IRB Advisor – September 1, 2013
September 1, 2013
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Risk-benefit assessment: One size doesn’t fit all
Assessing risks and benefits is an evolving process in the human research protection world especially for IRBs that handle social-behavioral, as well as biomedical, studies. One size in risk-benefit assessment definitely does not fit all. For instance, IRBs sometimes over-emphasize risks in studies involving social-behavioral topics without considering protections that researchers have put in place, IRB experts say. -
Yale reviewer worksheet helps with risk assessment
IRBs might help board members improve their protocol review process through the use of a tool that guides them through questions to ask about each study. -
Try "InfoShorts" for quick education strategy
Topics keep IRB up-to-date -
Be prepared for what’s up next: E-consent
Technology now is driving the way informed consent documents are formatted and presented, according to an expert. -
Ensure compliance with new PHS rules on COIs
As often happens in research, new rules, policies, and guidelines often follow media reports of research integrity and ethical breaches. -
For international consent, clarity is key
Creating clear, truly understandable informed consent documentation can sometimes be a challenge for IRB members and researchers, particularly in the area of international research. Making sure that details are not lost in translation and that the documentation meets U.S. federal and international regulations can also present some difficulty. -
University tests model for six-week protocol approval
When attempting to activate a clinical trial, one of the biggest concerns an institution faces is turnaround time. At Cedars-Sinai Medical Center in Los Angeles, activation of a new clinical trial could sometimes take 118 days, including IRB review, study team response time, and non-IRB required reviews such as contract negotiations. But for some protocols, including early-stage oncology or therapeutic studies, the institution looked for other ways to bring those new therapies to patients as efficiently and safely as possible.