A child’s objection, refusal and dissent regarding participation in non-beneficial biomedical research must be respected, even when the parents or legal representatives have given their permission. There is, however, no consensus on the definition and criteria of a meaningful and valid child’s objection. The aim of this article is to clarify this issue. In the first part we describe the problems of a child’s assent in research. In the second part we distinguish and analyze two models of a child’s objection (...) to research: the capacity-based model and the distress-based model. In the last part we present arguments for a broader and unified understanding of a child’s objection within regulations and practices. This will strengthen children’s rights and facilitate the entire process of assessment of research protocols. (shrink)

(2013). An Unbiased Response to the Open Peer Commentaries on “Does Consent Bias Research?”. The American Journal of Bioethics: Vol. 13, No. 4, pp. W1-W4. doi: 10.1080/15265161.2013.769824.

Since antiquity, doctors have employed case reports as an essential and ongoing part in communicating information about patients and their diseases to their colleagues and, at times, to the wider, nonmedical world. Given how useful case reports have been, a legitimate and persuasive argument could be made to retain them in modern medical literature. But there is an emerging problem with case reports. As the ability to publish and disseminate the information contained in them has become easier, the capacity for (...) individuals to maintain their privacy and restrict access to their personal information has become more strained, and it has become more difficult for doctors who tell clinical stories to respect the confidentiality of their patients while still communicating the pertinent details of their cases. Does the acknowledged educational and scientific value of (some) case reports justify the threat to personal privacy that may be entailed by the format itself? (shrink)

It is widely acknowledged that trust plays an important role for the acceptability of data sharing practices in research and healthcare, and for the adoption of new health technologies such as AI. Yet there is reported distrust in this domain. Although in the UK, the NHS is one of the most trusted public institutions, public trust does not appear to accompany its data sharing practices for research and innovation, specifically with the private sector, that have been introduced in recent years. (...) In this paper, we examine the question of, what is it about sharing NHS data for research and innovation with for-profit companies that challenges public trust? To address this question, we draw from political theory to provide an account of public trust that helps better understand the relationship between the public and the NHS within a democratic context, as well as, the kind of obligations and expectations that govern this relationship. Then we examine whether the way in which the NHS is managing patient data and its collaboration with the private sector fit under this trust-based relationship. We argue that the datafication of healthcare and the broader ‘health and wealth’ agenda adopted by consecutive UK governments represent a major shift in the institutional character of the NHS, which brings into question the meaning of public good the NHS is expected to provide, challenging public trust. We conclude by suggesting that to address the problem of public trust, a theoretical and empirical examination of the benefits but also the costs associated with this shift needs to take place, as well as an open conversation at public level to determine what values should be promoted by a public institution like the NHS. (shrink)

Scientists in earlier times considered personal research participation an essential component of their work. Exposing themselves to untested interventions was seen as the most ethical way to gauge the human response to those interventions. The practice was also educational, for it generated useful information that helped researchers plan subsequent human studies. Self-experimentation was eventually replaced by more comprehensive ethical codes governing human research. But it is time to bring back the practice of self-experimentation, albeit in modified form. Through serving as (...) a study subject, investigators and other research professionals can obtain valuable information about their work. (shrink)

Many features of the existing biomedical research enterprise rest on questionable judgments about the value of research. Policymakers and research ethicists make assumptions about research value that aren't necessarily warranted. A more balanced view of research value could contribute to more defensible decisions about research policy and practice.

The government-sponsored Tuskegee syphilis study had a huge impact on U.S. research ethics and policy. Study investigators regarded subjects as “mere means” to their research ends, which led to a variety of ethical violations. Investigators used deception so that subjects would see participation as therapeutic — researchers promoted the therapeutic misconception because this advanced study objectives. The research would produce important information, and this justified lying to research subjects.Today we see this sort of intentional deception as unjustified no matter how (...) important a study might be. But what do we make of the claim that the syphilis study had value? As James Jones reported, its objectives were to test the prevailing views that syphilis affected blacks and whites differently, and that the disease was less harmful to blacks than whites. U.S. Public Health Service researchers and officials assumed the study had sufficient value to justify not only deceiving subjects, but also depriving them of safe and effective treatment. (shrink)