IRB Advisor
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Tackling AAHRPP Accreditation Requires Time, Focus, Documentation
Research institutions seeking first-time accreditation or reaccreditation can always expect challenges. These hurdles are a little higher now as rules and regulations will change in 2019 under the new Common Rule.
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Does Use of Biospecimens From Children Require Reconsent When They Are Adults?
There is considerable ethical debate about the issue of reconsent at age 18 from research subjects who provided biospecimens as infants, children, or adolescents. Practices currently vary widely among institutions.
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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.
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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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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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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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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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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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FDA Proposes Including Children in Adult Cancer Trials
IRB members have until Aug. 3, 2018, to submit comments on FDA draft guidance that would open adult oncology clinical trials to children ages 12 to 17 years.
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IRBs Can Learn to Make the Most of Central IRB Partnerships
The IRB at Inova Health System of Falls Church, VA, began working with a central IRB 15 years ago — long before the new Common Rule encouraged IRBs to designate an IRB of record for multisite studies.