Internal Review Boards
RSSArticles
-
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.
-
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.
-
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.
-
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.
-
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?
-
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.
-
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.
-
The Search for Justice in the Human Genome
With sequencing of the human genome completed at the turn of this century, there was the heady expectation that the summit to great cures was about to be climbed like the iconic spiral staircase of DNA.
-
Try These Strategies for Improving Review Consistency
One IRB office created simple rules and a process to improve workflow efficiency. Using Toyota lean methodology, the office standardized interpretation of regulations and institutional policies.
-
Code of Ethics for IRBs Working With Indigenous Tribes
IRBs and researchers must recognize that “the truth comes from many places” if they want to work in good faith with Native American tribes.