| Administrative law - 1989 - 462 pages
...will be appropriately documented, in accordance with and to the extent required by § 50.27. (6) Where appropriate, the research plan makes adequate provision...data collected to ensure the safety of subjects. (7) Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain... | |
| International Validation Forum - Science - 1995 - 1114 pages
...will be appropriately documented, in accordance with and to the extent required by §50.27. (6) Where appropriate, the research plan makes adequate provision...data collected to ensure the safety of subjects. (7) Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain... | |
| United States. Congress. Senate. Committee on Governmental Affairs - Medical - 1996 - 450 pages
...consent will be appropriately documented in accordance with and to the extent required by 45 CFR Part 46. 6) When appropriate, the research plan makes adequate...monitoring the data collected to ensure the safety of human subjects. 7) When appropriate, there are adequate provisions to protect the privacy of human... | |
| Nancy J. Alexander, Anne C. Wentz - Medical - 1996 - 226 pages
...more persons who are knowledgeable about, and experienced in working with, the vulnerable subjects. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, IRBs must see that additional safeguards are included in the study protocol. Specific, detailed protections... | |
| Barbara Stanley, Joan E. Sieber, Gary B. Nelton - Psychology - 1996 - 296 pages
...regulations on research with human participants that "appropriate additional safeguards" be applied when "some or all of the subjects are likely to be vulnerable to coercion or undue influence" ("Protection," 1981/1992, 46.m(b)). With regard to elderly people with emotional disturbances and those... | |
| Robert M. Veatch - Medical ethics - 1997 - 482 pages
...makes adequate provision for monitoring the data collected to insure the safety of subjects. (7) Where appropriate, there are adequate provisions to protect...subjects and to maintain the confidentiality of data. (b) Where some or all of the subjects are likely to be vulnerable to coercion or undue influence, such... | |
| Adil E. Shamoo - Medical - 1996 - 340 pages
...are knowledgeable about, and experienced in working with, the vulnerable subjects [45 CFR 46.107(a)]. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, IRBs must see that additional safeguards are included in the study protocol [45 CFR 46.111(b)]. What... | |
| Graham Dukes, Maurice Nelson Graham Dukes, Mark Mildred, Barbara Swartz - Law - 1998 - 584 pages
...subject's legally authorized representative; i51 1nformed consent will be appropriately documented; l61 When appropriate, the research plan makes adequate...the data collected to ensure the safety of subjects; l71 When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain... | |
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