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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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Contrasts in American and Jewish Law

Daniel Pollack - Law - 2001 - 255 pages
...representative"). 806. See 45 CFR § 46.117(c) (2) (stating that the IRB may waive the signedconsent requirement if "the research presents no more than minimal risk of...normally required outside of the research context"); see also id. § 46.116(d) (1) (stating that the IRB may approve experimentation even if all the elements...
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How to Evaluate and Improve Your Grants Effort

David G. Bauer - Education - 2001 - 320 pages
...for a signed consent form is if the form is the only record linking the subject to the research or if the research presents no more than minimal risk of...normally required outside of the research context.) The detailed requirements for a consent form are described in OPRR Reports and in the IRB Guidebook...
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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
...a potential breach of confidentiality. Similarly, documentation can be waived when a study involves no more than minimal risk of harm to subjects and...normally required outside of the research context (45 CFR 46.117(c)). With the prospect of commercial gain and the use of exculpatory language, some...
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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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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...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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Medizinische Forschung an Kindern: rechtliche, ethische und ...

Dorothea Magnus - Law - 2006 - 321 pages
...subject and the research would be the consent document and the principal risk would be potential härm resulting from a breach of confidentiality. Each subject...the research presents no more than minimal risk of härm to subjects and involves no procedures for which written consent is normally required outside...
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Agent GCP and the Bloody Consent Form Guidebook

Daniel Farb, Bruce Gordon - Medical - 2005 - 332 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 Sec....
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The Total Survey Error Approach: A Guide to the New Science of Survey Research

Herbert F. Weisberg - Social Science - 2009 - 336 pages
...46.117c) indicate that IRBs can waive requirements for signed consent forms when the research poses only minimal risk of harm to subjects and involves no procedures...normally required outside of the research context, but local IRBs are responsible for interpreting these regulations. An IRB is most likely to require...
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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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Institutional Review Board: Management and Function

Elizabeth A. Bankert, Robert J. Amdur - Medical - 2006 - 530 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, find that the requirements in Sec. 50.24...
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