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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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H.R. 1271--the Family Privacy Protection Act of 1995: Hearing Before the ...

U. S. Congress Senate Committee on Governmental Affairs Staff, United States, United States. Congress. Senate. Committee on Governmental Affairs - Digital images - 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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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...subjects with a written statement regarding the research. 46. 7 18 Applications and Proposals Lacking Definite Plans for Involvement of Human Subjects Certain...
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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...statement regarding the research. (Approved by the Off1ce of Management and Budget under Control Number 9999-0020). APPENDIX C CIOMS Epidemiological Research...
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The Code of Federal Regulations of the United States of America

Administrative law - 2000
...representative. When this method is used, there shall be a witness to the oral presentation. Also, the ERB shall approve a written summary of what is to be said...the research. (Approved by the Office of Management anc Budget under control number 9999-0020) {16.118 Applications and proposals lacking definite plans...
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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...provide subjects with a written statement regarding research. (Approved by the Office of Management and Budget under Control Number 9999-0020.) 9.12 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...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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The Code of Federal Regulations of the United States of America

Administrative law - 2001
...for the investigator to obtain a signed consent form for some or all subjects if it finds either: (l) That the only record linking the subject and the research...research. (Approved by the Office of Management and Budget under control number 9999-0020) (Authority: 5 USC 301; 20 USC 1221e-3, 3474; and 42 USC 300v-1(b))...
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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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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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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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