Ethics & human research最新文献

This article brings a philosophical perspective to bear on issues of research ethics governance as it is practiced and organized in Canada. Insofar as the processes and procedures that constitute research oversight are meant to ensure the ethical conduct of research, they are based on ideas or beliefs about what ethical research entails and about which processes will ensure the ethical conduct of research. These ideas and beliefs make up an epistemic infrastructure underlying Canada's system of research ethics governance, but, we argue, extensive efforts by community members to fill gaps in that system suggest that these ideas may be deficient. Our aim is to make these deficiencies explicit through critical analysis by briefly introducing the philosophical literature on epistemic injustice and ignorance, and by drawing on this literature and empirical evidence to examine how injustice and ignorance show up across three levels of research ethics governance: research ethics boards, regulations, and training. Following this critique, and drawing on insights from the same philosophical tradition, we highlight the work that communities across Canada have done to rewrite and rework how research ethics as a site of epistemic resistance is practiced.

Since 1979, The Belmont Report has served as a guidebook for ensuring that basic standards for ethical research are upheld. The Belmont Report calls for special protections of vulnerable research participants, such as people who are incarcerated and economically and educationally disadvantaged individuals who are deemed susceptible to exploitation. With a growing focus on health equity and community-engaged approaches in health equity research, efforts to involve vulnerable participants are increasing. Yet there is little understanding of what matters most to vulnerable populations. This study sought to understand, from participant perspectives, ethical considerations when conducting research with two vulnerable populations: women experiencing homelessness and women who are incarcerated. Health care professionals and staff that work closely with homeless and incarcerated populations were also interviewed. The findings from semistructured interviews with these populations underscore the sustained importance of respect for persons, beneficence, and justice, and further highlight the need for self-determination; privacy/confidentiality; continuous consent; fair treatment; benefit-burden balance; nonauthoritarian relationships; and fair access to research participation. Although The Belmont Report durably serves to ethically guide standard conventional research, the Report's original concepts should be extended to include specific considerations when vulnerable populations are involved in community-engaged research.

Moral distress occurs when professionals are constrained from taking what they believe to be ethically appropriate actions or are forced to take actions they believe are ethically inappropriate, challenging their professional identities and representing systems-level issues within organizations. Moral distress has been recognized in a variety of health care-related fields; however, the phenomenon is still comparatively unexplored among clinical research professionals (CRPs). In this qualitative study, we interviewed ten CRPs to unearth root causes of moral distress in this ethically unique profession. Four themes emerged from the data as contributors to moral distress: commodification of research; concern for research participants; compromised science; and structures of hierarchy. The experience of racism as a source of moral distress is also explored. The findings of this study indicate that the existence of moral distress in clinical research is troubling not only for the welfare of CRPs but also for the greater clinical research enterprise.

In May 2022, the European Commission proposed the launch of a health-specific data sharing framework called the European Health Data Space (EHDS), underpinned by legislation, for the use of electronic health data by patients and for research, innovation, policy-making, patient safety, statistics, or regulatory purposes. In this essay, I review some of its more contentious features based on the latest version of the legislative proposal. I suggest that the EHDS is a useful case study to illustrate the need for a translational bioethics approach that shines a critical analytical light on contentious aspects of large-scale research infrastructures.

To protect research participants and ensure scientific integrity in clinical trials, independent data monitoring committees (DMCs, also known as data and safety monitoring boards) increasingly oversee randomized clinical trials and recommend modifying or stopping research. Little is known about the ethical issues DMCs face. We conducted semistructured interviews of DMC members using a qualitative description approach with low-inference interpretation. We recruited respondents through consultation with experts, an online registry of DMC members, and snowball sampling. We interviewed 22 DMC members who were statisticians, clinicians, and/or ethicists that had overseen a wide variety of trials globally. We identified three themes: finding common ground on responsibilities with variation; the need for judgment but not necessarily ethics expertise; and the resulting emotional distress from navigating ethical challenges. In the first case, DMC members identified 19 distinct duties, with some ethical responsibilities rarely mentioned. In the second case, not all DMC members saw the need for ethicists on DMCs or ethics training. In the third case, ethical challenges sometimes led to strong negative emotions. Developing tailored ethics training and decision-making procedures may help DMCs respond more effectively to ethical challenges.

The burden of research ethics review falls not just on researchers, but also on those who serve on research ethics committees (RECs). With the advent of automated text analysis and generative artificial intelligence (AI), it has recently become possible to teach AI models to support human judgment, for example, by highlighting relevant parts of a text and suggesting actionable precedents and explanations. It is time to consider how such tools might be used to support ethics review and oversight. This essay argues that with a suitable strategy of engagement, AI can be used in a variety of ways that genuinely support RECs to manage their workload and improve the quality of review. It would be wiser to take an active role in the development of AI tools for ethics review, rather than to adopt ad hoc tools after the fact.

The recent pandemic spurred interest in innovative design for clinical trials. In particular, constraints on the public's ability to gather led to an increase in remote or decentralized clinical trials (DCTs). DCTs present an opportunity to extend the benefits of research to underserved populations, decrease burdens, increase access to trials, and fill knowledge gaps surrounding rare conditions, though they are not without their own unique challenges and risks. These risks are far from irremediable, and the advantages are significant enough to merit attention. There is a scientific and moral case to increase the use of DCTs beyond the context of public health emergencies.

At the height of the Covid pandemic, there was much discussion in the literature about using human challenge trials (HCTs) to expedite the development of effective Covid-19 vaccines. Historically, reluctance to fully accept HCTs has largely been due to potential conflicts with the principle of nonmaleficence in bioethics. Only a few commentators have explored this topic in depth. In this paper, we claim that to address ethical concerns regarding HCTs, two types of ethical reasons should be identified and investigated: first-order reasons that can be given to claim that a practice in itself is in direct conflict with the principles of bioethics; and second-order reasons that take into consideration how a practice is carried out and its consequences. We argue that understanding these ethical reasons is crucial for guiding the implementation of HCTs. We investigate a first-order reason against HCTs when the practice is in conflict with the principle of nonmaleficence, and when it is not. Following this argument and assuming there is no first-order reason based on nonmaleficence that hinders using HCTs, we argue there may be second-order reasons to guide implementation of this practice, such as difficulty in obtaining informed consent; protection of the weaker party; and trust in the scientific enterprise.

The research and development of emerging technologies has potential long-term and societal impacts that pose governance challenges. This essay summarizes the development of research ethics in China over the past few decades, as well as the measures taken by the Chinese government to build its ethical governance system of science and technology after the occurrence of the CRISPR-babies incident. The essay then elaborates on the current problems of this system through the case study of ethical governance of brain-computer interface research, and explores how the transition from research ethics to translational bioethics, which encourages interdisciplinary collaboration and focuses on societal implications, may respond to the challenges of ethical governance of science and technology.

Research institutions often lack policies addressing the risks and benefits of enrolling “invested parties” such as investigators, research staff, and patient, caregiver, and community representatives (groups most affected by a disease or intervention) in studies where they have direct involvement. Invested parties may have both strong motivations to study the condition or intervention and to participate as study subjects. More guidance is needed to promote appropriate access to research participation and mitigate potential risks. This article addresses the gap in guidance by presenting an ethical framework and practical guidelines for the enrollment of invested parties. Drawing from experiences with the Researching COVID to Enhance Recovery (RECOVER) Initiative, a large multisite observational cohort study, we argue that invested parties should not be categorically excluded from enrollment in their own research studies if certain criteria are met and appropriate safeguards are in place. We underscore the need to balance inclusion with fairness, promote valid voluntary informed consent, ensure data privacy, protect scientific validity, and mitigate unique risks to invested parties as participants. Additionally, we recommend regular reporting and empirical assessment to evaluate the impact of enrolling invested parties on participants and study outcomes.