Research Ethics

Accessible and inclusive informed consent processes are crucial for ethical clinical research, yet little is known about how research staff implement these practices in Australia. This study aimed to explore current practice and perspectives of staff involved in informed consent processes for clinical research in Australia, including perceived barriers and enablers to facilitating accessible informed consent. To address this aim, we conducted a convergent parallel, mixed-methods study involving an online survey and semi-structured interviews (August to December 2024). Quantitative data were reported descriptively, while qualitative data were analysed using content analysis, with barriers and facilitators mapped to the Theoretical Domains Framework. Findings show that staff are motivated to employ a range of strategies to support their informed consent practice. The most frequently perceived facilitator to practice was providing information in varied formats, including the availability of video, audio, and language translations. However, there are challenges in offering information in multiple accessible formats due to limited skills, capability and resources (e.g. time, funding) to produce them. Industry leaders, regulators, funders and research organisations must lead and resource the delivery of accessible informed consent with focussed research staff training, funding accessibility, simplifying materials, promoting alternative formats, updating ethics guidance and convening shared-learning collaboratives with research participants to build sector confidence and ensure equitable, empowered consent.

If geroscience research delivers on its promise to increase healthy life years, societies around the globe will face profound moral questions. Unlike research addressing diseases such as cardiovascular disease, cancer, or diabetes, biological targeting of the process of senescence has a far wider, almost unprecedented sweep, potentially benefiting all people across the lifespan and future generations. This paper proposes that geroscience products must be allocated in a way that enhances global health equity, which requires setting an attainable, if difficult, goal of bringing everyone up to a minimal health span. After introducing the topic (in Section I), Section II responds to a range of ethical concerns geroscience research raises and argues that pursuing research in this area is a priority. Section III focuses on how to justly distribute possible future products of geroscience research and examines egalitarian, sufficientarian, and priority to the least well-off approaches. Section IV proposes a path forward that prioritizes ensuring people everywhere can attain health span sufficiency. Section V concludes that implementing the proposed approach will require large, collaborative efforts to be set in motion proactively, before inequities materialize. In this rapidly advancing field, there is an opportunity now to apply ethical forethought and planning.

Individuals with overweight and obesity represent the majority of U.S. adults, yet they are disproportionately excluded from clinical trials, particularly drug-development studies. Such exclusions raise serious ethical concerns related to justice and fair subject selection, while simultaneously compromising the generalizability of drug safety and efficacy. To better understand the scope of this issue, we conducted a systematic search of 251 active U.S.-based interventional drug-development trials registered on ClinicalTrials.gov. Among these, 186 (74.1%) studies used BMI-and/or-weight-based (BWB) eligibility criteria: 83 (44.4%) with BMI cutoffs only, 12 (6.4%) with weight cutoffs only, and 91 (49.2%) with both. BMI thresholds varied widely and frequently diverged from standard clinical categories. Only three (1.2%) studies offered an explicit justification for the criteria in publicly accessible documents. Meanwhile, 65 (25.9%) studies imposed no BWB limits, suggesting such exclusions are not universally believed to be necessary. We argue that BWB exclusions are not merely methodological deficits but expressions of structural injustice within research governance. Our descriptive analysis provides a foundation for future evaluation of whether such exclusions are scientifically or ethically justifiable. Inclusion of marginalized groups is a critical requirement for producing valid scientific knowledge and ethical clinical research. Oversight bodies, sponsors, institutions, and investigators must treat BWB criteria with careful discretion, requiring transparent justification and proactive inclusion to ensure justice, rigor, and equity in clinical research.

The purpose of this article is to examine how authorship norms and practices vary across academic disciplines – conceptualised here as “fields” – and how these differences influence research evaluation and the distribution of academic prestige. Drawing on the concepts of cultural capital and symbolic capital, the article argues that authorship order is not merely a reflection of individual contributions but is deeply intertwined with power dynamics and institutional practices within distinct disciplinary ‘fields.’ This theoretically informed discussion highlights substantial variation in authorship patterns across fields, reflecting different forms of value at stake. While some fields favour single authorship or alphabetical listings, others use first-last author emphasis models, making uniform interpretations of author order potentially misleading for evaluation systems. The paper further critiques the growing reliance on performance metrics such as publication counts and citation rates, arguing that, although interconnected with authorship practices, they fail to capture the complexities of collective knowledge production and may indeed incentivise problematic authorship behaviours. It contends that uniform policies risk distorting recognition, particularly in cross-disciplinary settings where field-specific norms differ sharply. In response, the article evaluates contribution-reporting systems as a pathway towards greater transparency and more equitable distribution of symbolic recognition across fields. These issues point to a broader ethical challenge. The conclusion advances the notion of a distributive ethics of academic capital, arguing that equitable authorship practices must account for the unequal structures of symbolic and cultural capital across disciplinary fields.

The growing use of Big Data and computational methods in health research poses significant challenges for research ethics committees (RECs), whose review frameworks were designed for conventional, hypothesis-driven studies. Empirical evidence on how RECs in continental Europe are responding to these challenges has been largely absent. We conducted a cross-sectional web-based survey of REC members in Germany, Austria, and German-speaking Switzerland (November 2024–March 2025). The structured questionnaire combined closed and open-ended items covering general review practices, prior experience with Big Data proposals, perceived challenges, and the need for additional expertise. Responses from 172 valid cases were analyzed using descriptive statistics and qualitative content analysis. The response rate was approximately 10.1%–12.6%. Review practices were highly heterogeneous: only 59% of participants used any standardized guideline, and a mere 3.5% applied protocols specifically tailored to Big Data studies, despite 48% having reviewed at least one such proposal. Participants identified four clusters of challenges: methodological opacity; regulatory ambiguity regarding the EU Medical Device Regulation and AI Act; data protection concerns including the growing instability of anonymization and inconsistent GDPR interpretations; and the inadequacy of classical informed consent frameworks for exploratory research. While 41% considered Big Data-specific guidance to be lacking and a majority acknowledged expertise gaps, only 8% favored specialized RECs. German-speaking RECs face significant and largely unaddressed challenges in reviewing Big Data health research. The findings point to an urgent need for consensual guidance, deliberate competency development in data science and data protection law, and active REC engagement with emerging European governance frameworks, including the European Health Data Space and the EU AI Act. The challenges identified mirror those in other jurisdictions, suggesting that adapting ethical oversight to data-intensive research requires coordinated responses at the national and European level.

Many non-governmental organisations (NGOs) conduct data collection on households, children, women, migrants and other vulnerable populations. These activities often meet internationally accepted definitions of human subject research, yet they routinely proceed without ethical review. In this commentary, I critically examine the NGO sector’s disengagement from ethical review processes in Ghana. This commentary critically examines both the structural gaps in national coordination of NGO research ethics governance and NGOs’ disengagement from existing ethics oversight mechanisms in Ghana. The paper argues that misperceptions, funding pressures and structural inadequacies drive NGOs’ reluctance to engage in ethical review processes, and proposes both short-term compliance reforms and the establishment of a national ethics review committee as complementary pathways for reform.

Cross-cultural fieldwork often requires researchers to navigate two ethical demands: institutional procedures designed to make ethical conduct auditable, and recruitment realities in which legitimacy and trust are negotiated through relationships, intermediaries, and organisational hierarchies. Drawing on collaborative autoethnography of two successive doctoral projects conducted at a university in Aotearoa/New Zealand, with recruitment in Hong Kong kindergartens and Mainland Chinese universities, this paper examines how recruitment proceeds when standardised consent and voluntariness procedures encounter relationship-mediated access. Voluntariness here means participants’ practical capacity to refuse or withdraw without social, institutional, or material penalty—a capacity that signed consent forms can document but cannot, on their own, guarantee. Combining contemporaneous recruitment journals with critical analysis of institutional ethics guidance, we show that recruitment breakdowns reflect misalignments between two co-existing ethical logics rather than cultural incompatibility: compliance visibility, where ethical conduct must be procedurally demonstrable, and relational legitimacy, where trust is established through intermediated endorsement and role-appropriate engagement. We identify three safeguards through which novice researchers protected voluntariness while maintaining legitimate access: in-person legitimacy-building, safety-valve recruitment (decoupling invitation from decision), and boundary work in messaging-platform ecosystems such as WeChat. We conceptualise the core capacity required to perform this alignment work as ethical hybridity: the reflexive capacity to recognise, negotiate, and document moments when governance templates and field relations diverge. The paper contributes to research ethics by rendering tacit recruitment judgement analytically visible, with implications for ethics review, decolonial research practice, and cross-cultural qualitative fieldwork.

This paper explores the complex ethical landscape of researching digital religious minorities, focusing on Instagram content related to Shiʿi Islam. Drawing from original case studies, it critically engages with the methodological and ethical dilemmas encountered in digital fieldwork. Core tensions examined include the questions of visibility and vulnerability, the boundaries between public and private content, and the balance between academic integrity and participant protection. The study interrogates assumptions about consent, copyright, and authorship in the context of high-follower Instagram accounts that function more like media platforms than personal profiles. Through a detailed review of internet research ethics literature, legal frameworks, and reflexive practice, the paper advocates for a flexible, context-sensitive approach that recognizes both the risks and responsibilities of working with online religious content. It argues that while public-facing social media posts may not legally require informed consent or IRB oversight, ethical obligations persist, especially when the content is politically sensitive or involves marginalized groups. Rather than applying rigid rules, researchers are encouraged to make informed, transparent decisions based on user intent, platform affordances, and the potential for harm. Ultimately, the paper proposes a “middle path” in digital ethics—one that resists both the erasure of marginalized voices and the overexposure of vulnerable actors. By openly documenting its decision-making process, this research contributes to ongoing discussions about ethical digital scholarship, emphasizing care, accountability, and methodological transparency.

Qualitative researchers working with trauma-exposed populations face predictable emotional risks, yet higher education policy frameworks rarely address researcher well-being as an institutional responsibility. This article introduces empathic strain—the cumulative impact of sustained engagement with distressing narratives without structured organizational care—as a critical but under-recognized occupational hazard in academia. Drawing on 4 workshops with 34 postgraduate students and interviews with 17 experienced trauma researchers, the study develops a three-phase, trauma-informed model for embedding emotional risk management into research governance. The framework spans planning/grounding; engagement/regulation; integration/reconnection phase combining individual strategies with systemic measures such as mandatory trauma-awareness training, integration of well-being assessments into ethics review, structured debriefing protocols, and access to trauma-informed counseling. Findings reveal that the prevailing reliance on individual resilience discourses perpetuates burnout, disengagement, and attrition, while institutional silence constitutes a form of structural neglect. The proposed model reframes researcher care as a core ethical and policy obligation, aligning with occupational safety principles and advancing debates on academic labor, ethics, and sustainability. By positioning emotional well-being as integral to research integrity, this article offers higher education institutions a scalable, governance-aligned pathway to creating ethically robust, humane, and sustainable research cultures.

This study examines the use of artificial intelligence (AI) in communication with research participants during the recruitment process, exploring stakeholder perspectives and evaluating ChatGPT’s ability to generate participant informational texts. A mixed-methods design was applied, combining an online survey with semi-structured interviews. The survey, conducted among clinical research professionals and laypersons, investigated perceived suitability, trustworthiness, ethical concerns, and requirements for responsible implementation of AI across use cases such as generating informational texts, visual aids, translations, and chatbot-based interactions. The interviews assessed how experts from diverse disciplines responded to AI-generated versus human-written texts, with particular attention to clarity, empathy, and emotional impact. Survey findings indicated that translation and writing assistance were viewed as the most appropriate and least controversial applications of AI, whereas answering participant questions or assessing eligibility were regarded with caution. AI appears to be rather underused, partly due to regulatory uncertainty and limited trust. Trust in AI was generally lower than trust in humans, especially among professionals. Key ethical concerns included unreliability, data-protection risks, and the potential for manipulation. In the empirical comparison, AI-generated texts were frequently described as clearer, more concise, and more empathetic than human-written materials, yet concerns persisted regarding missing content and oversimplification. Interviewees emphasized the need for strong human oversight, adequate researcher training, and continued involvement of patients in developing participant-facing materials. Maintaining a human role was seen as critical not only for accuracy and accountability, but also to prevent the dehumanization of research communication and preserve communication skills within research teams. Overall, the study highlights both the promise and the ethical complexities of integrating AI into participant communication during recruitment and offers a foundation for future research and policy development.

This article introduces Writing-With as a relational ethical orientation in qualitative inquiry, one that foregrounds presence, attunement, and responsibility in the act of writing. Rather than addressing research ethics as a matter of procedural compliance or misconduct prevention, we attend to the subtle, everyday decisions researchers make as they interpret, cite, paraphrase, and co-author. These quiet moments, often unspoken, unmeasured, are where ethics becomes lived. Through reflexive engagement with our own writing practices, we explore how Writing-With invites a shift from rules to relations, from surveillance to care. Writing becomes not only a site of knowledge production but a practice of ethical becoming, responsive, situated, and open to the tensions it carries. This stance does not replace existing frameworks of research integrity, but it expands them by insisting that how we write is inseparable from how we relate.

This paper seeks to address the challenges with applying a right to withdraw to pluripotent stem cell (PSC) research. PSC lines are unique in that they can be expanded indefinitely, disseminated globally, transformed into multiple derivatives, and employed as therapeutic products, rendering withdrawal not only logistically unfeasible, but also a substantive risk to research stability. Following an analysis of whether the classical right to withdraw can be suitably modified to address the tensions between donor freedoms and transformative biomedical research, we argue for a recalibration of donor control. Specifically, we present a hybrid model that combines up-front broad consent (including an expression of initial preferences for currently known ethically contentious areas of stem cell research), ongoing dynamic consent, and robust governance. While the paper reviews existing consent and withdrawal models, its primary contribution is to show why these models fail to adequately address the PSC-specific tension between respect for donor autonomy and provision of research certainty and to propose a hybrid, autonomy-preserving alternative that is designed to deliver greater research stability than a modified right to withdraw.

Conducting ethical research with children and young people presents complex challenges, shaped by gatekeepers, power dynamics, and procedural requirements that can limit children and young people’s ability to participate fully and autonomously on their own terms. Obstacles arise at every stage, from designing consent forms and seeking informed consent from parents/carers and children and young people, to ensuring children, and young people’s right to assent, dissent and/or withdraw altogether is continually respected. This paper reflectively and critically examines these challenges, drawing on our experiences of working with over 600 children and young people aged between 3 and 15 years old, at various stages of a 5-year action research project. Focussing on three key areas of consent, assent, and dissent, it explores how our illustrated ‘assent mat’ provided children and young people with the means to set the terms of their engagement with the research activities. Through our reflections, we highlight that the ‘assent mat’ was the beginning of an ongoing dialogue with children and young people, one which reinforced our responsibility as researchers to ensure children and young people’s participation rights and autonomy are enabled and respected throughout a project.

Qualitative research on sensitive topics (e.g. abuse, mental health difficulties, discrimination) is needed to understand lived experiences of complex issues. However, this type of research raises concerns about potential adverse effects on participants, especially with younger participants and those from marginalized populations. In this study, we conducted a reflexive thematic analysis of 20 trans adolescents’ (14–18 years of age) experiences of participating in research about their stigma experiences. Themes included: (1) lived experience in interviews matters; (2) negative effects are tolerable; and (3) sharing is important for self and others. Participants can value and even benefit from taking part in lived experience-informed sensitive research. Avenues for future research are discussed, and considerations for ethical research with marginalized populations suggested.

The term ‘N-of-1 trial’ has traditionally referred to a specific, well-defined, clinical trial methodology, involving evaluation of an intervention (or interventions) in a single individual, with alternating periods ‘on’ and ‘off’ an intervention. Given methodological constraints, such trials are best suited to the study of chronic, stable conditions, and so have had a limited role in progressive conditions like cancer. According to evidence-based medicine hierarchies, conventional, randomised, N-of-1 trials are considered ‘type 1’ evidence. In recent years, however, the term ‘N-of-1 trial’ has appeared with growing frequency within the academic cancer literature but with reference to a heterogeneous range of research activities (which diverge in various ways from the conventional N-of-1 trial design). In this qualitative study, 72 semi-structured interviews were conducted with key stakeholders across the cancer clinical trials landscape to explore perspectives regarding the notion of ‘N-of-1 trials’ in oncology. This included various types of ‘trial professionals’ (trialists, statisticians, ethicists and ethics review board members, industry, regulatory and reimbursement body representatives), as well as ‘consumer representatives’. Findings of this study highlight that two broad categories of issues are particularly salient to stakeholders in relation to single participant focused research: (1) issues to do with opportunity to participate, and (2) issues to do with consent and risk management. We draw attention to implications for those engaged in the review of various forms of single participant focused research, and how these differ from considerations pertinent to more traditional clinical research. In particular, we caution against any ‘one size fits all’ approach to assessment of ‘acceptable’ risk during ethical review of such activities. Finally, we consider whether novel forms of oversight may be required, including a possible role for ethics review boards to engage directly with individuals considering participation in such studies.

While large language models (LLMs) hold potential for informing prospective trial participants, their deployment raises critical questions regarding patient autonomy and the integrity of informed consent. This paper examines how LLM-mediated communication may influence trial participation decisions. We situate such influence along a continuum from ethically permissible persuasion to impermissible manipulation and coercion, highlighting the concepts of algorithmic nudging and hypernudging. These advanced techniques, capable of adapting messages in real time based on user-specific data, pose unique risks to voluntariness, especially in sensitive contexts such as clinical research. To explore these dynamics, we performed an explorative case analysis based on trial NCT04387916 (KC1036), a phase I oncology study. We prompted ChatGPT-5 to generate three consent texts: a standard informative summary, a strictly neutral version, and a nudged version employing positive framing and collective benefit appeals. We analyzed them against established ethical categories: voluntariness, risks and discomforts, potential benefits, and scientific and social value. The findings exemplify how even minor linguistic variations can introduce normative assumptions and shift the balance between supporting comprehension and exerting undue influence. We conclude that neutrality in LLM outputs cannot be assumed and persuasion cannot be excluded. Without safeguards that explicitly address the design space, LLMs risk transforming informed consent from a protective mechanism into a mere recruitment tool. Safeguarding autonomy in this context requires careful delineation of ethically acceptable influence, critical awareness of the design space of LLM prompts, and alignment with established research ethics principles to ensure that informed consent remains voluntary, informed, and free from hidden persuasion.

Members of under-represented, marginalized groups experience disparate health outcomes, warranting research that improves equitable engagement in research and subsequent care practices. However, in our online study conducted during the COVID-19 pandemic, we encountered systematic signs of fraudulent behavior corroborated by recent reports from other research teams, with differing approaches to mitigating fraudulent participation. We highlight our experiences during recruitment and pilot focus groups, along with our actions for mitigating further recruitment of fraudulent participants. Then, we synthesize our learnings with other scholars’ experiences to provide recommendations for the study development, recruitment, screening, and data collection stages of research. We also offer a critical analysis of current recommendations and their implications for reinforcing barriers to engaging under-represented groups in research. The recommendations provided emphasize the importance of preventing fraudulent participation in quantitative and qualitative research through adopting multiple strategies, while balancing considerations for meaningfully engagement with under-represented groups to ensure equitable and inclusive research.

Collaborative and open research combined with influential technological advancements and geopolitical tensions allow Higher Education Institutions (HEIs) and Research Performing Organisations (RPOs) to become prone to Research Security (RS) risks. Despite its recent conceptualisation, RS has been swiftly recognised as a critical issue globally, highlighting the need to quickly adopt policy actions. To this direction, the CHANGER consortium recommends policy actions particularly relevant to the European context. Policy actions are informed by the accumulated experience generated through established research ethics and integrity frameworks, in order to build resilience to RS risks, while ensuring freedom and openness of research. Adaptions to existing training programmes on research ethics and integrity programmes in order to embed RS considerations in the research culture, as well as the cultivation of professional expertise and capacity building in RS, are among these policy recommendations. Leveraging experience and insights from research ethics and integrity infrastructure offers valuable opportunities to raise awareness and establish procedures for safeguarding RS. The proposed policy actions offer flexibility to meet specific research needs of each HEI and RPO, and are proportionate to related risks rising from each research project. They foster capacity-building for researchers and cultivate a culture of awareness, shared responsibility and proactive responsiveness, facilitating the responsible internationalisation of research.

Following the dissolution of the Soviet Union in 1991, 15 newly independent states sought to establish national policy systems distinct from their shared past. Yet, many features of governance in these post-Soviet contexts continue to mirror the bureaucratic traditions of the former regime. This paper examines the governance of research ethics as a lens to understand the persistence and transformation of bureaucratic culture in three Central Asian countries—Kazakhstan, Kyrgyzstan, and Uzbekistan. While these states have articulated ambitions to modernise and internationalise their research sectors, the study finds that deeply embedded bureaucratic norms continue to shape institutional practices, constraining genuine reform and innovation. The analysis highlights how Soviet-era administrative legacies endure within contemporary research governance, limiting the development of autonomous and ethically robust research environments.

This reflection outlines the development of a Terms of Reference (ToR) for equity, diversity, and inclusion (EDI) in a 6-year energy transitions research project spanning 11 institutions and involving 100 researchers across science, technology, engineering and mathematics (STEM), social science, and humanities disciplines. This multi-disciplinary and multi-institutional project involves partnerships with industry and civil society organizations, attempts to center justice-oriented research, and includes communities and users in knowledge co-production in a field of research and practice known for exclusion and marginalization. An EDI ToR is a guiding document that outlines the shared understandings and practices necessary to foster a safe, equitable, and inclusive research environment. Here we describe how 42 researchers across all career stages and 5 time zones co-authored an EDI ToR that reflects the project’s context and goals while attempting to make the writing process inclusive. Using autoethnography, we reflect on the process of developing this ToR and evaluate its effectiveness in meeting project needs, fostering shared values, and supporting the education and training of diverse early career researchers. We found that, given the complexity of the project, our approach offered a valuable pathway for the team to reflect on shared values by encouraging early and continuous dialog and alignment among researchers. The ToR offered a compass to help researchers make decisions ethically and inclusively. Our contribution is to demonstrate how an EDI ToR development process can foster reflexivity and offer space to address the tensions that inevitably arise within research teams and tensions between the team’s needs and justice-oriented energy research in practice. Drawing on our findings, we recommend that other research teams and funders embed EDI goals, benchmarks, and commitments into their grant proposals and that they hold small-group discussions throughout the EDI ToR development and implementation phases to allow for reflection and iteration.