 | Nancy J. Alexander, Anne C. Wentz - 1996 - 226 sivua
...procedures that are experimental. 3. A description of any benefits to the subject or to others that may reasonably be expected from the research. 4. A...research subjects' rights, and whom to contact in the event of a research-related injury to the subject. 8. A statement that participation is voluntary,... | |
 | Jean-Noël Missa - 1996 - 234 sivua
...reasonably be expected from the research : - 4. A disclosure of appropriate alternative procedures of courses of treatment, if any, that might be advantageous...research subjects' rights, and whom to contact in the event of a researchrelated injury to the subject ; and - 8. A statement that participation is voluntary,... | |
 | Robert M. Veatch - 1997 - 482 sivua
...subparts, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective...research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and (8) A statement that participation is voluntary,... | |
 | 1997 - 756 sivua
...courses of treatment, if any, that might be advantageous to the subject; (5) A statement describing trie extent, if any, to which confidentiality of records...research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and (8) A statement that participation is voluntary,... | |
 | Adil E. Shamoo - 1996 - 340 sivua
...possibility that the FDA may inspect the records. 6. For research involving more than minimal risk,52 an explanation as to whether any compensation and...pertinent questions about the research and research subject's rights, and whom to contact in the event of a research-related injury to the subject. 8.... | |
 | DIANE Publishing Company - 1998 - 437 sivua
...the informed consent process. The regulations specif}' eight required elements of informed consent: 1) A statement that the study involves research, an...of, or where further information may be obtained. 284 7) An explanation of whom to contact for answers to pertinent questions about the research and... | |
 | 1998 - 668 sivua
...A description of any reasonably foreseeable risks or discomforts to the subject; §46.114 §46.116 (3) A description of any benefits to the subject or...research subjects' rights, and whom to contact in the event of a research-related Injury to the subject; and (8) A statement that participation is voluntary,... | |
 | Baruch A. Brody - 1998 - 412 sivua
...experimental; (2) a description of any reasonably foreseeable risks or discomforts to the subject; (4) a disclosure of appropriate alternative procedures...research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and (8) a statement that participation is voluntary,... | |
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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 experimental;... 
