Do Current Federal Regulations Adequately Protect People who Participate in Medical Research?: Hearing Before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources of the Committee on Government Reform, House of Representatives, One Hundred Sixth Congress, First Session, December 9, 1999 |
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Page 2
... oversight responsibil- ity to insure that such research is conducted both properly and safely . A key topic in this discussion is the critical roles played by institutional review boards , commonly referred to as IRBs . These IRBS ...
... oversight responsibil- ity to insure that such research is conducted both properly and safely . A key topic in this discussion is the critical roles played by institutional review boards , commonly referred to as IRBs . These IRBS ...
Page 3
... oversight of research studies involving human subjects . Such oversight includes examin- ing reports of adverse incidents involving research subjects and also requests for changes in the research methodology . The Federal department ...
... oversight of research studies involving human subjects . Such oversight includes examin- ing reports of adverse incidents involving research subjects and also requests for changes in the research methodology . The Federal department ...
Page 6
... oversight subcommittee of Congress . We have a broad range of authority and responsibility . We do swear in our witnesses , which I'll do in just a minute . I will introduce the first panel , and we have two panels today . The first ...
... oversight subcommittee of Congress . We have a broad range of authority and responsibility . We do swear in our witnesses , which I'll do in just a minute . I will introduce the first panel , and we have two panels today . The first ...
Page 7
... oversight responsibilities . With that , what we will do is begin , first I'll swear in all the wit- nesses that are here , and we will limit the principal witnesses to 5 minutes , approximately , of oral presentation . Then we'll ...
... oversight responsibilities . With that , what we will do is begin , first I'll swear in all the wit- nesses that are here , and we will limit the principal witnesses to 5 minutes , approximately , of oral presentation . Then we'll ...
Page 9
... oversight over the whole process are OPRR and when investigational drugs , devices or biologics are involved , the Food and Drug Administration as well . An additional layer of review which may be employed especially in large studies is ...
... oversight over the whole process are OPRR and when investigational drugs , devices or biologics are involved , the Food and Drug Administration as well . An additional layer of review which may be employed especially in large studies is ...
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Common terms and phrases
approved behavioral problems benefit Bioethics CASSELL Chairman clinical committee concerns conducted Criminal Justice December 9 Drug Policy Ellis ethical experimental experiments families Federal regulations fenfluramine challenge fenfluramine study Gary Ellis Health and Human hearing Hispanic Human Radiation Experiments Human Resources Subcommittee Human Services human subject research human subjects protections Iloperidone important individuals informed consent Institutional Review Board investigators IRB members IRB review issues LAWRENCE mental disorders mentally ill MICA minimal risk NBAC Office for Protection Oldham OPRR OPRR's oversight panel participants patients placebo potential procedures protecting human subjects Protection from Research protection of human psychotic pulmonary hypertension recommendations record research involving research protocol research subjects Resources Subcommittee December responsibilities schizophrenia Secretary serotonin Shamoo Steven Subcommittee December 9 testimony Thank there's Timothy Walsh TOWNS treatment vulnerable WALSH YESSIAN York Psychiatric Institute York State Psychiatric ZUCKER