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Research compliance is serious business, particularly when your studies involve humans. So serious, in fact that federal regulations exist, review boards have been developed to oversee the process, and organizations have sprung up to offer education and support to research professionals.
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IRBs may think their policies and procedures have covered all federal and state regulations, but in the experience of federal officials, there commonly are some lapses.
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Our institutions IRB is merging with another IRB. What can we do to make the transition efficient? (In other words, what can go wrong and how can we minimize the possibility?)
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IRBs and research institutions may have some disagreement and confusion over when its appropriate to send a pediatric research proposal to the Department of Health and Human Services (HHS) for a 407 review.
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As awareness of IRBs and human subjects research protection increases among the public and staff at institutions, IRB members sometimes are asked to consider new gray areas regarding studies that typically havent made it to the IRBs radar screen.
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IRBs and the research community soon may have new guidance in defining and clarifying some of the gray areas in regulations of human subject protection.
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For more than two centuries, the small communities that make up the Canadian province of Newfoundland and Labrador, on the countrys most northeastern coast, were largely isolated from the rest of the world.
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It has been five years since a complaint from the father of a study subject was lodged about a longitudinal study at Virginia Commonwealth University (VCU) in Richmond a complaint that precipitated a shutdown of all research involving human subjects.
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Question: Does the Food and Drug Administration require that an IRB have a certain number of members?
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A document exploring the implications of using biotechnical powers for reasons beyond therapy takes up controversial issues such as the prospect of creating designer babies and questions whether such scientific advances are possible and ethical.
