CERA Working Groups are interdisciplinary teams that aim to deepen our understanding of emerging, high priority, or understudied ELSI issues using innovative approaches. Working Group outcomes include new research, educational materials, publications for scholarly and lay audiences, online tools, and events. CERA selects one or two issue-based Working Groups biannually and awards each support for up to $20,000 in project costs.
The CERA Working Groups for 2020-2022 are:
Novel Gene Therapies for Pediatric and Young Adults with Sickle Cell Disease: Engaging Patient and Parent Stakeholders Working Group
Sickle Cell Disease (SCD) is an inherited disorder that results in premature mortality and severe morbidity in millions of afflicted individuals worldwide. Novel therapies are urgently needed and research to improve therapies for SCD is an NHLBI priority. Clinical trials using new methods of gene manipulation have begun in adults; however, it is most desirable to treat children, adolescents and young adults (AYA) before the onset of irreversible organ damage.
Expanding the availability of novel, potentially first-in-human clinical trials to children and AYA poses unique ethical challenges; particularly given that SCD affects a predominantly racial minority and socioeconomically disadvantaged patient population that has previously been underrepresented and historically mistreated in clinical research. For this reason, several groups including the SCD working group, believe that it is imperative that AYA and parent stakeholders are meaningfully engaged early in this process.
The 2017 National Academy of Medicine Report (NAMR) on Human Genome Editing called for public engagement around emerging gene-editing technologies for the purpose of, “monitoring public attitudes, information deficits, and emerging concerns,” which in this case are parents of children with, and AYA with SCD. The NAMR recommended that clinical applications of gene editing adhere to several principles including due care, respect for person, and transparency with transparency defined as the, “sharing of information in ways that are accessible and understandable to stakeholders.” The working group’s preliminary data demonstrate that many patients with SCD have low health literacy and limited understanding, especially with respect to gene therapy.
There is great opportunity to optimize understanding, improve communication, and enhance informed consent in this emerging area of research. The SCD working group (SCDGENE) will develop an advisory panel of patient, parent and AYA stakeholders with whom they will collaborate. The working group will systematically conduct needs assessments to elicit attitudes and identify knowledge gaps around novel gene therapies for the purpose of developing educational content and communication tools that honor the NAMR. The output of the group will include a qualitative manuscript delineating stakeholder recommendations. SCDGENE hopes to generate important data for use in the development and testing of decision-aids and educational tools. The working group co-leads will use the output to justify ongoing support to sustain the SCD stakeholder advisory panel. These aims will be executed through an interdisciplinary, multi-institutional group comprised of patients/caregivers, patient advocates, clinician-scientists, gene therapy experts, hematologists, ethicists, clinical educators, and health communication experts.
Consistent with several of the goals and objectives of CERA, the SCD Working Group will work to advance engagement of underrepresented communities (African Americans) in genomics research; establish a digital platform for scientists, scholars, and stakeholders to learn about the ethical, legal and social implications of genetics and genomics as it pertains to emerging gene therapies; and to foster a community of multidisciplinary researchers focused on this high priority issue.
- Akshay Sharma, MBBS, Co-leader, (Gene therapy for sickle cell disease expert, St. Jude Children’s Research Hospital, Memphis TN)
- Liza-Marie Johnson MD, MPH, MSB, Co-leader, (Bioethics, St. Jude Children’s Research Hospital, Memphis TN)
- Lakiea Bailey, PhD (Executive Director, Sickle Cell Community Consotium, Inc.)
- Yvonne M. Carroll, RN, JD (Patient Advocate and President of the International Association of Sickle Cell Nurses and Professional Associates (IASCNAPA), St. Jude Children’s Research Hospital)
- Ellen Clayton, MD, JD (Craig-Weaver Professor of Pediatrics and Professor of Health Policy at Vanderbilt University Medical Center and Professor of Law at Vanderbilt University)
- Catherine Hammack-Aviran, MA, JD (Research Director for the Ethics, Education, Policy, and Society, Office of Medical Student Research and Primary Research Immersion Mentor, Vanderbilt University School of Medicine)
- Jane Hankins, MD (Hematology, St. Jude Children’s Research Hospital)
- Kimberly Sawyer, MD (Bioethics, Baylor College of Medicine, Houston TX)
- Yoram Unguru, MD, MS, MA (Bioethics, Johns Hopkins Berman Institute of Bioethics, Baltimore MD)
- Mitchell Weiss, MD, PhD (Chair, Hematology Department, St. Jude Children’s Research Hospital)
- Benjamin Wilfond, MD (Bioethics, Seattle Children's Hospital and Research Institute, University of Washington School of Medicine, Seattle WA)
- Kelvin Womack (Vice President for Diversity and Inclusion, , St. Jude Children’s Research Hospital)
- Amanda Young, PhD (Health Communication, University of Memphis, Memphis TN)
Developing Resources for DNA Testing at the Border: BorderDNA Working Group
Emerging technological advances and political shifts have expanded immigration-related DNA applications beyond relationship tests within a family for visa petitions. Several U.S. government programs involve collection or use of DNA data:
- family reference DNA sample collection for identification of missing migrants
- DNA data collection of migrant detainees for the federal criminal DNA database
- rapid DNA technologies instated at border points for verification of familial relationship claims
DNA data is beneficial in immigration processes for demonstrating relatedness in family reunification, investigating human trafficking, identifying fraud, and identifying deceased migrants who die crossing the border. However, these applications bring an array of ethical, legal, and societal questions, including concerns for autonomy of movement, the disparate effects of collection practices on vulnerable populations, potential for abuses of power, and need for protections from unauthorized use of DNA data. For instance, DNA data collected for humanitarian purposes (e.g., missing persons) or to screen for human trafficking also might be used as surveillance or to track migrants that might be a threat to the state. Also, geneticization of the term “family” and stratification of visa petitioners and refugees based on biological interpretations of identity could shift policies towards stigmatization and discrimination. There is a realistic risk that genomic technologies implemented into immigration practices will develop into practices favoring biological relationships over other family and community links.
A truly informed consent process is not feasible in the outlined scenarios. If the risk of not participating is deportation, family separation, or an inability to identify a deceased family member, then the imbalance of power precludes free, informed consent. Our team recognizes the need for resources to inform migrant families of their rights, options (where they might have them), and descriptions of the policies and procedures they are facing. Providing migrant families information on the different DNA testing or collection processes is one step towards providing awareness and agency to the families and individuals undergoing DNA testing at the border. Operational DNA collectors (e.g., border agents, social workers, immigration attorneys) also would benefit from guidance on the nuances of using genetic information for testing for family relationships and how DNA data is shared (and protected) among agencies and across borders.
The working group will develop resources, such as FAQs on family reference DNA sample collection for transnational identification of missing migrants, DNA data collection from migrant detainees for the federal criminal DNA database, and rapid DNA technologies instated at border points for verification of familial relationship claims. Formats for resources will be a combination of printed materials, web-based information, and animated videos. All resources will be developed for limited English proficiency families and made publicly available.
The team will cooperate and collaborate with experts for help in reviewing drafts of our planned resources and assistance in disseminating or test fielding the resources. Experts include the following:
- law enforcement
- humanitarian groups
- federal agencies
- human rights advocates
- forensic DNA experts
- immigration experts
- Our intention is to focus on resource development, not research. Where possible, we will develop processes that could be researched, and keep data and information for future research
- We will maintain an unbiased approach to our product development, not advocate for or against policies
- The developed products will be fluid, alterable for future uses, and amendable. The DNA users and groups working with migrants are the experts informing the content. The BorderDNA Team is merely the conduit for amalgamating information and repackaging it for public use
- Many resources are needed and time needed to develop them all. We will maintain a list of needs and focus on achievable deliverables and take steps towards other deliverables. We are obligated to deliver at least one resource for each of the three topics
- Sara H Katsanis, MS (lead), Lurie Children’s, Northwestern (Policy, ethics, ELSI, genetics, forensic DNA)
- Diana Madden, MA (Res Coord), Lurie Children’s (Ethnography, science policy, social media)
- Bridget Algee-Hewitt, Stanford (Biological anthropology, migrants’ rights, forensic DNA, computational genomics, social media))
- Dan Berger, Curran, Berger, & Kludt (Immigration law, Migrants’ rights)
- Bob Cook-Deegan, Arizona State University (Genetics policy, genomics, human rights, ELSI)
- Carla Easter, NHGRI (Genetics education, Indigenous rights, ELSI)
- Chris Gunter, NHGRI (Communication, genomics, ELSI)
- Cris Hughes, University of Illinois (Biological anthropology, genetics)
- Anya Prince, University of Iowa (Law, discrimination, ELSI)
- Jennifer Wagner, Geisinger (Law, genetics policy, anthropology)