Compliance
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Chief Ethical Considerations for Continued COVID-19 Vaccine Research
The COVID-19 pandemic has created more uncertainty in human research protections in 2021. One issue IRBs will face is whether the benefits continue to outweigh the risks for people who enroll in COVID-19 vaccine studies.
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Research World Can Help Build Trust Among Minorities
The COVID-19 vaccine rollout has raised issues about trust among many Americans who are hesitant or unwilling to take the vaccine. The issue of trust is especially problematic among minority communities that have been harmed in historic medical and research incidences. People also are skeptical of a vaccine that was developed in record time, considering most vaccines take 10-15 years to make it to market.
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Research Trust Issues Affect Vaccine Rollout
The first month of the COVID-19 vaccine rollout among frontline healthcare workers was a reality check to the human research world after many people said no to the vaccine. There are several reasons for vaccine hesitancy, including distrust in the accelerated vaccine development process.
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Court Orders New Trial Over Hospital’s Improper Closing Arguments
The appellate court’s decision focused on whether the non-party status of the nurse who allegedly dropped plaintiff was determinative in the case at hand. The court of appeals found the trial court failed to exercise its full range of discretion and had not carefully considered the fact that although the nurse was not a party to the case, her conduct was the object of the case, and it was unclear whether the jury fully understood that she was not a party to the matter.
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Hospital to Stand Trial for Botched Brain Surgery Performed with Recalled Laser
As often is the case in medical malpractice cases, defendants made a concerted effort to dismiss the case based on the insufficiency of the plaintiff’s expert report. Here, however, the court of appeals began its analysis by specifying that based on the applicable standard of review, the purpose of the plaintiffs’ expert report is to demonstrate the plaintiff is not filing a frivolous lawsuit.
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New and Proposed HIPAA Rules May Offer More Protection
New legislation and proposed rules will affect HIPAA compliance. Both actions are good news for covered entities and business associates.
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Nurse in Jeopardy for Refusing Hospital’s COVID-19 Policy on Scrubs
A Minnesota nurse refused to follow his hospital’s policy on taking scrubs home and laundering them, rather than using hospital-provided scrubs. The hospital fired the nurse, who is alleging whistleblower retaliation. Nurses at the hospital resisted the policy because they did not want to take COVID-19 home to their families.
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Understanding Emergency Use Authorization Issues with COVID-19 Vaccine
Current COVID-19 vaccines have not undergone the process for full FDA approval, but have been authorized under a streamlined process known as an emergency use authorization. Because of this, the vaccines are technically considered experimental and are subject to regulations that may affect whether employers are permitted to mandate their use by employees.
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EEOC Says Employers Can Mandate Vaccines — with Exceptions
Under certain circumstances, employers are permitted to mandate their employees to receive a COVID-19 vaccination as a condition of their employment. That position was outlined by the Equal Employment Opportunity Commission in guidance published in December 2020. However, this guidance is not without its limits.
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HIPAA Issues Can Arise with COVID-19 Vaccinations
HIPAA can become an issue if healthcare employers require proof that employees have received a COVID-19 vaccine. Under HIPAA, immunization records are protected health information.