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IRBs across the nation are bracing for budget cuts as states slice funding to higher education and the recession's impact is felt by IRBs and research institutions.
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In lean times, IRBs will have to become more disciplined. And part of their discipline will need to include collecting data about their own efficiency, outcomes, and cost-effectiveness, an expert says.
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An innovative program at M.D. Anderson Cancer Center in Houston, TX, provides continuous oversight of investigational new drug (IND) trials over the life of a trial, using a monitoring services office created expressly for that purpose.
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IRBs in the United States and research ethics committees (RECs) in the developing world who review HIV vaccine trials must struggle with a number of tough ethical issues ensuring adequate, culturally sensitive informed consent, protecting privacy, determining the standard of treatment for participants who become infected with HIV during a trial.
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Several institutions have received grants to implement their ideas for engaging the community in cancer clinical trials.
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As IRBs face budget cuts, they can make some improvements in their processes that will make them more cost efficient.
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Tracy Arwood, MS, director of research compliance at Clemson University's office of research compliance in Clemson, SC, has dealt with a variety of consent issues over the years, including handling informed consent of college students and from community leaders. She offers this advice about how to improve the informed consent process to IRB Advisor readers:
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As IRBs review the rollout of new biobanks, they need to ensure that people who agree to participate in them truly understand what that means.
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Because of the unusual scope of the National Children's Study (NCS), it raises a significant range of ethical issues for its designers and for the IRBs that have been reviewing it at 105 study centers across the United States.
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The 1960s obedience experiments of Stanley Milgram have become a hallmark of social behavioral research, as well as a cautionary tale for those involved in human subjects protection.
