) That the only record linking the subject and the...consent is normally required outside of the research context.315"-"'"1" This section of the regulations addresses two situations where documentation of...
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Handbook of Neuroemergency Clinical Trials

Wayne M. Alves, Brett E. Skolnick - Science - 2006 - 360 pages
...wants documentation linking the subject with the research, and the subject's wishes will govern. 2. The research presents "no more than minimal risk"...outside of the research context. In cases in which the consent documentation requirement is waived, the IRB may require the investigator to provide subjects...
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Ethical Considerations for Research Involving Prisoners

Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research, Board on Health Sciences Policy, Institute of Medicine - Political Science - 2007 - 20 pages
...documentation linking the subject with the research, and the subject's wishes will govern; or jects and involves no procedures for which written consent...research. (Approved by the Office of Management and Budget under control number 0990-0260.) §46.118 Applications and proposals lacking definite plans...
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The Code of Federal Regulations of the United States of America

Administrative law - 1998
...authorized representative. A copy shall be given to the person signing the form. (b) Except as provided in paragraph (c) of this section, the consent form...which the documentation requirement Is waived, the ШВ may require the Investigator to provide subjects with a written statement regarding the research....
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