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" When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. (7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality... "
AIDS Issues: Hearings Before the Subcommittee on Health and the Environment ... - Page 166
by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment - 1985 - 357 pages
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Code of Federal Regulations: Containing a Codification of Documents of ...

1998 - 902 pages
...plan makes adequate provision for monitoring the data collected to en-sure the safety of subjects. (7) When appropriate, there are ade-quate provisions to...subjects and to maintain the con-fidentiality of data. When some or all of the subjects kely to be vulnerable to coercion idue Influence, such as children,...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1999 - 704 pages
...plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. (7) When appropriate, there are adequate provisions to...subjects and to maintain the confidentiality of data. (b) When some or all of the subjects are likely to be vulnerable to coercion or undue Influence, such...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1998 - 760 pages
...plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. (7) When appropriate, there are adequate provisions to...subjects and to maintain the confidentiality of data. (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such...
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Code of Federal Regulations: Containing a Codification of Documents of ...

2000 - 544 pages
...makes adequate provision for monitoring the data collected to ensure the safety of subjects. (7) Where appropriate, there are adequate provisions to protect...subjects and to maintain the confidentiality of data. (b) When some or all of the subjects, such as children, prisoners, pregnant women, handicapped, or...
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Code of Federal Regulations: Containing a Codification of Documents of ...

2001 - 784 pages
...provision for monitoring the data collected to ensure the safety of subjects. (7) When appropriate, tBere are adequate provisions to protect the privacy of...subjects and to maintain the confidentiality of data. (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such...
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FDA Consumer, Volume 20

1986 - 410 pages
...for monitoring the data as it is collected to ensure continued safety of the subjects. • There are provisions to protect the privacy of subjects and to maintain the confidentiality of the data. Having developed the regulations by which IRBs operate, FDA inspects the review groups' records...
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Recombinant DNA Research, Volume 9

1986 - 588 pages
...point is self-explanatory. E. Privacy and Confidentiality The IRB shall determine that: "(7) Where appropriate, there are adequate provisions to protect...subjects and to maintain the confidentiality of data." A specific point regarding gene therapy that follows fron this general requirement is that pediatric...
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Protecting Human Subjects: First Biennial Report on the Adequacy and ...

United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research - 1981 - 286 pages
...makes adequate provision for monitoring the data collected to insure the safety of subjects; (g) where appropriate, there are adequate provisions to protect...subjects and to maintain the confidentiality of data; and (h) where some or all of the subjects are likely to be vulnerable to coercion or undue influence,...
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The Code of Federal Regulations of the United States of America

1998 - 668 pages
...plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. (7) When appropriate, there are adequate provisions to...subjects and to maintain the confidentiality of data. (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such...
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Health and the Law: A Primer for Health Professionals

Tom Christoffel - 1985 - 472 pages
...makes adequate provision for monitoring the data collected to insure the safety of subjects. 7. Where appropriate, there are adequate provisions to protect the privacy of subjects and maintain the confidentiality of data. No human subjects may be involved in research unless legally...
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