Stakeholders In Clinical Research Research Articles

The role of remote data capture, wearables, and digital biomarkers in decentralized clinical trials.

Decentralized clinical trials (DCTs) are gaining momentum in clinical research as these studies can be executed remotely through telemedicine and mobile/local health-care providers. The COVID-19 pandemic has further accelerated advances and adoption in this area. In the past few years, there has been significant development and growth in the use of remote data that are electronically transmitted from a clinical trial (CT) participant, from outside the clinical setting, to a data repository. Such data may include laboratory data, safety data, or outcome measures reported by the participant, the clinician or the observer. Similarly, wearable health monitoring devices are being increasingly used in health-care and CT settings. Digital biomarkers, which can support continuous measurement of physiologic parameters outside the physical confines of the clinical environment, are also creating new and improved opportunities for patient care and biomedical research, enabling remote monitoring and DCTs. There are several benefits to using remote data capture, wearables, and digital biomarkers in clinical health-care research; however, several questions and challenges still need to be addressed. In an effort to understand the adoption of these technologies in DCTs, and the challenges therein, the authors of this workstream conducted an online survey of clinical research stakeholders across India and reviewed 80 responses. The review article summarizes the key findings from this online survey.

Clinical research stakeholders’ experiences of clinical research during COVID-19: a qualitative study

BackgroundThe COVID-19 pandemic created a complex high-risk clinical research environment with clinical research activities significantly impacted. Clinical research stakeholders adapted rapidly to new clinical practices; PPE, infection control policies, all while engaging with a more unwell patient demographic. The aim of this study is to explore the experiences of conducting clinical research during COVID-19 with clinical research stakeholders.MethodsThis qualitative study of semi-structured interviews conducted with clinical research stakeholders in an acute Hospital setting across a variety of disciplines; Consultant Geriatrician, Clinical Research Nurse, Occupational Therapy, Physiotherapy. Interviews were fully transcribed prior to reflexive thematic analysis. NVivo software was used to support data management and analysis.ResultsThree main themes were produced; (1) The challenging COVID-19 clinical research landscape, (2) COVID-19 clinical research communication barriers, and (3) Adaptations and learnings from clinical research during COVID-19.ConclusionsThis study explored the experiences of conducting clinical research during COVID-19 with clinical research stakeholders examining challenges faced and adaptations required. The findings inform, equip and support clinical research stakeholders in the event of future adverse public health events.

Understanding organizational perspectives from clinical research stakeholders involved in recruitment for biopharmaceutical-sponsored clinical trials in the United States: Recommendations for organizational initiatives to improve access and inclusivity in clinical research

BackgroundEquitable representation of racially and ethnically diverse subpopulations in clinical trials continues to be a problem, and trial participants do not always reflect the demographics of the population that the investigational product will be used to treat. The imperativeness of equitable representation of clinically relevant populations in clinical trials has implications for improving health outcomes, increasing knowledge about the safety and efficacy of new treatments across a wider population, and broadening access to innovative treatment options offered in clinical trials. MethodsThe purpose of this study was to understand organizational elements that are involved in the active implementation of racially and ethnically diverse inclusive recruitment practices for biopharmaceutical-funded trials in the United States. Semi-structured, in-depth interviews were used in this qualitative study. The interview guide was designed to explore the perceptions, practices and experiences of 15 clinical research site professionals related to recruiting diverse trial participants. Data analysis utilized an inductive coding process. ResultsFive themes were identified pertaining to the actual implementation of inclusive recruitment practices that provided explanations for organizational components: 1) provision of culturally appropriate, general disease and clinical trial education 2) organizational structure tailored for diverse recruitment 3) strong sense of mission related to improving healthcare through clinical research 4) culture of inclusion 5) inclusive recruitment practices evolving based on learning. ConclusionThe findings from this study offer insight into improving access to clinical trials by focusing on organizational change initiatives.

The application of data altruism in clinical research through empirical and legal analysis lenses.

The legal framework for clinical research in the EU is complex and the lack of harmonization of the relevant legal and ethical rules remains one of the main challenges for stakeholders in the field. The recently adopted Data Governance Act (DGA) and the proposal for a European Health Data Space (EHDS) promise to solve the existing challenges with respect to access to and (re)use of personal data for research, but also risk to further complexify the field. The DGA introduced a novel mechanism - data altruism. Data altruism is understood as the voluntary sharing of personal and non-personal data, based on the consent of data subjects or the permission of natural and legal persons, without seeking a reward and for objectives of general interest. This study aimed to gain insights into the opinion of clinical research stakeholders on data altruism, and to critically discuss key issues pertaining to the application of data altruism from a legal point of view. Semi-structured interviews with (1) data protection officers (DPOs) and legal experts working with commercial and academic sponsors of clinical trials, (2) investigators, and (3) members of research ethics committees. Data underwent framework analysis. The legal discussion was comprised of legal doctrinal research with focus on the DGA, EHDS proposal, and the interplay with the EU General Data Protection Regulation (GDPR). Fourteen experts took part in the interviews, more than half of which were DPOs/legal experts. Interviewees were based in seven EU Member states and the United Kingdom. The majority of participants were critical towards the data altruism mechanism and pointed out challenges and risks associated with its application. Although data altruism holds the potential to facilitate data sharing, its application in clinical research at the moment is still riddled with uncertainties. The interplay of the DGA rules with the provisions of the GDPR and the EHDS proposal are insufficiently clear and further efforts from the legislator are required to build a working, patient-centered, and research fostering data altruism system.

Challenges related to data protection in clinical research before and during the COVID-19 pandemic: An exploratory study.

BackgroundThe COVID-19 pandemic brought global disruption to health, society and economy, including to the conduct of clinical research. In the European Union (EU), the legal and ethical framework for research is complex and divergent. Many challenges exist in relation to the interplay of the various applicable rules, particularly with respect to compliance with the General Data Protection Regulation (GDPR). This study aimed to gain insights into the experience of key clinical research stakeholders [investigators, ethics committees (ECs), and data protection officers (DPOs)/legal experts working with clinical research sponsors] across the EU and the UK on the main challenges related to data protection in clinical research before and during the pandemic.Materials and methodsThe study consisted of an online survey and follow-up semi-structured interviews. Data collection occurred between April and December 2021. Survey data was analyzed descriptively, and the interviews underwent a framework analysis.Results and conclusionIn total, 191 respondents filled in the survey, of whom fourteen participated in the follow-up interviews. Out of the targeted 28 countries (EU and UK), 25 were represented in the survey. The majority of stakeholders were based in Western Europe. This study empirically elucidated numerous key legal and ethical issues related to GDPR compliance in the context of (cross-border) clinical research. It showed that the lack of legal harmonization remains the biggest challenge in the field, and that it is present not only at the level of the interplay of key EU legislative acts and national implementation of the GDPR, but also when it comes to interpretation at local, regional and institutional levels. Moreover, the role of ECs in data protection was further explored and possible ways forward for its normative delineation were discussed. According to the participants, the pandemic did not bring additional legal challenges. Although practical challenges (for instance, mainly related to the provision of information to patients) were high due to the globally enacted crisis measures, the key problematic issues on (cross-border) health research, interpretations of the legal texts and compliance strategies remained largely the same.

Project R. Evolution for improving clinical research in Italy: challenges and strategies

Objective The R.Evolution project aimed to reach a consensus on the main challenges of conducting clinical research in Italy and possible strategies and approaches to address them and optimize clinical research management. Methods A scientific board of experts initially discussed potentially critical areas in clinical research conduct and further explored them through an online national survey. The survey results were further examined by a group of 35 panelists representing different clinical research stakeholders. A Nominal Group Technique and a Delphi approach (two rounds) were used to generate a consensus on critical factors, tools and strategies in clinical research. Results Four main critical areas were identified: study feasibility, authorization procedures, operational aspects and patient management. The main issues are scarce awareness of the value of clinical research, lack of trained workforce and excessive complexity of protocols and administrative procedures. The Delphi panel identified six intervention areas: culture and patient involvement; procedures; staff, contracts, training and incentives; organization and infrastructure; administrative procedures; and ethics committee. Conclusion According to the R.Evolution project, possible strategies to improve clinical research management in Italy include a deeper understanding of the value of clinical research, the creation of long-term plans for hiring, training, organizing and motivating clinical trial staff, the simplification and harmonization of administrative procedures, as well as protocol design, and the development of stronger networks of centers and stakeholders.

Building and implementing a quality assurance/quality improvement program for clinical research.

A major goal of the Clinical and Translational Science Award programs is to build and grow clinical and translational research, including the need to ensure that study teams are educated and adhere to best clinical research practices. One of the primary objectives of the Center for Clinical and Translational Science at the University of Kentucky is to help investigators implement standard operating procedures and provide resources to conduct clinical research that is rigorous, ethical and safe. The University of Kentucky Center for Clinical and Translational Science sought to establish a Quality Assurance/Quality Improvement program for Principal Investigator (PI) initiated clinical research studies using Center for Clinical and Translational Science services. Initiated in 2011, this program's goal was to improve research design quality and from the start of the project, "find it, fix it", leading to improved PI education, without being viewed as punitive. Since the initiation of our Quality Assurance/Quality Improvement program, PI acceptance has been good and we have expanded its footprint and adjusted our review style to better match the needs of our PIs. This article discusses our experiences with Quality Assurance/Quality Improvement program development and growth. A Quality Assurance/Quality Improvement program can be developed that is efficient, effective, educational and well accepted by all clinical research stakeholders.

460 Adaptive Capacity and Preparedness of CTSAs: The Environmental Scan Approach and Findings

OBJECTIVES/GOALS: Illuminate processes and findings of the Environmental Scan of Adaptive Capacity and Preparedness of CTSAs done by the CTSA Working Group. Share challenges, strategies, and lessons learned for CTSAs to build Capacity to address clinical and translational barriers while responding to emergencies. METHODS/STUDY POPULATION: An Environmental Scan approach for searching, collecting, analyzing and using information from diverse sources regarding CTSA hubs experiences during emergency as related to research implementation, translation, support, adaptation, and preparedness: - Triangulating multiple data sources and mixed methods (e.g., literature review, document/RPPR analysis, and expert review); - Secondary analysis of the JCTS COVID-19 Survey of the CTSAs: challenges, lessons learned, and practices that work in various program components/areas; - Using feedback of CTSA professionals from multiple disciplines to enhance our knowledge of emergency preparedness and efficient adaptation to public health and other crises. RESULTS/ANTICIPATED RESULTS: The E-scan approach helped identify challenges, successful practices, and evidence-based strategies for building adaptive capacity and preparedness of CTSAs across various scientific sectors of the translational science spectrum. Some of the findings include: - Roadmaps for the creation of new collaborative research resources (biobanks; data repositories, etc.); - Rapid clinical and research decision making during public health crises; - New community-based research strategies to facilitate communication, research dissemination, and participant recruitment based on existing trust-based networks; - Innovative resource allocation to guarantee continuity of training and research opportunities for trainees. DISCUSSION/SIGNIFICANCE: The Environmental Scan of the Adaptive Capacity of CTSA hubs provides useful knowledge and tools to diverse clinical research stakeholders for mitigating the impact of a disaster via adjusting programs, practices, and processes, and building capacity for effective, emergency-ready and responsive research, training, and community engagement.

Sharing data among clinical trials of therapeutics in COVID-19: Barriers and facilitators to collaborating in a crisis.

The Clinical and Translational Science Award Program (CTSA) Trial Innovation Network (TIN) was launched in 2016 to increase the efficiency and effectiveness of multisite trials by supporting the development of national infrastructure. With the advent of the COVID-19 pandemic, it was therefore well-positioned to support clinical trial collaboration. The TIN was leveraged to support two initiatives: (1) to create and evaluate a mechanism for coordinating Data and Safety Monitoring Board (DSMB) activities among multiple ongoing trials of the same therapeutic agents, and (2) to share data across clinical trials so that smaller, likely underpowered studies, could be combined to produce meaningful and actionable data through pooled analyses. The success of these initiatives was understood to be dependent upon the willingness of investigators, study teams, and US National Institutes of Health research networks to collaborate and share information. To inform these two initiatives, we conducted semistructured interviews with members of CTSA hubs and clinical research stakeholders that probed barriers and facilitators to collaboration. Thematic analysis identified topics relevant across institutions, individuals, and DSMBs. The DSMB coordination initiative was viewed as less controversial, while the data pooling initiative was seen as complex because of its potential impact on publication, authorship, and the rewards of discovery. Barriers related to resources, centralization, and technical work were significant, but interviewees suggested these could be handled by the provision of central funding and supportive frameworks. The more intractable findings were related to issues around credit and ownership of data. Based on our interviews, we conclude with nine recommended actions that can be implemented to support collaboration.

Towards integrative, patient-centred clinical research

What does clinical research in Switzerland need in order to increase its benefit to patients and society? What changes are necessary? This year, the Swiss Academy of Medical Sciences (SAMS) published its White Paper: Clinical Research, which formulates seven goals that bring together clinical research stakeholders around a shared vision. This vision – to strengthen the impact of clinical research – is based on a solid partnership with patients and the public.

A questionnaire based institutional assessment of ‘knowledge’, ‘attitude’ and ‘practice’ about bio-ethics in clinical research among postgraduate residents

Background: Research ethics govern the standards of conduct for scientific researchers. Post graduate residents are one of the key stakeholders in clinical research. Therefore, the present study is designed to assess the Knowledge, Attitude and Practice about bio-ethics in clinical research among post-graduate residents.Methods: A self-administered pretested questionnaire was given to 40 students selected on the basis of convenience sampling. The questionnaire consists of questions related to knowledge and attitude toward principles and practice of bioethics in clinical research, informed consent, and role of the ethics committee in the institution. Descriptive statistics was used to analyse the results.Results: 70% of the students have formally taken Hippocratic Oath. Knowledge, attitude, and practice regarding Institutional Ethics Committee, and informed consent were more among final year students when compared to their juniors. Source of knowledge of bioethics were multiple. Department lectures were not a preferred mode of learning.Conclusions: There is an urgent need to include practical education of ethics to bridge the gap in the knowledge, attitude, and practices regarding ethics in clinical practice and research.

Enhancing community engagement in Patient-Centered Outcomes Research: Equipping learners to thrive in translational efforts.

Community engagement is a critical component of translational research. Innovative educational approaches to support meaningful involvement of stakeholders in clinical research allows for bidirectional learning and greater engagement in translational efforts. Our Penn State Community-Engaged Research Core (CeRC) team has developed an innovative research curriculum for a variety of stakeholders, including patient partners, organizational representatives, and Community Health Workers (CHWs). This brief report will outline unique curricular approaches, guided by adult learning principles, to enhance stakeholder education and engagement in activities. Initial evidence of impact on learning is also reported.

A Novel Collaborative Approach to Building Better Clinical Trials: New Insights From a Patient Engagement Workshop to Propel Patient-Centricity Forward.

(1) A growing number of pharmaceutical and biotechnology organizations are engaging patients, their support networks, and clinical trial site staff at various touchpoints along the clinical research development spectrum to solicit feedback on how to reduce the burden of clinical trial participation and administration. (2) However, many organizations are still evaluating how to best implement such engagement initiatives in a manner that will evoke meaningful, sustainable results and change. In an effort to support meaningful engagement in a novel way, Janssen organized a 2-day innovative workshop designed to promote collaboration and foster mutual understanding among a cross-functional group of clinical research stakeholders. Over the course of the workshop, patients, sponsor team members, and clinical trial site staff each leveraged their unique experiences to address the challenges of today's clinical trials, and collectively envision the ideal clinical trial of the future. The workshop design created a level playing field for the stakeholders to interact with one another as partners with the shared goal of building better clinical trials. A significant number of transformative ideas were generated as a result of the innovative workshop exercises. Participants agreed that future clinical trials must be convenient and customizable and truly put the patient at the center of research. Creating a comfortable atmosphere and engaging environment for patients, site staff, and pharmaceutical companies to discuss current challenges of clinical trial participation and potential solutions together as partners in real time is critical and has proven to be a valuable novel engagement option for other organizations to consider adopting.

A Novel Collaborative Approach to Building Better Clinical Trials: New Insights From a Patient Engagement Workshop to Propel Patient-Centricity Forward.

(1) A growing number of pharmaceutical and biotechnology organizations are engaging patients, their support networks, and clinical trial site staff at various touchpoints along the clinical research development spectrum to solicit feedback on how to reduce the burden of clinical trial participation and administration. (2) However, many organizations are still evaluating how to best implement such engagement initiatives in a manner that will evoke meaningful, sustainable results and change. In an effort to support meaningful engagement in a novel way, Janssen organized a 2-day innovative workshop designed to promote collaboration and foster mutual understanding among a cross-functional group of clinical research stakeholders. Over the course of the workshop, patients, sponsor team members, and clinical trial site staff each leveraged their unique experiences to address the challenges of today's clinical trials, and collectively envision the ideal clinical trial of the future. The workshop design created a level playing field for the stakeholders to interact with one another as partners with the shared goal of building better clinical trials. A significant number of transformative ideas were generated as a result of the innovative workshop exercises. Participants agreed that future clinical trials must be convenient and customizable and truly put the patient at the center of research. Creating a comfortable atmosphere and engaging environment for patients, site staff, and pharmaceutical companies to discuss current challenges of clinical trial participation and potential solutions together as partners in real time is critical and has proven to be a valuable novel engagement option for other organizations to consider adopting.

Integrating Parents in Neonatal and Pediatric Research

Background: Parents and their infants are the beneficiaries of neonatal and pediatric research, but in the past they have been excluded from most stages of research projects. As a result, many projects may fail to produce the most worthwhile information for parents and families. Lately, veteran resource parents and patients have been increasingly integrated in research initiatives. Methods: Benchmarking of neonatal and pediatric research initiatives where resource parents and/or ex neonatal patients have helped to optimize pediatric research. We review ways in which resource parents/patients can be involved in research, with examples and practical ideas of how to proceed. Results: Resource parents/patients can be collaborators in research and be integrated in many steps: prioritizing research projects, designing trials, determining the outcomes of interest, ethics review, developing and improving consent procedures, collection and interpretation of data, participation in data safety monitoring committees, publication of results, and presentation to peer groups. Some of the strategies for integration of stakeholders in clinical research are more complex, may involve risk and require more training than others. Conclusion: We suggest that groups wanting to involve parents in their research endeavors start with simpler tasks that entail less risk and develop teams of resource parents who have differing interests and abilities. Quality control of programs is essential, such as frequently giving and obtaining feedback from resource parents/patients and researchers. In the future, integration of resource parents/patients into every step of clinical research will be essential to ensure that parent and family important outcomes are examined.

Insufficient recruitment and premature discontinuation of clinical trials in Switzerland: qualitative study with trialists and other stakeholders.

Premature discontinuation occurs in about 25% of randomised clinical trials in Switzerland; it mainly affects investigator-initiated trials and is mostly due to problems with recruitment of patients. The aim of this study was to qualitatively investigate reasons for trial discontinuation due to poor patient recruitment and suggestions to address those reasons in the Swiss context. We conducted semi-structured interviews with trialists whose trials were discontinued because of recruitment problems, other experienced trialists, and stakeholders in clinical research in Switzerland. Interviews were audio-recorded, transcribed verbatim, and anonymised. We analysed the transcripts using deductive coding and built up themes that were continuously discussed within the research team. Of 65 invited Swiss trialists and stakeholders, 39 (60%) agreed to be interviewed and contributed to this analysis. We identified four main themes of reasons for poor recruitment: (1) Switzerland has a decentralised healthcare system with many small hospitals and few patients per hospital, many research regulations, no standardisation of medical records across hospitals, and a heterogeneous ethics assessment of study protocols. There is little collaboration of different stakeholders in clinical research and a lack of prioritisation of projects. (2) Limited human and financial resources, especially in the academic setting, compromise research questions and size of clinical trials. When funding is used up this typically triggers discontinuation of already delayed clinical trials. (3) Investigators face underdeveloped research networks and a limited collaborative attitude among clinical researchers. They typically embark on clinical studies with a great deal of optimism but insufficient preparation. (4) Swiss patients have universal health coverage and many treatment options. Negative media coverage of clinical research and a lack of accessible information for patients about ongoing clinical studies frequently make participation in clinical trials less attractive. More interactive structures and collaboration across stakeholders were mentioned as potential solutions to tackle the problems. Recruitment of participants into clinical trials in Switzerland is challenging because of various, often interlinked factors related to the Swiss health system, available funding, investigators, and patients. Common goals and concerted efforts by involved stakeholders appear necessary to achieve improvement.

Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality.

ObjectiveTo systematically survey existing definitions, concepts, and criteria of clinical research quality, both developed by stakeholder groups as well as in the medical literature. This study serves as a first step in the development of a comprehensive framework for the quality of clinical research.Study design and settingWe systematically and in duplicate searched definitions, concepts and criteria of clinical research quality on websites of stakeholders in clinical research until no further insights emerged and in MEDLINE up to February 2015. Stakeholders included governmental bodies, regulatory agencies, the pharmaceutical industry, academic and commercial contract research organizations, initiatives, research ethics committees, patient organizations and funding agencies from 13 countries. Data synthesis involved descriptive and qualitative analyses following the Framework Method on definitions, concepts, and criteria of clinical research quality. Descriptive codes were applied and grouped into clusters to identify common and stakeholder-specific quality themes.ResultsStakeholder concepts on how to assure quality throughout study conduct or articles on quality assessment tools were common, generally with no a priori definition of the term quality itself. We identified a total of 20 explicit definitions of clinical research quality including varying quality dimensions and focusing on different stages in the clinical research process. Encountered quality dimensions include ethical conduct, patient safety/rights/priorities, internal validity, precision of results, generalizability or external validity, scientific and societal relevance, transparency and accessibility of information, research infrastructure and sustainability. None of the definitions appeared to be comprehensive either in terms of quality dimensions, research stages, or stakeholder perspectives.ConclusionClinical research quality is often discussed but rarely defined. A framework defining clinical research quality across stakeholders’ individual perspectives is desirable to facilitate discussion, assessment, and improvement of quality at all stages of clinical research.

Patient Empowerment and Involvement in Research.

Patients with rare diseases often face difficulties in clinical care due to the low prevalence of their diseases and the resulting healthcare professionals' lack of expertise. Valid and standardized guidelines for clinical management are also lacking due to the scarcity of research and the variability of the clinical expressivity within each disease. In addition, in cases of rare diseases, the patient and health professional relationship may not fit with the traditional assumptions of medical care. Although the communication process between patients and healthcare professionals shares most of the general features of the standard patient-health professional interaction, rare diseases may be burdened with additional issues.In this sense, clinical decision-making in an uncertainty context should take advantage of involving patients in deeper informational process to promote valid shared decision-making between patients/caregivers and healthcare professionals. This process of patient/caregiver empowerment is a priority in the context of rare diseases, as it encourages acquisition of information that will help improving patient-healthcare professional's interaction, and building a collaborative relationship. It is also a chance for healthcare professionals to learn about rare diseases from the perspective of patients.Engagement of patients and other stakeholders in clinical research may help to ensure that research efforts in rare diseases address relevant clinical questions and patient-centered health outcomes. However, the effectiveness of patient-engagement approaches, particularly for the study of rare diseases, has not been well studied.

A systematic review of approaches for engaging patients for research on rare diseases.

Patients with rare diseases have limited access to useful information to guide treatment decisions. Engagement of patients and other stakeholders in clinical research may help to ensure that research efforts in rare diseases address relevant clinical questions and patient-centered health outcomes. Rare disease organizations may provide an effective means to facilitate patient engagement in research. However, the effectiveness of patient-engagement approaches, particularly for the study of rare diseases, has not been well studied. To synthesize evidence about engagement of patients and other stakeholders in research on rare diseases, including the role of rare disease organizations in facilitating patient-centered research. A systematic review and gray literature search were guided by a technical expert panel composed of patient representatives, clinicians, and researchers. English-language studies that engaged patients or other stakeholders in research on rare diseases or evaluated engagement were included. Studies were assessed on how well key research questions were answered, based on the level of detail describing engagement activities and whether outcomes from engagement were assessed. Thirty-five studies were included, although many reported minimal information on engagement. Patients and other stakeholders were most commonly engaged to identify patient-centered research agendas, to select which study outcomes were important to patients, to provide input on study design, and to identify strategies for increasing enrollment in trials. Rare disease organizations mainly helped provide access to patients and communicated research opportunities and findings. They also helped promote collaborative networks and provided financial support for research infrastructures. Although authors reported benefits of engagement and identified changes to their research processes, no empirical assessments of engagement practices and their effectiveness were found. Researchers studying rare diseases can obtain patient input regarding which research questions and health outcomes to study; however, the most effective approaches to engagement have not been well defined.

Attitudes and views of the general public towards research participation

While the challenges of recruitment into clinical trials are well described, little is known about the public's perceptions towards research. We sought to describe the attitudes, beliefs and knowledge of the public towards research and research participation, focusing on clinical trials, contrast these attributes among individuals with different relationships with the healthcare system and to identify predictors of willingness to participate. We conducted a self-administered cross-sectional survey of patients and their significant others in two clinics and two intensive care unit waiting rooms and in three public venues. We analysed responses from 417 respondents (102 and 105 in dialysis and oncology clinics, and 106 in intensive care unit (ICU) waiting rooms, 104 in public locations). While most (68.3%) respondents favoured the use of humans in clinical trials, 53% felt that trial participants always or almost always receive the best quality of care, only 30.4% had participated in clinical research. Approximately 70% felt that subjects are always advised of the risks and benefits of participation, and 30% expressed ambiguity regarding whether participants are informed of their involvement. Oncology and dialysis respondents were the most and least informed regarding research methods and ethics. The perceived risks and benefits associated with clinical circumstances influence research participation decisions and vary with healthcare experiences. We identified six predictors of willingness to participate. Attitudes of the public towards research participation are beleaguered by misconceptions. Stakeholders in clinical research must educate the general public regarding research methods and ethics.