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Background: Historically the voices of people with intellectual disability have been occluded by barriers imposed by research practice. More recently, adaptive research approaches have been proposed to enhance the inclusion of people with intellectual disability in qualitative research. Method: This article presents an adaptive interviewing approach employed with five people ageing with intellectual disabilities in rural South Australia. The interviews were conducted within a broader participatory action research project in which tools and resources were co-designed for post-parental care planning. Results: We describe our adaptive interviewing approach incorporating multiple methods: (i) responsive communication techniques; (ii) the inclusion and support of family carers; (iii) visual tools; (iv) walking interviews. Conclusion: Findings contribute knowledge about how an adaptive interview approach supports the participation of people with an intellectual disability in qualitative research.

The management of human fetal and embryological collections presents an ethical challenge that can be explored from different perspectives, particularly when considering informed consent. The "micro ethics" level focuses on parties engaged in giving and receiving human tissue while the "macro ethics" level focusses on the collective responsibility of the discipline and society. Additionally, adopting a framework, where ways of working are designed with relevant communities, requires understanding the perspectives of individuals, communities, and organizations. The aim of this study therefore was to assess the perceptions of education-focused Australian stakeholders. A survey collected the perspectives of 198 participants. The majority of participants (61.6%; n = 122/198) indicated that human fetal and embryological remains obtained prior to era of informed consent should be retained for use in education/research. It is likely that their perspective is based on the notion that if human fetal and embryological collections are used for good, then disposing of them would deny this benefit. Women (p < 0.001) indicated a preference for obtaining fetuses and embryos with informed consent for education and research (38.4%; n = 76/198). Majority were in favor of recording both maternal (MI) (59.6%; n = 118/198) and paternal information (PI) (58.1%; n = 115/198) with each donation. Majority (56.1%; n = 111/198) expressed that donations should be accepted from both parental sources. Consideration of stakeholder perspectives is important in developing guidelines regarding these collections. The results from this study demonstrate a level of discomfort with respect to collections without informed consent, which should be considered at the macro ethical and micro ethical level.

Participatory, rights-based methodologies in childhood studies have explored conditions that realise children's rights to participation. One avenue of investigation has been to explore assent procedures that respect children's rights to make informed decisions about participation. Less attention has been directed towards the ways in which children indicate their dissent. This paper highlights children's self-chosen ways to participate (or not) in a study that explored their perspectives of play in an Australian early childhood education setting. The study analysed the design of ethical spaces in research with children's expressions as departure points for their participatory experiences. This highlighted three concepts that characterised their choices: agency; privacy; and relationships. The outcomes informed the development of a framework of ethical research spaces, incorporating physical, creative and social-emotional spaces. How the concepts of agency, privacy and relationships are anchored in the three spaces is addressed.

This article presents the findings of a systematic qualitative analysis of research in the ethics of digital trace data use in learning and education. From the resulting analysis of 77 peer-reviewed studies, we (1) map the characteristics of research by study type, academic community, institutional setting, and national context; (2) identify the primary ethical concerns and related responses; and (3) highlight the research gaps. Four areas of focus are identified in this emerging area: (1) privacy, informed consent, and data ownership; (2) validity and integrity; (3) ethical decision making; and (4) governance and accountability. We highlight the lack of evidence particularly for preschool and school-aged children and the disparate communities working in this domain, and we suggest a more cohesive approach, where the wider learning and educational ecosystem is recognized, explicit engagement with ethical theory is central, and mid- to long-term ethical issues are considered alongside immediate concerns.

Adolescent populations have become increasingly accessible through online data collection methods. Online surveys are advantageous in recruiting adolescent participants and can be designed for adolescents to provide informed consent without the requirement of parental consent. This study sampled 338 Australian adolescents to participate in a low risk online survey on adolescents' experiences and perceptions of their learning in science classes, without parental consent. Adolescents were recruited through Facebook and Instagram advertising. In order to judge potential participants' capacity to consent, two multiple-choice questions about the consent process were required to be answered correctly prior to accessing the survey. This simple strategy effectively determined whether middle adolescents had the capacity to provide informed consent to participate in low risk online educational research.

There has been growing enthusiasm amongst those who undertake research with children, for the development of participatory and visual research methods. The greater availability and affordability of digital technology (such as digital cameras, tablets and smart phones) has meant that there has been greater scope for digital technology to support participatory research methods, or augment more traditional qualitative research methods. While digital technology provides new opportunities for qualitative researchers, they also come with a series of challenges -- some of which have been grappled with by those using more traditional research methods but also some which are new. Our study was undertaken in Victoria, Australia, and used a combination of interviews, focus groups and digital storytelling to bring together two strands of work which have historically occurred separately: work with children experiencing domestic violence and programs for men who use domestic violence. While digital storytelling proved to be an effective method of engaging children and young people in the research, a range of challenging ethical issues emerged. Some of these issues were considered as part of the formal 'procedural ethics' process, but additional and more challenging issues relating to anonymity and the complex safety considerations of using of the children's digital stories within programs for men who use violence and dissemination emerged in practice. It is hoped that sharing our experiences and decision-making will contribute to the knowledge base for others considering engaging in sensitive research using digital technology.

Considerations for conducting ethical research with human participants in languages other than English are addressed to some extent in regulatory and guiding statements for researchers, but in ways that are minimal or vague. In this article, I examine guiding documents for research ethics from four countries: the UK, Canada, Australia and the USA, with a view to analysing how the issue of research in other languages is addressed. Specific attention is paid to four key aspects of research as it relates to language. The first is informed consent. This includes a discussion of how written forms may not be the most appropriate method to ensure consent is informed. The second aspect of language is that of translation and interpretation, including budgetary implications for research. Third, the use of intermediaries such as (but not limited to) translators and local contacts is considered. Finally, considerations for knowledge mobilisation and dissemination of findings are explored. The article concludes with recommendations for researchers, graduate supervisors and research ethics boards.

Increasingly learning analytics (LA) has begun utilising staff- and student-facing dashboards capturing visualisations to present data to support student success and improve learning and teaching. The use of LA is complex, multifaceted and raises many issues for consideration, including ethical and legal challenges, competing stakeholder views and implementation decisions. It is widely acknowledged that LA development requires input from various stakeholders. This conceptual article explores the LA literature to determine how student perspectives are positioned as dashboards and visualisations are developed. While the sector acknowledges the central role of students, as demonstrated here, much of the literature reflects an academic, "teacher-centric" or institutional view. This view reflects some of the key ethical concerns related to informed consent and the role of power translating to a somewhat paternalistic approach to students. We suggest that as students are the primary stakeholders -- they should be consulted in the development and application of LA. An ethical approach to LA requires that we engage with our students in their learning and the systems and information that support that process rather than assuming we know we know what students want, what their concerns are or how they would like data presented.

Historically, legislature has been utilized to facilitate appropriate use of cadavers in the anatomical sciences. However, cadaver acquisition and use have also been guided by ethically appropriate and morally acceptable principles. Various global and regional frameworks of "ethical practice" guide body donation, including the use of unclaimed bodies by institutions. These frameworks are responsive to, and reciprocal with the various ethical, moral and legal factors that influence the development of body donation programs. This reciprocity supports the notion that anatomists and anatomical societies have a responsibility to advocate for legal reform when required. In this study, two body bequest programs from geopolitically and socially disparate countries are used as cases to contrast existing legal and governance frameworks for body donation and to examine whether anatomists can direct the acquisition of ethically donated cadavers. The study includes an Australian donor program that has exclusively accepted bequests since its inception, and a South African program that has recently transitioned to a bequest system. Elements such as consent by next-of-kin and Inspector of Anatomy, use of unclaimed bodies and ethics committee approval amongst others, are compared. It is acknowledged that legal frameworks for cadaver acquisition generally deliver broad guidance on acceptable utilization of bodies for the anatomical sciences. However, professional discretion is of importance in adapting to societal needs and values. Thus, while anatomists have been able to progress toward more ethical practice than that which is required by the law, they must continue to do so as societal values evolve.

Social media is a central component in the lives of many young people, and provides innovative potential to conduct research among this population. Ethical issues around online research have been subject to much debate, yet young people have seldom been consulted to provide a youth perspective and voice. Eight (8) focus groups involving 48 Grade 9 Western Australian secondary school students aged 13-14 years were held in 2012, to investigate how young people perceive the feasibility and acceptability of social media when used as a research tool to investigate various issues relevant to their mental health and wellbeing. Whilst young people recognise many benefits of researchers using social media in this way, such as its relevance, innovation and accessibility, there were salient issues of privacy, consent, and practicality that require careful negotiation. There is a need for continued exploration and scientific debate of the moral and ethical implications of using social media for research, to help ensure this is employed in an appropriate and effective way that is respectful of and sensitive to the needs and views of young people.

This research explored how young children's research participation can be enhanced when an interactive narrative approach is embedded within research to enhance children's consent to participation and their understanding of the research process. The context for this research was a 1-h, science outreach programme delivered into Australian playgroups. An interactive digital story was devised to inform nine children (aged 3-4 years) about the purposes of the research. Across a period of 11-16 weeks and across three occasions, an informing story about the research was used with the children to elicit their descriptions and explanations about their research role. Data gathered from semi-structured interviews with parents and audio- and video-recorded conversations with children also aided in the analyses to understand how children perceived their role as a research participant. Through cross-case analysis, six aspects of meaningful research participation were identified from children's and parents' responses: engagement, journeying, authenticity, consequence, ownership, and identity. The research extends current knowledge about young children's rights to understand their participatory role in research and about the considerations that can be put in place to ensure participation is personally meaningful to children.

Non-consensual sterilization is one of the characteristic historical abuses that took place mainly in the first half of the 20th century. People with intellectual disability (ID) were a prime target as part of the ideology of negative eugenics. In certain jurisdictions, laws were in force for several decades that permitted sterilization without the need for consent or with consent from third parties. The long-term adverse effects on those sterilized against their will have only more recently been recognized. In the latter half of the 20th century, human rights treaties were introduced and developed; they have, in the main, curbed sterilization abuses. Courts have developed more stringent criteria for making decisions on applications for sterilization, and nowadays there are mostly adequate safeguards in place to protect those with ID from non-consensual sterilization. The only exception should be the particular case in which, all medical and social factors having been taken into account, sterilization is overwhelmingly thought to be the right decision for the individual unable to give consent.

'Vulnerability' is a key concept used to understand the ethical implications of conducting refugee-focused research. This case study illustrates the need to follow Luna's (2009) call for a shift from a 'labels' to a 'layers' approach to vulnerability by analysing how two university ethics committees responded to issues of informed consent in two similar refugee research projects using the PhotoVoice method. The following commentary argues that, when driven by a research governance regime, ethics review risks viewing refugees through a static label of vulnerability, negatively affecting research viability and data quality. In contrast, a layers approach opens space for understanding the potential for vulnerability amongst refugee research participants while supporting PhotoVoice's goals of empowerment and facilitating agency. The case study highlights the need for national-level ethics statements that encourage a more flexible approach within research institutions.

The Convention on the Rights of the Child foregrounds the right to participate. Contributing to decision-making on matters concerning children's lives is fundamental to rights education. This paper discusses ethical and methodological considerations of children's rights-based epistemology, arguing that children are competent to reflect upon and exercise their participation rights. The present study explores 4/5-year-old children's perspectives on play in an Australian early childhood education service. It aims to identify ethical spaces in research involving children. The findings address children's participation choices; including conditional assent, dissent, and their influence on the research. These outcomes are important because (a) little is known about the ways children choose to participate, and (b) they raise questions about the realisation of children's participation rights. This paper concludes by examining the implications for research that acknowledges children's demonstration of their participation rights in physical, creative, and social-emotional spaces. [Paper presented at the International Conference on Human Rights Education (ICHRE) (9th, Sydney, Australia, 2018).]

Research is increasingly recognised as a key component of medical curricula, offering a range of benefits including development of skills in evidence-based medicine. The literature indicates that experienced academic supervision or mentoring is important in any research activity and positively influences research output. The aim of this project was to investigate the human research ethics experiences and knowledge of three groups: medical students, and university academic staff and clinicians eligible to supervise medical student research projects; at two Australian universities. Training in research ethics was low amongst academic staff and clinicians eligible to supervise medical student research. Only two-thirds of academic staff (67.9 %) and students (65.7 %) and less than half of clinicians surveyed (47.1 %; p = 0.014) indicated that specific patient consent was required for a doctor to include patient medical records within a research publication. There was limited awareness of requirements for participant information and consent forms amongst all groups. In the case of clinical trials, fewer clinicians (88.4 %) and students (83.3 %) than academics (100 %) indicated there was a requirement to obtain consent (p = 0.009). Awareness of the ethics committee focus on respect was low across all groups. This project has identified significant gaps in human research ethics understanding among medical students, and university academic staff and clinicians. The incorporation of research within medical curricula provides the impetus for medical schools and their institutions to ensure that academic staff and clinicians who are eligible and qualified to supervise students' research projects are appropriately trained in human research ethics.

This paper argues that specific individual informed consent and other forms of consent predicated on a right to autonomy may not in all circumstances be appropriate for the establishment and use of large data sets of health information. We suggest that there are inherent failings in such an approach, shortcomings that we analyse below. We argue that individuals share an obligation to contribute their data, as doing so is cost-free (however cost is construed) and benefits accrue to the population as a whole. Large health data sets can be considered public goods -- goods that are non-rival in consumption (they are not depleted in being used, so others are not prevented from using them) and in some cases non-exclusive in use (e.g. when large datasets of non-identifiable information are publicly-accessible without cost, such as some Australian Bureau of Statistics data) -- and contributing to these goods may be an obligation, the meeting of which allows citizens to invest in knowledge infrastructure. The approach argued for here is a variation of a communitarian ethic in which people have an obligation to contribute their data but have no correlative right to expect or receive an individual benefit.

The length of participant information sheets (ISs) for research and difficulties in their comprehension have been a cause of increasing concern. We aimed to examine the information sheets in research proposals submitted to an Australian HREC in one year, comparing the results with national recommendations and published data. Information sheets in all 86 research submissions were analysed using available software. The work of Flesch was used for Reading Ease or Readability and that of Flesch and Kincaid for the level of education required for comprehension, the Reading Grade Level. The mean length of 86 information sheets was 3110 words; many had more than 5000 words. Using the Flesch scale of 0 to 100, with 0 meaning most difficult and 100 very easy to read, the mean readability level was 47. The mean length of education needed to easily grasp the information was 11.6 years, equivalent to senior secondary school. Information sheets in research projects submitted to an HREC were often too long to be read in a reasonable time and too difficult to be easily understood. Recommended standards for information sheets were infrequently met.

Increasingly, researchers are required to obtain active (explicit) parental consent prior to surveying children and adolescents in schools. This study assessed the potential bias present in a sample of actively consented students, and in the estimates of associations between variables obtained from this sample. Students (n = 3496) from 36 non-government metropolitan schools in Perth, Western Australia completed an online survey in 2010 as part of the Cyber Friendly Schools Project. Students with active (35%) and passive (65%) parental consent were compared on a range of variables including demographic, bullying and social-emotional outcomes. The moderating effects of consent status were also tested. Comparisons of the two consent groups showed that older students and students involved in problem behaviours such as bullying others, with lower pro-social scores, who lived with one parent and reported doing less well academically than their peers, were underrepresented in the sample with active parental consent. Additionally, consent status was a significant moderator of the associations between bullying victimisation and certain social-emotional variables. Active only parental consent leads to biased samples and biased estimates of associations between outcomes of interest, which could lead to miss-targeted behavioural policies and interventions. Strategies to boost response rates to levels sufficient to warrant the conduct of the research are labour-intensive and costly, and the obtained samples are still likely to be biased. For low risk research, such as bullying surveys, rigorous active--passive consent procedures which result in higher participation rates, lower costs and reduced burden on teachers and schools, are recommended.

Acting in the best interests of students is central to the moral and ethical work of schools. Yet tensions can arise between principals and school counsellors as they work from at times opposing professional paradigms. In this article we report on principals' and counsellors' responses to scenarios covering confidentiality and the law, student/teacher relationships, student welfare and psychological testing of students. This discussion takes place against an examination of ethics, ethical dilemmas and professional codes of ethics. While there were a number of commonalities among principals and school counsellors that arose from their common belief in education as a moral venture, there were also some key differences among them. These differences centred on the principals' focus on the school as a whole and counsellors' focus on the welfare of the individual student. A series of recommendations is offered to assist principals to navigate ethical dilemmas such as those considered in this article.

The unique features and educational affordances of Web 2.0 technologies pose new challenges for conducting learning and teaching research in ways that adequately address ethical issues of informed consent, beneficence, respect, justice, research merit and integrity. This paper reviews these conceptual bases of human research ethics and gives examples of their consideration in the literature of research into learning and teaching with Web 2.0. The paper goes on to give an account of reflective practice by two academic developers in relation to ethical issues they encountered, considered and addressed in eight case studies, which were part of a larger multi-university Australian study into learning and teaching with Web 2.0. The paper concludes that the human research ethics approval process needs to be understood as a series of measures that are important to protect not only the students but also the teacher-researchers and their institutions when doing learning and teaching research with Web 2.0. This understanding is important for educators and as well for educational developers, educational technologists and human research ethics review committees (also known as institutional review boards).

The gap between theoretical expectations of research ethics as outlined in the bureaucratic processes associated with University Ethics Committees and the situated realities of students undertaking studies within their own sociocultural contexts is explored in this paper. In particular, the authors investigate differences in ethical norms and practices by providing "subaltern" voices from the field, as three of the authors narrate their experiences during their doctoral field work that led them to challenge the validity of ethics review processes in institutions at the Centre when undertaking research at the periphery. The field work experiences produced unavoidable tensions as the students attempted to construct the hybridity required when working within transnational contexts of higher education. The paper concludes with some advice to students and advisors and members of Ethics Review Committees to encourage the destabilization of essentialist assumptions often made in Eurocentric research designs.

When conducting research with young children it is important to consider not only the data which have been produced as a result of the research, but also the research process itself. This article presents a parallel analysis of data which has been articulated elsewhere from a three-year study of children's understandings about measurement. This article considers the overarching methodological issues which arose from the study and implications for the ways in which the data should be viewed. Specific points for discussion which emerged during this research are: ethical considerations; notions of shared perspectives, recurring images, and socially-constructed images; the perceived "reality" of the events depicted; differences between children's perspectives and adults' perspectives; the risk of intervention; and the competence of children in the research process.

This paper examines the risk communication strategies currently being employed by seven outdoor education co-ordinators in Government schools in Victoria, Australia. Of particular interest are the beliefs and assumptions held by these co-ordinators in relation to communicating risk with parents. Current policy stipulates that parents must be sufficiently informed in order to provide consent for their child to participate in an outdoor education program, however it does not specify a specific model or approach to be followed. Coronial reports, recommendations and litigation following several fatal outdoor education incidents both in Australia and other countries, suggest that parents were not appropriately informed of the risks involved, or were given insufficient information on which to base their consent. These types of incidents, coupled with the assertion that we are now living in an increasingly litigious and "blamist" society, serve to highlight the need for communications where parents are viewed as integral stakeholders. A qualitative research methodology was used and the seven co-ordinators provided examples of their risk communication and participated in a semi-standardised interview. Co-ordinators' current methods for communicating risk were analysed within the context of current theoretical thinking in risk communication and the interview findings solicited the associated beliefs and assumptions behind these strategies. Overall, the "deficit" model of risk communication was being employed by the co-ordinators. This model does not consciously allow for the perceptions and worldviews of the parents. It is essentially "one-way." Finally, I suggest strategies for developing a holistic model of risk communication, within the context of current theoretical thinking, where parents are invited to be more involved in decisions about risk involving their child.

Aim: Previous research has shown patients and the public in Australia generally support medical researchers in making de‐identified research data available to other scientists. However, this research has focussed on certain types of data and recipients. We surveyed Australians affected by cancer to characterize their attitudes toward the sharing of research data with multiple third parties, including the public. Methods: A short, anonymous online survey of Australians with a previous diagnosis of cancer was advertised between October 27, 2022, and February 27, 2023. Quantitative responses were analyzed with descriptive statistics. Free‐text responses were coded deductively and summarised using content analysis. Results: In total, 551 respondents contributed data to the survey. There was strong support for cancer researchers sharing non‐human and de‐identified human research data with clinicians (90% and 95%, respectively) and non‐profit researchers (both 94%). However, fewer participants supported sharing data with for‐profit researchers (both 64%) or publicly (both 61%). When asked if they would hypothetically consent to researchers at their treatment location using and sharing their de‐identified data publicly, only half agreed. In contrast, after being shown a visual representation of the de‐identified survey data, 80% of respondents supported sharing it publicly. Conclusion: Australians affected by cancer support the sharing of research data, particularly with clinicians and non‐profit researchers. Our results also imply that visualization of the data to be shared may enhance support for making it publicly available. These results should help alleviate any concerns about research participants' attitudes toward data sharing, as well as boost researchers' motivation for sharing. [ABSTRACT FROM AUTHOR]

In recent years, concerns about the financial burdens of health care and growing recognition of the relevance of cost to decision making and patient experience have increasingly focused attention on financial 'transparency' and disclosure of costs to patients. In some jurisdictions, there have been calls not only for timely disclosure of costs information, but also for 'informed financial consent'. However, simply putting the 'financial' into 'informed consent' and invoking an informed consent standard for cost information encounters several ethical, legal, and practical difficulties. This article will examine the viability and desirability of 'informed financial consent', and whether it is possible to derive ideas from traditional informed consent that may improve decision making and the patient experience. We argue that, while there are important legal, ethical, and practical challenges to consider, some of the principles of informed consent to treatment can usefully guide financial communication. We also argue that, while medical practitioners (and their delegates) have an important role to play in bridging the gap between disclosure and enabling informed (financial) decision making, this must be part of a multi-faceted approach to financial communication that acknowledges the influence of non-clinical providers and other structural forces on discharging such obligations. [ABSTRACT FROM AUTHOR]

This section explores the decision of the New South Wales Professional Standards Committee, in Re Teo [2023] NSWMPSC 2. The case provides insights into how the Health Practitioner Regulation National Law Act 2009 (Qld) regulates practitioners who practise outside of conventional practice. The section compares the decision to similar cases and then concludes with a proposal that an express policy on unconventional practice is needed in Australia. [ABSTRACT FROM AUTHOR]

In this paper, we discuss several problems with current Big data practices which, we claim, seriously erode the role of informed consent as it pertains to the use of personal information. To illustrate these problems, we consider how the notion of informed consent has been understood and operationalised in the ethical regulation of biomedical research (and medical practices, more broadly) and compare this with current Big data practices. We do so by first discussing three types of problems that can impede informed consent with respect to Big data use. First, we discuss the transparency (or explanation) problem. Second, we discuss the re-repurposed data problem. Third, we discuss the meaningful alternatives problem. In the final section of the paper, we suggest some solutions to these problems. In particular, we propose that the use of personal data for commercial and administrative objectives could be subject to a 'soft governance' ethical regulation, akin to the way that all projects involving human participants (e.g., social science projects, human medical data and tissue use) are regulated in Australia through the Human Research Ethics Committees (HRECs). We also consider alternatives to the standard consent forms, and privacy policies, that could make use of some of the latest research focussed on the usability of pictorial legal contracts. [ABSTRACT FROM AUTHOR]

Background: Participant information sheets and consent forms (PICFs) used in interventional studies are often criticised for being hard to read and understand. We assessed the readability and its correlates of a broad range of Australian PICFs.Methods: We analysed the participant information sheet portion of 248 PICFs. Readability scores were measured using three formulae: the Flesch Reading Ease, the Flesch-Kincaid Grade Level, and the Simple Measure of Gobbledygook (SMOG). We investigated how various features (including sponsor type and PICF type) correlated with PICF length and readability and examined compliance with other measures known to improve readability.Results: For a sample of 248 PICFs, the mean (standard deviation) Flesch Reading Ease score was 49.3 (5.7) and for the Flesch-Kincaid Grade Level 11.4 (1.1). The mean (SD) SMOG score was 13.2 (0.9). The median document length was 3848 words (8 pages). Commercial PICFs were more than twice as long as non-commercial, but statistically more readable (p = 0.03) when analysed using the SMOG formula. Subgroup analyses indicated that PICFs for self-consenters were statistically more readable than those for proxy consenters. The use of tables, but not the use of illustrations was associated with better readability scores.Conclusions: The PICFs in our sample are long and complex, and only 3 of the 248 achieved the recommended readability score of grade 8 or below. The broader use of best practice principles for writing health information for consumers and the development of more context-sensitive templates could improve their utility. [ABSTRACT FROM AUTHOR]

Background: Dynamic consent has the potential to address many of the issues facing traditional paper-based or electronic consent, including enrolling informed and engaged participants in the decision-making process. The Australians Together Health Initiative (ATHENA) program aims to connect participants across Queensland, Australia, with new research opportunities. At its core is dynamic consent, an interactive and participant-centric digital platform that enables users to view ongoing research activities, update consent preferences, and have ongoing engagement with researchers., Objective: This study aimed to describe the development of the ATHENA dynamic consent platform within the framework of the ATHENA program, including how the platform was designed, its utilization by participants, and the insights gained., Methods: One-on-one interviews were undertaken with consumers, followed by a workshop with health care staff to gain insights into the dynamic consent concept. Five problem statements were developed, and solutions were posed, from which a dynamic consent platform was constructed, tested, and used for implementation in a clinical trial. Potential users were randomly recruited from a pre-existing pool of 615 participants in the ATHENA program. Feedback on user platform experience was gained from a survey hosted on the platform., Results: In the 13 consumer interviews undertaken, participants were positive about dynamic consent, valuing privacy, ease of use, and adequate communication. Motivators for registration were feedback on data usage and its broader community benefits. Problem statements were security, trust and governance, ease of use, communication, control, and need for a scalable platform. Using the newly constructed dynamic consent platform, 99 potential participants were selected, of whom 67 (68%) were successfully recontacted. Of these, 59 (88%) agreed to be sent the platform, 44 (74%) logged on (indicating use), and 22 (57%) registered for the clinical trial. Survey feedback was favorable, with an average positive rating of 78% across all questions, reflecting satisfaction with the clarity, brevity, and flexibility of the platform. Barriers to implementation included technological and health literacy., Conclusions: This study describes the successful development and testing of a dynamic consent platform that was well-accepted, with users recognizing its advantages over traditional methods of consent regarding flexibility, ease of communication, and participant satisfaction. This information may be useful to other researchers who plan to use dynamic consent in health care research., (©Eddy Xiong, Carissa Bonner, Amanda King, Zoltan Maxwell Bourne, Mark Morgan, Ximena Tolosa, Tony Stanton, Kim Greaves. Originally published in JMIR Formative Research (https://formative.jmir.org), 06.11.2024.)

Background: High-dose corticosteroids have been used to attenuate the inflammatory response to cardiac surgery and cardiopulmonary bypass, but patient outcome benefits remain unclear. The primary aim was to determine whether using dexamethasone was superior to not using dexamethasone to increase the number of home days in the first 30 days after cardiac surgery. The secondary aim was to evaluate efficiency, value, and impact of the novel trial design., Methods: This pragmatic, international trial incorporating a prerandomized consent design favoring local practice enrolled patients undergoing cardiac surgery across seven hospitals in Australia and The Netherlands. Patients were randomly assigned to dexamethasone 1 mg/kg or not (control). The primary outcome was the number of days alive and at home up to 30 days after surgery ("home days"). Secondary outcomes included prolonged mechanical ventilation (more than 48 h), sepsis, renal failure, myocardial infarction, stroke, and death., Results: Of 2,562 patients assessed for eligibility, 1,951 were randomized (median age, 63 yr; 80% male). The median number of home days was 23.0 (interquartile range, 20.1 to 24.1) in the no dexamethasone group and 23.1 (interquartile range, 20.1 to 24.6) in the dexamethasone group (median difference, 0.1; 95% CI, -0.3 to 0.5; P = 0.66). The rates of prolonged mechanical ventilation (risk ratio, 0.72; 95% CI, 0.48 to 1.08), sepsis (risk ratio, 1.02; 95% CI, 0.57 to 1.82), renal failure (risk ratio, 0.94; 95% CI, 0.80 to 1.12), myocardial infarction (risk ratio, 1.20; 95% CI, 0.30 to 4.82), stroke (risk ratio, 1.06; 95% CI, 0.54 to 2.08), and death (risk ratio, 0.72; 95% CI, 0.22 to 2.35) were comparable between groups (all P > 0.10). Dexamethasone reduced intensive care unit stay (median, 29 h; interquartile range, 22 to 50 h vs. median, 43 h; interquartile range, 24 to 72 h; P = 0.004). The authors' novel trial design was highly efficient (89.3% enrollment)., Conclusions: Among patients undergoing cardiac surgery, high-dose dexamethasone decreased intensive care unit stay but did not increase the number of home days after surgery., (Copyright © 2024 American Society of Anesthesiologists. All Rights Reserved.)

Considering consumer preferences, this paper proposes computer-readable policy expressions to govern data sharing and use in consent-based health information exchange. Consent automation is an essential component of digital health transformation efforts, enabling better consumer choices in using their sensitive data while unlocking new values through policy-aware workflow expressions. The approach is based on the HL7 FHIR standard while using the obligation and responsibility concepts formally defined in the ISO ODP Enterprise Language (ODP-EL) standard. These concepts were expressed using a domain specific language (DSL) to support code generation for integration with digital health applications. The approach enables improved interoperability, considering consent, privacy, security requirements, and the ability to adopt new business, regulative or jurisdictional policies. Additionally, it accommodates generative AI solutions for faster alignment with existing document-based policies, ensuring clear provenance. Finally, consent automation and a broader policy framework in the context of the latest Australian Government initiatives in digital health are discussed.

Objectives: This paper aims to highlight the evolution of informed consent in medical practice in general and pediatric practice in particular, as well as current international regulations on the involvement of children in decision-making. Material and methods: A literature review was conducted from Pub Med, Proquest Central, Scopus Elsevier, and Springer Link Journal databases for the period 2001 - 2022. Outcomes: Informed consent is the process by which clinical staff obtains patients' permission to perform invasive procedures. Serious discussions about the meaning and ethics of informed consent began in medicine, research, law, and philosophy only around 1972. For a pediatric patient, a natural response in medical decision making is to delegate authority to the parent or caregiver who is supervising them. In recent years there has been an increasing emphasis on involving the child in decisionmaking. The principle of autonomy is essential when discussing informed consent. Leading organizations in Australia, the UK, and the US have developed recommendations on involving children in decision-making. Pediatricians should share medical information with children and their families in ways that are helpful and empowering. This information should be complete, honest, and unbiased. However, these recommendations have no specific, non-prescriptive references, which demonstrate that in practice there is very little established practice of telling children the truth. Conclusions: this subject will always remain an extremely sensitive and challenging one for professionals, who will have to use all their knowledge and skills to ensure high-quality care for children. [ABSTRACT FROM AUTHOR]

Objectives: Consent forms that are difficult to understand may jeopardize informed consent. The aim of this study was to determine whether consent documents for cardiology-related procedures could be easily read and understood by patients with low health literacy.Methods: All 37 cardiology-related consent forms with patient information material were retrieved from a publicly available suite of documents from one state in Australia. Two raters independently assessed documents and resolved discrepancies through discussion. Understandability was assessed using the Patient Education Materials Assessment Tool for Printed materials (PEMAT-P). Readability was assessed using the Gunning Fog Index, SMOG and Flesch Reading Ease formulas. Images were assessed using the 5C Image checklist. Results were analyzed descriptively.Results: Only 1 of 37 forms met the general PEMAT-P threshold (70%) for being 'understandable'. The average readability score was high, requiring a grade 10-12 level of education to understand. Most images lacked useful captions, had low visual clarity, and were not purpose-designed for the material.Conclusions: The current format for cardiology consent forms does not meet recommended standards for understandability and readability.Practice Implications: Development of consent forms would benefit from taking health literacy principles into account with patient input, and purpose-designed images should be included in all forms to reinforce text. [ABSTRACT FROM AUTHOR]

The increasing dementia prevalence worldwide is driving the testing of novel therapeutic approaches, such as invasive brain technologies, despite limited clinical evidence and the risk of accelerating cognitive decline. Our manuscript (a) reviews the NIH Clinicaltrials.gov database for deep brain stimulation, stem cell implantation, and gene therapy trials on people with dementia; (b) discusses issues on beneficence, nonmaleficence, and autonomy associated with these trials; and (c) proposes nine recommendations that build on elements from the Declaration of Helsinki. We found 49 preregistered high‐risk trials from nine countries planning to or involving 11,801 people with Alzheimer's or Lewy body dementia or dementia secondary to Parkinson's or Huntington's disease. Most of the people with Alzheimer's who are in these trials are from North America and East Asia. There is substantial heterogeneity in the enrolment criteria, even for trials recruiting only those with Alzheimer's disease. Although most trials enrol people in mild to moderate stages of Alzheimer's disease, trials in China enrol people who have severe Alzheimer's. Our findings highlight a pressing need to review and refine the enrolment criteria for invasive neural trials in people with dementia, considering risks, potential benefits, and capacity for informed consent. As a multidisciplinary team from Australia, the USA, Canada, and Germany with expertise in neurology, neuroscience, and ethics, we examine how it is essential to balance the risks of invasive neural research in a vulnerable population with limited capacity to provide informed consent to help advance the body of knowledge regarding a disease with limited therapeutic options. [ABSTRACT FROM AUTHOR]

Introduction: Communicating complex information about haemodialysis (HD) and ensuring it is well understood remains a challenge for clinicians. Informed consent is a high-impact checkpoint in augmenting patients' decision awareness and engagement prior to HD. The aims of this study are to (1) develop a digital information interface to better equip patients in the decision-making process to undergo HD; (2) evaluate the effectiveness of the co-designed digital information interface to improve patient outcomes; and (3) evaluate an implementation strategy., Methods and Analysis: First, a co-design process involving consumers and clinicians to develop audio-visual content for an innovative digital platform. Next a two-armed, open-label, multicentre, randomised controlled trial will compare the digital interface to the current informed consent practice among adult HD patients (n=244). Participants will be randomly assigned to either the intervention or control group. Intervention group: Participants will be coached to an online platform that delivers a simple-to-understand animation and knowledge test questions prior to signing an electronic consent form., Control Group: Participants will be consented conventionally by a clinician and sign a paper consent form. Primary outcome is decision regret, with secondary outcomes including patient-reported experience, comprehension, anxiety, satisfaction, adherence to renal care, dialysis withdrawal, consent time and qualitative feedback. Implementation of eConsent for HD will be evaluated concurrently using the Consolidation Framework for Implementation Research (CFIR) methodology., Analysis: For the randomised controlled trial, data will be analysed using intention-to-treat statistical methods. Descriptive statistics and CFIR-based analyses will inform implementation evaluation., Ethics and Dissemination: Human Research Ethics approval has been secured (Metro North Health Human Research Ethics Committee B, HREC/2022/MNHB/86890), and Dissemination will occur through partnerships with stakeholder and consumer groups, scientific meetings, publications and social media releases., Trial Registration Number: Australian and New Zealand Clinical Trials Registry (ACTRN12622001354774)., Competing Interests: Competing interests: PFG: Consentic shareholder; RBS: CEO of Consentic., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

This research identifies the circumstances in which Human Research Ethics Committees (HRECs) are trusted by Australians to approve the use of genomic data - without express consent - and considers the impact of genomic data sharing settings, and respondent attributes, on public trust. Survey results ( N  = 3013) show some circumstances are more conducive to public trust than others, with waivers endorsed when future research is beneficial and when privacy is protected, but receiving less support in other instances. Still, results imply attitudes are influenced by more than these specific circumstances, with different data sharing settings, and participant attributes, affecting views. Ultimately, this research raises questions and concerns in relation to the criteria HRECs use when authorising waivers of consent in Australia., Competing Interests: Declaration of Conflicting InterestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Before providing any form of medical treatment, medical practitioners are generally required to discharge their duty to warn. It is argued in this article that the duty to warn, at least as it relates to frail and elderly patients, requires the principles of shared decision-making to be adopted. Doing so will ensure a comprehensive biopsychosocial understanding of the patient and assist in identifying material risks that may not be readily apparent. Such risks include risks that threaten the patient's values, preferences, treatment aims and long-term outcomes. Once such risks are identified, in discharging the duty to warn, they should be contextualised in a manner that makes clear how that risk will manifest in that particular patient. These risks should then also be synthesised within the context of their other medical issues and longer-term interests. Finally, it is suggested that the traditional consent process may need restructuring., Competing Interests: None.

Hepatitis C has long been a public health problem in Australia. 'Revolutionary' new drugs with the potential to cure hepatitis C have now emerged. The Australian government has invested heavily in them, and has an ambitious goal to eliminate hepatitis C by 2030. Numerous shifts in policy and practice are required if the elimination agenda is to be realised. This paper explores the significance of these shifts. We ask: what is the race to elimination doing with the subject? We argue that the race to elimination can be understood, simultaneously, as a product of posthuman forces, capable of being analysed using the theoretical tools made available via the posthuman turn; producing an intervention in what it means to be human; and generating a dilemma for people who use (or used) drugs, people with hepatitis C, and posthuman scholarship. In drawing out these issues, we aim to: trace the significant developments underway in hepatitis C medicine and raise awareness of them; encourage reflection on the consequences of these developments; and invite reflections on what might be lost when the human is remade by hepatitis C medicine. [ABSTRACT FROM AUTHOR]

Objective: The implementation of medical aid-in-dying (MAID) poses new challenges for clinical communication and counseling. Among these, health care providers must consider whether to initiate a discussion of MAID with eligible patients who do not directly ask about it. Norms and policies concerning this issue vary tremendously across jurisdictions where MAID is legally authorized, reflecting divergent assumptions about patients' rights to information about end-of-life options and the purpose and potential harms of clinical disclosure.Method: This discussion forum essay draws on informed consent doctrine to analyze two policies concerning clinical communication about MAID: the legal prohibition against provider-initiated discussions of MAID in Victoria, Australia, and the Canadian Association of MAID Assessors and Providers (CAMAP) position that providers have an ethical and professional responsibility to inform eligible patients about MAID.Conclusions: Informed consent requires that clinicians strike a balance between minimizing potential harms to patients caused by initiating discussions of MAID and the imperative to inform and counsel patients about all of their legally available medical options.Practice Implications: Clinicians should be aware of both the importance of communication as a tool to inform patients and the potential for clinical language to cause harm to or to unduly influence patients. [ABSTRACT FROM AUTHOR]

Although the concept of biobanking is not new, the open and evolving nature of biobanks has created profound ethical, legal, and social implications, including issues around informed consent, community engagement, secondary uses of materials over time, ownership of materials, data sharing, and privacy. Complexities also emerge because of increasing international collaborations and differing national positions. In addition, the degrees and topics of concern vary as legislative, ethical, and social frameworks differ across developed and developing countries. Implementing national laws in an internationally consistent manner is also problematic. However, these concerns should not cause countries, especially developing countries, to lag behind as this novel wave of research gains momentum, particularly while several biobank initiatives are already underway in the developing world. As the law has always struggled to keep up with the fast-evolving scientific arena, this article seeks to identify the ethico-legal frameworks in place in the United Kingdom, Australia, Uganda, and South Africa, for human biobank research, in an attempt to compare and contextualize the approaches to human biobanking in specific developed and developing countries. [ABSTRACT FROM AUTHOR]

The history of human-subject experimentation has shown the need for safeguards to protect participants from abuse. Balancing participant protection with adequate representation of the adult intellectual disability population in research presents an important challenge. Our study aimed to analyze guidance on the appropriate inclusion of adults with intellectual disability who are or are not able to consent to biomedical research participation. Terminology, consent and type of ethically acceptable research provisions relevant to adult participants with intellectual disability were comprehensively reviewed in a selection of 17 international and national ethical research guidelines and statements. Most guidelines and statements recommend that adult participants with intellectual disability who are unable to consent be included when it is not possible to conduct the same research with adults capable of independent decision-making, or when there is therapeutic benefit and only minimal risk. Instead of naming specific requirements, the Australian statement stands out by asserting the "individual right" to participate. Assent requirements for incapacitated adults are not explicitly mentioned in most documents reviewed. There appears to be room for further description of the importance of careful capacity assessments and solid assent requirements in ethical research guidance documentation to promote meaningful participation of adults with intellectual disability.

The management of human fetal and embryological collections presents an ethical challenge that can be explored from different perspectives, particularly when considering informed consent. The "micro ethics" level focuses on parties engaged in giving and receiving human tissue while the "macro ethics" level focusses on the collective responsibility of the discipline and society. Additionally, adopting a framework, where ways of working are designed with relevant communities, requires understanding the perspectives of individuals, communities, and organizations. The aim of this study therefore was to assess the perceptions of education-focused Australian stakeholders. A survey collected the perspectives of 198 participants. The majority of participants (61.6%; n = 122/198) indicated that human fetal and embryological remains obtained prior to era of informed consent should be retained for use in education/research. It is likely that their perspective is based on the notion that if human fetal and embryological collections are used for good, then disposing of them would deny this benefit. Women (p < 0.001) indicated a preference for obtaining fetuses and embryos with informed consent for education and research (38.4%; n = 76/198). Majority were in favor of recording both maternal (MI) (59.6%; n = 118/198) and paternal information (PI) (58.1%; n = 115/198) with each donation. Majority (56.1%; n = 111/198) expressed that donations should be accepted from both parental sources. Consideration of stakeholder perspectives is important in developing guidelines regarding these collections. The results from this study demonstrate a level of discomfort with respect to collections without informed consent, which should be considered at the macro ethical and micro ethical level., (© 2024 The Authors. Anatomical Sciences Education published by Wiley Periodicals LLC on behalf of American Association for Anatomy.)

Background: At present in Australia women are not routinely, systematically informed of the risks of childbirth. Aims: It is hoped this presentation of the perspective of some women who suffer unexpected obstetric complications will encourage change. Materials and Methods: The experience of women involved in obstetric medicolegal reports prepared by a colorectal surgeon over ten years is analysed. Results: Twenty women were identified. Sixteen had vaginal deliveries. All 16 suffered third or fourth‐degree tears, six developed rectovaginal fistulae, six required stomas and 11 developed faecal incontinence. Of the four women who delivered by caesarean section, there were two post‐operative caecal perforations, one unrecognised small bowel enterotomy, and one patient developed sepsis due to an infected haematoma. Seventeen of the 20 women were noted to suffer psychological sequalae. None of the women recollected being warned of the complication they suffered, and there was no record of such warnings in their medical records. Conclusion: Informed written 'consent' for natural vaginal delivery is, understandably, a contentious topic. Although learning from medicolegal cases may go against the grain, as medical professionals it is very difficult to ethically justify the status quo, where women are not routinely simply informed of the risks of childbirth. This is not fair. Even if informing women does not decrease the incidence of complications, the women who subsequently suffer these complications may well handle them much better, recognising they could occur. [ABSTRACT FROM AUTHOR]

The UK Supreme Court in Montgomery v Lanarkshire Health Board imposes a duty on healthcare professionals in relation to information disclosure. The obligation is to take reasonable care to ensure that patients are aware, not just of material risks inherent in any recommended treatment, but of any reasonable alternative treatments. While liability for information non-provision was previously decided according to whether the profession would deem disclosure appropriate, the law now judges the sufficiency of information from a patient's perspective. In doing so, it adopts the approach advocated for Australia in Rogers v Whitaker. However, commentators, in this journal and elsewhere, have expressed concern that the disclosure obligation is unclear. Although Montgomery defines what is 'material' for the purpose of identifying notifiable treatment risks, it offers less guidance as to when alternative treatments will be sufficiently 'reasonable' to warrant disclosure. Through an analysis of Australian and UK case law and examples, this article considers the ambit of a practitioner's duty to discuss alternatives. It concludes that although likely subject to further litigation, the identification of reasonable treatment options requiring disclosure will be influenced by the patient's clinical condition, their prognosis and viable options from a medical perspective, and various non-clinical matters influenced by the test of materiality. [ABSTRACT FROM AUTHOR]

Background: Informed consent is often cited as the "cornerstone" of research ethics. Its intent is that participants enter research voluntarily, with an understanding of what their participation entails. Despite agreement on the necessity to obtain informed consent in research, opinions vary on the threshold of disclosure necessary and the best method to obtain consent. We aimed to investigate Australian researchers' views on, and their experiences with, obtaining informed consent.Methods: Semi-structured interviews were conducted with 23 researchers from NSW institutions, working in various fields of research. Interviews were analysed and coded to identify themes.Results: Researchers reported that consent involved information disclosure, understanding and a voluntary decision. They emphasised the variability of consent interactions, which were dependent on potential participants' abilities and interests, study complexity and context. All researchers reported providing written information to potential participants, yet questioned the readability and utility of this information. The majority reported using signed consent forms to 'operationalise' consent and reported little awareness of, and lack of support in implementing more dynamic informed consent procedures, such as verbal informed consent, that was fit for the purposes of their studies. Views on Human Research Ethics Committees (HRECs) varied. Some reported inconsistent, arduous inputs on the information form and consent process. Others expressed reliance on HRECs for guidance, viewing them as institutional safeguards.Conclusions: This study highlights the importance of transparent relationships, both between researchers and participants, and between researchers and HRECs. Where the relationship with study participants was reported as more robust, researchers felt that they were better able to ensure participants made better, more informed decisions. Where the relationship with HRECs was reported as more robust, researchers were more likely to view them as institutional safeguards, rather than as bureaucratic hindrances. Conscientious and mindful researchers are paramount to ensuring the procedure accommodates individual requirements. This study advocates that when designing ethical informed consent practices, researchers should be integrated as autonomous players with a positive input on the process, rather than, in the worst case, predatory recruiters to be curtailed by information forms and oversight. [ABSTRACT FROM AUTHOR]

Background: Novel rationales for randomizing clusters rather than individuals appear to be emerging from the push for more pragmatic trials, for example, to facilitate trial recruitment, reduce the costs of research, and improve external validity. Such rationales may be driven by a mistaken perception that choosing cluster randomization lessens the need for informed consent. We reviewed a random sample of published cluster randomized trials involving only individual-level health care interventions to determine (a) the prevalence of reporting a rationale for the choice of cluster randomization; (b) the types of explicit, or if absent, apparent rationales for the use of cluster randomization; (c) the prevalence of reporting patient informed consent for study interventions; and (d) the types of justifications provided for waivers of consent. We considered cluster randomized trials for evaluating exclusively the individual-level health care interventions to focus on clinical trials where individual randomization is only theoretically possible and where there is a general expectation of informed consent. Methods: A random sample of 40 cluster randomized trials were identified by implementing a validated electronic search filter in two electronic databases (Ovid MEDLINE and Embase), with two reviewers independently extracting information from each trial. Inclusion criteria were the following: primary report of a cluster randomized trial, evaluating exclusively an individual-level health care intervention, published between 2007 and 2016, and conducted in Canada, the United States, European Union, Australia, or low- and middle-income country settings. Results: Twenty-five trials (62.5%, 95% confidence interval = 47.5%–77.5%) reported an explicit rationale for the use of cluster randomization. The most commonly reported rationales were those with logistical or administrative convenience (15 trials, 60%) and those that need to avoid contamination (13 trials, 52%); five trials (20%) were cited rationales related to the push for more pragmatic trials. Twenty-one trials (52.5%, 95% confidence interval = 37%–68%) reported written informed consent for the intervention, two (5%) reported verbal consent, and eight (20%) reported waivers of consent, while in nine trials (22.5%) consent was unclear or not mentioned. Reported justifications for waivers of consent included that study interventions were already used in clinical practice, patients were not randomized individually, and the need to facilitate the pragmatic nature of the trial. Only one trial reported an explicit and appropriate justification for waiver of consent based on minimum criteria in international research ethics guidelines, namely, infeasibility and minimal risk. Conclusion: Rationales for adopting cluster over individual randomization and for adopting consent waivers are emerging, related to the need to facilitate pragmatic trials. Greater attention to clear reporting of study design rationales, informed consent procedures, as well as justification for waivers is needed to ensure that such trials meet appropriate ethical standards. [ABSTRACT FROM AUTHOR]

The public and patients are primary contributors and beneficiaries of pandemic-relevant clinical research. However, their views on research participation during a pandemic have not been systematically studied. We aimed to understand public views regarding participation in clinical research during a hypothetical influenza pandemic. This is an international cross-sectional survey. We surveyed the views of nationally representative samples of people in Belgium, Poland, Spain, Ireland, the United Kingdom, Canada, Australia and New Zealand, using a scenario-based instrument during the 2017 regional influenza season. Descriptive and regression analyses were conducted. Of the 6804 respondents, 5572 (81.8%) thought pandemic-relevant research was important, and 5089 (74.8%) thought 'special rules' should be applied to make this research feasible. The respondents indicated willingness to take part in lower risk (4715, 69.3%) and higher risk (3585, 52.7%) primary care and lower risk (4780, 70.3%) and higher risk (4113, 60.4%) intensive care unit (ICU) study scenarios. For primary care studies, most (3972, 58.4%) participants preferred standard enrolment procedures such as prospective written informed consent, but 2327 (34.2%) thought simplified procedures would be acceptable. For ICU studies, 2800 (41.2%) preferred deferred consent, and 2623 (38.6%) preferred prospective third-party consent. Greater knowledge about pandemics, trust in a health professional, trust in the government, therapeutic misconception and having had ICU experience as a patient or carer predicted increased willingness to participate in pandemic-relevant research. Our study indicates current public support for pandemic-relevant clinical research. Tailored information and initiatives to advance research literacy and maintain trust are required to support pandemic-relevant research participation and engagement. • There is strong public support for pandemic-relevant clinical research initiatives. • Willingness to take part and to sign up under permissive approaches depends on type of research and key participant factors. • Knowledge of pandemics, trust in doctors and government, and experience of critical illness influence research participation. [ABSTRACT FROM AUTHOR]