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" ... (2) A description of any reasonably foreseeable risks or discomforts to the subject; (3) A description of any benefits to the subject or to others which may reasonably be expected from the research; (4) A disclosure of appropriate alternative procedures... "
The Code of Federal Regulations of the United States of America - Página 117
2002
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Code of Federal Regulations: Containing a Codification of Documents of ...

1998 - 668 páginas
...release the Investigator, the sponsor, the Institution or its agents from liability for negligence. (а) Basic elements of Informed consent. Except as provided...records identifying the subject will be maintained; (б) For research involving more than minimal risk, an explanation as to whether any compensation and...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1998 - 902 páginas
...release the investigator, the sponsor, the insti-tution or its agents from liability for negligence. (а) Basic elements of Informed con-sent. Except as provided...records identifying the subject will be maintained; (б) For research involving more than minimal risk, an explanation as to whether any compensation and...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1999 - 692 páginas
...release the investigator, the sponsor, the institution or its agents from liability for negligence. (a) Basic elements of informed consent. Except as provided...confidentiality of records identifying the subject will tie 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

1993 - 1178 páginas
...release the investigator, the sponsor, the institution or its agents from liability for negligence. (a) Basic elements of informed consent. Except as provided...describing the extent, if any, to which confidentiality of 311 40 CFR Ch. I (7-1-93 Edtton) records identifying the subject will be maintained; (6) For research...
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The Code of Federal Regulations of the United States of America

1995 - 440 páginas
...52817, Dec. 21, 1990] §50.25 Elements of informed consent. (а) Basic elements of informed consent. In seeking informed consent, the following information...records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records. (б)...
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Code of Federal Regulations: Containing a Codification of Documents of ...

2001 - 524 páginas
...51528, Oct. 2, 1996] § 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 21 CFR Ch. i (4-1-01 Edition) maintained and that notes the possibility that the Food and Drug Administration...
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The Code of Federal Regulations of the United States of America

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...
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The Code of Federal Regulations of the United States of America

2002 - 996 páginas
...release the investigator, the sponsor, the institution or its agents from liability for negligence. (a) Basic elements of informed consent. Except as provided...procedures or courses of treatment, if any, that might be advar tageous to the subject; (5) A statement describing the ea tent, if any, to which confidentiality...
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The Code of Federal Regulations of the United States of America

1993 - 616 páginas
...release the investigator, the sponsor, the institution or its agents from liability for negligence. (a) Basic elements of informed consent. Except as provided...of appropriate alternative procedures or courses of treat§46.114 §46.116 ment, if any, that might be advantageous to the subject; (5) A statement describing...
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The Code of Federal Regulations of the United States of America

1990 - 460 páginas
...subject's participation, a description of the proce§50.20 Food and Drug Administration, HHS dures to be followed, and identification of any procedures...records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records. (6) For...
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