Internal Review Boards
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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.
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Shaking the IRB Foundation
“I think the local IRB has seen its day."
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IRB newsletter gives visually appealing info and updates
The Emory University IRB sends out a monthly newsletter updating IRB members about educational opportunities, new tools for review, regulatory and policy updates, and other news.
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Variety of strategies needed to educate IRB members & chairs
Human research protection rules and regulations evolve and change, and it’s difficult for even the most experienced IRB members and chairs to keep up with them.
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The doc who kicked the hornet’s nest: Is conflict of interest overkill stalling medical advances?
Lisa Rosenbaum, MD, a cardiologist at Brigham and Women’s Hospital in Boston, caused quite a stir earlier this year when she challenged medical orthodoxy in writing a three-part series on conflict of interest issues.