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Whole genome sequencing research raises important informed consent issues for IRBs and investigators, and the recent report by the Presidential Commission for the Study of Bioethical Issues (PCSBI) addresses these in its recommendations.
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Human research protection programs (HRPPs) often must balance the need to handle research complaints with the goal of conducting fair and reasonable investigations into any potential problem. HRPPs also must use staff time efficiently and not get bogged down in disputes that clearly are not pertinent to protecting research subjects, an expert says.
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Medical and electronic data advances in the 21st century have made it possible to determine the entire DNA sequence of any individual on the planet. The first question that many bioethicists ask is, "How do you protect individuals' privacy from the misuse or unauthorized use of this information?"
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With the smartphone application market seemingly exploding with apps for just about anything, it's no surprise that clinical research is starting to get in on the action. Technology companies and academic institutions are working on research apps and other programs to assist with clinical trial data reporting.
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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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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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Robert Klitzman's survey of IRB chairs, members and administrators revealed a number of ideas that can be adopted by other institutions that want to improve relations with their investigators.
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The human subjects protection field continues to search for ways to improve the informed consent (IC) process. IRB professionals often express concern that potential research participants do not understand their rights or the true risks and benefits of a study, although they might sign the IC forms and say they have no questions.
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Most IRB directors or chairs can recount stories about their tensions with investigators. All boards must balance the institution's need to protect subjects with investigators' concerns about unduly hampering their research.
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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.
