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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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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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More subject diversity is needed in clinical trials to reduce the risk of adverse outcomes, according to the keynote speaker at the Clinical Trials in Georgia conference.
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Research institutions should make their complaint process as accessible as possible to researchers, participants, and others, an expert says.
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The Presidential Commission for the Study of Bioethical Issues (PCSBI) has made these 12 recommendations for how to better develop public trust and protect privacy in the era of whole genome sequencing in research:
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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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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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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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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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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.
