IRB Advisor – March 1, 2019
March 1, 2019
View Issues
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Implementing the New Common Rule Is No Easy Task
The new rule also forces institutions to decide whether older studies should move forward under the new Common Rule or be grandfathered under the old rule.
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IRB Develops Method for Creating Informed Consent Summary
The informed consent template that now is required through the revised Common Rule can be developed thoughtfully and effectively through the use of an expert panel or working group, experts say.
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Collaboration Between IRBs Can Result in Better SOPs, Tools
IRBs can ensure smoother, more effective collaboration between institutions and pave the way for reliance agreements through the use of an IRB working group.
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Working Group Created Common Rule 'To-Do' List
An IRB working group in Texas created a new Common Rule to-do list through collaboration between the University of Texas at Arlington IRB and other area IRBs.
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Does Federal Right to Try Law Imperil State RTT Laws?
Adding to the considerable confusion on Right to Try laws, by which dying patients may seek access to experimental drugs, a legal expert tells IRB Advisor that the 41 RTT state laws may be found unconstitutional if they conflict with the federal law passed last year.
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Social Media Use By Participants Can Undermine Trials
The rapid communication enabled by various devices and platforms could undermine clinical trials, allowing research subjects to share notes and possibly manipulate the study.
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Consortium Pushes for Evidence-Based Research Oversight
Rather than careful forethought of action, many of the principles of human research protections are essentially reactionary, formed in the aftermath of a succession of horrific episodes of unethical experimentation, experts say.