Ethics & human research最新文献

Clinical research is essential for establishing the safety, efficacy, and contextualized effectiveness of medical products. Data from multiple sources such as representative target population studies and health and demographic data obtained through health surveillance systems are required for designing clinical research protocols and for recruitment of participants. In this essay, we review barriers from a complex interplay of ethical, legal, and practical challenges in data governance that hamper sharing health data from these sources in Sub-Saharan Africa. We suggest that a translational bioethics approach offers a valuable framework for addressing these challenges to bridge the gap between theory and practical application of ethical principles in data governance.

Research ethics guidance on deception does not seem to provide extensive support to researchers and ethics reviewers on how to assess the justifiability of specific deceptive studies. One potential explanation for this shortcoming is that guidance does not offer precise and coherent descriptions of the ethically relevant characteristics of deceptive studies. To facilitate the development of improved guidance, we report on the findings of interviews with a diverse group of 24 researchers who use deception. Interviewees discussed how the interests of participants, society, and researchers can be affected by characteristics of the deceptive methods used. These characteristics pertained to the deceptive act (i.e., false, truthlike, or vague information; standardized or flexible deception), participants’ belief formation (i.e., credibility and suspicions), and deception-induced behaviors and experiences (i.e., consent validity, negative value, and duration of induced study behaviors and experiences). In addition, researchers described as ethically relevant the characteristics of the social context in which deceptive studies were embedded. These characteristics related to the deceiver-participant relationship and the participants’ community. Overall, our study contributes to a more coherent and precise, as well as complex and nuanced, understanding of the study characteristics that affect the justifiability of deception.

This study investigated the perceptions of institutional review board (IRB) professionals regarding the use of gender-neutral language in IRB guidance and informed consent documents, and whether respondents’ IRBs incorporated gender-neutral language in those documents. A survey was disseminated to a diverse group of IRB professionals whose emails were generated from a list received from the Office for Human Research Protections. Responses indicated substantial endorsement of gender-neutral language, although actual usage remains limited. The findings suggest that while the willingness to adopt inclusive language is high, barriers such as resource limitations and a lack of regulatory guidelines often impede its broader application. This study underscores the importance of developing explicit guidelines and resources to facilitate the adoption of gender-neutral language, enhancing inclusivity in research settings.

There is consensus that an inducement to participate in clinical research is undue if it compromises individual decision-making, thereby undermining voluntariness—a would-be research participant is made an excessive offer that prevents him or her from deciding well, however that is understood. I set forth and defend a view that conceptualizes inducements as undue if they result in the disparate enrollment of a protected class of individuals. I argue that this new conception avoids the problems with the standard view, is easy to operationalize, and clarifies the relation between exploitation and undue inducement.

Although young people are increasingly being included in research that affects them, commonly used research ethics training programs are designed for highly educated adult learners. In this paper, we describe our process of adapting and implementing an adolescent-appropriate version of an existing Collaborative Institutional Training Initiative (CITI) training module. Our research team adapted content from the CITI program's Researcher Basic Course—No Prisoners. Based on consultation with our youth researchers, this comprehensive training included audiovisual storytelling and information delivery, incorporation of relevant examples and connections to our research project, and interactive discussions. We successfully adapted a research ethics training for a nonacademic youth audience in partnership with them. Our adaptation was acceptable to participating youth researchers who reported greater understanding of ethical issues in social-behavioral research, increased understanding regarding the safeguarding of human subjects, and heightened confidence in their research abilities. Meaningful community and youth engagement in research necessitate the adaptation of training modules and materials that are accessible and appropriate for nonacademic audiences. We demonstrate the feasibility and success of one such adaptation for a youth participatory action research team involved in a study of adolescent mental health.

The creation and study of brain organoids may hold significant promise for understanding brain functions, disorders, and diseases. This research may also raise novel considerations and ethical concerns, but it has significant public and professional support when thoughtfully undertaken. Current legislative and judicial restrictions on abortion and pronouncements about fetal personhood could, however, have a surprisingly broad and unintended reach, even conceivably restricting the development and use of brain organoids and other biomedical and bioengineered research tools. Brain organoid research thus may constitute a cautionary tale about the risks of performative policy-making.

Lengthy consent forms are poorly suited for clinical trials in emergency contexts; however, innovations in consent processes are challenging to implement. A previously developed, context-sensitive consent form and information sheet were approved by a single institutional review board (sIRB) of record for use in a multisite stroke treatment clinical trial. This study sought views on using these materials by research teams and representatives from local institutional review boards (IRBs) and human research protection programs (HRPPs). Semistructured interviews were conducted with 22 local IRB/HRPP respondents and study team members from various study sites. Study teams appreciated the abbreviated length of the consent form and how the information tailored to help patients’ decisions was included while supplementary information was placed in an information sheet. They also described positive impacts on their interactions and processes; IRB/HRPP respondents valued the simplicity of the language, formatting, and attention to what was in the consent form versus what was on the information sheet. They supported the efforts and questioned whether local IRBs would have given approval. Some respondents were unsure of how to best use the information sheet. The consent forms were found to be patient-centered and implementable by study teams. Further experience is needed to identify optimal ways of incorporating supplemental written information. Since many of the IRB/HRPP respondents were uncertain whether their local IRBs would have approved the consent materials that were approved by the sIRB, these findings reinforce the potential for sIRB processes to facilitate the implementation of innovative approaches to consent.

Of the many burdens cancer patients face, the impact on personal finances is often invisible to clinicians. Financial toxicity refers to the negative impact on patients’ and families’ quality of life due to a combination of high out-of-pocket costs of medical treatment, diminished savings, and psychological distress as a result of diminished finances. Financial toxicity in cancer care has been more closely examined in the standard-of-care setting. Financial toxicity in the early phase clinical trial setting, and the ethical implications of making patients pay out of pocket to access experimental interventions that may not have therapeutic benefit, have yet to be explored. This article seeks to highlight hidden costs of clinical trial participation in the U.S., and to illustrate how patients are susceptible to financial toxicity from nonmedical direct costs and indirect costs even though a trial intervention itself is not charged to the patient. We argue that not informing prospective participants of the potential costs of trial participation threatens their autonomy and interferes with researchers’ prima facie duties to beneficence and nonmaleficence.

Research is increasingly claimed to be done in collaboration with communities, but community members may have entirely different expectations of engagement and research participation than what typically follows the logic of academia. In South Africa, intersecting inequalities further complicate relationships with communities and stakeholders. To understand how different actors view and construct the relationships between academic institutions and communities, we undertook a multiperspective discourse analysis. We conducted 11 in-depth interviews with 12 participants categorized as researchers, community representatives, and community members. These interviews reflect three interconnected discourses: expectations, tensions, and brokerage. Expectations pattern intergroup dynamics, such as community members’ expectations of research benefits, while tensions primarily capture challenging relationships between different research actors. Our analysis also illustrates how, in the absence of comprehensive institutional support, community engagement relies on brokerage by community representatives, and how this reliance disproportionately burdens them. There is a need to lessen this ethical burden and invite community input without also burdening community members and representatives with the challenges of academia. Our findings also have wider relevance for community-based health research because engagement practices are often hindered by institutional and structural factors.

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.