The case (Dawson et al. 2024) describes an Institutional Review Board (IRB) chair who seeks consultation about waiving the requirement that investigators obtain prospective, informed consent for collection of microbiome samples by swabbing the perianal region of severely burned patients shortly after their admission to an intensive care unit (ICU). We argue that it is ethically permissible to waive informed consent requirements for the perianal swab and that the IRB should approve a waiver as permitted by regulations.

Experimental design is one aspect of a scientific method. A well-designed, properly conducted experiment aims to control variables in order to isolate and manipulate causal effects and thereby maximize internal validity, support causal inferences, and guarantee reliable results. Traditionally employed in the natural sciences, experimental design has become an important part of research in the social and behavioral sciences. Experimental methods are also endorsed as the most reliable guides to policy effectiveness. Through a discussion of some of the central concepts (...) associated with experimental design, including controlled variation and randomization, this chapter will provide a summary of key ethical issues that tend to arise in experimental contexts. In addition, by exploring assumptions about the nature of causation and by analyzing features of causal relationships, systems, and inferences in social contexts, this chapter will summarize the ways in which experimental design can undermine the integrity of not only social and behavioral research but policies implemented on the basis of such research. (shrink)

Governments are increasingly making use of field experiments to evaluate policy interventions in the spheres of education, public health and welfare. However, the research ethics literature is largely focused on the clinical context, leaving investigators, institutional review boards and government agencies with few resources to draw on to address the ethical questions they face regarding such experiments. In this article, we aim to help address this problem, investigating the conditions under which informed consent is required for ethical policy research conducted (...) or authorized by government. We argue that investigators need not secure participants' informed consent when conducting government policy experiments if: the government institution conducting or authorizing the experiment possesses a right to rule over the spheres of policy targeted by the research; and data collection does not involve the violation of participants' autonomy rights. (shrink)

Clinicians have good moral and professional reasons to contribute to pragmatic clinical trials (PCTs). We argue that clinicians have a defeasible duty to participate in this research that takes place in usual care settings and does not involve substantive deviation from their ordinary care practices. However, a variety of countervailing reasons may excuse clinicians from this duty in particular cases. Yet because there is a moral default in favor of participating, clinicians who wish to opt out of this research must (...) justify their refusal. Reasons to refuse include that the trial is badly designed in some way, that the trial activities will violate the clinician’s conscience, or that the trial will impose excessive burdens on the clinician. (shrink)

The future of health research will be characterised by three continuing trends: rising demand for health data; increasing impracticability of obtaining specific consent for secondary research; and decreasing capacity to effectively anonymise data. In this context, governments, clinicians and the research community must demonstrate that they can be responsible stewards of health data. IRBs and RECs sit at heart of this process because in many jurisdictions they have the capacity to grant consent waivers when research is judged to be of (...) particular value. However, several different terms are used to refer to this value, indicating a lack of conceptual clarity regarding the appropriate test for access to health data for research without consent. In this paper we do three things. First we describe the current confusion and instability in terminology relating to public interest in the context of consent waivers. Second we argue for harmonisation of terminology on the grounds of clarity, transparency and consistency. Third we argue that the term ‘public interest’ best reflects the normative work required to justify consent waivers because it is the broadest of the competing terms. ‘Public interest’ contains within its scope positive and negative implications of a study, as well as welfare, justice and rights considerations. In making this argument, we explain the normative basis for consent waivers, and provide a starting place for further discussion about the precise conditions in which a given study can be said to advance the public interest. Ipsos MORI study found that: … the public would be broadly happy with administrative data linking for research projects provided Those projects have social value, broadly defined. Data are de-identified. Data are kept secure. Businesses are not able to access the data for profit. (shrink)

In clinical research, decision-making capacity is often equated with unspecified conceptions of autonomy, and autonomy is often equated with personhood. On this view, the loss of decision-making capacity is seen as a loss of autonomy, and the loss of autonomy subsumes a loss of personhood. An ethical concern arises at the intersection of those philosophical considerations with the legal considerations in informed consent. Because persons with inadequate decision-making capacity cannot provide legally effective consent, enrollment in research can occur only if (...) a surrogate gives permission on the person’s behalf. Federal regulations and resulting institutional policies allow permission from surrogates empowered under state law to consent to medical treatment procedures, typically in a hierarchy of legislatively prioritized relationships lacking regard for what the surrogate actually knows about the current research-related values and preferences of the potential subject. As a result, the research enterprise often countenances reliance on surrogates who have no relational or informational basis for an enrollment decision that aligns with the values and preferences of the subject. Arguing from the perspective that losing decision-making capacity does not alter the moral status of persons, and that respect for persons rather than respect for autonomy is the central ethical obligation, I assess the ethical implications of allowing persons with no knowledge of the values and preferences of the potential subject to make enrollment decisions, concluding that reliance on uninformed surrogates is not an ethically defensible approach to enrolling subjects in clinical research. (shrink)

Online controlled experiments, also known as A/B tests, have become ubiquitous. While many practical challenges in running experiments at scale have been thoroughly discussed, the ethical dimension of A/B testing has been neglected. This article fills this gap in the literature by introducing a new, soft ethics and governance framework that explicitly recognizes how the rise of an experimentation culture in industry settings brings not only unprecedented opportunities to businesses but also significant responsibilities. More precisely, the article (a) introduces a (...) set of principles to encourage ethical and responsible experimentation to protect users, customers, and society; (b) argues that ensuring compliance with the proposed principles is a complex challenge unlikely to be addressed by resorting to a one-solution response; (c) discusses the relevance and effectiveness of several mechanisms and policies in educating, governing, and incentivizing companies conducting online controlled experiments; and (d) offers a list of prompting questions specifically designed to help and empower practitioners by stimulating specific ethical deliberations and facilitating coordination among different groups of stakeholders. (shrink)

Hastings Center Report, Volume 52, Issue 3, Page 18-29, May–June 2022.

This thesis addresses the tension in pragmatic cluster-randomized trials between their social value and the requirement to respect the autonomy of research participants. Pragmatic trials are designed to evaluate the effectiveness of treatments in real-world settings to inform clinical decision-making and promote cost-efficient care. These trials are often embedded into clinical settings and ideally include all patients who would receive the treatments under investigation as a part of routine care. Trialists increasingly adopt cluster-randomized designs—in which intact groups, such as hospitals (...) or clinics, are allocated randomly to study interventions—to simplify the inclusion of all patients. But including all-comers conflicts with the requirement to obtain written informed consent from research participants. Since informed consent is central to respecting patient autonomy, the question arises: how can the ends of autonomy and pragmatism be served simultaneously? Some philosophers argue that patients have an obligation to participate in clinical research and that this may negate consent requirements. I argue that while there may be grounds for a prima facie obligation for patients to participate in clinical research, no compelling argument has demonstrated that the obligation is enforceable. Others assert that broad application of a waiver of consent will facilitate the conduct of pragmatic cluster-randomized trials. I demonstrate that this proposal sharply conflicts with the historical origins of the waiver. I articulate a novel moral foundation for the use of a waiver of consent and show that when trials evaluate treatments delivered directly to patients, the autonomy interests at stake for participants are too substantial to permit its use. My solution draws a distinction between consent requirements in existing policy and consent as an autonomous authorization. As many pragmatic cluster-randomized trials are conducted in primary care settings with no research staff, I argue that patient autonomy can be promoted and protected using clinical-style consent, in which health providers seek verbal informed consent from patients and document it in the electronic health record. This approach has been associated with high rates of recruitment and, thus, may satisfy both requirements for social value and respect for autonomy. (shrink)

The field of leadership studies frequently focuses on defining leadership traits in abstraction from the context in which leadership operates. The first aim of this article is to provide a brief overview of reasons why this might be the case. Reasons include: leadership studies being dominated by the perspectives of leaders; the lack of definition and visibility of followership studies; the status and limitations of much qualitative research; and a predominant focus on good leadership. Consequently, many people who experience the (...) effects of leadership, and particularly those of bad leadership, do not recognise their experiences in the literature. However, recognising that followers who experience bad leadership personally increasingly engage in autoethnographic studies, my second aim is to draw out some examples of bad leadership from the autoethnographic literature, as well as their effects. In spite of its negative effects, bad leadership frequently remains unchallenged. My third aim is to explain why this might be the case, where I argue that this stems partly from the pitfalls of autoethnographic studies. I also sketch how these pitfalls might be overcome and how doing so and adopting the principle of ‘accountability for reasonableness’ might help to tackle bad leadership. (shrink)

Phishing is a fraudulent form of email that solicits personal or financial information from the recipient, such as a password, username, or social security or bank account number. The scammer may use the illicitly obtained information to steal the victim’s money or identity or sell the information to another party. The direct costs of phishing on consumers are exceptionally high and have risen substantially over the past 12 years. Phishing experiments that simulate real world conditions can provide cybersecurity experts with (...) valuable knowledge they can use to develop effective countermeasures and prevent people from being duped by phishing emails. Although these experiments contravene widely accepted informed consent requirements and involve deception, we argue that they can be conducted ethically if risks are minimized, confidentiality and privacy are protected, potential participants have an opportunity to opt out of the research before it begins, and human subjects are debriefed after their participation ends. (shrink)

In an insightful article published in this issue of the Hastings Center Report, Danielle Wenner criticizes what she describes as transactional approaches to the social value requirement in clinical research and defends a “basic structure approach.” Transactional approaches understand social value obligations as arising from transactions (or relationships) between research subjects, investigators, sponsors, and other parties. The basic structure approach, by contrast, understands social value obligations as stemming from the demands of Rawlsian social justice. According to Wenner, “The primary justification (...) for the social value requirement lies not in the ethics of free and fair transactions but rather in the goals of the clinical research enterprise and the nature of its impacts on society. The requirement is justified because it ensures that biomedical progress occurs in a manner constrained by considerations of justice.” In this commentary, I will not critique the basic structure approach per se but will raise some concerns that arise when oversight committees, such as institutional reviews boards, attempt to apply it to proposed studies involving human subjects. (shrink)

There is a growing interest in aggregating more biomedical and patient data into large health data sets for research and public benefits. However, collecting and processing patient data raises new ethical issues regarding patient’s rights, social justice and trust in public institutions. The aim of this empirical study is to gain an in-depth understanding of the awareness of possible ethical risks and corresponding obligations among those who are involved in projects using patient data, i.e. healthcare professionals, regulators and policy makers. (...) We used a qualitative design to examine Swiss healthcare stakeholders’ experiences and perceptions of ethical challenges with regard to patient data in real-life settings where clinical registries are sponsored, created and/or used. A semi-structured interview was carried out with 22 participants between July 2014 and January 2015. The interviews were audio-recorded, transcribed, coded and analysed using a thematic method derived from Grounded Theory. All interviewees were concerned as a matter of priority with the needs of legal and operating norms for the collection and use of data, whereas less interest was shown in issues regarding patient agency, the need for reciprocity, and shared governance in the management and use of clinical registries’ patient data. This observed asymmetry highlights a possible tension between public and research interests on the one hand, and the recognition of patients’ rights and citizens’ involvement on the other. The advocation of further health-related data sharing on the grounds of research and public interest, without due regard for the perspective of patients and donors, could run the risk of fostering distrust towards healthcare data collections. Ultimately, this could diminish the expected social benefits. However, rather than setting patient rights against public interest, new ethical approaches could strengthen both concurrently. On a normative level, this study thus provides material from which to develop further ethical reflection towards a more cooperative approach involving patients and citizens in the governance of their health-related big data. (shrink)