IRB Advisor – August 1, 2018
August 1, 2018
View Issues
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Right to Try Law in Regulatory Limbo
The new Right to Try law has been dogged by implementation questions and remains in regulatory limbo.
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Unresolved Issues With 'Right to Try'
New York University School of Medicine Working Group on Compassionate Use and Pre-Approval Access recently issued a statement that cited unresolved issues on the federal Right to Try law.
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Researcher Explains How Data Sets Can Affect Study Privacy
Human subjects research increasingly involves the use of large data sets that allow analysts to drill down to the most specific of details from healthcare records or other databases. This creates challenges in ethical data analysis and information privacy.
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Final Common Rule Compliance Date Set
The revised Common Rule has been issued in final form, with IRBs allowed to use three “burden-reducing” provisions to prepare for a Jan. 21, 2019, compliance date.
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Studies of Insects as Food Now Heading to IRBs
It is still unusual for IRBs to receive protocols involving insect-derived food, but it can and does occur, so they should be prepared.
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Report Examines How Research on Donated Organs Can Be Ethically Performed
Almost 5,000 organs from deceased donors were discarded in 2015 because they were deemed unsuitable for transplantation. Some donated organs are used solely for research because they don’t meet the criteria for transplantation.