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It took investigators years of research to create the new consent form template for phase I oncology trials, which provides several pages of simple, clear language in an informed consent outline.
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The checklist includes examples of words and graphics that could be used to simplify the IC document, as well as advice on how to discuss a study with potential participants and how to assess their understanding.
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IRBs mostly are familiar with research that enrolls individuals, and their attention is paid to the individual informed consent. But there are other types of human subjects research, including cluster-randomized trials, which require IRBs to focus on interventions at a wider level, an expert says.
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Qualitative research based on in-depth interviews has the potential to reveal rich details about the lives of participants. As a result, it also has the potential to identify those participants, even in the absence of protected health information such as name, address or birth date.
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Pediatric biobanks which include samples taken from children treated for specific diseases or collected in large population-based studies require consent from parents at the time of collection.
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On the positive side, IRB professionals appear to be better insulated from the country's current economic troubles than people in many other industries.
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Recognizing that patients who don't take medication for chronic conditions as prescribed are more likely to have poor control over their independence, Blue Cross has launched a program to coach people on medication adherence.
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It's a moment dreaded by every occupational health manager learning that an employee was seriously injured at work. It's also the "moment of truth" for how well the occupational health manager does his or her job.
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Getting employees to commit to hour-long workouts at the gym might be expecting the impossible in many cases. However, new research shows that short bouts of exercise also have significant benefits.
