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An Institute of Medicine (IOM) committee studying the effects of the HIPAA Privacy Rule has painstakingly documented the strain it is putting on research.
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Giving children a chance to assent to their own participation in research is an important goal of the pediatric research community. Done properly, it can empower young patients, help them develop their decision-making skills, and prompt them to take their participation more seriously.
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The controversy of the past few years over possible suicidality associated with various drugs pointed out the importance of tracking suicidal thoughts or behavior in subjects involved in clinical trials.
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Over the past decade, the Internet has become an invaluable tool for researchers, linking colleagues across nations or even continents and enabling huge amounts of data to be transmitted quickly and securely. It even makes applying to IRBs faster and (well, relatively) painless.
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IRBs and research institutions occasionally should revisit their conflict of interest policies and update them to make certain they effectively protect human subjects, as well as pass the "smell" test.
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It might take an individual IRB member from six months to a year to become fully acclimated to participating on an ethics board. So research institutions should do what they can to improve both new IRB member orientation and continuing education and training.
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When Sarah Fowler-Dixon, PhD, an education specialist in Washington University's Human Research Protection Office, began a project to develop the university's Internet research guideline for the university, she gathered a task force of IRB members, investigators involved in Internet research, and a technical advisor to help work through the complicated security issues involved.
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Videography can be a useful data collection tool in research, giving researchers access to information records of events, subtle non-verbal cues that can't be elicited any other way.
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When a Boston, MA, research team decided to study HIV/AIDS prevention among the mentally ill, a group that is particularly vulnerable to infection with the disease, they had to ensure their research volunteers were recruited with appropriate privacy safeguards and thoroughly understood their research participation.
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When trying to explain a complicated clinical trial to participants, which approach is better: a jam-packed standard-issue informed consent document, or a lower reading level, more interactive model? And which would subjects prefer?
