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The National Academies have released a set of recommended guidelines for research using human embryonic stem cells, advising research institutions to establish separate oversight committees for such research.
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Every compliance department has encountered the occasional investigator who causes staff to pop antacid pills the minute he or she walks into the room. And such personalities may have been tolerated in the past, with todays tighter focus on research compliance and ethical concerns, such personalities now can be a real problem.
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The Office for Human Research Protections of the U.S. Department of Health and Human Services has added a new page to its web site detailing the history of the Belmont Report.
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More IRBs are being drawn into the complex and controversial world of human embryonic stem cell research.
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The Medical College of Wisconsin is enlisting technology in the task of teaching investigators and research participants about the importance of obtaining truly informed consent in clinical research.
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Mistrust of the medical and science communities may be discouraging non-Caucasian cancer patients from enrolling in clinical trials, a research group has discovered.
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Individual states, including California, Illinois, Massachusetts, New Jersey, New York, and Wisconsin, now are moving forward to fill the funding gap for stem cell research. So far, California leads the pack voters approved a $3 billion bond measure for stem cell research in November.
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A survey of warning letters sent to IRBs by the FDA shows that most of the offenders were deficient in some of the most fundamental areas of responsibility failing to have or follow adequate review procedures and failure to maintain adequate documentation of IRB activities.
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Support groups for people who suffer from chronic or life-threatening illnesses can be a valuable source of community members for IRBs, says a woman who founded a support group and serves on two boards.
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The federal Office for Human Research Protections (OHRP) is seeking public comment through May 24 on recommendations regarding the use of human subjects protection procedures of foreign countries in overseas research.
