Beyond "Good Governance":Trust, Consent, Exploitation and Vulnerability in Cross-Cultural Biobanking (original) (raw)

Article 1 is co-authored by Jesper Lassen and Peter Sandøe. I am responsible for the collection, transcription and analysis of interview data, and for developing and drafting the manuscript. Jesper Lassen and Peter Sandøe have both contributed with supervision in qualitative methods (semistructured interviews), in analysis and interpretation of data, and with substantial critical discussion and revision of the manuscript. Article 2 is co-authored by Klemens Kappel. I am responsible for the development and drafting of the manuscript. Klemens Kappel has contributed with development of ideas and arguments, as well as substantial critical discussion and revision of the manuscript. Article overview The present dissertation is comprised of three research articles. Article 1 details the findings of our empirical study executed in Pakistan, and Articles 2 and 3 each provide a thorough philosophical investigation of two issues that emerged as relevant in this study. Article 1, "I didn't have anything to decide, I wanted to help my kids"-An interview based study of consent procedures in sampling human biological material for genetic research in rural Pakistan", details the qualitative study that has served as empirical basis for the dissertation's other two articles. This study was comprised of 10 semi-structured interviews with families who have donated blood samples to NIBGE for research on a genetic disorder in their family, and 5 semi-structured interviews with NIBGE researchers. Interviews with donors focused on their motivations to donate samples, their experience of consent and donation, and what factors were central in the decision to give consent. Interviews with researchers focused on the institute's requirements for consent, and the researchers' strategies for and experiences with obtaining consent in the field. The study found that researchers often modify standard procedures for informed consent in the field to the local context, in order to gain the trust, good will and cooperation of the families. In turn, the donors reported that central to their participation in the research was their hope for getting something out of their participation (in the form of a cure, or knowledge about the disorder), and above all their trust in the researchers as both human beings and medical professionals as being capable and willing to look after their interests in this regards. Noting that several of the donors may have suffered from therapeutic misconception with respect to the potential benefits they may gain from their participation, the article concludes that while trust is important in consent to research, it should be supplemented by efforts to ensure proper provision and understanding of relevant information, specifically about the nature of research per se (as opposed to diagnostics). This article is co-authored with Peter Sandøe and Jesper Lassen, and has been accepted with revisions for publication in AJOB Empirical Bioethics. Article 2, "Is consent based on trust morally inferior to consent based on information?" engages in the philosophical and medico-ethical discussion regarding the theoretical justifications for the practice of informed consent to medical research. In much of medical ethics it is standardly assumed and claimed that decisions based on information (e.g., about a medical intervention, or about the drug used in a clinical trial) are more robust and prudent than decisions based merely on trust (in e.g. the doctor, researcher and/or the medical institution). This attaches a superior moral value to decisions based on information, and in turn places moral weight on the information itself, as a means to reach decisions that are, ostensibly, morally superior. In contrast to this standard claim, we argue that decisions based on trust are not morally inferior to decisions based on information. This argument is carried forward through a systematic analysis of the moral values underlying and essential to informed consent-i.e., autonomy, voluntariness, nonmanipulation and non-exploitation-with respect to whether these values are less protected by consent based on trust than they are by consent based on information. The analysis finds that this is not the case, and on this basis we conclude that trust-based consent is not inferior to information-based consent. The article concludes by considering and rejecting possible objections to this stance, and considers the implications this new perspective on informed consent may have for current practice, e.g. in the case of practices for ethical committees, and the practice of broad consent to genomic and biobank research.