IRB Advisor – May 1, 2018
May 1, 2018
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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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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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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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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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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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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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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.