 | 1995 - 440 páginas
...Jan. 27, 1981, as amended at 55 FR 52817, Dec. 21, 1990] §50.25 Elements of informed consent. (а) Basic elements of informed consent. In seeking informed...Food and Drug Administration may inspect the records. (б) For research involving more than minimal risk, an explanation as to whether any compensation and... | |
 | 2001 - 524 páginas
...been, or are, asked to review this or a substantially equivalent investigation by that sponsor. [61 FR 51528, Oct. 2, 1996] § 50.25 Elements of informed...confidentiality of records identifying the subject will be 21 CFR Ch. i (4-1-01 Edition) maintained and that notes the possibility that the Food and Drug Administration... | |
 | 1998 - 902 páginas
...(а) Basic elements of Informed con-sent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information...records identifying the subject will be maintained; (б) For research involving more than minimal risk, an explanation as to whether any compensation and... | |
 | 2000 - 508 páginas
...(a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information...records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any compensation and... | |
 | 1999 - 786 páginas
...(a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information...records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any compensation and... | |
 | 1993 - 808 páginas
...Basic elements of informed consent. Except as provided In paragraph (c) or (d) of this section, hi seeking informed consent the following information...records Identifying the subject will be maintained; (8) For research Involving more than minimal risk, an explanation as to whether any compensation and... | |
 | 1999 - 692 páginas
...(a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information...confidentiality of records identifying the subject will tie maintained; (6) For research involving more than minimal risk, an explanation as to whether any... | |
 | 1992 - 842 páginas
...section, In seeking informed consent the following information shall be provided to each subject: '!> 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... | |
 | 2002 - 802 páginas
...the following information shall be provided to each subject: (DA statement that the study in'olves research, an explanation of the purposes of the research...records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any compensation and... | |
 | 1992 - 464 páginas
...of the purposes of the research and the expected duration of the subject's par§1230.116 ticipation, a description of the procedures to be followed, and...records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any compensation and... | |
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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... 
