IRB Advisor – November 1, 2015
November 1, 2015
View Issues
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Shaking the IRB Foundation
“I think the local IRB has seen its day."
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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.
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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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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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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.