Linus Broström

Involving children in non-therapeutic research: on the development argument

Non-therapeutic research on children raises ethical concerns. Such research is not only conducted on individuals who are incapable of providing informed consent. It also typically involves some degree of risk or discomfort, without prospects of medically benefiting the participating children. Therefore, these children seem to be instrumentalized. Some ethicists, however, have tried to sidestep this problem by arguing that the children may indirectly benefit from participating in such research, in ways not related to the medical intervention as such. It has been argued, for example, that non-therapeutic pediatric research does not instrumentalize the children enrolled since it has the prospects of furthering their moral development. We argue that this argument is far too undeveloped to be taken seriously.

Counterfactual Reasoning in Surrogate Decision Making – Another Look

Incompetent patients need to have someone else make decisions on their behalf. According to the Substituted Judgment Standard the surrogate decision maker ought to make the decision that the patient would have made, had he or she been competent. Objections have been raised against this traditional construal of the standard on the grounds that it involves flawed counterfactual reasoning, and amendments have been suggested within the framework of possible worlds semantics. The paper shows that while this approach may circumvent the alleged problem, the way it has so far been elaborated reflects insufficient understanding of the moral underpinnings of the idea of substituted judgment. Proper recognition of these moral underpinnings has potentially far-reaching implications for our normative assumptions about accuracy and objectivity in surrogate decision making.

Turning failures into successes: a methodological shortcoming in empirical research on surrogate accuracy

Decision making for incompetent patients is a much-discussed topic in bioethics. According to one influential decision making standard, the substituted judgment standard, a surrogate decision maker ought to make the decision that the incompetent patient would have made, had he or she been competent. Empirical research has been conducted in order to find out whether surrogate decision makers are sufficiently good at doing their job, as this is defined by the substituted judgment standard. This research investigates to what extent surrogates are able to predict what the patient would have preferred in the relevant circumstances. In this paper we address a methodological shortcoming evident in a significant number of studies. The mistake consists in categorizing responses that only express uncertainty as predictions that the patient would be positive to treatment, on the grounds that the clinical default is to provide treatment unless it is refused. We argue that this practice is based on confusion and that it risks damaging the research on surrogate accuracy.

Empirical Fallacies in the Debate on Substituted Judgment

According to the Substituted Judgment Standard a surrogate decision maker ought to make the decision that the incompetent patient would have made, had he or she been competent. This standard has received a fair amount of criticism, but the objections raised are often wide of the mark. In this article we discuss three objections based on empirical research, and explain why these do not give us reason to abandon the Substituted Judgment Standard.

Does peer benefit justify research on incompetent individuals? The same-population condition in codes of research ethics

Research on incompetent humans raises ethical challenges, especially when there is no direct benefit to these research subjects. Contemporary codes of research ethics typically require that such research must specifically serve to benefit the population to which the research subjects belong. The article critically examines this “same-population condition”, raising issues of both interpretation and moral justification. Of particular concern is the risk that the way in which the condition is articulated and rationalized in effect disguises or downplays the instrumentalization of incompetent individuals.

Transgender and gender diverse people's experience of non-transition-related health care in Sweden

ABSTRACT Introduction: The transgender population is a marginalized group in society and research suggests that they experience significant barriers when accessing health care. However, little is known about transgender and gender-diverse people and their experiences of encounters with healthcare professionals in Sweden. Aim: To explore transgender and gender-diverse peoples experiences of accessing health care in Sweden. Method: Semi-structured interviews with 12 self-identified transgender or gender-diverse individuals were analyzed in a latent thematic analysis. Results: Participants experienced difficulties in having their gender identity acknowledged in encounters with healthcare staff. Most healthcare professionals were believed to lack knowledge about transgender people, and participants felt they needed to take a lot of responsibility themselves to ensure they received adequate care. Due to negative experiences, or fear of them, some participants delayed seeking health care or they chose to withhold their transgender identity during healthcare consultations. Discussion: Participants’ experiences suggest that healthcare professionals in Sweden may be insufficiently equipped to provide competent and gender affirming care for transgender individuals. There appears to be an urgent need for interventions specifically designed to improve the quality of health care for these individuals. Further research is needed to determine what specific interventions would be most effective, and to elucidate the specific needs of differing groups within the transgender community to promote optimal care for each person.

The protection of unrepresented patients in emergency care research

ABSTRACT In emergency care research, it may be the case that neither informed consent nor surrogate consent is possible. In order to nonetheless allow for such research, codes and regulations of research ethics have increasingly incorporated provisions regarding this specific situation. The protection that those provisions offer need to be better understood. This article addresses in what ways they protect individuals, and especially the extent to which the suggested protection compensates for the loss of surrogate consent. The Declaration of Helsinki, the Additional Protocol to the Convention on Human Rights and Biomedicine, and the EU Clinical Trials Regulation serve as the main illustrations.

Surrogate consent to non-beneficial research: erring on the right side when substituted judgments may be inaccurate

Part of the standard protection of decisionally incapacitated research subjects is a prohibition against enrolling them unless surrogate decision makers authorize it. A common view is that surrogates primarily ought to make their decisions based on what the decisionally incapacitated subject would have wanted regarding research participation. However, empirical studies indicate that surrogate predictions about such preferences are not very accurate. The focus of this article is the significance of surrogate accuracy in the context of research that is not expected to benefit the research subject. We identify three morally relevant asymmetries between being enrolled and not being enrolled in such non-beneficial research, and conclude that when there is a non-negligible probability that surrogates’ predictions are wrong, it will generally be better to err on the side of not authorizing enrollment.

The role of oversight in the protection of research subjects

During a five-year period, the Regional Ethical Review Boards (cf. IRB) in Sweden handled applications regarding more than 13 000 studies. This may seem to offer significant protection, but the question is to what extent this review procedure really protects research subjects, if the way in which research is actually conducted is not monitored as well. For instance, do researchers really apply for ethical approval whenever this is required by the law, and do those who get an ethical approval proceed as described in their experimental treatment ondying patients – implanting an artificial trachea – was conducted without any approval from the Regional Ethical Review Board. It is reasonable to assume that there is a need for an effective and efficient system of oversight. Indeed, TheEthical Review Act and the preparatory work on which it is based explicitly acknowledges the need for oversight. Moreover, there are authorities responsible for conducting it. In this presentation, however, we will provide empirical data that reveals an almost total lack of actual oversight in Sweden. We shall also discuss the significance of oversight in more general terms. (Less)