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The Equal Employment Opportunity Commission guidance includes two important exceptions. Employers remain limited by the provisions of Title VII of the Civil Rights Act of 1964 and the Americans with Disabilities Act. Title VII requires employers to provide exemptions from any vaccine requirement to employees with sincerely held religious beliefs preventing them from taking the vaccine. Further, the ADA requires employers to provide exemptions from any vaccine requirement to employees with a disability that prevents them from taking the vaccine.
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Guidance from the Equal Employment Opportunity Commission indicates healthcare employers can require employees to receive a COVID-19 vaccine. These mandates come with some obligations and risks.
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The new COVID-19 requirements from OSHA for healthcare employers create substantial obligations, but many hospitals already are carrying out much of what is required. The challenge may come in formalizing a written plan and ensuring it addresses all of OSHA’s expectations.
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IRBs can resolve most research-related complaints, but a policy implemented last year by the National Institutes of Health’s Office of Human Subjects Research Protections offers assistance when the conflict reaches a stalemate.
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An associate professor at Columbia Law School in New York City wrote about the handling of research grievances from research studies. The processes for resolving research participants’ concerns are a “curiously unregulated space." While the United States court system might recognize claims about physical injuries during a trial or a negligent study design, it usually is left to the IRB to resolve disputes between trial participants and research staff.
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Like many of its counterparts, the IRB at New York State Psychiatric Institute (NYSPI) evaluates any complaint from a research participant on an individual, case-by-case basis. IRB Advisor spoke with Corinne Rogers, MS, CIP, NYSPI IRB director, to find out more about her research-related dispute procedures.
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Data safety monitoring boards (DSMBs) have played a big role in delivering vaccines and treatments to the public faster in the past 18 months. DSMBs reviewed results and safety data of the various studies involving treatments and vaccines for COVID-19. IRB Advisor asked two scientists about how DSMB work has helped improve research protections during the pandemic.
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An IRB process improvement project reduced the protocol modification time by half. The change required the IRB chairs to give up some of their responsibilities and put these new responsibilities on the IRB coordinators.
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The results of a recent study indicate potential research participants are open to alternative vaccine trial designs, including challenge trials in which participants are exposed to COVID-19.
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As of Jan. 1, 2022, accredited facilities must educate, train, monitor, and assess more often.