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Protocol Activation Model Leads to Reduction in Time-to-IRB Approval
A large cancer research institution in New York City overhauled its protocol review process, devised a library of scientific terms commonly used in consent forms, and invested in more staff. Within a couple of years, the updated process resulted in a striking reduction in the median time for protocol and consent review by the IRB. Time-to-IRB approval decreased from 135 days in 2017 to 80 days in 2018.
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Consent Calendar for Continuing Reviews Can Save IRB Meeting Time
The consent calendar is a century-old tool, but it can work well in saving time during IRB meetings. Typically, IRBs review each study up for continuing review, discussing and voting for each, separately. But that might not be the most efficient way to handle these on the board meeting agenda.
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IRB Devises Efficient, Time-Saving Annual Review Process
Continuing review might have gone away for many studies, but a research protection program’s responsibilities have not. This is why many IRBs have devised an alternative annual review process that combines workflow efficiency with enhanced research protection. One model for this regular review is an annual status report. Minimum risk, expedited review, and some additional studies do not need to go through the annual continuing review by the IRB, but they can be monitored through this review.
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IRBs Can Work on Ground Floor With Start-Up Technology Firms
New companies using cutting-edge technology can enter the research arena, but they might lack resources and a knowledge base that academic research organizations take for granted. IRBs can help companies fill some of those knowledge and experience gaps by forming a collaborative relationship and working with them from the beginning of the study design process.
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New Tech Research Raises Ethical Challenges for IRBs and Investigators
Some new technology companies that are developing novel human subjects research face challenges and design issues that have never been explored. Companies engaging in cutting-edge technological services and solutions can raise public concerns for what they do on the business side, but there is less public awareness of privately funded research.
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Wrong Person Receives Bill, OCR Secures $2.175 Million Fine
Sentara Hospitals in Virginia and North Carolina agreed to take corrective actions and pay $2.175 million to settle potential HIPAA violations stemming from a complaint alleging the organization sent a bill to an individual containing another patient’s PHI. OCR determined Sentara mailed 577 patients’ PHI to wrong addresses.
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HIPAA Settlements Hold Lessons on Right of Access, Breach Reporting
The Office for Civil Rights (OCR) recently announced two HIPAA settlements that offer lessons for covered entities regarding right of access and failure to notify after a breach. In early 2019, OCR announced it would take steps to enforce the rights of patients to receive copies of their medical records timely and at a reasonable cost. This led to the introduction of the HIPAA Right of Access Initiative.
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Expect More High-Tech Breaches, Attorney General Audits This Year
The trend for HIPAA compliance is toward more breaches and complex breaches than seen in earlier years of efforts to follow the privacy rule, say some experts. A sharp increase in cyberattacks also may be coming this year.
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Appellate Court Reverses Summary Judgment Based on Expert’s Disqualification
This case demonstrates the importance of expert witnesses, which not only can determine a case at trial, but even potentially before trial. Although the outcome of this case remains uncertain, and the patient has not been awarded any monetary damages, the appellate court ruling certainly is a setback for the defendant care provider, and reopens a window of opportunity for the patient to continue the allegations of malpractice.
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Failure to Remove Sponge Results in $10.5 Million Verdict
The facts of the case left little doubt as to whether hospital staff had violated their duty of care. In addition to the ethical requirement to tell the patient about the retained sponge, there is a licensing and regulatory requirement as well.