BRIDGES Phase I

Applications of “personalized prevention” have focused primarily on chronic diseases such as cancer, heart disease and diabetes, and their behavioral risk factors including diet and smoking.

Infectious diseases, on the other hand, account for a significant component of disease burden worldwide, and are responsible for a large proportion of morbidity and mortality across all aspects of society. The prevention and control of infectious diseases and epidemics for both individuals and populations challenge medicine, public health, and domestic and international policy.

Applications of genomic technologies are providing insights into the evolution and spread of infectious diseases as well as differences in people’s susceptibility to and severity of infection and in their immune responses to prevention (vaccines) and drug therapies.

For example: there are genes that play a role in how likely an individual is to become infected with diseases including HIV, active tuberculosis, and chronic hepatitis C; particular gene variants are associated with the risk of becoming more severely ill from influenza infection; and people with certain forms of a gene (or genes) are less likely to be protected by the hepatitis B vaccine.

With the potential for tailored interventions for particular individuals, populations or subpopulations, the use of such genetic information for decision making in a clinical or public health setting might bring about new ELSI considerations.

A number of factors will contribute to the types of issues that arise, including characteristics of the disease in question (for example, how it is transmitted, whether it is acute or chronic, and whether it is vaccine-preventable or treatable), environmental/political/geographic challenges such as pandemic situations or resource scarcity, existing laws and policies, public attitudes, and cultural differences.

Ethical, legal, and societal issues that arise might include balancing health-related benefits and harms between individuals and the larger community, minimizing threats to individual privacy and autonomy, and ensuring just distribution of scarce resources. It will be important to have a way to identify, analyze and address the issues that accounts for the many contributing factors and challenges.

1. To explore and analyze the ethical, legal, social and policy significance for P5 medicine of communicable disease transmission, and variation in the modes and patterns of transmission among diverse communities and populations, and to consider the role of P5 medicine in reducing disparities in infectious disease burden.
2. To evaluate the ethical, legal and social tensions that arise with the application of Precision Medicine to infectious disease management at the level of individuals, communities and populations, and to inform policies that protect individuals and vulnerable populations while promoting the common good.
3. To anticipate, evaluate and develop policy responses to ELSI issues as genomic technologies and information are applied to infectious disease prevention, outbreak control, and clinical care.

There are three distinct yet related research programs that fall under the Center-wide aims:

• Research Program 1: Implications for the Research Enterprise
  Pilot Project: Genetic Variation, Research Cohorts and Vulnerable Populations at risk of HIV and HCV Infection.
  Project Leaders: Priya Duggal, Chloe Thio
• Research Program 2: Implications for Public Health Policy
  Pilot Project: Pandemic Prevention and Vaccinomics.
  Project Leaders: Daniel Salmon
• Research Program 3: Implications for Clinical Practice
  Pilot Project: Application of Genomics to Clinical Management of High-consequence Infections.
  Project Leaders: Lisa Maragakis, Brian Garibaldi

By developing multiple education and career development opportunities, BRIDGES aims to identify, educate, and launch the next generation of scholars with particular interests in the ethical, legal, social and policy implications of genomics and infectious disease prevention, control and treatment.  Education and career development activities:

1. Angie Boyce, BRIDGES co-investigator and Project Director, created a new course, Germs, Genes, Patients, Populations, that examines past, present and future ELSI issues at the intersection of infectious disease and genomics. The course challenges individualistic assumptions in bioethical models with frameworks that consider the interactions between hosts, vectors, pathogens, and environments. How are individualistic conceptions of autonomy, privacy and liberty being challenged in an “omic” era of microbial multiplicity?
2. Dr. Alexis Walker and Rebecca Wilbanks were recruited and started in September 2017 as fellows in the Berman Institute Hecht-Levi post-doctoral fellowship program. Alexis completed her PhD (May 2017) at Cornell University in the Science and Technology Studies program, and Rebecca received her PhD from Stanford’s program in Modern Thought and Literature in June 2017. Alexis has been directing BRIDGES Pilot Project 1 (PP1).  Rebecca brings a focus on the theme of “engineering life” from her previous research on synthetic biology.  In collaboration with BRIDGES co-investigators in the History of Medicine department, Rebecca is exploring the history and contemporary status of the genetically modified mosquito as a public health tool, and is particularly interested in questions of public engagement: should communities have a say in whether genetically modified mosquitos are released in their area, and if so, what would an ethical procedure for community engagement or community consent look like?
3. Partial tuition support for jointly-enrolled Master of Bioethics Program student Hunter Smith working in this subject area.
4. Mentorship from CEER co-investigators available to students pursuing theses, capstone projects, and other research on CEER-relevant topics. Programs may include but are not limited to the Genetic Counseling Training Program, the General Preventive Medicine Residency, masters and doctoral training in genetic epidemiology and infectious disease epidemiology, and preclinical students in the School of Medicine.
5. Establishment of the Genomics and Society Mentorship Program for undergraduates from under-represented groups with demonstrated interest in the ethics of research, clinical care and/or public health. Beginning with a 10-week summer internship through the Johns Hopkins School of Medicine and continuing for 15 months, Program participants will gain experience doing research centered on ethical, legal and social implications of genomics.

In the future, we plan to create a research education program for students from underrepresented groups; organize an ELSI Research Day to highlight ELSI research being undertaken at JHU and to foster new collaborations; develop a new genomics/infectious disease ELSI concentration for MBE and MPH students; and offer the 8-week course as a BI intensive.

• NIH funds new studies on ethical, legal and social impact of genomic information, National Institutes of Health
• NIH Names Johns Hopkins Berman Institute a Center of Excellence for Bioethics Research on Genomics and Infectious Disease
• Press Release: Personal Genome, Public Health: Johns Hopkins Establishes a Center to Study the Ethical Issues of Applying Genomics to Infectious Disease Treatment and Prevention
• Gail Geller, Rachel Dvoskin, Chloe L Thio, Priya Duggal, Michelle H Lewis,Theodore C Bailey, Andrea Sutherland, Daniel A Salmon and Jeffrey P Kahn. Genomics and infectious disease: a call to identify the ethical, legal and social implications for public health and clinical practice. Genome Medicine2014, 6:106  doi:10.1186/s13073-014-0106-2. This article is part of the series Genomics of infectious diseases special issue.
• Walker A, Boyce A, Geller G, Thio CL, Kahn JP. 2018. Direct-acting Antivirals and Hepatitis C: The Ethics of Price and Rationing by Genotype. Clinical Infectious Diseases 67(6): 983-984.
• Coltart C, Hoppe A, Parker M, Dawson L, Amon JJ, Simwinga M, Geller G, Henderson G, Laeyendecker O, et al. Ethical Considerations in global HIV phylogenetic research. Lancet HIV2018;5:e656 – e666.
• Boyce, A., 2019. Genomic Contextualism, Genetic Determinism, and Causal Models. The American Journal of Bioethics, 19(1), pp.73-75.
• Lewis, MH, “Should Genetic Testing for Variants Associated with Influenza Infection Be Mandatory for Health Care Employees?” AMA J Ethics; 20(9):  E819-825. doi:10.1001/amajethics.2018.819.
• Boyce, A.M. and Garibaldi, B.T., 2019. Genomics and High-Consequence Infectious Diseases: A Scoping Review of Emerging Science and Potential Ethical Issues. Health Security.
• Priya Duggal, Gail Geller, and Andrea Sutherland. Genetic Epidemiology, Infectious Disease, and Public Health Ethics. In A.C. Mastroianni, J.P. Kahn, and N.E. Kass (Eds.), The Oxford Handbook of Public Health Ethics. Oxford University Press.

• Priya Duggal, PhD, Genetic Epidemiology, Johns Hopkins Bloomberg School of Public Health
• Brian Garibaldi, MD, Pulmonary and Critical Care Medicine, Johns Hopkins Medicine
• Lisa Maragakis, MD, MPH, Infection Prevention, Johns Hopkins Medicine
• Daniel Salmon, PhD, Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health
• Chloe Thio, MD, Johns Hopkins Medicine

• Nathaniel Comfort, PhD, Institute of the History of Medicine, Johns Hopkins University
• Leslie Meltzer Henry, JD, PhD, MSc, University of Maryland Francis King Carey School of Law & Johns Hopkins Berman Institute of Bioethics
• Ruth Karron, MD, Department of International Health, Johns Hopkins Bloomberg School of Public
• Oliver Laeyendecker, PhD, MS, MBA, Johns Hopkins Bloomberg School of Public Health & NIAID
• Carl Latkin, PhD, Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health
• Michelle Lewis, MD, JD, Johns Hopkins Berman Institute of Bioethics
• Graham Mooney, PhD, Institute of the History of Medicine, Johns Hopkins University

• Johns Hopkins Medicine Biocontainment Unit (BCU)
• International Vaccine Access Center (IVAC)
• Center for Immunization Research (CIR)
• Institute for Vaccine Safety