 ... (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...  Do Current Federal Regulations Adequately Protect People who Participate in ... - Page 17by United States. Congress. House. Committee on Government Reform. Subcommittee on Criminal Justice, Drug Policy, and Human Resources - 2000 - 144 pagesFull view - About this book
 | Administrative law - 2002 - 532 pages
...consent. In seeking informed consent, the following information shall be provided to each subject: (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... | |
 | Administrative law - 1997 - 762 pages
...this section, in seeking informed consent the following information shall be provided to each subject: (1) A statement that the study involves research,...records identifying the subject will be maintained; (в) For research involving more than minimal risk, an explanation as to whether any compensation and... | |
 | Administrative law - 1998 - 902 pages
...this section, in seeking informed consent the following information shall be provided to each subject: (1) A statement that the study in-volves research,...records identifying the subject will be maintained; (б) For research involving more than minimal risk, an explanation as to whether any compensation and... | |
 | Administrative law - 2001 - 524 pages
...consent. In seeking informed consent, the following information shall be provided to each subject: (1) A statement that the study involves research,...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... | |
 | Administrative law - 1999 - 692 pages
...this section, in seeking informed consent the following information shall be provided to each subject: (1) A statement that the study involves research,...confidentiality of records identifying the subject will tie maintained; (6) For research involving more than minimal risk, an explanation as to whether any... | |
 | Administrative law - 1993 - 1178 pages
...this section, in seeking informed consent the following information shall be provided to each subject: (1) A statement that the study involves research,...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... | |
 | Administrative law - 1990 - 460 pages
...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... | |
 | Administrative law - 1998 - 688 pages
...the procedures to be followed, and identification of any procedures which are experimental; (2) Л description of any reasonably foreseeable risks or...records identifying the subject will be maintained; (б) For research involving more than minimal risk, an explanation as to whether any compensation and... | |
 | Administrative law - 2004 - 1132 pages
...experimental; (2) A description of any reasonably foreseeable risks or discomforts to the subject; (31 A description of any benefits to the subject or to...records identifying the subject will be maintained; (61 For research involving more than minimal risk, an explanation as to whether any compensation and... | |
 | Administrative law - 1993 - 816 pages
...disclosure of appropriate alternative procedures or courses of treatment, if any. that might be advantaiwna to the subject; (5) A statement describing the extent,...confidentiality of records identifying the subject will >* maintained; (6) For research Involving more than minimal risk, an explanation as to whether any... | |
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