Research in Developing Countries: Taking "Benefit" Seriously

Glantz, Leonard H.; Annas, George J.; Grodin, Michael A.; Mariner, Wendy K.

doi:10.2307/3528268

Cited by 130 publications

(47 citation statements)

References 3 publications

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“…(2006). ''The [following] illustrates almost all of the issues presented by research in developing countries… (1) [difficulty in defining appropriate level of benefit required for the] population represented by the research subjects…, (2) [undereducated] or uneducated populace…, (3)…profound poverty…'' (Glantz et al 1998). The goal has been to ensure that a research participant's decision to take part in a clinical trial is made autonomously, free from coercion, and with full understanding of all the relevant information involved in agreeing to participate in a human clinical trial (O'Neill 2002).…”

Section: Beyond Informed Consentmentioning

confidence: 99%

The Abandoned Stakeholders: Pharmaceutical Companies and Research Participants

Chang

2016

J Bus Ethics

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Most discussions concerned with advancing the just and ethical treatment of research participants in developing countries have revolved around the moral principle of autonomy and the legal doctrine of informed consent (O'Neill 2002). However, if emerging ethical concerns are to be addressed effectively, the discussion needs to expand into the domain of business ethics where arguments addressing issues such as fair/appropriate compensation, entitlement, and corporate obligations to stakeholders are commonplace. The argument I present in this paper will conclude that emerging ethical considerations regarding the treatment of research participants in developing countries have evolved well beyond the scope of the principle of informed consent and that in order to resolve these concerns more appropriately and effectively, the new default or status quo should be to consider research participants as stakeholders of the sponsoring pharmaceutical company, even after the clinical trial is completed. This conclusion is significant because although it is fair to assume that, at some point in the timeline, most stakeholder theorists already do consider research participants stakeholders of the pharmaceutical company sponsoring the trial, the completion date of the clinical trial usually signifies and marks the termination of their stakeholder status and thus any consideration of what is owed further to the research participant.

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Section: Beyond Informed Consentmentioning

confidence: 99%

The Abandoned Stakeholders: Pharmaceutical Companies and Research Participants

Chang

2016

J Bus Ethics

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“…Many ethicists consider research benefits to include posttrial access to research products. [21][22][23] With this interpretation, conflicts arise regarding justice in research when the product of successful research is not available to the society in which the research was performed-the society that has been exposed to potential risk during the research process. If the end product of research will not benefit all people, including those who have borne the burden of research, some believe that the concept of justice in research is not, in the strictest sense, met.…”

Section: Case 3: Justicementioning

confidence: 99%

Ethics in Acute Care Research: A Global Perspective and Research Agenda

Hirshon

Hansoti

Hauswald

et al. 2013

Academic Emergency Medicine

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The 2013 Academic Emergency Medicine consensus conference focused on global health and emergency care research. One conference breakout session discussed research ethics and developed a research agenda concerning global acute care research ethics. This article represents the proceedings from that session, particularly focusing on ethical issues related to protecting human subjects while conducting acute care research. Protecting human research subjects from unnecessary risk is an important component of conducting ethical research, regardless of the research site. There are widely accepted ethical principles related to human subjects research; however, the interpretation of these principles requires specific local knowledge and expertise to ensure that research is conducted ethically within the societal and cultural norms.There is an obligation to conduct research ethically while recognizing the roles and responsibilities of all participants. This article discusses the complexities of determining and applying socially and culturally appropriate ethical principles during the conduct of global acute care research. Using case studies, it focuses both on the procedural components of ethical research conducted outside of "Western" culture and on basic ethical principles that are applicable to all human subjects research.

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“…US-amerikanische Bioethiker haben eine ähnliche Position eingenommen [42]. Die nationale bioethische Beratungskommission der USA "stimmte darin überein,dass Sponsoren von Forschung erfolgreiche Produkte der Forschung den Teilnehmern einer Studie zur Verfügung stellen sollten, wenn sie sie auch nach Beendigung der Studie weiter benötigen,und ebenfalls,dass Sponsoren den Aufbau eigener Kapazitäten in jenen Ländern unterstützen sollten" (zit.…”

Section: Forschung In Entwicklungsländernunclassified

“…Hasselmo N (2003) discusses "efforts to manage real and potential conflicts of interest in university research in the United States.The focus is on the report by an Association of American Universities (AAU) task force that addresses both individual and institutional conflict of interest issues 41 Ein Beispiel ist das Klinische Studienzentrum Chirurgie (KSC) in Heidelberg [93]. 42 "The most problematic aspect of the current situation, and the one that creates the most potential for conflict of interest, is the ownership of equity by individual investigators.Ownership of even a small account of stock in a small publicly traded or private company, whose value can depend on the outcome of a clinical trial or access to a key laboratory discovery, has proven difficult to manage....The pressures can best be reduced by diluting them, i.e.minimizing the potential for individual actions to influence the value of their personal or institution's holdings by combining all equity in a new vehicle.This could then be managed, at arm's length, like a mutual fund" [75] …”

Section: Spezielle Empfehlungen Für Forschung In Entwicklungsländernmentioning

confidence: 99%

Psychiater und pharmazeutische Industrie

Helmchen

2003

Der Nervenarzt

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Relationships between psychiatrists and the pharmaceutical industry have increased in frequency and intensity, both on the individual level and particularly on the institutional level. They extend from necessary and desirable cooperation to questionable practices and to unacceptable misconduct. Especially the latter has provoked a lively discussion and has initiated recommendations as well as guidelines. Their aim is to safeguard the integrity of physicians as well as the industry and to avoid endangering the relationship between the physician and the patient. They will do this by establishing clear norms, unequivocal documentation, and disclosure of relevant relationships in order to build up more mutual trust including that of the public. Based on a detailed review of the literature, 27 recommendations are put forward for discussion. Psychiatric associations should develop explicit guidelines for the relationships between psychiatrists and the pharmaceutical industry.

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Research in Developing Countries: Taking "Benefit" Seriously

Cited by 130 publications

References 3 publications

The Abandoned Stakeholders: Pharmaceutical Companies and Research Participants

The Abandoned Stakeholders: Pharmaceutical Companies and Research Participants

Ethics in Acute Care Research: A Global Perspective and Research Agenda

Psychiater und pharmazeutische Industrie

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