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Much of social-behavioral research is, at its heart, the study of social relationships between ourselves and our family, our friends, our coworkers, and others in our lives.
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An IRB data management software system currently being rolled out at institutions across the country gives IRBs the ability to minutely tailor their own systems and to suggest their own additions.
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Formal ethics training and education for community representatives who serve on IRBs or otherwise provide an ethical perspective regarding human subjects research is one area of research training that has been overlooked by many institutions.
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The Ethical Force Program, a collaborative effort of the American Medical Association (AMA) to develop health care systemwide performance measures for ethics, will be field-testing a tool kit on patient-centered communication with diverse populations from March to December 2006 with eight volunteer hospitals and eight physician groups.
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Whether investigators are conducting pharmaceutical research domestically or overseas, there always is a question about what will happen to subjects when the study ends. There are a variety of ethical questions regarding whether its better to continue to provide access to a study drug or whether its best to let the access end with the trial.
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Research institutions and clinical trial sites often pay close attention to investigator training, particularly to whats required through regulations and institutional policies. But an important educational opportunity often is overlooked, and that involves the training of research coordinators.
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Requirements for research staff education may not include hard and fast regulations, but they might be part of the expectations held by regulators, sponsors, and others in the research industry.
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The informed consent process has become much more complicated and burdened with legalistic language in recent years, and there is little research available to show what the impact is on subjects understanding of their role in studies, experts say.
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Its not necessary to conduct a major research project each time a new informed consent form is written, but its only sensible to obtain the readability perspective from someone who is not familiar with the protocol vocabulary, an expert suggests.