Das Konzept der Vulnerabilität im Kontext transnationaler Biomedizin

Eine ethische Analyse am Beispiel Forschung mit Frauen in Indien

The concept of vulnerability in the context of transnational biomedicine

An ethical analysis on the example of research with women in India

by Helen Grete Orth
Doctoral thesis
Date of Examination:2015-06-19
Date of issue:2015-05-12
Advisor:Prof. Dr. Silke Schicktanz
Referee:Prof. Dr. Silke Schicktanz
Referee:Prof. Dr. Uwe Groß
Referee:Prof. Dr. Martin Oppermann
Persistent Address: http://dx.doi.org/10.53846/goediss-5068

 

 

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Abstract

English

Background & aim: Transnational medical research has increased tremendously in the past years. While this is an important part of globalization and internationalization of science and health care, it also raises questions of ethical standards. From an ethical point of view one concern regarding transnational research is that participants of clinical trials in low- (or even middle) income countries are vulnerable and therefore could be subjects of exploitation. Although the concept of vulnerability is often used to describe special groups of potential research participants, e.g. psychiatric patients, the concept itself is notoriously unclear and highly debated. Beyond a formal theoretical clarification of the concept of vulnerability, its normative value should be tested in the context of reducing/avoiding risks and exploitation for particular research participants. Since India is for many reasons, - such as lower costs but at the same time high technical standards, - popular for transnational research, ethical concerns in terms of a possible vulnerability of research participants are important to discuss in the context of the Indian society. Regarding certain socio-economical, educational and cultural aspects, especially women in India could be even more vulnerable in the context of transnational research. Therefore I investigated whether the concept of vulnerability can be helpful to address ethical issues in the context of transnational biomedicine by focusing on the example of research with women in India. If I can show its practical value for such a group not yet particularly mentioned, this allows me to make suggestions about how the concept of vulnerability could be applied in research ethics in general. Methodology: First, I analyzed from a predominantly theoretical ethical and philosophical point the meaning and different definitions of 'vulnerability' and how it is connected to the concept of informed consent. By analyzing and interpreting two case studies, an HIV- and an HPV-vaccination trial, that have been conducted with female participants in India, I demonstrate how criteria for vulnerability that we elaborated especially for the context of transnational research with women could be applied. Results & Outlook: The theoretical analysis provides 5 subcriteria that take into account the context of the study as well as characteristics and the current socio-economic situation of the participants: 1. Problematic conception of the study 2. Ethically invalid informed consent 3. Predisposition to be harmed 4. Incompetence to give informed consent and/or susceptibility to give informed consent involuntarily 5. Susceptibility to be exploited The analysis of the two case studies show that vulnerability is an issue in transnational research that helps to identify ethical problematic issues easily to be overseen by researchers and reviewers. I conclude, that vulnerability is a normative concept that should urgently be discussed more in research ethics. Considering vulnerability should lead to certain methods of protection for research participants, which I suggest examples for, such as comprehension tests, providing fair benefits for research participation and community advisory boards to ensure the inclusion of communities in decision-making processes.
Keywords: vulnerability; bioethics; transnational biomedicine; transnational research; India; women; vulnerable groups; HIV-trial; HPV-trial; medical ethics; ethics; international research
Schlagwörter: Vulnerabilität; transnationale Biomedizin; Frauen; internationale Forschung; Medizinethik; Bioethik; vulnerable Gruppen
 
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