...regulations. F. Informed consent will be appropriately documented, in accordance with regulations. G. Where appropriate, the research plan makes adequate provision...the data collected to ensure the safety of subjects. H. Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain...

...investigator recognizes a problem, the IRB must be notified. The research plan must also demonstrate that there are adequate provisions to protect the privacy...subjects and to maintain the confidentiality of data. Protection of privacy involves such issues as ensuring that the subject's disease status is not revealed...

...research." The IRB is also required by 45 CFR 465is«-"""«"1 and 21 CFR 566is-111(al|6)1 to ensure that "when appropriate, the research plan makes adequate...data collected to ensure the safety of subjects." These provisions are currently interpreted as granting the institution, the IRB, and/or its representative(s)...

...events ( AEs), although the term is not used in the Common Rule itself. • when appropriate, that the research plan makes adequate provision for monitoring...the data collected to ensure the safety of subjects; • when appropriate, that there are adequate provisions to protect the privacy of subjects and to...

...Vulnerable to Coercion or Undue Influence (Table 5-1, #4) Federal regulations direct IRBs to ensure that when some or all of the subjects are likely to be...coercion or undue influence, such as children, prisoners, TABLE 5-4 Vulnerable (or Potentially Vulnerable) Research Subjects This is a noninclusive list of research...

...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...

...certain categories of research that can be approved on an expedited basis.7 It also specifies that, when "some or all of the subjects are likely to be vulnerable to coercion or undue influence," the IRB must find that "additional safeguards have been included to protect the rights and welfare...

...there is coercion or "undue influence." (CFR 46.116). The Common Rule, further states that When one or all of the subjects are likely to be vulnerable...children, prisoners, pregnant women, mentally disabled, economically or educationally disadvantaged persons, additional safeguards have been included in the...