What Research Ethics Should Learn from Genomics and Society Research: Lessons from the ELSI Congress of 2011

Research on the ethical, legal, and social implications (ELSI) of human genomics has devoted significant attention to the research ethics issues that arise from genomic science as it moves through the translational process. Given the prominence of these issues in today's debates over the state of research ethics overall, these studies are well positioned to contribute important data, contextual considerations, and policy arguments to the wider research ethics community's deliberations, and ultimately to develop a research ethics that can help guide biomedicine's future. In this essay, we illustrate this thesis through an analytic summary of the research presented at the 2011 ELSI Congress, an international meeting of genomics and society researchers. We identify three pivotal factors currently shaping genomic research, its clinical translation, and its societal implications: (1) the increasingly blurred boundary between research and treatment; (2) uncertainty — that is, the indefinite, indeterminate, and incomplete nature of much genomic information and the challenges that arise from making meaning and use of it; and (3) the role of negotiations between multiple scientific and non-scientific stakeholders in setting the priorities for and direction of biomedical research, as it is increasingly conducted “in the public square.

The Challenge of Informed Consent and Return of Results in Translational Genomics: Empirical Analysis and Recommendations

As exome and genome sequencing move into clinical application, questions surround how to elicit consent and handle potential return of individual genomic results. This study analyzes nine consent forms used in NIH-funded sequencing studies. Content analysis reveals considerable heterogeneity, including in defining results that may be returned, identifying potential benefits and risks of return, protecting privacy, addressing placement of results in the medical record, and data-sharing. In response to lack of consensus, we offer recommendations

What Research Ethics Should Learn from Genomics and Society Research: Lessons from the ELSI Congress of 2011

Research on the ethical, legal, and social implications (ELSI) of human genomics has devoted significant attention to the research ethics issues that arise from genomic science as it moves through the translational process. Given the prominence of these issues in today's debates over the state of research ethics overall, these studies are well positioned to contribute important data, contextual considerations, and policy arguments to the wider research ethics community's deliberations, and ultimately to develop a research ethics that can help guide biomedicine's future. In this essay, we illustrate this thesis through an analytic summary of the research presented at the 2011 ELSI Congress, an international meeting of genomics and society researchers. We identify three pivotal factors currently shaping genomic research, its clinical translation, and its societal implications: (1) the increasingly blurred boundary between research and treatment; (2) uncertainty — that is, the indefinite, indeterminate, and incomplete nature of much genomic information and the challenges that arise from making meaning and use of it; and (3) the role of negotiations between multiple scientific and non-scientific stakeholders in setting the priorities for and direction of biomedical research, as it is increasingly conducted “in the public square.

Corrigendum to ‘Decision making for invasive and non-invasive optional procedures within an acute HIV research cohort in Bangkok,’ [Contemporary Clinical Trials Communication (2023)101054](S2451865422001715)(10.1016/j.conctc.2022.101054)

The authors regret that Dr. Sandhya Vasan was missed in the author list for this article. The revised author order is as follows: Sinéad Isaacson1,2, Kristine Kuczynski1, Nuchanart Ormsby1, Holly L. Peay3, Stuart Rennie1,4, R. Jean Cadigan1,4, Eugène Kroon5, Nittaya Phanuphak 5, Jintanat Ananworanich6, Sandhya Vasan7,8, Thidarat Jupimai9, Peeriya Prueksakaew5, Gail E. Henderson1§ 1 Social Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA. 2 Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA. 3 RTI International, Research Triangle Park, Durham, North Carolina, USA. 4 Center for Bioethics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA. 5 SEARCH, Institute of HIV Research and Innovation, Bangkok, Thailand. 6 Department of Global Health, Amsterdam University Medical Centers, University of Amsterdam, and Amsterdam Institute for Global Health and Development, Amsterdam, The Netherlands. 7 US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA. 8 The Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA. 9 Center of Excellence in Pediatric Infectious Diseases and Vaccines Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. The authors regret that Acknowledgements omitted reference to cooperative agreements that funded this work, and the Disclaimer was omitted. The corrected versions are as follows

The Challenge of Informed Consent and Return of Results in Translational Genomics: Empirical Analysis and Recommendations

As exome and genome sequencing move into clinical application, questions surround how to elicit consent and handle potential return of individual genomic results. This study analyzes nine consent forms used in NIH-funded sequencing studies. Content analysis reveals considerable heterogeneity, including in defining results that may be returned, identifying potential benefits and risks of return, protecting privacy, addressing placement of results in the medical record, and data-sharing. In response to lack of consensus, we offer recommendations

Adolescents’, mothers’, and fathers’ gendered coping strategies during conflict: Youth and parent influences on conflict resolution and psychopathology

We observed gendered coping strategies and conflict resolution outcomes used by adolescents and parents during a conflict discussion task to evaluate associations with current and later adolescent psychopathology. We studied 137 middle-to-upper-middle class predominantly Caucasian families of adolescents (aged 11–16 years, 65 males) who represented a range of psychological functioning including normative (~1/3) sub-clinical (~1/3) and clinical (~1/3) levels of problems. Adolescent coping strategies played key roles both in the extent to which parent-adolescent dyads resolved conflict and in the trajectory of psychopathology symptom severity over a two-year period. Gender-prototypic adaptive coping strategies were observed in parents but not youth, i.e. more problem-solving by fathers than mothers and more regulated emotion-focused coping by mothers than fathers. Youth-mother dyads more often achieved full resolution of conflict than youth-father dyads. There were generally not bidirectional effects among youth and parents’ coping across the discussion except boys’ initial use of angry/hostile coping predicted fathers’ angry/hostile coping. The child was more influential than the parent on conflict resolution. This extended to exacerbation/alleviation of psychopathology over two years: higher conflict resolution mediated the association of adolescents’ use of problem-focused coping with decreases in symptom severity over time. Lower conflict resolution mediated the association of adolescents’ use of angry/hostile emotion coping with increases in symptom severity over time. Implications of findings are considered within a broadened context of the nature of coping and conflict resolution in youth-parent interactions, as well as how these processes impact on youth well-being and dysfunction over time

The Rise of Population Genomic Screening: Characteristics of Current Programs and the Need for Evidence Regarding Optimal Implementation

Purpose: Advances in clinical genomic sequencing capabilities, including reduced costs and knowledge gains, have bolstered the consideration of genomic screening in healthy adult populations. Yet, little is known about the existing landscape of genomic screening programs in the United States. It can be difficult to find information on current implementation efforts and best practices, particularly in light of critical questions about equity, cost, and benefit. Methods: In 2020, we searched publicly available information on the Internet and the scientific literature to identify programs and collect information, including: setting, program funding, targeted population, test offered, and patient cost. Program representatives were contacted throughout 2020 and 2021 to clarify, update, and supplement the publicly available information. Results: Twelve programs were identified. Information was available on key program features, such as setting, genes tested, and target populations. Data on costs, outcomes, or long-term sustainability plans were not always available. Most programs offered testing at no or significantly reduced cost due to generous pilot funding, although the sustainability of these programs remains unknown. Gene testing lists were diverse, ranging from 11 genes (CDC tier 1 genes) to 59 genes (ACMG secondary findings list v.2) to broad exome and genome sequencing. This diversity presents challenges for harmonized data collection and assessment of program outcomes. Conclusions: Early programs are exploring the logistics and utility of population genomic screening in various settings. Coordinated efforts are needed to take advantage of data collected about uptake, infrastructure, and intervention outcomes to inform future research, evaluation, and program development