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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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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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Ethical questions on organ transplantation have focused mainly on resource allocation — access to transplantation and prioritization of donor organs. A recent analysis revealed few consults were called for questions about appropriate resource allocation.
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Ethics consults called by surgical specialties differ somewhat from consults called by other hospital specialties.
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Chaplains often serve on ethics committees, as ethics consultants, and as institutional review board members. Yet there are no standardized ethics curricula in Clinical Pastoral Education programs.
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Supporting families faced with making critical decisions for incapacitated loved ones is a core ethical duty for ICU clinicians. Yet little is known about family characteristics that predict their dissatisfaction with support during decision-making.
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Updated guidelines offer specific recommendations for embryo research, stem cell embryo models, organoids, chimeras, germline genome editing, and mitochondrial replacement techniques. Public support for controversial research is an overarching goal.
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A Virginia-based health system has learned much about moral distress and why it is important to recognize and intervene.