Research Ethics最新文献

The integration of artificial intelligence (AI), particularly large language models (LLMs) like OpenAI's ChatGPT, into clinical research could significantly enhance the informed consent process. This paper critically examines the ethical implications of employing LLMs to facilitate consent in clinical research. LLMs could offer considerable benefits, such as improving participant understanding and engagement, broadening participants' access to the relevant information for informed consent and increasing the efficiency of consent procedures. However, these theoretical advantages are accompanied by ethical risks, including the potential for misinformation, coercion and challenges in accountability. Given the complex nature of consent in clinical research, which involves both written documentation (in the form of participant information sheets and informed consent forms) and in-person conversations with a researcher, the use of LLMs raises significant concerns about the adequacy of existing regulatory frameworks. Institutional Review Boards (IRBs) will need to consider substantial reforms to accommodate the integration of LLM-based consent processes. We explore five potential models for LLM implementation, ranging from supplementary roles to complete replacements of current consent processes, and offer recommendations for researchers and IRBs to navigate the ethical landscape. Thus, we aim to provide practical recommendations to facilitate the ethical introduction of LLM-based consent in research settings by considering factors such as participant understanding, information accuracy, human oversight and types of LLM applications in clinical research consent.

Restrictions put in place during the COVID-19 pandemic necessitated a rapid shift towards remote qualitative recruitment and data collection. This shift generated considerable opportunities to conduct qualitative research, but also introduced novel challenges to data integrity in the form of inauthentic participants. While newer literature describes potential strategies that may be deployed to target concerns related to inauthentic participation, an explicit focus on equity and ethical considerations has been largely absent from current discourse. Here we describe our experiences and challenges conducting a study aimed at exploring reasons for recent firearm acquisition among Black Americans. We describe the mitigation strategies we implemented, as well as the ethical challenges and potential consequences that emerged. Our team identified three specific ethical considerations: identity and processes of categorization, trust and mistrust in research engagement, and privacy and honoring sensitive context. These considerations are critical to consider in conducting qualitative research, especially among marginalized groups, and expand the current literature on qualitative research ethics.

While genomic data sharing enhances transparency and research efficiency, it also raises significant ethical and social challenges. This study explored stakeholders' perspectives on these issues, particularly around privacy, confidentiality, and equity in collaborative research. A phenomenological qualitative study was conducted between August and December 2023 at Makerere University College of Health Sciences, other research-intensive institutions, and national regulatory bodies. The study engaged 86 participants: 47 key informants (16 researchers, 14 ethics committee members, nine community advisory board members, and eight research regulators) and four deliberative focus group discussions with 39 participants. Interviews were transcribed verbatim, and thematic analysis was conducted using NVivo 14. Three major themes emerged: (1) stakeholders' experiences in genomic research, including their roles as participants, implementers, or overseers; (2) ethical concerns, such as informed consent, third-party data access, inequities between high-income and low- and middle-income country (LMIC) researchers and participants, and the lack of benefit-sharing frameworks; and (3) social implications, including stigma, discrimination, labeling, community perceptions of fairness, and the need for meaningful engagement. Participants emphasized the importance of protecting participant rights, promoting equity, and ensuring robust data governance and security. The theoretical frameworks of principlism and distributive justice provided a valuable lens for examining these concerns, particularly by highlighting the need to safeguard privacy and fairly distribute responsibilities and benefits in global collaborations. Participants also noted that perceptions of fairness are shaped by trust, local context, and past experiences with research factors that are critical for building equitable and respectful partnerships. This study underscores the urgent need to strengthen protections for research participants and promote fairness in genomic data sharing. Policies should, if adopted, emphasize culturally contextualized consent, active community engagement, restricted third-party data access, and strong data protection mechanisms to address existing inequities and prevent misuse.

Africa has a colonial past that renders it a linguistic melting pot, where language is not only important for communication but is inextricably related to cultural identity. In Africa, there are over 2000 languages that are still being used and spoken. Language diversity coupled with cultural diversity may affect the process of obtaining informed consent in data-intensive research. We explore some of the challenges and opportunities of multilingualism in handling informed consent in the context of data-intensive research. In multilingual contexts, as in most African countries, language is exceptionally central, and translation has potential cultural, social, historical, functional and scientific importance. However, it is recognised that terminological and translation activities may not always be cost-effective or feasible. We consider alternative mechanisms of harmonisation of data-related terminology and concepts in multilingual contexts, such as iconography, graphic elicitation and other multimedia formats of information sharing. The inclusion of visual or multimedia explanations in informed consent forms can improve comprehension, enhance information transfer and learning, reduce potential vulnerabilities associated with low literacy levels or the inability to interpret technical language associated with data-intensive research, build trust with participants and their communities, and promote autonomy of potential participants. We recognise that the inclusion of visual or multimedia content to facilitate information transfer is only one component of the informed consent process for data-intensive research. Research ethics committees (RECs) should be mindful of other key considerations and challenges of informed consent for data-intensive research in sub-Saharan Africa (SSA), and to explore whether these alternative forms of consent are ethical and effective in multilingual contexts.

The responsible conduct of research must be sensitive to the unique ethical concerns of the police setting, but we have yet to develop an empirical understanding of the ethics of research involving police officers as participants. To develop such an understanding, this study collected qualitative data from 30 officers serving in eight agencies throughout the United States. The interviews situated their ethical sensibilities about research in relation to the Belmont principles that serve as the dominant source of norms in U.S. research ethics, then evoked reactions about consent, compensation, confidentiality, and researchers' motives. The interviews focused on a) how police officers characterize the responsible conduct of research; b) the extent to which their reasoning tracks established ethical principles, and c) which elements of these principles they emphasize. The study also probed which actors and factors were likely to best protect the ethical interests of police as research participants, and how they could be operationalized in a police research setting. Officers stressed the role of the police sergeant as their ethical fiduciary in the planning and execution of research, the distinction between being neutral versus impartial in research, the acceptability of withholding research questions and hypotheses to ensure candid and forthcoming responses, and, generally, the importance of a form of procedural justice in the conduct of research in police settings. The findings provide recommendations for police participatory research that would empower investigators to interpret and navigate the attendant ethical concerns in the context of their own research tradition, encouraging more frequent and higher quality participation in research among police agencies and their officers.

Researchers have been using generative artificial intelligence (GenAI) to support writing manuscripts for several years now. However, as GenAI evolves and scientists are using it more frequently, the case for mandatory disclosure of GenAI for writing assistance continues to diverge from the initial justifications for disclosure, namely (1) preventing researchers from taking credit for work done by machines; (2) enabling other researchers to critically evaluate a manuscript and its specific claims; and (3) helping editors determine if a submission satisfies their editorial policies. Our initial position (communicated through previous publications) regarding GenAI use for writing assistance was in favor of mandatory disclosure. Nevertheless, as we show in this paper, we have changed our position and now support instituting a voluntary disclosure policy because currently (1) the credit due to machines for assisting researchers is moving below the threshold of requiring recognition; (2) it is impractical (if not impossible) to accurately specify what parts of the text are human-/GenAI-generated; and (3) disclosures could increase biases against non-native speakers of the English language and compromise the integrity of the peer review system. Consequently, we argue, it should be up to the authors of manuscripts to disclose their use of GenAI for writing assistance. For example, in disciplines where writing is the hallmark of originality, or when authors believe disclosure is beneficial, a voluntary checkbox in manuscript submission systems, visible only after publication (rather than a free-text note in the manuscripts) would be preferable.

Although the use of the cluster randomized trial (CRT) design to evaluate vaccines, public health interventions or health systems is increasing, the ethical issues posed by the design are not adequately addressed, especially in low- and middle-income country settings (LMICs). To help reveal ethical challenges, qualitative interviews were conducted with key stakeholders experienced in designing and conducting two selected CRTs in Malawi. The 18 interviewed stakeholders included investigators, clinicians, nurses, data management personnel and community workers who were invited to share their experiences related to implementation of CRTs. Data analysis revealed five major themes with ethical implications: (1) The moral obligation for health care providers to participate in health research and its compensation; (2) Suboptimal care services compromising the integrity of CRT; (3) Ensuring scientific validity and withholding care service; (4) Obtaining valid consent and permission for waiver of consent; and (5) Inadequate risk assessment for trial participation. Understanding key ethical issues posed by CRTs in Malawi could improve ethical review and research oversight of this particular study design.