 | Karen M. Becker, John J. Whyte - 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...records identifying the subject will be maintained and that notes the possibility that the FDA may inspect the records. 6. For research involving more... | |
 | Elizabeth A. Bankert, Robert J. Amdur - 2006 - 568 pages
...release the investigator, the sponsor, the institution or its agents from liability for negligence. (a) Basic elements of informed consent. Except as provided...records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any compensation and... | |
 | 2006 - 508 pages
...51528, Oct. 2, 1996] ยง 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... | |
 | American College of Emergency Physicians - 2006 - 386 pages
...regulations.42-43 These regulations state, in part, that the information provided to each patient will include: (1) A statement that the study involves research,...records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records; (6) For... | |
 | Sana Loue, Earl C. Pike - 2007 - 347 pages
...to be provided to study participants in the context of the informed consent process. This includes 1 . A statement that the study involves research,...records identifying the subject will be maintained; 6. For research involving more than minimal risk, an explanation as to whether any compensation and... | |
 | Margaret L. Eaton, Donald Kennedy - 2007 - 188 pages
...the informed consent process. The regulations specify eight required elements of informed consent: i. A statement that the study involves research, an explanation...records identifying the subject will be maintained. 6. For research involving more than minimal risk, an explanation as to whether any compensation and... | |
 | A. M. James Shapiro, James A. M. Shaw - 2007 - 368 pages
...participation, a description of the procedures to be followed, and identification of any procedures that are experimental 2. A description of any reasonably...records identifying the subject will be maintained 6. For research involving more than minimal risk, an explanation as to whether any compensation and... | |
 | John I. Gallin, Frederick P Ognibene - 2011 - 448 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...records identifying the subject will be maintained. 6. For research involving more than minimal risk, an explanation as to whether any compensation and... | |
 | David M. Reid, Colin G. Miller - 2008 - 328 pages
...may be societal benefit if the study adds to knowledge of the disease or to treatment of the disease. 4. A disclosure of appropriate alternative procedures...records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration, other regulatory authorities,... | |
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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... 
