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When IRB directors are coping with the repercussions of staff burnout, they should keep in mind that burnout typically only happens to people who have a strong passion for their job, an expert notes.
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One of the most important ways IRBs can improve the informed consent process is by encouraging investigators to confirm comprehension for their potential subjects, an expert suggests.
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The FDA briefly suspended the ability of an independent IRB to conduct expedited reviews after raising concerns over the conduct of one such review.
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Research institutions and officials increasingly are finding that extra layers of oversight are better than too few. While IRBs once were the only organizations to oversee human subjects protection of research participants, now there are additional committees and offices assisting with this task.
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IRBs ordinarily are concerned with studies that test a specific drug or intervention on patients, students, or other end-users of health care services.
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To achieve success in pediatric research, investigators need to reach and convince one vital group of people parents, who must decide whether to expose their children to the inconveniences and even potential risk of research participation.
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IRBs and investigators continually look for ways to improve the informed consent (IC) process. One novel idea is to create an interactive informed consent program that serves a dual purpose of providing education to patients and trial participants.
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The National Cancer Institute (NCI) of Bethesda, MD, decided to address a deficit in quality of biospecimens collected for research purposes with the recent publication of improved recommendations.
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When IRBs approve a clinical trial site's informed consent documents, they often have no way of knowing how the informed consent process is played out at the site.
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IRB members have different opinions and policies on whether to permit investigators to attend IRB meetings. But are these policies based on any evidence that one way works better than another?