June 2017

Making a Difference Grantees, Spring 2017

We are pleased to announce the Spring 2017 Making a Difference awards.

Peter Ubel, MD (Duke University)
2 years / $176,503

Exploring ethical dilemmas facing private payers

The team plans to conduct normative analyses of ethical dilemmas raised by the evolving role of healthcare payers in shaping healthcare spending and medical decision making in the United States. These analyses will be informed by our involvement on a payer’s ethics committee, and through interviews we conduct of stakeholders and practitioners. We strive to gain a thorough understanding of the dilemmas that arise as third party payer’s balance duties to shareholders, beneficiaries and society.

Lawrence Gostin, JD (Georgetown University)
18 months / $189,569

Establishing ethical interpretations of not yet fully interpreted public health and evidentiary standards in the Federal Tobacco Control Act

The U.S. Tobacco Control Act generally empowers FDA to act within its authorities to reduce tobacco use harms whenever FDA determines, without being “arbitrary or capricious,” that the action is “appropriate for the protection of the public health.” But these statutory standards have not yet been fully defined or clarified. This project will use bioethical principles and analyses to develop those legally viable interpretations that would operate most effectively and ethically to promote the public health - and then show how the clarified standards apply to FDA’s pre-market review of new tobacco products and possible future rulemaking. This ethical analysis will facilitate more rapid and constructive FDA action to reduce tobacco’s toll by providing a clearer, more complete framework to guide stakeholders, FDA staff, government officials who clear proposed FDA actions, and researchers, and by helping ensure that future court rulings on the Tobacco Act’s standards consider their ethical dimensions.

Kirstin Matthews, PhD (Rice University)
18 months / $153,637

Drawing the line: Assessing and analyzing the US Rule on embryo research from ethical, political, and scientific perspectives

Human embryo research is restricted in vitro to the 14th day of development in the United States, a stage prior to the formation of the primitive streak—an observable, early step towards the formation of neural tissue. In 2016, scientists published the first reports cultivating human embryos to this time point. Many scientists and ethicists are now questioning the validity of the deadline. Is it an ethically justifiable point to end research? Or is it just a public policy tool to limit research that previously was only hypothetically possible? In this project, we will assess the human embryo 14-day limit through scientific, legal and ethical perspectives and make recommendations regarding the ethical and scientific advisability of an extension. Project outcomes include at least several open-access and peer-reviewed publications, a public event, and a workshop. The results will help guide current policy and future assessments of human embryo research.

Seema Shah, JD (Seattle Children’s Hospital)
2 years / $199,117

A new ethical and regulatory approach for the use of human challenge studies with emerging infectious diseases

Recent outbreaks of Ebola and Zika virus have revealed the threats posed by emerging infectious diseases (EIDs). Although interventions are urgently needed, research during an outbreak can raise logistical and ethical challenges. Human challenge studies, where researchers deliberately expose healthy volunteers to disease, are powerful tools to prepare for future EID outbreaks and accelerate product development. However, some human challenge studies have been controversial, and systematic ethical analysis is limited. The overall objective of this project is to bring together a diverse group of experts and stakeholders to develop a new, comprehensive, and practical ethical framework for the use of human challenge studies for EIDs. This project has two aims: (1) To determine under what conditions human challenge studies on EIDs can be ethically justified, and (2) to identify additional safeguards to protect and respect participants and communities and foster public trust.

Jeremy Snyder, PhD (Simon Fraser University)
12 months / $47,688

Developing best practices for medical crowdfunding

Medical crowdfunding uses social networks to raise funds for health-related needs. This rapidly growing practice helps address gaps in insurance coverage and inadequate savings. However, bioethicists worry that it may unfairly distribute these benefits, shift attention from the systemic causes of inadequate access to health resources, and undermine privacy. Little is known about medical crowdfunding by US residents. The aim of this project is to gather and analyze data to help assess these and other ethical concerns. We will compile a summary document of what is known about medical crowdfunding by US residents, collect and analyze data from medical crowdfunding campaigns, and hold consultative meetings with medical crowdfunding organizations with the aim of establishing ethical best practices in this industry. This will be the first project to gather and analyze data on medical crowdfunding through a bioethics lens, a significant need given the increased scale and visibility of this practice.