CIOMS Guidelines

This dissertation investigates ethical issues that arise in biobanking (i.e., the systematic collection and storage of samples of human material for research) across national and cultural borders. Building on an empirical study of the expectations, motivations and strategies of biobank donors and researchers in rural Pakistan, the dissertation examines four concepts that are relevant in this context: trust, consent, vulnerability and exploitation.

The dissertation consists of three articles, preceded by an introductory chapter showing how the articles relate to my main topic and the ongoing ethical debates in this field.
In the introduction I first set the scene for my investigation by giving an account of relevant features of the societal and ethical landscape in Pakistan, and of the nature of biobanks. I then discuss the various ethical issues that have been raised regarding biobank research and medical research in developing countries, respectively; focusing on the issues of informed consent and exploitation.

Article 1 details the empirical interview study conducted with biobank donors and researchers in rural Pakistan. The study found that central to the decision to consent to give blood samples for research was the trust they held in the researchers - either as interpersonal, institutional or indirect trust. In addition, the study found that in order to gain the trust and cooperation of donor families, researchers in the field often modify standard ethical requirements for informed consent to the local circumstances, and employ alternative strategies for obtaining consent.

Article 2 examines the moral value of this sort of trust-based consent. The practice of informed consent is a cornerstone in medical ethics, as the provision of information about a given intervention or study is held and hailed to be the optimal way to protect and promote the autonomy of patients and research participants, and protect them against coercion, manipulation and exploitation. This attaches a significant moral value to information and decisions made on the basis of it. In the article we analyze whether these values underlying the ideal of informed consent (autonomy, voluntariness, non-manipulation and non-exploitation) are protected to a lesser extent by trust, as compared to information. We find that this is not the case, and argue - in contrast to the common claim in medical ethics - that trust-based consent is not morally inferior to informed consent. We conclude by discussing the implications of our argument for current medical ethics.

In Article 3 I investigate whether the case of sample collection for biobanking detailed in Article 1 is one of exploitation; that is, whether the donors are being exploited in any sense, and if so, what features of the case make it so. I do this initially by analyzing the case from the point of view of standard theories of exploitation (which I group into Kantian; unfairness-centered, and circumstance-centered theories). Generally, this analysis shows that the case is not one of exploitation. However, I argue that this result is unsatisfactory, and that the consulted theories are inadequate in that they overlook relevant features of the case that might be grounds for exploitation. I suspect that this is because their conception of vulnerability is overly fixed and narrow. Hence, I then analyze the role and nature of vulnerability in relation to exploitation and consent, and on this basis suggest a more refined and contextually sensitive conception of vulnerability in exploitation.

I wrap up the dissertation by offering some general conclusive remarks and perspectives based on my findings, and by briefly reflecting on how philosophical and empirical research methods may complement each other.

The discussion on ethical issues, it is said, should not be confined to experts but should be extended to patients and local communities, because of the real need to engage stakeholders and non-stakeholders alike not only in carrying out any biomedical research project, but also in the drafting and legislation of bioethics instruments. Several local and inter-country consultations have already been conducted in furtherance of this goal, but there is much left to be desired in them. The consultations may have helped in articulating local principles, but not in making the instruments embody these principles. As such, instruments turn incompossible, i.e. the principles and actions they legitimate are not performable. In an ethnographic study conducted in the Philippines, for example, paragraphs 29 and 30 of the Declaration of Helsinki and CIOMS guidelines 8 and 15 are construed as not only contradictory to one another but also to local principles. This problem can be solved by taking deliberate steps to ensure that consultations are grounded in ethnographic data about local principles, which the instruments would embody. A steering committee can be of help in gathering ethnographic data, in conducting consultations at the local level, and in providing a venue for discourse on various bioethical issues.

The " socially valuable knowledge " (SVK) principle has been widely acknowledged as one of the most important guiding principles for biomedical research involving human subjects. The principle states that the potential of producing socially valuable knowledge is a necessary requirement, although not sufficient, for the ethical conduct of research projects. This is due to the assumption that the social value of knowledge avoids exploitation of research subjects and justifies the use of health resources. However, more recently, several authors have started interrogating the validity of SVK in research and offered various lines of argument against the SVK principle as a necessary constraint to research. In this paper, I will reconstruct the main arguments of this discussion between defenders and debunkers of the SVK principle and offer a third way to consider the social value of knowledge in research studies. I will argue the social value of knowledge can be supported by an independent justification. This justification of the SVK principle addresses the rationality and common interest of researchers. Thus, I will introduce the SVK principle as a safeguarding principle

This paper reviews the 2016 CIOMS International Ethical Guidelines for Health-related Research Involving Humans. I argue that these new guidelines constitute a significant improvement over the guidelines they replace. However, the procedures put in place by CIOMS resulted in an authoring group consisting of a majority of authors and advisors hailing from the global North, while the guidelines squarely aim at influencing policies in the global South. I question CIOMS' strategy to produce a consensus-based document, and raise concerns about frequent appeals to authority designed to establish the credibility of these guidelines and the processes that led to them. It is unclear why it should be the role of a small organisation such as CIOMS to try to guide the research ethics policies in countries of the global South.