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Despite evidence suggesting that tobacco use can hamper cancer treatments, patients with cancer who enter clinical trials are rarely asked about their use of tobacco, according to a recent study.
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Research institutions that plan to use the teach-back method as part of their informed consent process should make certain there is adequate training for clinical trial professionals. One research site has found that simulations work best for this purpose.
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It's important that IRB meetings are run efficiently, keeping discussions brisk and on the important human subjects protection issues. But it's also important that these discussions are well-documented in the IRB meeting minutes.
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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.
