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The Department of Health and Human Services (HHS) announced that the federal government is contemplating various ways of enhancing the regulations overseeing research on human subjects.
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All over the world, illegal organ trafficking is being reported. Most people have probably heard the urban myths of many out-of-country vacationers who wake up in a bathtub full of ice and their kidneys removed.
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Applying community engagement to mental health research can help researchers design studies that incorporate the priorities of people with mental illness and arrive at the best strategies for working with them.
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As high school students get exposed to more sophisticated science and health programs, some are also having their first encounters with human subjects protection issues.
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The National Hospice and Palliative Care Organization (NHPCO) issued a position statement and commentary, "Hospice and Palliative Care: Ethical Marketing Practices," that guides providers to the use of sound, ethical practices that enhance the perception of hospice in the community.
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When IRBs and research organizations' quality improvement offices work together, the net effect is a more thorough and efficient human subjects research process, experts say.
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[Editor's note: Wendy Lloyd, LPN, CCRP, CIP, regulatory affairs and compliance specialist, at Vanderbilt University Medical Center in Nashville, TN, has compiled a list of frequent audit findings of the informed consent document process. She answers questions for IRB Advisor about these findings in this question and answer session.]
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Practice-based researchers have long complained that IRBs don't understand their work, which is based in physicians' practices and often consists of low-risk activities such as chart reviews and surveys.
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IRB offices might improve their staff and IRB members' training and education if they provide an occasional refresher course on the National Institutes of Health (NIH) Guidelines for the Conduct of Research Involving Human Subjects, also known as the Rules of Review.
