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Methods to Improve the IRB/PI Relationship

There are natural conflicts between IRBs and principal investigators, but IRBs can take several steps to improve this crucial relationship. For instance, IRBs should treat everything on a case-by-case basis, depending on the situation, the principal investigator, and the IRB’s policies.

Protecting Research Data in the Digital Age

The increasing array of devices and systems to access, store, and transfer research data calls for diligence and common sense to prevent breaches. How seriously is the research community taking this threat? The National Institutes of Health has essentially hired hackers to constantly probe and test its database for the All of Us genome research project.

Is ‘Informed Consent’ an Oxymoron?

A study asking readers to consent to a short form containing only the key information about the research resulted in suboptimal comprehension, suggesting participants only skimmed through it or skipped it outright.

OHRP Holds Workshop on ‘Pervasive’ Data

The unprecedented level of digital data available across an expanding electronic landscape poses complex challenges for IRBs as they attempt to provide ethical insight and ensure participant privacy. Some of these data are collected in clinical care, but the public also is generating data through health monitoring devices, GPS location systems, social media, and information collected and shared on mobile apps.

Focus on the Differences Between IRBs and HRPPs

As research institutions move toward a single IRB model and more studies are deemed exempt, there is a greater need for all stakeholders to understand the differences between an IRB and a human research protection program.

Single IRB Common Rule Changes Arrive in January

Academic institutions are grappling with ensuring their IRBs are prepared for the January 2020 deadline to move multisite research to a single IRB. This deadline looms over all policy and procedural changes.

Provider Stress Can Trickle Down to Affect Patient Safety

The healthcare industry can be stressful for everyone involved, with clinicians sometimes suffering greatly from the workload, time demands, bureaucracy, and the emotional nature of their work. Minimizing stress is important for the health of the caregivers, but also to maintain patient safety. When staff are exhausted, experiencing depersonalization from their work and feeling less effective, they are more likely to fail to follow practices that support high-quality, safer care.

CMS Issues 2020 Final Rules for Inpatient and Long-Term Acute Care

The Centers for Medicare & Medicaid Services issued its final rule in August to update the Medicare payment policies for hospitals under the Inpatient Prospective Payment System and the Long-Term Care Hospital Prospective Payment System for fiscal year 2020. Changes were made to the rural hospital wage index, all-cause readmissions, and interoperability.

Physician Not Liable for Alleged Complications After Gallbladder Removal

This successful defense case reveals potent methods for defeating medical malpractice claims. On the substance, the defendant physician successfully challenged one of the necessary elements that an injured patient must prove when alleging medical malpractice: causation. Causation includes factual and legal aspects, where the physician’s actions must have been a “substantial factor” in contributing to the patient’s harm, but there may be an intervening action or event that cuts off the physician’s liability. If the risk of injury exists, even when a procedure is performed correctly, then simply because an injury occurred does not mean that the physician was negligent.

Negligent Thyroid Surgery Results in $2.2 Million Verdict

One of the primary lessons from the case for physicians and care providers is that assistant physicians, including residents, may be subject to liability for failing to provide services within the standard of care as well, and that standard does not change for a resident still in training.