November 2015

Making a Difference Grantees, Fall 2015

We are pleased to announce the Fall 2015 Making a Difference awards

Clara Berridge, PhD (Brown University)
1 year/ $52,980

Autonomy in the Balance: Incorporating User Preferences for Ethical Decision-Making About Remote Monitoring Technologies in Elder Care

Remote monitoring technologies that include GPS, activity sensors, and monitoring cameras are now allowable in some state Medicaid Home and Community-Based Services waiver programs. The spread of these technologies presents an urgent need to identify the considerations that shape older adults’ preferences for how and when they are monitored. The development of these technologies has largely been divorced from an understanding of the perceptions and desires of older adults, and research indicates that older adults are unlikely to understand fully what data are collected about them. This disconnect presents a bioethical problem when respect for the autonomy of older adults falls out of focus against a concern for their safety and restrictions on human and financial resources. This research is designed to identify what is needed to ensure comprehension by older adults of GPS, sensor systems, and cameras to enable informed consent. It will examine how older adults and their adult children weigh values at play in the use of these technologies. This study will inform future guidelines to ensure that these potential differences between the preferences of older adults and their family members are considered in decision-making as remote monitoring technologies are implemented in long-term care.

Giselle Corbie-Smith, MD (University of North Carolina, Chapel Hill)
21 months/ $269,650 

Re-Engaging Ethics: Ethical Issues in Engaged Research

‘Engaged scholarship’ is a growing concept that embraces the involvement of those who are to be researched as potential participants and co-conductors of the research. The goal of engaged scholarship is to achieve more informed research questions that result in readily translatable outcomes. However, there is limited guidance for conducting ethical engaged research. Current research ethics guidelines were primarily created to protect research participants. Engaged scholarship requires a complimentary set of principles to guide review and conduct research that protects individual rights and enhances community welfare. This project examines the ethical issues that arise when researchers and lay community members partner as equals in the conduct of research. The community-academic team will review current literature and analyze case studies from the perspective of researchers, community members, and representatives of Institutional Review Boards (IRBs) to develop community-influenced and academic-influenced recommendations to guide organizations and researchers funding and conducting engaged research.  The team will disseminate the recommendations through a webinar, regional and national conferences and events, and across the network of professional organizations and networks interested in community-academic partnered research and patient-centered research.  These recommendations will support investigators and community members involved in engaged research. 

Ellen Fox, MD (Altarum Institute)
27 months/ $306,864 

Healthcare Ethics Consultation (HEC) in U.S. Hospitals: Current Practices and Perspectives of HEC Practitioners and Hospital Administrators 

Healthcare ethics consultation is a service that is routinely offered by U.S. hospitals to help patients, families, and healthcare providers resolve ethical concerns. In recent years, concerns have been raised about the quality of HEC and the fact that HEC services operate with little oversight. Bioethics experts have been actively debating how best to improve HEC practices. The problem is that these experts lack critical information about the hospitals they seek to change. This new research study will provide much-needed data about how HEC is currently practiced, the gap between current HEC practices and newly established quality standards, and perspectives of key stakeholders who are responsible for HEC. Dr. Fox and her research team will contact HEC practitioners and hospital administrators at 600 U.S. hospitals and ask them about their hospitals’ HEC practices and their views on potential improvement strategies. The team will also assess current HEC quality using expert reviews of written HEC records. This information will give policymakers the information they need to determine the best strategies to improve HEC quality nationwide.

Keren Ladin, PhD (Tufts University)
18 months/ $136,000 

The Social Support Criterion in Transplantation: Considerations for Distributive and Procedural Justice

To ensure fairness and transparency, standardized evaluation criteria have been established to determine eligibility for transplantation. These include: medical, demographic, and psychosocial factors, including social support. Although evaluation criteria are largely evidence-based, there is weak evidence linking social support and transplant outcomes. Using social support to determine eligibility remains controversial for multiple reasons. First, social support remains the only criterion that uses information about others to determine patient eligibility. Second, there is lack of consensus about definitions, evaluation procedures, and consideration of social support in the listing decision. Third, continued use of the social support criterion may restrict access for vulnerable populations who have more difficulty demonstrating adequate support, may have more strained social support systems, and may be less able to finance home-based assistance.  This study examines evaluation practices and interventions related to social support in a national sample of transplant centers. Investigators will survey the transplant community’s attitudes about the legitimacy of the social support criterion and their perception of the importance of social support to transplant outcomes. Using qualitative and quantitative approaches, they will examine whether vulnerable populations are more likely to be scrutinized for inadequate support. The study’s ethical analysis will consider whether the continued use of the social support criterion can be morally defended. 

Jonathan D. Moreno, PhD (University of Pennsylvania)
1 year/ $53,829 

Neurotechnologies and the Biological and Chemical Weapons Conventions 

Dual use refers to the possibility that a technology can be used for malign as well as beneficent purposes. As the U.S. BRAIN Initiative and the European Human Brain Project publish their results, some of those results may present opportunities for dual use.  An example is the use of “calmatives,” aerosolized drugs that may be used for crowd control but have been shown to be unmanageable and dangerous. This project will address the prospect that dual-use neurotechnologies may be developed and consider how they might be managed under international arms control regimes including the Biologic and Toxin Weapons Convention and the Chemical Weapons Convention.

Jeffrey Peppercorn, MD (Massachusetts General Hospital)
18 months/ $165,010

Promoting Ethical Research with Stored Biospecimens as Science Evolves  

This study is intended to inform debates and real-world decisions over the use of archived biospecimens by seeking to understand the views and expectations of cancer patients who contribute to biobanks. Investigators will address the question of whether stored biospecimens should be used in research when the methods and risks of modern scientific techniques were not well described in the original informed consent documents. The study involves focus groups and survey research among over 700 cancer patients at a major academic cancer center. Aims of the research are:

  1. To evaluate preferences and expectations among patients who contribute or who may contribute biospecimens for future research. 
  2. To identify specific characteristics of the proposed research, informed consent documents, or potential or societal benefits that may impact patient views.
  3. To evaluate how sociodemographic and clinical differences correlate with views and preferences in this area.

This research will provide some of the first evidence of patient views and expectations regarding use of archived biospecimens when scientific and ethical standards have changed since the time of initial consent.  Investigators anticipate that these data will directly inform the frequent debates over specific cases that confront research consortia involved in biobank research across the United States and internationally.

Ameet Sarpatwari, JD, PhD (Brigham and Women’s Hospital)
1 year/ $183,393 

Ethical Issues in Prescription Drug Access under Restricted Distribution Programs 

In 2007, Congress granted the Food and Drug Administration (FDA) the power to mandate that manufacturers implement so-called risk evaluation and mitigation strategies (REMS) for approved drugs with serious side effects. One possible REMS component—elements to assure safe use (ETASU)—are typically reserved for drugs with the most serious safety concerns and can range from patient monitoring; person, place, and volume restrictions on dispensation; and physician and pharmacist training and certification. Between 2010 and 2014, over 10% of newly approved drugs have been issued ETASU REMS. Despite such frequent use, however, little is known about the effects of ETASU REMS, including whether the additional prescribing burdens they impose reduce patient access, enhance costs, or improve patients’ experiences with their illnesses. This project seeks to address these questions. First, investigators will construct a comprehensive database of ETASU REMS and identify trends in the prescribing of certain medications subject to these programs. They will then conduct a series of interviews/surveys with patients and physicians exposed to ETASU REMS, FDA regulators overseeing such programs, and manufacturer representatives to better understand the administration of ETASU REMS and their impact on patient care. Based on their findings, investigators will propose ethical norms for the effective and equitable use of ETASU REMS.