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" ... 1 . a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are... "
Code of Federal Regulations: Containing a Codification of Documents of ... - Page 268
1999
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Ethics in Neurobiological Research with Human Subjects: The Baltimore ...

Adil E. Shamoo - Medical - 1996 - 280 pages
...investigator considers most likely, or the least objectionable risks, but any reasonably foreseeable risks. 3. A description of any benefits to the subject or...appropriate alternative procedures or courses of treatment that might be advantageous to the subject. This is an important element that is often omitted entirely...
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Human Radiation Experiments: Hearing Before the Committee on Governmental ...

DIANE Publishing Company - 1998 - 434 pages
...the informed consent process. The regulations specif}' eight required elements of informed consent: 1) A statement that the study involves research, an...confidentiality of records identifying the subject will be maintained. 6) For research involving more than minimal risk, an explanation as to whether any compensation...
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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
...experimental; (2) a description of any reasonably foreseeable risks or discomforts to the subject; (4) a disclosure of appropriate alternative procedures...confidentiality of records identifying the subject will be maintained; (6) for research involving more than minimal risk, an explanation as to whether any...
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Source Book in Bioethics: A Documentary History

Albert R. Jonsen, Robert M. Veatch, LeRoy Walters - Medical - 1999 - 640 pages
...reasonably foreseeable risks or discomforts to the sub)ect; )3) A description of any benefits to the sub)ect or to others which may reasonably be expected from...treatment, if any, that might be advantageous to the sub)ect; )5) A statement describing the extent, if any, to which confidentiality of records identifying...
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Medical Care Law

Edward P. Richards, Katharine C. Rathbun - Law - 1999 - 520 pages
...similar arrangements for avoiding duplication of effort.21 General Requirements for Informed Consent22 Except as provided elsewhere in this policy, no investigator...confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any...
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Institutional Review Boards, a System in Jeopardy: Hearing Before the ...

United States, United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources - Clinical trials - 1999 - 179 pages
...to that picture. DHHS regulations specify 14 elements of informed consent, 8 of which are required: 1) A statement that the study involves research, an...confidentiality of records identifying the subject will be maintained. 6) For research involving more than minimal risk, an explanation as to whether any compensation...
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Institutional Review Boards, a System in Jeopardy: Hearing Before the ...

United States, United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources - Clinical trials - 1999 - 179 pages
...that picture. DHHS regulations specify l4 elements of informed consent, 8 of which are required: l ) A statement that the study involves research, an explanation...confidentiality of records identifying the subject will be maintained. 6) For research involving more than minimal risk, an explanation as to whether any compensation...
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Case Studies in Nursing Ethics

Sara T. Fry, Robert M. Veatch - Medical - 2000 - 402 pages
...does, whether the consent is adequate for the purpose. Federal Regulations: Basic Elements of Consent 1 . A statement that the study involves research,...confidentiality of records identifying the subject will be maintained; 6. For research involving more than minimal risk, an explanation as to whether any compensation...
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Do Current Federal Regulations Adequately Protect People who Participate in ...

United States. Congress. House. Committee on Government Reform. Subcommittee on Criminal Justice, Drug Policy, and Human Resources - Electronic government information - 2000 - 144 pages
...to that picture. DHHS regulations specify 14 elements of informed consent, 8 of which are required: 1) A statement that the study involves research, an...confidentiality of records identifying the subject will be maintained. 6) For research involving more than minimal risk, an explanation as to whether any compensation...
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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
...that picture. Federal regulations specify 14 elements of informed consent, 8 of which are required: (1) A statement that the study involves research,...confidentiality of records identifying the subject will be maintained. (6) For research involving more than minimal risk, an explanation as to whether any...
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