Program in Research Ethics
Welcome to the Program in Research Ethics (PRE)
The pursuit of clinical and translational science confronts us with numerous pressing ethical and policy challenges. Longstanding concerns include how to maximize benefits and minimize risks for participants while maintaining scientific rigor, how to obtain valid informed consent from participants or their legally authorized representatives, how to include patients and communities in the design and conduct of research, how to promote equity and justice while pursuing research, how to recruit participants across the lifespan while respecting ethical parameters, and how to ensure effective, efficient, high-quality mechanisms for the protection of human subjects. However, our very success in translational therapeutics has presented new ethical challenges such as how to ensure access for both domestic and global patient populations given the complexities of pricing and payment and how to ensure the integrity of and public trust in the research enterprise in light of the financial relationships between academic institutions and the for-profit entities that key to translation.
As an integral part of the ITMAT, the Program in Research Ethics will establish a working group and select a topic each year that is of critical relevance to clinical and translational science. The goal of the working group each year will be twofold: to define the state of the ethics and to offer a set of recommendations for addressing or overcoming ethical challenges posed by the issue chosen for focus. Initial candidates are (i) Pricing of and access to novel one-time therapies such as gene therapy; (ii) Financial relationships between academic institutions and the biomedical products industry; (iii) Patient and community partnership in the governance of clinical and translational research; and (iv) race, racism, and justice in biomedical research. Outputs may include a public workshop, a policy-oriented article in a peer-reviewed journal, an op-ed in a mass media forum, and a video presenting the issues identified and the proposed solutions or recommendations in a concise, accessible form. These will be posted on the ITMAT website and disseminated to CTSA Hubs and through multiple social media channels. Through these working groups, the Program aims to produce a series of policy recommendations, grounded in rigorous analysis of the ethical problems and of the relevant data, that will aid in overcoming critical barriers to the progress of clinical and translational research.
Response to COVID-19. The rapid arrival of large numbers infected patients and the need rapidly to assess the safety and efficacy of potential therapeutics provides an opportunity for the development and application of novel and diversified approaches to trial design, statistical analysis ( e.g. “basket trials” of multiple therapies; Bayesian analyses) and regulatory approval, all of which will rely on the BERD and RKS teams. Prioritization of access to resources – from ventilators to entry into clinical trials to compassionate use approvals –and the conduct of research under conditions of a dire global public health emergency present complex ethical challenges that will draw on the expertise of the members of the Program in Research Ethics and the broader Penn bioethics community.
Steve Joffe, MD, MP
Interim Chair, Department of Medical Ethics & Health Policy
Chief, Division of Medical Ethics
Founders Professor of Medical Ethics and Health Policy Professor of Pediatrics