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Nearly every baby born in the United States undergoes a simple heel-stick in the first few days of life that has potentially profound health implications for his or her life.
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As institutions seek to expand their international research portfolios, IRBs face increasing challenges differing regulations in different countries, cultural distinctions that may lead to unexpected risks and the difficulties of oversight at such a distance.
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As Internet use has exploded worldwide, so has Web-based research. Between 2004 and 2009, the number of web-based research studies published in the American Psychological Association's (APA) Journal of Personality and Social Psychology rose by more than 500%.
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The University of CaliforniaBerkeley's office for the protection of human subjects has developed new guidance for investigators involved in Web-based research. One of the main sections of the guidance involves informed consent issues.
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As IRBs continue to contemplate various models of centralized review for multisite studies, projects have begun to pop up, trying out these models.
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When the National Institutes of Health (NIH) released its policy regarding data sharing for NIH-supported genome-wide association studies (GWAS) in 2007, officials at the University of Washington in Seattle knew it would have an effect on their operations.
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The report prepared for the University of Michigan about international research conducted there lays out a series of recommendations that can aid other institutions' investigators and IRBs.
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IRBs and investigators sometimes waste time on unnecessary IRB submissions. A simple initial review triage checklist can eliminate this problem, one IRB has discovered.
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With federal regulators shifting toward policies that would facilitate more central IRBs for multisite research, human subjects research protection offices need to take note and develop guidelines and tools for handling shared IRB responsibilities in multisite trials, an expert says.
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There have been many surveys of IRBs and their operations gauging how long protocols take in their journey through review, how much it costs to operate a human subjects protection program, and IRB members' attitudes about various aspects of their work.
