Compliance
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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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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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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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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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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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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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HIPAA Requires Security for Printers, Just Like Other Servers and Endpoints
Most covered entities and business associates do not appreciate how printers have evolved from “dummy copiers” to today’s complex business machines that include multiple servers built directly into them.
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OCR May Alter HIPAA Rules to Ease Compliance, Care Coordination
The healthcare industry has complained about the difficulty of complying with HIPAA since the law was enacted. Now, the HHS Office for Civil Rights is asking for suggestions on how to make HIPAA more manageable.
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Doctor Not Liable After Allegedly Concealing Outcome of Spinal Disc Surgery
Lessons from these events highlight the importance of corroboration, whether by a supporting colleague or staff, or by appropriate and thorough documentation.
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$32.5 Million Award Affirmed for Patient Who Suffered Permanent Injuries During Childbirth
This case demonstrates the important need for accurate medical records, and that the failure to provide them can constitute action below the applicable standard of care.