IRB Advisor
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All of Us: NIH Looks to the Future, Tries to Overcome the Past
Trying to address “big data” threats to privacy and step out of the long shadow of human research travesties, the National Institutes of Health recently launched its ambitious All of Us project.
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FDA Outlines Position on Stem Cell Research
The FDA outlined its stance on the exploding field of regenerative medicine in a new paper, trying to strike a balance in stem cell research oversight to temper risk without blunting reward.
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Should Research Subjects Be Guaranteed Care if Injured?
At a time when social justice movements are coming to the fore, what if research subjects boycotted trials until they were guaranteed medical care if injured?
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SACHRP Approves Guidance on Exemptions From Single IRB
A committee recently approved a “points to consider” document that outlines three general areas where exceptions to single IRB oversight can be an option.
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Rule Delay, Confusion Cloud SACHRP Meeting
Most of the requirements of the final rule were to become effective Jan. 19, 2018. However, HHS and a host of other federal agencies issued an 11th-hour “interim final rule” that moved the effective date to July 19, 2018.
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Committee Helps IRB Prepare for Accreditation and New Common Rule
Accreditation experts say IRBs should not make too many changes when they first seek accreditation from the Association for the Accreditation of Human Research Protection Programs. It’s better to focus on what has to be done and to not do everything.
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Change Management Process Can Bring All Sides Together for Quality Improvement
One IRB receives process improvement help from a well-designed change management process that provides information, implements new procedures, and addresses the revised Common Rule and its effects.
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Preparing for Revised Common Rule? Aim for Efficient, Faster, Better IRB
With just a couple of months remaining to prepare for the revised Common Rule, the question for human research protection programs is: What needs to be done to make programs more efficient, faster, better quality, and compliant?
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Into the Gray: Local IRBs Must Define Research
It’s only fitting, with the revised Common Rule in limbo, that there should remain some uncertainty about what constitutes human research — and what doesn’t.
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Five Years in the Making, FDA Issues Final Rule on Data and Devices
The FDA issued a final rule, effective Feb. 21, 2019, to revise regulations about accepting data from clinical studies involving medical devices.