Faculty Bibliography

Tissue-engineered medical products are now entering the clinical testing phase of development. Therefore, an open discussion is warranted regarding ethical issues that may arise as these novel 'combination' products move forward, such as when to conduct clinical trials, how to regulate such trials, when and how to responsibly introduce these strategies into clinical practice and how to maintain a positive public perception of the tissue-engineering field as a whole. These issues are discussed, and recommendations are provided for conducting first-in-human clinical studies.

Lung transplantation is a potentially life-saving procedure for patients with irreversible lung failure. Five-year survival rates after lung transplantation are >50% for children and young adults. But there are not enough lungs to save everyone who could benefit. In 2005, the United Network for Organ Sharing developed a scoring system to prioritize patients for transplantation. That system considered transplant urgency as well as time on the waiting list and the likelihood that the patient would benefit from the transplant. At the time, there were so few pediatric lung transplants that the data that were used to develop the Lung Allocation Score were inadequate to analyze and prioritize children, so they were left out of the Lung Allocation Score system. In 2013, the family of a 10-year-old challenged this system, claiming that it was unjust to children. In the article, we asked experts in health policy, bioethics, and transplantation to discuss the issues in the Murnaghan case.

The New York City Clinical Data Research Network (NYC-CDRN), funded by the Patient-Centered Outcomes Research Institute (PCORI), brings together 22 organizations including seven independent health systems to enable patient-centered clinical research, support a national network, and facilitate learning healthcare systems. The NYC-CDRN includes a robust, collaborative governance and organizational infrastructure, which takes advantage of its participants' experience, expertise, and history of collaboration. The technical design will employ an information model to document and manage the collection and transformation of clinical data, local institutional staging areas to transform and validate data, a centralized data processing facility to aggregate and share data, and use of common standards and tools. We strive to ensure that our project is patient-centered; nurtures collaboration among all stakeholders; develops scalable solutions facilitating growth and connections; chooses simple, elegant solutions wherever possible; and explores ways to streamline the administrative and regulatory approval process across sites.

Some argue that to be effective in healthcare settings autonomy needs to be strengthened. The author thinks autonomy is fundamentally inadequate in healthcare settings and requires supplementation by experience-based paternalism on the part of doctors and healthcare providers.

Parents of school-age children are increasingly claiming nonmedical exemptions to refuse vaccinations required for school entry. The resultant unvaccinated pockets in many areas of the country have been linked with outbreaks of vaccine-preventable diseases. Many states are now focused on reducing rates of nonmedical exemptions by making exemption processes more restrictive or burdensome for the exemptor. These strategies, however, pose ethical problems and may ultimately be inadequate. A shift to strategies that raise the financial liabilities of exemptors may lead to better success and prove ethically more sound. Potential areas of reform include tax law, health insurance, and private school funding programs. We advocate an approach that combines this type of incentive with more effective vaccination education.

PURPOSE: Outcome reporting bias is a well-known fact in clinical research. It's critical since readers believe that published articles are reliable and accurate. METHODS: The need for investigators to register the trials at the start have made it possible to compare the content of the published article with the registered information. RESULTS: Nearly one-third of clinical trials have changed their primary outcome from the time of registration to publication. CONCLUSIONS: Editors should implement measures aimed at preventing outcome reporting bias. To this end, it is proposed that authors, when submitting a manuscript to a journal, should also submit all trial information they have posted on a registry. Authors should comment on the accuracy and completeness of the information provided in the manuscript with respect to that included on the registry. Peer review should only start after the editorial staff has checked the accuracy of the manuscript content with the trial's registered information. This straightforward, although admittedly somewhat demanding exercise for editorial staff, will help ensure the accuracy of published articles and, hence, reduce outcome reporting bias.