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In response to concerns raised about IRB review of genetic research, a group of investigators, ethicists and other stakeholders has surveyed genetic researchers and IRB professionals to discern what issues are complicating review.
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It's a well-accepted position in human subjects protection circles that in order to improve IRBs and their relationships with investigators, it's important to actually study IRBs how they work, how long it takes to do things, the knowledge and attitudes that members carry into discussions of various types of research.
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An overwhelming majority of research subjects with schizophrenia monitored over the course of a long-term medication study retained the capacity to give consent for research.
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All it takes is for an IRB member or investigator to experience those intrusive, evening phone calls about a new study enrolling people with their health condition to convince them that there must be a better way to approach potential research participants.
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Research institutions could improve recruitment data collection and efficiency, as well as make their IRBs happy, if they develop a standardized recruitment tool for use with new studies, an expert says.
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Research institutions that make it a goal to improve ethical conduct among staff, researchers, and students engaged in research should focus on providing better ethics education, developing sound policies & procedures, and leading by example, an expert says.
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While IRBs and researchers seem to agree on the most vexing issues in IRB review of genetic research, consensus still is elusive.
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Adverse drug event (ADE) reporting often is inaccurate, has omissions, and sends unnecessary information to IRBs, an expert says.
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Everyone does more work with less time these days. So how can an IRB make new board member training effective without being time demanding? One IRB has found that the answer is to hold brief educational sessions during its board meetings.
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Human research protection program staff at the VA Medical Center in Tuscaloosa, AL, knew there was a problem with the IRB's expedited review process.
