This video presentation on the additional protections for certain vulnerable subjects, including pregnant women, children, and prisoners starts out at the end of a panel presentation on the additional protections afforded to vulnerable populations described in the subparts B, C, and D or the HHS regulations at 45 CFR part 46.
25m 18s
Dr. Michael Carome, former OHRP Associate Director of Regulatory Affairs, is interviewed and discusses the criteria for determining if, in the context of human subjects research, an experience, incident, or outcome is an unanticipated problem involving risk to subjects or others, as described in the HHS regulations at 45 CFR part 46. watch...
28m 13s
This video presentation on the additional protections for certain vulnerable subjects, including pregnant women, children, and prisoners starts out at the end of a panel presentation on the additional protections afforded to vulnerable populations described in the subparts B, C, and D or the HHS regulations at 45 CFR part 46. watch...
18m 39s
In this video, all of the characters are fictional.In the first scene an investigator meets with the IRB Chair to discuss issues for obtaining informed consent from potential subjects with schizophrenia before protocol submission to IRB. In the second scene, Dr. Presley obtains appropriate informed consent from a potential subject, Mr. Smith, who has the capacity to consent. watch...
2m 16s
This video shows the Clinical and Epidemiological Centre within CRP-Santé and its role in promoting clinical research in Luxembourg. watch...
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