IRB Advisor
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Is it a study or not? Decision tree helps
When researchers told the Cornell University IRB in a survey how difficult it was to determine whether a study should be submitted for IRB review, the IRB office created a tool that would make it easier for researchers to make the correct choice.
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Small IRBs can demonstrate value to research institutions
Among the anticipated changes with the Common Rule’s recent Notice of Proposed Rulemaking (NPRM) is a shift from having IRBs make exempt determinations to researchers using an exempt status tool to make their own determination.
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Columbia researchers observing students in social situations to detect signs, clues to sexual violence
Students at Columbia University in New York City have expressed curiosity and concern about an ongoing ethnographic study wherein researchers observe their behavior in public settings that have included bars and parties in campus housing. One student termed it “pretty weird and uncomfortable,” while others said the researchers were friendly and forthcoming.
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Draft guidance for IRB meeting minutes calls for documenting a broad array of actions
When in doubt, document. That may be the best default position for IRBs based on draft federal guidelines created in part because some boards were being cited or warned about having inadequate meeting minutes.
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People with lower incomes less likely to participate in cancer clinical trials
In cancer research findings that could have implications for other diseases and human subjects, investigators found that patients with annual household income below $50,000 were 32% less likely to participate in a clinical trial.
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IRB solutions for the age of health system growth
North Shore-LIJ Health System decided in July 2014 to restructure the local IRB into a flexible IRB model, and use videoconferencing instead of the typical board meetings in person.
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Incidental findings in research subjects: It’s complicated
Incidental findings in research subjects — which can be completely benign or herald significant health problems — raise thorny issues for IRBs that are best addressed through informed consent and a detailed contingency plan.
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Comments, concerns on ANPRM draft may forecast NPRM reaction
A recently published analysis of comments on biospecimen research submitted in response to the 2011 Advance Notice of Proposed Rulemaking indicates institutional review boards and researchers are facing a series of “tradeoffs” that will likely carry over in the next iteration of the human research Common Rule.
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Changes to Common Rule would change exemptions
The NPRM of the Common Rule in human research protection provides for eight categories of exemption to IRB reviews and discusses a tool that investigators and others could use to determine whether a study is exempt.
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IC under revised Common Rule is transparent, tightened
Common Rule changes under the Notice of Proposed Rulemaking could impact how IRBs handle the informed consent process, by both increasing transparency and imposing stricter new requirements about information provided to prospective subjects.