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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.

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.

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.

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.

Right to Try Law in Regulatory Limbo

The new Right to Try law has been dogged by implementation questions and remains in regulatory limbo.

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IRB members have until Aug. 3, 2018, to submit comments on FDA draft guidance that would open adult oncology clinical trials to children ages 12 to 17 years.

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.

IRBs and IBCs: Critical Partners in Gene Research

In addition to IRB oversight, the National Institutes of Health requires that research using “recombinant or synthetic nucleic acid molecules” for gene transfer into human research subjects be approved by institutional biosafety committees.