Humboldt-Universität zu Berlin

Humboldt-Universität zu Berlin | Über die Universität | Menschen | Ehrungen und Preise | Humboldt-Preis | Preisträgerinnen und Preisträger | Humboldt-Preis 2018 | „Ethical regulations of research involving human subjects: comparing the perspective of institutions regulating the conduct of clinical research to the perspective of human subjects“

„Ethical regulations of research involving human subjects: comparing the perspective of institutions regulating the conduct of clinical research to the perspective of human subjects“

Anna Kravet studiert im Master das Global Studies Programme an der Humboldt-Universität


The industry of commercialized clinical research has expanded in the last two decades and there is a growing demand for clinical trials to test new drugs worldwide. Though instrumentalizing human bodies to determine drug safety is acknowledged to be ethically problematic, medical experiments are justified as an unavoidable aspect of biomedicine due to its orientation to the methodology of natural sciences. Such experiments are considered acceptable when regulations are imposed. In my work, I approach the question of whether existing regulations on research involving human subjects actually ensure the well-being of trial participants. Within the example of Berlin, Germany, I consider two contrasting perspectives: that of institutions meant to protect the ethical validity of clinical research and the perspective of human subjects involved in the research. Contrasting these two perspectives enables to frame the problem of human-subject protection more broadly.

Approaching the perspective of institutions, I look into regulations on conducting clinical trials as well as administrative mechanisms meant to ensure compliance with these regulations. To provide a deeper insight into this perspective, particularly within the context of Berlin, I introduce the findings of an interview with Dr. Michael Stoeter from the local Ethik-Kommission. To explore the perspective of human subjects who participate in clinical research, I conducted a one-month fieldwork. Here I consider biographies and lived experience of so-called professional human subjects, providing an insight into their logic, reasoning and attitudes. Professional human subjects are those who participate in three or more Phase 1 trials (the first in-man studies aimed to determine drug safety) each year. This paper also provides a glimpse into the every-day practices at a company conducting clinical trials, noting my own experiences of enrolment at a clinic in Berlin.

In this paper, I seek to highlight gaps in regulations and question basic assumptions of existing institutions regarding clinical trials. These institutions operate in a framework, defined by basic assumptions of biomedicine and by bureaucratic type of organization. In this context, the body of a human subject is seen as a machine to determine drug safety. The protection of human subjects is then primarily a question of the soundness of research protocol. The actual implementation of research protocol, as well as the broad spectrum of processes and interactions involved in clinical research beyond the protocol are omitted from responsibilities of institutions like Berlin Ethik-Kommission.

Such institutions are therefore unable to ensure ethical clinical research and address issues of exploitation. While considering recruitment strategies used by clinics in Berlin, one sees how the pharmaceutical industry promotes professionalisation among human subjects and unavoidably targets specific networks of people. Considering stages of enrolment, one sees how the industry of commercialized clinical research deals with potential human subjects: they take one's blood, urine, and electrocardiogram yet are not particularly interested in one's work permit or one’s in-depth medical history. Moreover, the distance between Berlin Ethik-Kommission and the clinic allows for many minor and major violations of research protocol. It also allows companies conducting clinical research to take advantage of disadvantaged populations. The scope and implications of established exploitation remain unknown and deserve further investigation.

The argument of this paper is that the inability of institutions such as Berlin Ethik-Kommission to address protection of the well-being of human subjects originates from the bureaucratic logic of its organization. Drawing on Bauman’s (1992) argument that the bureaucratic machine is characterized by separation between morality and purpose, and with the example of Berlin Ethik-Kommission, I argue that a bureaucratic machine cannot be sensitive to morality and ethics, even if these are its main purposes.