scholarly journals Avoiding Justice: Research at the Auction Block

2021 ◽  
pp. 343-374
Author(s):  
Alex John London
Keyword(s):  
Community Health ◽  
Research Ethics ◽  
International Research ◽  
Standard Of Care ◽  
High Income ◽  
Host Community ◽  
Health Needs ◽  
Justice Research ◽  
Principle Of Justice ◽  
Post Trial

Although the principle of justice plays a peripheral role in domestic research in high-income countries, it grounds a series of requirements in international research relating to responsiveness to host community health needs, the standard of care, and assurances of post-trial access. This chapter reviews a proposal to eliminate what is seen as a cumbersome mix of requirements on international research in favor of a framework of procedures that render considerations of fairness more manageable within the confines of orthodox research ethics. This might appear to be an alternative to the approach defended in this book because it would avoid having to engage with difficult issues of justice that reach beyond the confines of the field as it is currently configured. This chapter argues that efforts to avoid substantive conceptions of justice wind up tacitly enforcing a particular conception of justice, and it is shown that the proposal to streamline the ethics of international research cannot satisfy some of the requirements that its proponents advocate.

scholarly journals Fear of the Common Good and the Neglect of Justice

2021 ◽  
pp. 27-86
Author(s):  
Alex John London
Keyword(s):  
Research Ethics ◽  
Social Order ◽  
International Research ◽  
Common Good ◽  
Moral Dilemma ◽  
Standard Of Care ◽  
Host Community ◽  
The Common ◽  
Post Trial

This chapter traces the practical and conceptual origins of eight problematic commitments including the perception that there is an inherent moral dilemma at the heart of research with humans and the tendency to conceptualize research as a private transaction between researchers and participants without clear connections to the requirements of a just social order. It introduces readers who are new to research ethics to key cases and documents relating to domestic and international research and illustrates how they gave rise to the problematic views that produce conceptual and practical tensions in the field. The chapter frames the questions that will be addressed in subsequent chapters, including issues about research risk; the role of paternalism in research ethics; and requirements relating to responsiveness to host community health needs, the standard of care, and post-trial access in international research.

scholarly journals Justice and the Human Development Approach to International Research

2021 ◽  
pp. 375-422
Author(s):  
Alex John London
Keyword(s):  
Human Development ◽  
International Research ◽  
Common Good ◽  
Social Institutions ◽  
Standard Of Care ◽  
Host Community ◽  
Integrative Approach ◽  
Research Oversight ◽  
Development Approach ◽  
Post Trial

This chapter articulates and defends the human development approach to international research. This approach extends into the international context the egalitarian research imperative outlined in chapter 4, the integrative approach to research risk in chapter 6, and the non-paternalistic approach to research oversight in chapter 7. In this approach, requirements related to responsiveness to host community health needs, the standard of care, and post-trial access to study interventions are grounded in requirements of justice and the egalitarian research imperative. The result is a unified foundation for both domestic and international research ethics that treats research as a social undertaking, recognizes justice as the first virtue of social institutions, and gives moral force to the imperative to generate the information needed to improve the ability of social institutions to advance the common good.

The 2008 Declaration of Helsinki — First among Equals in Research Ethics?

2010 ◽  
Vol 38 (1) ◽  
pp. 143-148 ◽  
Author(s):  
Annette Rid ◽  
Harald Schmidt
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Standard Of Care ◽  
The United States ◽  
Basic Principles ◽  
Declaration Of Helsinki ◽  
The World ◽  
Ethical Guidance ◽  
Post Trial ◽  
The U.S

The World Medical Association's (WMA) Declaration of Helsinki is one of the most important and influential international research ethics documents. Launched in 1964, when ethical guidance for research was scarce, the Declaration comprised eleven basic principles and provisions on clinical research. The document has since evolved to a complex set of principles, norms, and directions for action of varying degrees of specificity, ranging from specific rules to broad aspirational statements. It has been revised six times in an effort to maintain its influence. While all revisions were the result of vigorous debate, the 2000 revision and two subsequent notes of clarification spurred particular controversy surrounding the use of placebo in clinical research and the standard of care and post-trial obligations in research in developing countries. Several institutions opted to cite earlier versions of the Declaration, and the U.S. Food and Drug Administration (FDA) recently removed all reference to the Declaration in its approval requirements for drugs and biological products that are studied outside the United States.

scholarly journals How can Clinical Research Trials Conducted in Developing Countries Minimize Exploitation?

2021 ◽  
Vol 4 (3) ◽  
Author(s):  
Gia Mukherjee
Keyword(s):  
Developing Countries ◽  
International Research ◽  
Cost Savings ◽  
Standard Of Care ◽  
Ethical Guidelines ◽  
Undue Influence ◽  
Regulatory Oversight ◽  
Clinical Research Trials ◽  
Post Trial ◽  
Current Utilization

Western scholars, pharmaceutical companies, and academic institutions are and have been conducting research in developing countries for many years. These locations boast substantial cost savings, expedited timelines, and little to no regulatory oversight, making them attractive to developed-world researchers. Residents of these communities are impoverished, often illiterate, unemployed, and with untreated health conditions. Because established ethical protocols for international research are often compromised or misconstrued by researchers and/or their sponsors, these individuals are left vulnerable to exploitation and abuse. In this paper, I explore how current utilization of ethical guidelines is enabling exploitation. I identify ethical questions regarding subject recruitment, informed consent, standard of care, and the post-trial obligations of researchers. I then examine specific situations in which exploitation occurred because of drug, vaccine, or clinical trials. I conclude by offering recommendations to create a more streamlined approach to international research that takes into account the experiences and needs of vulnerable populations. This approach helps ensure that participants are fully involved in the ethical approval process; able to choose whether or not to participate without any undue influence or pressure; treated with the standard of care best suited to their context and surroundings; and reasonably given access to any interventions proven effective during the course of the trial.. A respect for beneficence, justice, and self-autonomy should guide researchers’ interactions with subjects before, during, and after the trial.

Identifying Communities’ Perspectives on their Health Needs in Impoverished Villages to Guide Non-government Organizations’ Health Promotion Efforts in Guatemala

2020 ◽  
Vol 7 (5) ◽  
pp. 9-20
Author(s):  
Claudia Bale
Keyword(s):  
Health Promotion ◽  
Community Health ◽  
Health Care Access ◽  
Family Health ◽  
Community Based Participatory Research ◽  
Health Needs ◽  
Health Conditions ◽  
Personal Health ◽  
Structured Interviews ◽  
Non Profit

Objective: The aim of this mixed-methods study is to capture and understand impoverished Guatemalan community members’ perspectives of their own health needs on a community level in order to guide Hope of Life (HOL) Non-Profit organization’s health promotion interventions in the villages they serve. Methods: A modified health needs assessment survey was conducted with 96 participants from four impoverished villages in the department of Zacapa, Guatemala. Survey responses were analyzed for significant differences in 4-item individual, family, and community health scores across demographic variables and significant correlations with reported personal health conditions and children’s health conditions. Five semi-structured interviews were also conducted with community leaders from three of the villages surveyed. Interviews were audio recorded and responses were transcribed verbatim and translated from Spanish to English. Thematic analysis using HyperRESEARCH qualitative analysis software version 4.5.0. was conducted to identify major themes. Results: The mean age of the 96 participants surveyed was 40.4 years and the majority were women, married or in Union, and have children. Women reported a significantly lower individual and family health score than men. The most rural village included in the study had significantly lower family health scores than the three sub-urban villages in the study. Among the personal health problems reported by participants, alcohol consumption, dental problems, and malnutrition were significant predictors of lower individual health scores. Themes that emerged from the interview analysis included the greatest community health needs, perceived negative community health behaviors, barriers to health care access, HOL’s impact, and suggestions for community health promotion.   Conclusion: The results of this study reveal many unmet health needs and barriers to healthcare that Guatemalan village communities face. Community-based participatory research using a mixed approach voices communities’ perspective on their perceived needs and is an important tool to guide non-profit aid and intervention serving impoverished communities.

International Health Research Ethics

2020 ◽  
Author(s):  
Bridget Pratt
Keyword(s):  
Research Ethics ◽  
Health Research ◽  
International Research ◽  
International Health ◽  
Middle Income Country ◽  
Income Country ◽  
Benefit Sharing ◽  
Middle Income ◽  
Ethical Concerns ◽  
Low And Middle Income

Health research funded by organizations from HICs and conducted in low- and middle-income countries has grown significantly since 1990. Power imbalances and inequities frequently (but not always) exist at each stage of the international research process. Unsurprisingly then, a variety of ethical concerns commonly arise in the context of international health research, such as inequities in funding, the semi-colonial nature of international research models, the brain drain of low- and middle-income country researchers, and inequities in partnerships between HIC and low- and middle-income country researchers. In this chapter, these (and other) ethical concerns are introduced and the following ethical concepts to address the concerns are then discussed: responsiveness, standard of care, benefit sharing, community engagement, and social value. Existing guidance and remaining debates about how to specify each of the concepts are summarized. The chapter concludes by highlighting the existence of epistemic injustices within the field of international research ethics.

Community health worker interventions for older adults with complex health needs: A systematic review

2021 ◽  
Author(s):  
Meaghan A. Kennedy ◽  
Kayla E. Hatchell ◽  
Peter R. DiMilia ◽  
Stephanie M. Kelly ◽  
Heather B. Blunt ◽  
...  
Keyword(s):  
Systematic Review ◽  
Older Adults ◽  
Community Health ◽  
Health Worker ◽  
Community Health Worker ◽  
Health Needs

Community Health Needs Assessments: A Framework for America's Hospitals

2016 ◽  
Vol 19 (2) ◽  
pp. 78-80 ◽  
Author(s):  
Christopher J. King ◽  
Jessica L. Roach
Keyword(s):  
Community Health ◽  
Health Needs ◽  
Needs Assessments
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