| 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,... | |
| 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... | |
| 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... | |
| 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... | |
| 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... | |
| 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... | |
| 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... | |
| 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... | |
| 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... | |
| |