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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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Human Radiation Experiments: Hearing Before the Committee on Governmental ...

United States, United States. Congress. Senate. Committee on Governmental Affairs - Gene therapy - 1996 - 434 pages
...a breach of confidentiality. Informed consent can also be waived under HHS and FDA regulations when the research presents no more than minimal risk of...normally required outside of the research context GAO/HEHS-M-72 Protecting 6 • Research Subjects research motivates researchers and IKBS to follow...
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Medical Ethics

Robert M. Veatch - Medical - 1997 - 461 pages
...or the subject's legally authorized representative. A copy shall be given to the person signing the form. (c) An IRB may waive the requirement for the...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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H.R. 1271--the Family Privacy Protection Act of 1995: Hearing Before the ...

U. S. Congress Senate Committee on Governmental Affairs Staff, United States. Congress. Senate. Committee on Governmental Affairs, United States - Domestic relations - 1997 - 196 pages
...individual with the research conducted and this would present a potential risk to the individual; or, 2)when the research presents no more than minimal risk of...normally required outside of the research context. 2. What is the relation of Federal guidelines to State or local laws or rules affecting research? To...
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Oversight of NIH and FDA: Bioethics and the Adequacy of Informed Consent ...

U. S. Government Staff, United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources - Bioethics - 1997 - 228 pages
...person or in writing. The IRB must approve the informed consent fora that will be used. If it finds that the research presents no more than minimal risk...which written consent is normally required outside the research context, the IRB may waive the requirement that informed consent be documented. Where...
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The Ethics of Biomedical Research: An International Perspective

Baruch A. Brody, Leon Jaworski Professor of Biomedical Ethics Director of the Center for Medical Ethics and Health Policy Baruch A Brody - Medical - 1998 - 386 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...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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Clinical Trial Subjects: Adequate FDA Protections? : Hearing Before the ...

United States, United States Government Printing Office, United States. Congress. House. Committee on Government Reform and Oversight - Clinical trials - 1998 - 217 pages
...person or in writing. The IRB must approve the informed consent form that will be used. If it finds that the research presents no more than minimal risk...which written consent is normally required outside the research context, the IRB may waive the requirement that infoned consent be documented. Where the...
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Beyond Regulations: Ethics in Human Subjects Research

Nancy M. P. King, Gail Henderson, Jane Stein - Medical - 1999 - 279 pages
...requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: breach of confidentiality. Each subject will be asked...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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Suspension of Medical Research at West Los Angeles and Sepulveda VA Medical ...

United States. Congress. House. Committee on Veterans' Affairs. Subcommittee on Oversight and Investigations - Informed consent (Medical law) - 2000 - 253 pages
...wants documentation linking the subject with the research, and the subject's wishes will govern; or (b) That the research presents no more than minimal risk...which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding research. (Approved...
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Suspension of Medical Research at West Los Angeles and Sepulveda VA Medical ...

United States. Congress. House. Committee on Veterans' Affairs. Subcommittee on Oversight and Investigations - Informed consent (Medical law) - 2000 - 253 pages
...wants documentation linking the subject with the research, and the subject's wishes will govern; or (b) That the research presents no more than minimal risk...normally required outside of the research context. ln cases in which the documentation requirement is waived, the lRB may require the investigator to...
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Psychological Perspectives on Prayer: A Reader

Leslie John Francis, Jeff Astley - Religion - 2001 - 392 pages
...requirement for the investigator to obtain a signed consent form for some or all subjects if it finds . . . that the research presents no more than minimal risk...normally required outside of the research context. Scientifically, a study design with complete blinding was preferred because it eliminated any possibility...
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