Faculty Bibliography

Patients who suffer from life-threatening illnesses or are stricken with conditions that could result in serious morbidity who have exhausted all appropriate treatments may choose to try, through the Food and Drug Administration's expanded access program, an investigational drug or device in development. The program has succeeded for decades in allowing patients to access potentially helpful but still experimental agents. Nevertheless, the administration of investigational drugs outside of clinical trials raises several ethical issues. Of particular concern are the validity of informed consent and the absence of a framework to ensure that experimental drugs are allocated justly and transparently. Although there are some safeguards to help protect the soundness of consent, little work to date has been done to guarantee that investigational medical products are allocated justly and transparently. We introduce a novel pilot project that seeks to address this issue.

Institutional review boards (IRBs) have become beleaguered by a growth in responsibilities related to research oversight in the past several decades. A number of regulatory bodies have appeared in response to these novel and complex responsibilities, seeking to respond to among other issues, conflicts of interest, new technologies, and the potential misuse of research findings. Here, we examine several examples of these novel regulatory bodies as well as a number of concerns related to them that have been largely unacknowledged. Evidence suggests that there can be disharmony and conflicts between these regulatory bodies and IRBs, a lack of clarity with regard to their roles and responsibilities, as well as shortcomings within these entities that, at times, look a lot like the worries that have long been raised in relation to IRBs. We offer a brief discussion of how some of these concerns might be ameliorated, either through a significant restructuring of the system of research oversight, or perhaps through smaller changes to these regulatory bodies.

The United States is the only major nation to not yet have ratified the United Nations Convention on the Rights of the Child (UNCRC). Recently, there has been an erosion of the rights of children across America, Europe, and elsewhere, but through science, we may have an opportunity to counter some of this alarming trend. In the area of vaccines, the scientific community can raise its voice on the dangers that nonmedical exemptions and delays pose to children at risk for measles, influenza, and other childhood illnesses. Poverty places infants and children at high risk for illness and homelessness. Gun violence and gun-related accidents are killing on average four American children daily, and climate change is promoting global pediatric malnutrition. Increasing international, federal, and state support to seek innovative solutions to these and related issues is a moral imperative.

In critically ill patients, it is frequently challenging to identify who will benefit from admission to the intensive care unit and life-sustaining interventions when the chances of a meaningful outcome are unclear. In addition, the acute illness not only affects the patients but also family members or surrogates who often are overwhelmed and unable to make thoughtful decisions. In these circumstances, a time-limited trial (TLT) of intensive care treatment can be helpful. A TLT is an agreement to initiate all necessary treatments or treatments with clearly delineated limitations for a certain period of time to gain a more realistic understanding of the patient's chances of a meaningful recovery or to ascertain the patient's wishes and values. In this article, we discuss current research on different aspects of TLTs in the intensive care unit. We propose how and when to use TLTs, discuss how much time should be taken for a TLT, give an overview of the potential impact of TLTs on healthcare resources, describe ethical challenges concerning TLTs, and discuss how to evaluate a TLT.