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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 270
1999
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Issues in Palliative Care Research

Russell K. Portenoy, Eduardo Bruera - Medical - 2003 - 432 pages
...subject 3. A description of any benefits to the subject or to others that may reasonably be expected 4. A disclosure of appropriate alternative procedures...confidentiality of records identifying the subject will be maintained 6. An explanation as to whether any compensation or medical treatments are available...
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Environmental Contaminants: Assessment and Control

Daniel A. Vallero - Business & Economics - 2004 - 801 pages
...expected duration of the subject's participation D. a description of the procedures to be followed E. identification of any procedures which are experimental...confidentiality of records identifying the subject will be maintained 6 A. an explanation as to whether any compensation is available if injury occurs B. an...
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Clinical Contact Lens Practice

Edward S. Bennett, Barry A. Weissman - Medical - 2005 - 1072 pages
...risks or discomforts to the subject 3. A description of any benefits to the subject or to others that may reasonably be expected from the research 4. A...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 Code of Federal Regulations of the United States of America

Administrative law - 2004
...reasonable manner. (Approved by the Office of Management and Budget under control number 9999-0020) 11.116 General requirements for informed consent. Except...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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Medizinische Forschung an Kindern: rechtliche, ethische und ...

Dorothea Magnus - Law - 2006 - 321 pages
...institution or its agents from liability for negligence. (a) Basic elements of informed consent. Except s provided in paragraph (c) or (d) of this section,...confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation s to whether any...
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Agent GCP and the Bloody Consent Form Guidebook

Daniel Farb, Bruce Gordon - Medical - 2005 - 332 pages
...51528, Oct. 2, 1996] Sec. 50.25 Elements of informed consent. (a) Basic elements of informed consent. In seeking informed consent, the following information...confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the...
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Measurement in Nursing and Health Research

Carolyn Feher Waltz - Medical - 2005 - 461 pages
...Department of Health and Human Services, 200 Ib) the information provided to the potential subject includes: (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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Clinical Evaluation of Medical Devices: Principles and Case Studies

Karen M. Becker, John J. Whyte - Technology & Engineering - 2007 - 360 pages
...risks or discomfort to the patient. 3. A description of any benefits to the subject or to others that may reasonably be expected from the research. 4. A...confidentiality of records identifying the subject will be maintained and that notes the possibility that the FDA may inspect the records. 6. For research...
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Institutional Review Board: Management and Function

Elizabeth A. Bankert, Robert J. Amdur - Medical - 2006 - 530 pages
...manner. (Approved by the Office of Management and Budget under Control Number 9999-0020.) 46.116 General requirements for informed consent Except as...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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The Code of Federal Regulations of the United States of America

Administrative law - 2006
...51528, Oct. 2, 1996] 50.25 Elements of informed consent. (a) Basic elements of informed consent. In seeking informed consent, the following information...extent, if any, to which confidentiality of records identifying1 the subject will be maintained and that notes the possibility that the Food and Drug Administration...
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