Maria Merritt - Academia.edu (original) (raw)

Papers by Maria Merritt

Research paper thumbnail of How medicine becomes trash: disposability in health care

Research paper thumbnail of Ethical Considerations for Global Health Decision-Making: Justice-Enhanced Cost-Effectiveness Analysis of New Technologies for Trypanosoma brucei gambiense

Public Health Ethics, Jul 18, 2018

We sought to assess formally the extent to which different control and elimination strategies for... more We sought to assess formally the extent to which different control and elimination strategies for human African trypanosomiasis Trypanosoma brucei gambiense (Gambiense HAT) would exacerbate or alleviate experiences of societal disadvantage that traditional economic evaluation does not take into account. Justice-enhanced costeffectiveness analysis (JE-CEA) is a normative approach under development to address social justice considerations in public health decision-making alongside other types of analyses. It aims to assess how public health interventions under analysis in comparative evaluation would be expected to influence the clustering of disadvantage across three core dimensions of well-being: agency, association and respect. As a case study to test the approach, we applied it to five strategies for Gambiense HAT control and elimination, in combination with two different other evaluations: a cost-effectiveness analysis and a probability of elimination analysis. We have demonstrated how JE-CEA highlights the ethical importance of adverse social justice impacts of otherwise attractive options and how it indicates specific modifications to policy options to mitigate such impacts. JE-CEA holds promise as an approach to help decision makers and other stakeholders consider social justice more fully, explicitly and systematically in evaluating public health programs.

Research paper thumbnail of Incorporating social justice and stigma in cost-effectiveness analysis: drug-resistant tuberculosis treatment

International Journal of Tuberculosis and Lung Disease, Nov 1, 2017

Novel therapies for multidrug-resistant tuberculosis (MDR-TB) are likely to be expensive. The cos... more Novel therapies for multidrug-resistant tuberculosis (MDR-TB) are likely to be expensive. The cost of novel drugs (e.g., bedaquiline, delamanid) may be so prohibitively high that a traditional cost-effectiveness analysis (CEA) would rate regimens containing these drugs as not costeffective. Traditional CEA may not appropriately account for considerations of social justice and may put the most disadvantaged populations at greatest risk. Using the example of novel drug regimens for MDR-TB, we demonstrate a novel methodology ("justice-enhanced CEA") and demonstrate how such an approach can simultaneously assess social justice impacts alongside traditional cost-effectiveness ratios. Justice-enhanced CEA, as we envision it, is performed in 3 steps: 1) systematic data collection about patients' lived experiences, 2) use of empirical findings to inform social justice assessments, and 3) incorporation of data-informed social justice assessments into a decision analytic framework that includes traditional CEA. These components are organized around a core framework of social justice developed by Bailey and colleagues to compare impacts on disadvantage not otherwise captured by CEA. Formal social justice assessments can produce 3 composite levels-'Expected not to worsen…'; 'May worsen…'; and 'Expected to worsen clustering of disadvantage'. Levels of social justice impact would be assessed for each major type of outcome under each policy scenario compared. Social justice assessments are then overlaid side-by-side with cost-effectiveness assessments corresponding to each branch pathway on the decision tree. In conclusion we present "justice-enhanced" framework that enables the incorporation of social justice concerns into traditional cost-effectiveness analysis for evaluation of new regimens for MDR-TB.

Research paper thumbnail of Aristotelian Virtue and the Interpersonal Aspect of Ethical Character

Research paper thumbnail of Development and Validation of a Capacity for Wonder Scale for Use in Educational Settings

Journal of Psychoeducational Assessment, May 14, 2020

Experiences of wonder should be valued, protected, and promoted in academic settings. Identificat... more Experiences of wonder should be valued, protected, and promoted in academic settings. Identification of learning environments and interventions that cultivate students' capacity for wonder (CfW) first requires a means to measure it. We used a mixed-methods approach to develop and validate a measure of CfW. In the qualitative component (Studies 1-3), we content analyzed open-ended descriptions of wonder (Study 1), interviewed people whom others identified as exemplifying CfW (Study 2), and conducted focus groups to review, for quality and consistency, and to establish face validity of, potential inventory items that capture wonder (Study 3). These items were then subjected to standard psychometric analyses in the quantitative component of our methods (Studies 4-6). In Study 4, exploratory factor analysis (EFA) revealed CfW may contain two subscales representing "Perspective Shifting" and "Emotional Reawakening." In Study 5, confirmatory factor analysis (CFA) corroborated this two-factor structure in an independent sample and longitudinally across 17 months, establishing a final 10-item CfW scale; In Study 6, we assessed the scale's discriminant and convergent validity. CfW was weakly to moderately correlated with theoretically related constructs of curiosity, tolerance for ambiguity, humility, and empathy. We conclude with a discussion of future directions and potential applications.

Research paper thumbnail of Integrating social justice concerns into economic evaluation for healthcare and public health: A systematic review

Social Science & Medicine, Feb 1, 2018

Social justice is the moral imperative to avoid and remediate unfair distributions of societal di... more Social justice is the moral imperative to avoid and remediate unfair distributions of societal disadvantage. In priority setting in healthcare and public health, social justice reaches beyond fairness in the distribution of health outcomes and economic impacts to encompass fairness in the distribution of policy impacts upon other dimensions of well-being. There is an emerging awareness of the need for economic evaluation to integrate all such concerns. We performed a systematic review (1) to describe methodological solutions suitable for integrating social justice concerns into economic evaluation, and (2) to describe the challenges that those solutions face. To be included, publications must have captured fairness considerations that (a) involve crossdimensional subjective personal life experience and (b) can be manifested at the level of subpopulations. We identified relevant publications using an electronic search in EMBASE, PubMed, EconLit, PsycInfo, Philosopher's Index, and Scopus, including publications available in English in the past 20 years. Two reviewers independently appraised candidate publications, extracted data, and synthesized findings in narrative form. Out of 2388 publications reviewed, 26 were included. Solutions sought either to incorporate relevant fairness considerations directly into

Research paper thumbnail of Emotional Reasoning

Hastings Center Report, Sep 1, 2002

Research paper thumbnail of Capacity for wonder among medical students: Assessment and educational implications

Medical Teacher, Jul 20, 2022

Research paper thumbnail of An Overview of Conceptual Foundations, Ethical Tensions, and Ethical Frameworks in Public Health

The field of public health ethics has plural foundations in major normative ethical theories, pri... more The field of public health ethics has plural foundations in major normative ethical theories, principally consequentialism and deontology, and in ethical concepts such as social justice and human rights. This overview provides some basic background on ethical theory and introduces chapters in the related section of The Oxford Handbook of Public Health Ethics. The four chapters together elucidate the moral foundations of public health ethics. One chapter characterizes public health and describes the ethical challenges raised by its distinctive characteristics, while the next examines the ways in which public health interventions may be morally justifiable. The following two chapters focus, respectively, on justice and human rights, considering the operation of each not only as moral foundations, but also as side constraints in frameworks of public health ethics.

Research paper thumbnail of Integración de la ética, la política sanitaria y los sistemas de salud en los países de ingresos bajos y medios: estudios de casos de Malasia y el Pakistán

Bulletin of The World Health Organization, Aug 1, 2008

Scientific progress is a significant basis for change in public-health policy and practice, but t... more Scientific progress is a significant basis for change in public-health policy and practice, but the field also invests in valueladen concepts and responds daily to sociopolitical, cultural and evaluative concerns. The concepts that drive much of public-health practice are shaped by the collective and individual mores that define social systems. This paper seeks to describe the ethics processes in play when public-health mechanisms are established in low-and middle-income countries, by focusing on two cases where ethics played a crucial role in producing positive institutional change in public-health policy. First, we introduce an overview of the relationship between ethics and public health; second, we provide a conceptual framework for the ethical analysis of health system events, noting how this approach might enhance the power of existing frameworks; and third, we demonstrate the interplay of these frameworks through the analysis of a programme to enhance road safety in Malaysia and an initiative to establish a national ethics committee in Pakistan. We conclude that, while ethics are gradually being integrated into publichealth policy decisions in many developing health systems, ethical analysis is often implicit and undervalued. This paper highlights the need to analyse public-health decision-making from an ethical perspective.

Research paper thumbnail of The Value of Explicit, Deliberative, and Context-Specified Ethics Analysis for Health Technology Assessment: Evidence From a Novel Approach Piloted in South Africa

Value in Health Regional Issues

Research paper thumbnail of Determining a Trusting Environment for Maternity Care: A Framework Based on Perspectives of Women, Communities, Service Providers, and Managers in Peri-Urban Kenya

Frontiers in Global Women's Health

Trust in health service providers and facilities is integral to health systems accountability. Un... more Trust in health service providers and facilities is integral to health systems accountability. Understanding determinants of trust, a relational construct, in maternity settings necessitates exploring hierarchical perspectives of users, providers, and influencers in the care environment. We used a theoretically driven qualitative approach to explore trust determinants in a maternity setting across patient-provider, inter-provider, and community-policymaker interactions and relationships in peri-urban Kenya. Focus groups (n = 8, N = 70) with women who recently gave birth (WRB), pregnant women, and male partners, and in-depth-interviews (n = 33) with WRB, health care providers and managers, and community health workers (CHWs) were conducted in 2013, soon after the national government's March 2013 introduction of a policy mandate for “Free Maternity Care.” We used thematic coding, memo writing, and cross-perspective triangulation to develop a multi-faceted trust determinants framew...

Research paper thumbnail of Introducing an Ethics Framework for health priority-setting in South Africa on the path to universal health coverage

South African Medical Journal, 2022

Background. South Africa (SA) has embarked on a process to implement universal health coverage (U... more Background. South Africa (SA) has embarked on a process to implement universal health coverage (UHC) funded by National Health Insurance (NHI). The 2019 NHI Bill proposes creation of a health technology assessment (HTA) body to inform decisions about which interventions NHI funds will cover under UHC. In practice, HTA often relies mainly on economic evaluations of cost-effectiveness and budget impact, with less attention to the systematic, specific consideration of important social, organisational and ethical impacts of the health technology in question. In this context, the South African Values and Ethics for Universal Health Coverage (SAVE-UHC) research project recognised an opportunity to help shape the health priority-setting process by providing a way to take account of multiple, ethically relevant considerations that reflect SA values. The SAVE-UHC Research Team developed and tested an SA-specific Ethics Framework for HTA assessment and analysis. Objectives. To develop and tes...

Research paper thumbnail of Implementing post-trial access plans for HIV prevention research

Journal of Medical Ethics, 2018

Ethics guidance increasingly recognises that researchers and sponsors have obligations to conside... more Ethics guidance increasingly recognises that researchers and sponsors have obligations to consider provisions for post-trial access (PTA) to interventions that are found to be beneficial in research. Yet, there is little information regarding whether and how such plans can actually be implemented. Understanding practical experiences of developing and implementing these plans is critical to both optimising their implementation and informing conceptual work related to PTA. This viewpoint is informed by experiences with developing and implementing PTA plans for six large-scale multicentre HIV prevention trials supported by the HIV Prevention Trials Network. These experiences suggest that planning and implementing PTA often involve challenges of planning under uncertainty and confronting practical barriers to accessing healthcare systems. Even in relatively favourable circumstances where a tested intervention medication is approved and available in the local healthcare system, system-le...

Research paper thumbnail of Ethical Considerations for Global Health Decision-Making: Justice-Enhanced Cost-Effectiveness Analysis of New Technologies for Trypanosoma brucei gambiense

Public Health Ethics, 2018

We sought to assess formally the extent to which different control and elimination strategies for... more We sought to assess formally the extent to which different control and elimination strategies for human African trypanosomiasis Trypanosoma brucei gambiense (Gambiense HAT) would exacerbate or alleviate experiences of societal disadvantage that traditional economic evaluation does not take into account. Justice-enhanced costeffectiveness analysis (JE-CEA) is a normative approach under development to address social justice considerations in public health decision-making alongside other types of analyses. It aims to assess how public health interventions under analysis in comparative evaluation would be expected to influence the clustering of disadvantage across three core dimensions of well-being: agency, association and respect. As a case study to test the approach, we applied it to five strategies for Gambiense HAT control and elimination, in combination with two different other evaluations: a cost-effectiveness analysis and a probability of elimination analysis. We have demonstrated how JE-CEA highlights the ethical importance of adverse social justice impacts of otherwise attractive options and how it indicates specific modifications to policy options to mitigate such impacts. JE-CEA holds promise as an approach to help decision makers and other stakeholders consider social justice more fully, explicitly and systematically in evaluating public health programs.

Research paper thumbnail of Referral of Research Participants for Ancillary Care in Community-Based Public Health Intervention Research: A Guiding Framework

Public Health Ethics, 2015

Research paper thumbnail of Ancillary Care for Public Health Research in Developing Countries

JAMA, 2009

BELSKY AND RICHARDSON 1 DEFINED ANCILLARY CARE as care needed by research participants but not ne... more BELSKY AND RICHARDSON 1 DEFINED ANCILLARY CARE as care needed by research participants but not necessary to ensure scientific validity, prevent study-related harms, or address study-related injuries and introduced a framework for evaluating ancillary care based on 2 questions. 2 Does a participant's need for care fall within the scope of the investigator's responsibility for the participant's health, as defined by aspects of health implicitly entrusted to the investigator through the participant's consent to comply with research procedures? If so, what is the strength of the participant's moral claim on the investigator to address that need? The strength of the claim is modulated by attributes of the participant-investigator relationship, such as depth of involvement, degree of participant's vulnerability, and degree of participant's dependence, together with limits on available resources. 2 Dickert et al 3 questioned the narrow limits of Belsky and Richardson's definition of the investigator's scope of responsibility and exposed the tensions between vulnerability, dependency, cost, and scientific objectives in assessing the strength of a potential ancillary care claim. Participants at a workshop also highlighted the need for additional ethical guidelines to address ancillary care. 4 They proposed 4 "guidance points" to help researchers and sponsors act on their ancillary care obligations-identifying a positive duty, planning for ancillary care, building partnerships, and making practical provisions. 4 Although the contributions reviewed above move the discussion of ancillary care forward, they are constrained by 3 issues. First, by focusing on the ethics of researchers' relationship to the individual participant, the discussion to date has yet to consider studies in which the primary unit of research interest is a group. Second, separate analyses of research-specific and context-specific factors might help stakeholders assess the strength of ancillary care claims more systematically. Third, an operational process is needed to help researchers and sponsors implement the proposed guidance points. The goal of this Commentary is to advance the discussion of ancillary care in developing countries addressing these 3 issues.

Research paper thumbnail of GLIDE Wellcome Open Research Gateway

Wellcome Open Research

The Global Infectious Disease Ethics (GLIDE) Collaborative is launching a new Wellcome Open Resea... more The Global Infectious Disease Ethics (GLIDE) Collaborative is launching a new Wellcome Open Research (WOR) Gateway, and we as the leaders of GLIDE hope to encourage submissions to this timely and necessary new platform for publishing open access peer-reviewed articles focusing on this area.

Research paper thumbnail of Developing and piloting a context-specified ethics framework for health technology assessment: the South African Values and Ethics for Universal Health Coverage approach

International Journal of Technology Assessment in Health Care, 2022

Objectives While ethics has been identified as a core component of health technology assessment (... more Objectives While ethics has been identified as a core component of health technology assessment (HTA), there are few examples of practical, systematic inclusion of ethics analysis in HTA. Some attribute the scarcity of ethics analysis in HTA to debates about appropriate methodology and the need for ethics frameworks that are relevant to local social values. The “South African Values and Ethics for Universal Health Coverage” (SAVE-UHC) project models an approach that countries can use to develop HTA ethics frameworks that are specific to their national contexts. Methods The SAVE-UHC approach consisted of two phases. In Phase I, the research team convened and facilitated a national multistakeholder working group to develop a provisional ethics framework through a collaborative, engagement-driven process. In Phase II, the research team refined the model framework by piloting it through three simulated HTA appraisal committee meetings. Each simulated committee reviewed two case studies ...

Research paper thumbnail of Disadvantage and the experience of treatment for multidrug-resistant tuberculosis (MDR-TB)

SSM - Qualitative Research in Health, 2022

Research paper thumbnail of How medicine becomes trash: disposability in health care

Research paper thumbnail of Ethical Considerations for Global Health Decision-Making: Justice-Enhanced Cost-Effectiveness Analysis of New Technologies for Trypanosoma brucei gambiense

Public Health Ethics, Jul 18, 2018

We sought to assess formally the extent to which different control and elimination strategies for... more We sought to assess formally the extent to which different control and elimination strategies for human African trypanosomiasis Trypanosoma brucei gambiense (Gambiense HAT) would exacerbate or alleviate experiences of societal disadvantage that traditional economic evaluation does not take into account. Justice-enhanced costeffectiveness analysis (JE-CEA) is a normative approach under development to address social justice considerations in public health decision-making alongside other types of analyses. It aims to assess how public health interventions under analysis in comparative evaluation would be expected to influence the clustering of disadvantage across three core dimensions of well-being: agency, association and respect. As a case study to test the approach, we applied it to five strategies for Gambiense HAT control and elimination, in combination with two different other evaluations: a cost-effectiveness analysis and a probability of elimination analysis. We have demonstrated how JE-CEA highlights the ethical importance of adverse social justice impacts of otherwise attractive options and how it indicates specific modifications to policy options to mitigate such impacts. JE-CEA holds promise as an approach to help decision makers and other stakeholders consider social justice more fully, explicitly and systematically in evaluating public health programs.

Research paper thumbnail of Incorporating social justice and stigma in cost-effectiveness analysis: drug-resistant tuberculosis treatment

International Journal of Tuberculosis and Lung Disease, Nov 1, 2017

Novel therapies for multidrug-resistant tuberculosis (MDR-TB) are likely to be expensive. The cos... more Novel therapies for multidrug-resistant tuberculosis (MDR-TB) are likely to be expensive. The cost of novel drugs (e.g., bedaquiline, delamanid) may be so prohibitively high that a traditional cost-effectiveness analysis (CEA) would rate regimens containing these drugs as not costeffective. Traditional CEA may not appropriately account for considerations of social justice and may put the most disadvantaged populations at greatest risk. Using the example of novel drug regimens for MDR-TB, we demonstrate a novel methodology ("justice-enhanced CEA") and demonstrate how such an approach can simultaneously assess social justice impacts alongside traditional cost-effectiveness ratios. Justice-enhanced CEA, as we envision it, is performed in 3 steps: 1) systematic data collection about patients' lived experiences, 2) use of empirical findings to inform social justice assessments, and 3) incorporation of data-informed social justice assessments into a decision analytic framework that includes traditional CEA. These components are organized around a core framework of social justice developed by Bailey and colleagues to compare impacts on disadvantage not otherwise captured by CEA. Formal social justice assessments can produce 3 composite levels-'Expected not to worsen…'; 'May worsen…'; and 'Expected to worsen clustering of disadvantage'. Levels of social justice impact would be assessed for each major type of outcome under each policy scenario compared. Social justice assessments are then overlaid side-by-side with cost-effectiveness assessments corresponding to each branch pathway on the decision tree. In conclusion we present "justice-enhanced" framework that enables the incorporation of social justice concerns into traditional cost-effectiveness analysis for evaluation of new regimens for MDR-TB.

Research paper thumbnail of Aristotelian Virtue and the Interpersonal Aspect of Ethical Character

Research paper thumbnail of Development and Validation of a Capacity for Wonder Scale for Use in Educational Settings

Journal of Psychoeducational Assessment, May 14, 2020

Experiences of wonder should be valued, protected, and promoted in academic settings. Identificat... more Experiences of wonder should be valued, protected, and promoted in academic settings. Identification of learning environments and interventions that cultivate students' capacity for wonder (CfW) first requires a means to measure it. We used a mixed-methods approach to develop and validate a measure of CfW. In the qualitative component (Studies 1-3), we content analyzed open-ended descriptions of wonder (Study 1), interviewed people whom others identified as exemplifying CfW (Study 2), and conducted focus groups to review, for quality and consistency, and to establish face validity of, potential inventory items that capture wonder (Study 3). These items were then subjected to standard psychometric analyses in the quantitative component of our methods (Studies 4-6). In Study 4, exploratory factor analysis (EFA) revealed CfW may contain two subscales representing "Perspective Shifting" and "Emotional Reawakening." In Study 5, confirmatory factor analysis (CFA) corroborated this two-factor structure in an independent sample and longitudinally across 17 months, establishing a final 10-item CfW scale; In Study 6, we assessed the scale's discriminant and convergent validity. CfW was weakly to moderately correlated with theoretically related constructs of curiosity, tolerance for ambiguity, humility, and empathy. We conclude with a discussion of future directions and potential applications.

Research paper thumbnail of Integrating social justice concerns into economic evaluation for healthcare and public health: A systematic review

Social Science & Medicine, Feb 1, 2018

Social justice is the moral imperative to avoid and remediate unfair distributions of societal di... more Social justice is the moral imperative to avoid and remediate unfair distributions of societal disadvantage. In priority setting in healthcare and public health, social justice reaches beyond fairness in the distribution of health outcomes and economic impacts to encompass fairness in the distribution of policy impacts upon other dimensions of well-being. There is an emerging awareness of the need for economic evaluation to integrate all such concerns. We performed a systematic review (1) to describe methodological solutions suitable for integrating social justice concerns into economic evaluation, and (2) to describe the challenges that those solutions face. To be included, publications must have captured fairness considerations that (a) involve crossdimensional subjective personal life experience and (b) can be manifested at the level of subpopulations. We identified relevant publications using an electronic search in EMBASE, PubMed, EconLit, PsycInfo, Philosopher's Index, and Scopus, including publications available in English in the past 20 years. Two reviewers independently appraised candidate publications, extracted data, and synthesized findings in narrative form. Out of 2388 publications reviewed, 26 were included. Solutions sought either to incorporate relevant fairness considerations directly into

Research paper thumbnail of Emotional Reasoning

Hastings Center Report, Sep 1, 2002

Research paper thumbnail of Capacity for wonder among medical students: Assessment and educational implications

Medical Teacher, Jul 20, 2022

Research paper thumbnail of An Overview of Conceptual Foundations, Ethical Tensions, and Ethical Frameworks in Public Health

The field of public health ethics has plural foundations in major normative ethical theories, pri... more The field of public health ethics has plural foundations in major normative ethical theories, principally consequentialism and deontology, and in ethical concepts such as social justice and human rights. This overview provides some basic background on ethical theory and introduces chapters in the related section of The Oxford Handbook of Public Health Ethics. The four chapters together elucidate the moral foundations of public health ethics. One chapter characterizes public health and describes the ethical challenges raised by its distinctive characteristics, while the next examines the ways in which public health interventions may be morally justifiable. The following two chapters focus, respectively, on justice and human rights, considering the operation of each not only as moral foundations, but also as side constraints in frameworks of public health ethics.

Research paper thumbnail of Integración de la ética, la política sanitaria y los sistemas de salud en los países de ingresos bajos y medios: estudios de casos de Malasia y el Pakistán

Bulletin of The World Health Organization, Aug 1, 2008

Scientific progress is a significant basis for change in public-health policy and practice, but t... more Scientific progress is a significant basis for change in public-health policy and practice, but the field also invests in valueladen concepts and responds daily to sociopolitical, cultural and evaluative concerns. The concepts that drive much of public-health practice are shaped by the collective and individual mores that define social systems. This paper seeks to describe the ethics processes in play when public-health mechanisms are established in low-and middle-income countries, by focusing on two cases where ethics played a crucial role in producing positive institutional change in public-health policy. First, we introduce an overview of the relationship between ethics and public health; second, we provide a conceptual framework for the ethical analysis of health system events, noting how this approach might enhance the power of existing frameworks; and third, we demonstrate the interplay of these frameworks through the analysis of a programme to enhance road safety in Malaysia and an initiative to establish a national ethics committee in Pakistan. We conclude that, while ethics are gradually being integrated into publichealth policy decisions in many developing health systems, ethical analysis is often implicit and undervalued. This paper highlights the need to analyse public-health decision-making from an ethical perspective.

Research paper thumbnail of The Value of Explicit, Deliberative, and Context-Specified Ethics Analysis for Health Technology Assessment: Evidence From a Novel Approach Piloted in South Africa

Value in Health Regional Issues

Research paper thumbnail of Determining a Trusting Environment for Maternity Care: A Framework Based on Perspectives of Women, Communities, Service Providers, and Managers in Peri-Urban Kenya

Frontiers in Global Women's Health

Trust in health service providers and facilities is integral to health systems accountability. Un... more Trust in health service providers and facilities is integral to health systems accountability. Understanding determinants of trust, a relational construct, in maternity settings necessitates exploring hierarchical perspectives of users, providers, and influencers in the care environment. We used a theoretically driven qualitative approach to explore trust determinants in a maternity setting across patient-provider, inter-provider, and community-policymaker interactions and relationships in peri-urban Kenya. Focus groups (n = 8, N = 70) with women who recently gave birth (WRB), pregnant women, and male partners, and in-depth-interviews (n = 33) with WRB, health care providers and managers, and community health workers (CHWs) were conducted in 2013, soon after the national government's March 2013 introduction of a policy mandate for “Free Maternity Care.” We used thematic coding, memo writing, and cross-perspective triangulation to develop a multi-faceted trust determinants framew...

Research paper thumbnail of Introducing an Ethics Framework for health priority-setting in South Africa on the path to universal health coverage

South African Medical Journal, 2022

Background. South Africa (SA) has embarked on a process to implement universal health coverage (U... more Background. South Africa (SA) has embarked on a process to implement universal health coverage (UHC) funded by National Health Insurance (NHI). The 2019 NHI Bill proposes creation of a health technology assessment (HTA) body to inform decisions about which interventions NHI funds will cover under UHC. In practice, HTA often relies mainly on economic evaluations of cost-effectiveness and budget impact, with less attention to the systematic, specific consideration of important social, organisational and ethical impacts of the health technology in question. In this context, the South African Values and Ethics for Universal Health Coverage (SAVE-UHC) research project recognised an opportunity to help shape the health priority-setting process by providing a way to take account of multiple, ethically relevant considerations that reflect SA values. The SAVE-UHC Research Team developed and tested an SA-specific Ethics Framework for HTA assessment and analysis. Objectives. To develop and tes...

Research paper thumbnail of Implementing post-trial access plans for HIV prevention research

Journal of Medical Ethics, 2018

Ethics guidance increasingly recognises that researchers and sponsors have obligations to conside... more Ethics guidance increasingly recognises that researchers and sponsors have obligations to consider provisions for post-trial access (PTA) to interventions that are found to be beneficial in research. Yet, there is little information regarding whether and how such plans can actually be implemented. Understanding practical experiences of developing and implementing these plans is critical to both optimising their implementation and informing conceptual work related to PTA. This viewpoint is informed by experiences with developing and implementing PTA plans for six large-scale multicentre HIV prevention trials supported by the HIV Prevention Trials Network. These experiences suggest that planning and implementing PTA often involve challenges of planning under uncertainty and confronting practical barriers to accessing healthcare systems. Even in relatively favourable circumstances where a tested intervention medication is approved and available in the local healthcare system, system-le...

Research paper thumbnail of Ethical Considerations for Global Health Decision-Making: Justice-Enhanced Cost-Effectiveness Analysis of New Technologies for Trypanosoma brucei gambiense

Public Health Ethics, 2018

We sought to assess formally the extent to which different control and elimination strategies for... more We sought to assess formally the extent to which different control and elimination strategies for human African trypanosomiasis Trypanosoma brucei gambiense (Gambiense HAT) would exacerbate or alleviate experiences of societal disadvantage that traditional economic evaluation does not take into account. Justice-enhanced costeffectiveness analysis (JE-CEA) is a normative approach under development to address social justice considerations in public health decision-making alongside other types of analyses. It aims to assess how public health interventions under analysis in comparative evaluation would be expected to influence the clustering of disadvantage across three core dimensions of well-being: agency, association and respect. As a case study to test the approach, we applied it to five strategies for Gambiense HAT control and elimination, in combination with two different other evaluations: a cost-effectiveness analysis and a probability of elimination analysis. We have demonstrated how JE-CEA highlights the ethical importance of adverse social justice impacts of otherwise attractive options and how it indicates specific modifications to policy options to mitigate such impacts. JE-CEA holds promise as an approach to help decision makers and other stakeholders consider social justice more fully, explicitly and systematically in evaluating public health programs.

Research paper thumbnail of Referral of Research Participants for Ancillary Care in Community-Based Public Health Intervention Research: A Guiding Framework

Public Health Ethics, 2015

Research paper thumbnail of Ancillary Care for Public Health Research in Developing Countries

JAMA, 2009

BELSKY AND RICHARDSON 1 DEFINED ANCILLARY CARE as care needed by research participants but not ne... more BELSKY AND RICHARDSON 1 DEFINED ANCILLARY CARE as care needed by research participants but not necessary to ensure scientific validity, prevent study-related harms, or address study-related injuries and introduced a framework for evaluating ancillary care based on 2 questions. 2 Does a participant's need for care fall within the scope of the investigator's responsibility for the participant's health, as defined by aspects of health implicitly entrusted to the investigator through the participant's consent to comply with research procedures? If so, what is the strength of the participant's moral claim on the investigator to address that need? The strength of the claim is modulated by attributes of the participant-investigator relationship, such as depth of involvement, degree of participant's vulnerability, and degree of participant's dependence, together with limits on available resources. 2 Dickert et al 3 questioned the narrow limits of Belsky and Richardson's definition of the investigator's scope of responsibility and exposed the tensions between vulnerability, dependency, cost, and scientific objectives in assessing the strength of a potential ancillary care claim. Participants at a workshop also highlighted the need for additional ethical guidelines to address ancillary care. 4 They proposed 4 "guidance points" to help researchers and sponsors act on their ancillary care obligations-identifying a positive duty, planning for ancillary care, building partnerships, and making practical provisions. 4 Although the contributions reviewed above move the discussion of ancillary care forward, they are constrained by 3 issues. First, by focusing on the ethics of researchers' relationship to the individual participant, the discussion to date has yet to consider studies in which the primary unit of research interest is a group. Second, separate analyses of research-specific and context-specific factors might help stakeholders assess the strength of ancillary care claims more systematically. Third, an operational process is needed to help researchers and sponsors implement the proposed guidance points. The goal of this Commentary is to advance the discussion of ancillary care in developing countries addressing these 3 issues.

Research paper thumbnail of GLIDE Wellcome Open Research Gateway

Wellcome Open Research

The Global Infectious Disease Ethics (GLIDE) Collaborative is launching a new Wellcome Open Resea... more The Global Infectious Disease Ethics (GLIDE) Collaborative is launching a new Wellcome Open Research (WOR) Gateway, and we as the leaders of GLIDE hope to encourage submissions to this timely and necessary new platform for publishing open access peer-reviewed articles focusing on this area.

Research paper thumbnail of Developing and piloting a context-specified ethics framework for health technology assessment: the South African Values and Ethics for Universal Health Coverage approach

International Journal of Technology Assessment in Health Care, 2022

Objectives While ethics has been identified as a core component of health technology assessment (... more Objectives While ethics has been identified as a core component of health technology assessment (HTA), there are few examples of practical, systematic inclusion of ethics analysis in HTA. Some attribute the scarcity of ethics analysis in HTA to debates about appropriate methodology and the need for ethics frameworks that are relevant to local social values. The “South African Values and Ethics for Universal Health Coverage” (SAVE-UHC) project models an approach that countries can use to develop HTA ethics frameworks that are specific to their national contexts. Methods The SAVE-UHC approach consisted of two phases. In Phase I, the research team convened and facilitated a national multistakeholder working group to develop a provisional ethics framework through a collaborative, engagement-driven process. In Phase II, the research team refined the model framework by piloting it through three simulated HTA appraisal committee meetings. Each simulated committee reviewed two case studies ...

Research paper thumbnail of Disadvantage and the experience of treatment for multidrug-resistant tuberculosis (MDR-TB)

SSM - Qualitative Research in Health, 2022