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" When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. "
Code of Federal Regulations: Containing a Codification of Documents of ... - Page 18
2000
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Code of Federal Regulations: Containing a Codification of Documents of ...

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...
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Problems in Securing Informed Consent of Subjects in Experimental ..., Volume 4

United States. Congress. House. Committee on Small Business. Subcommittee on Regulation, Business Opportunities, and Technology - Law - 1994 - 280 pages
...individuals 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...
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Validation Compliance Annual: 1995

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...
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Human Radiation Experiments: Hearing Before the Committee on Governmental ...

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...
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Idea to Product: The Process

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...
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Research Ethics: A Psychological Approach

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...
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Medical Ethics

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...
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Ethics in Neurobiological Research with Human Subjects: The Baltimore ...

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...
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Oversight of NIH and FDA: Bioethics and the Adequacy of Informed Consent ...

United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources - Medical - 1997 - 246 pages
...individuals who are knowledgeable about and experienced in working with the vulnerable population. 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...
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Responsibility for Drug-induced Injury: A Reference Book for Lawyers, the ...

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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