Research Ethics Regulations Research Articles

Ethics in Research: An Overview for Novice Researchers

Research studies involving human participants must be approved by the organization’s Institutional Review Board before data collection can begin. To a frustrated novice researcher who is struggling to obtain approval, this process can, at times, feel excessively rigorous. Inhumane and unethical experiments from the past have driven the evolution of research ethics regulations. Understanding the past and present requirements of ethical research helps novice and seasoned researchers alike to better appreciate the process. This paper will briefly introduce the history, landmark reports, current regulations, and ethical issues when conducting and publishing research that includes human subjects.

From vulnerable subjects to research partners: a critical policy analysis of biomedical research ethics guidelines and regulations

Over the last three quarters of a century, international guidelines and regulations have undergone significant changes in how children are problematised as participants in biomedical research. While early guidelines enacted children as vulnerable subjects with diminished autonomy and in need of special protection, beginning in the early 2000s, international regulatory frameworks defined the paediatric population as vulnerable due to unaddressed public health needs. More recently, ethical recommendations have promoted the active engagement of minors as research partners. In this paper, I adopt a post-structuralist approach to policy analysis to examine deep-seated assumptions and presuppositions underlying the changes in the problematisation of children as biomedical research participants over time. While biomedical research ethics focuses on the autonomy and vulnerability of minors, ethical guidelines are situated in specific sociocultural contexts, shaped, among other things, by contingent public health needs and changing conceptions of the value of research and science for society. In the process, I demonstrate the challenge of moving away from an approach that in taking adults as the model overshadows the complexity of children’s lived experiences as well as their personal, cultural, and social lives. The lack of acknowledgement of this complexity makes children vulnerable to epistemic injustice, which is particularly crucial to address in public involvement initiatives.

Ethical human participant research in Central Asia: a quantitative analysis of attitudes and practices among social science researchers based in the region

Central Asian researchers are underrepresented in the global research production in social sciences, resulting in a limited Central Asian perspective on many social issues. To stimulate the production of local knowledge, it is important to develop strong research cultures, including knowledge of ethical practices in research with human participants. There is currently scarce evidence about research ethics regulations used by social science researchers working in the Central Asian region. This article reports findings from an online survey conducted in Kazakhstan, Kyrgyzstan, and Uzbekistan ( n = 296) from October 2021 to January 2022. Focusing on three Central Asian countries, this article addresses the following research questions: What are the attitudes and practices of social science researchers based in Central Asia toward research ethics regulations and research ethics committees (RECs)? Is research ethics training associated with improved attitudes and practices in relation to research ethics among social scientists based in Central Asia? Is research experience associated with improved attitudes and practices in relation to research ethics among social scientists based in Central Asia? Regression analyses results demonstrate that locally based social scientists with prior research ethics training implement ethical procedures in their empirical research practice more often compared to researchers without any prior research ethics training. The preliminary findings indicate that research ethics training is positively associated with Central Asia-based social science researchers’ engagement in ethical research, thus potentially increasing the amount and quality of empirical social science research produced in the region.

Awareness and Perception About Research Ethics and Misconduct Among the Teaching Staff of Health Colleges, Jazan University, Saudi Arabia.

Despite adopting biomedical research ethics rules, regulations, and statements, unethical behavior is pervasive and frequently reported. This study assessed the perception and awareness of research Ethics and Misconduct among the Teaching Staff of Health Colleges at Jazan University, southwest Saudi Arabia. This research aimed to assess the awareness and perception of research ethics and misconduct among the teaching staff of the health colleges at Jazan University in southwest Saudi Arabia. Observational cross-sectional study targeted 424 faculty members randomly chosen from health-related colleges at Jazan University. A structured questionnaire was used to collect data using a web-based survey. The overall level of knowledge about medical ethics indicated that more than half of respondents (57.8%) had a good level of knowledge, 23.4% had a fair level of knowledge, and only 18.4% had poor knowledge. The Saudi National Committee on Bioethics was only known by 49.5% of the study participants. In addition, just 48.3% of respondents knew Saudi Arabia's national standards of ethics and principles for conducting scientific research. The knowledge of research ethics was found to be significantly (P<0.05) higher in participants with higher academic positions, such as professors, MD degree holders, and participants with more extensive work experience. About 48.2% reported that the severity of penalties for scientific misconduct would highly affect scientific integrity, and 74.3% found that their understanding of rules and procedures related to scientific misconduct has a very high effect on scientific integrity. Poor knowledge of research ethics is typically associated with an individual's academic job title, as "lecturer" showed a lower level of knowledge in comparison to other job titles. Even though about 50% of participants in the study had a good understanding of research ethics, it's crucial to ensure that all faculty members have a universal understanding. Therefore, it's essential to implement an appropriate research ethics training program.

Governance of research involving people with psychosocial disabilities.

Health-related research with human participants is governed by research ethics regulations in most jurisdictions. Globally, the 2016 International Ethical Guidelines for Health-related Research Involving Humans, published by the Council for International Organizations of Medical Sciences (CIOMS), are especially influential and widely held as an international standard. The CIOMS guidelines support the inclusion of people with psychosocial disabilities in research and offer clear guidance to promote their recruitment, including by outlining provisions for substitute decision-making. The CIOMS guidelines sit alongside the United Nations' Convention on the Rights of Persons with Disabilities (CRPD). Adopted in 2006 and ratified in 2008, the CRPD offers a robust framework for recognizing the rights of persons with disabilities, including individuals with psychosocial disabilities. Though the CRPD does not explicitly reference research inclusion, its core principles-especially pertaining to the right to universal legal capacity-have clear implications for research ethics governance, specifically with respect to the use of substitute decision-making for research participation. In this paper, we review the extent to which existing research ethics regulations across selected jurisdictions concord with each of these two frameworks, offering first a broad analysis of regulations across 26 African countries, and then exploring two country-specific case studies from Malaysia and Peru. We find that, while many countries' research ethics regulations align with key aspects of the CIOMS guidelines, core principles of the CRPD are absent. Given the shortcomings of existing regulations, we analyse a key point of tension between CIOMS and the CRPD-the right to participate in research-and offer a proposal for revised regulations that aims to bridge this tension and meet the standards of both frameworks.

Empowering the Research Community to Investigate Misconduct and Promote Research Integrity and Ethics: New Regulation in Scandinavia

Researchers sometimes engage in various forms of dishonesty and unethical behavior, which has led to regulatory efforts to ensure that they work according to acceptable standards. Such regulation is a difficult task, as research is a diverse and dynamic endeavor. Researchers can disagree about what counts as good and acceptable standards, and these standards are constantly developing. This paper presents and discusses recent changes in research integrity and ethics regulation in Norway, Denmark, and Sweden. Recognizing that research norms are developed through practice and are therefore unsuited for comprehensive national regulation, the Scandinavian countries focus on empowering the research community to regulate itself instead, except for the most severe cases of misconduct. This empowerment takes the form of giving research institutions tools and investigatory powers while also holding them responsible for ensuring that both the institution and individual researchers are up to date on relevant norms. In this way, the Scandinavian governments seek to avoid some of the challenges found in more legalistic approaches, which risk lagging behind the continuous development of research norms and can be insensitive to the fact that different disciplines have different norms. While the new approach in Scandinavian has several potential benefits, it also involves potential trade-offs and limitations. The new laws can create confusion about what researchers are allowed to do. Another issue is that it only addresses the fundamental drivers of misconduct to a limited extent.

Democratising Ethical Regulation and Practice in Educational Research

This paper sets the context for questions covered in the Education Sciences Special Issue: Regulation and Ethical Practice for Educational Research: What are appropriate ethical appraisal and approval practices for particular contexts? How can ethics committees effectively support educational researchers and educational research? To do so, the paper argues for a democratising of ethical regulation and practice in educational research, which includes the decolonization agenda, to break away from enduring power imbalances in knowledge production. A key focus is on the regulation of educational research through ethics committees (whether institutional, regional and/or national) and how this affects research practice. While intended to help researchers to protect and benefit potential research participants, ethics committees themselves can have an important part to play in recognizing and removing barriers to inclusivity, as well as in erecting them, to maximise the benefits of educational research. To overturn the dominance of global North knowledge, for post-colonial research ethics regulation, broader conversations of researcher values and experiences in different parts of the world are needed. This paper explores how ethics committees’ expectations do and could shape researcher decision-making. It presents examples of approaches to ethical appraisal which would support empowerment and participation, not only for gatekeepers and participants but also for the research community, whether experienced researcher, ethics committee member or neophyte researcher. Evidence of ethical research practice which paves the way forward is drawn from a range of contexts to help acknowledge the enduring and wide-ranging impact of colonialism, neo-liberalism and neo-imperialism.

Can We Justify Military Enhancements? Some Yes, Most No.

The United States Department of Defense has, for at least 20years, held the stated intention to enhance active military personnel ("warfighters"). This intention has become more acute in the face of dropping recruitment, an aging fighting force, and emerging strategic challenges. However, developing and testing enhancements is clouded by the ethically contested status of enhancements, the long history of abuse by military medical researchers, and new legislation in the guise of "health security" that has enabled the Department of Defense to apply medical interventions without appropriate oversight. This paper aims to reconcile existing legal and regulatory frameworks on military biomedical research with ethical concerns about military enhancements. In what follows, we first outline one justification for military enhancements. The authors then briefly address existing definitional issues over what constitutes enhancement before addressing existing research ethics regulations governing military biomedical research. Next, they argue that two common justifications for rapid military innovation in science and technology, including enhancement, fail. These justifications are (a) to satisfy a compelling military need and (b) strategic dominance. The authors then turn to an objection that turns on the idea that we need not have these justifications if warfighters are willing to adopt enhancement, and argue that laissez-faire approaches to enhancement fail in the context of the military due to pressing and historically significant concerns about coercion and exploitation. The paper concludes with what is referred to as the "least-worst" justification: Given the rise of untested enhancements in civilian and military life, we have good reason to validate potential enhancements even if they do not satisfy reasons (a) or (b) above.

Relational research ethics and disengagement from collaborative research projects in higher education: A conceptual analysis

Research collaboration is a common practice in higher education, and so is the discourse of research ethics. However, the colonial orientation of some research as well as the managerial models of higher education practices undermine the connectedness and relationality of collaborative research. In this article, I argue this point with a focus on disengagement or withdrawal of collaborators from research projects before they are completed. I argue that this practice has ethical implications at various levels, especially the level of the researched or colonised communities. Drawing from multi-disciplinary literature, I follow a conceptual analysis method, focusing on research collaboration, research ethics and disengagement. The article identifies the types and benefits of collaborative research, as well as common reasons and ethical implications of disengagement from such projects. It concludes by recommending an extension of research ethics regulations to incorporate disengagement, in consideration of the relationality of collaborative research projects. Keywords: collaborative research, disengagement, relational ethics, managerialism, higher education

Controversies between regulations of research ethics and protection of personal data: informed consent at a cross-road.

This paper explores some key discrepancies between two sets of normative requirements applicable to the research use of personal data and human biological materials: (a) the data protection regime which follows the application of the European Union General Data Protection Regulation (GDPR), and (b) the Declaration of Helsinki, CIOMS guidelines and other research ethics regulations. One source of this controversy is that the GDPR requires consent to process personal data to be clear, concise, specific and granular, freely given and revocable and therefore has challenged the concept of ‘broad consent’, which has been widely applied in the context of biobanking. Another source of controversy is the interplay between regulations of research ethics and protection of personal data related to the secondary use of personal data and biological materials. In this case, the GDPR ‘research condition’ provides an alternative to re-consent for the use of previously collected personal data and biological materials. Although the mentioned controversies have been raised in the legal literature, they have not been explicitly addressed from the research ethics perspective. Should consent be regarded as a priority legal basis for personal data processing in health data research? Can broad consent still be a suitable legal ground for biobanking? What should be the role of research ethics provisions that differ from the GDPR standards, and what should be the role and function of research ethics committees in the changing environment of health data research? These are the ongoing controversies to be explored in the paper.

An Observational Study to Assess the Safety and Efficacy on Quality of Life and Patient Satisfaction With Raloxifene/Cholecalciferol Combination Therapy in Postmenopausal Women Requiring Prevention or Treatment for Osteoporosis

Background: Preventing bone loss is an important concern for women during post-menopausal period. Menopause significantly speeds bone loss and increases the risk for osteoporosis. The aim of this study was to investigate the effectiveness on quality of life (QOL), patient satisfaction in postmenopausal women receiving raloxifene/cholecalciferol combination therapy. In addition, we analyzed adverse events to assess the safety profile of this drug. Methods: This study is a multicenter, prospective, non-interventional observational study of women receiving raloxifene/cholecalciferol (raloxifene 60 mg + cholecalciferol 800 IU, Rabone D®, Hanmi Pharma, South Korea) combination therapy to treat or prevent postmenopausal osteoporosis. Data have been collected from patients receiving routine clinical practice at 99 hospitals (local clinics and general hospitals) in South Korea. Patients were followed for more than 6 months to evaluate changes in, and QOL (EQ-5D-5L), patient satisfaction with efficacy and convenience (questionnaire), and safety. This study has been approved by Institutional Review Board and is in compliance with clinical research ethics regulations. Results: A total of 3,907 subjects with an average age of 67.68 ± 9.34 (Mean ± SD) were enrolled from November 2017 to July 2020. QOL was significantly improved from 0.77 ± 0.15 to 0.80 ± 0.12, 0.82 ± 0.11 (3 months, 6 months, respectively) after raloxifene/cholecalciferol therapy (p<0.001). Compared to prior drug regimens of all types (bisphosphonates, bisphosphonates with vitamin D, selective estrogen receptor modulators, etc.), QOL after raloxifene/cholecalciferol treatment was significantly improved (p<0.001). Patient satisfaction of efficacy was significantly increased from 37.25% to 67.70% over 6 months (p<0.0001), and patient satisfaction of convenience was significantly increased from 42.75% to 74.07% (p<0.0001). Serious adverse drug reaction (ADR) did not occur. Hot flush as ADR occurred in 12 subjects (0.30%), lower than Caucasian but similar with previous reports in Asians. Conclusion: In postmenopausal women, combination therapy with raloxifene/cholecalciferol significantly improved quality of life, and patient satisfaction with no serious adverse events. This drug regimen has been proven to be suitable therapy for postmenopausal women with osteoporosis in a real-world clinical setting.

Key criteria for the ethical acceptability of COVID-19 human challenge studies: Report of a WHO Working Group

This report of the WHO Working Group for Guidance on Human Challenge Studies in COVID-19 outlines ethical standards for COVID-19 challenge studies. It includes eight Key Criteria related to scientific justification, risk-benefit assessment, consultation and engagement, co-ordination of research, site selection, participant selection, expert review, and informed consent. The document aims to provide comprehensive guidance to scientists, research ethics committees, funders, policymakers, and regulators in deliberations regarding SARS-CoV-2 challenge studies by outlining criteria that would need to be satisfied in order for such studies to be ethically acceptable.

Ética em pesquisas

Nós examinamos a fundamentação legal das normas, exaradas pelo Conselho Nacional de Saúde (CNS), que disciplinam a ética na pesquisa acadêmica. Nossa investigação revela que o CNS não tem poder legal para criar normas sobre pesquisa, ainda que no campo biomédico.

Clinical Trials [and Tribulations]: The Immediate Effects of COVID-19 on IBD Clinical Research Activity in the UK.

There have been immediate and profound impacts of SARS-CoV-2 and COVID-19 on health care services worldwide, with major consequences for non COVID-19 related health care. Alongside efforts to reconfigure services and enable continued delivery of safe clinical care for patients with IBD, consideration must also be given to management of IBD research activity. In many centres there has been an effective shutdown of IBD clinical trial activity as research sites have switched focus to either COVID-19 related research or clinical care only. As a result, the early termination of trial programmes, and loss of potentially effective therapeutic options for IBD, has become a real and worrying prospect. Moreover, in many countries research activity has become embedded into clinical care—with clinical trials often providing access to new therapies or strategies—which would otherwise not have been available in standard clinical pathways. This pandemic has significant implications for the design, conduct, analysis, and reporting of clinical trials in IBD. In this Viewpoint, we share our experiences from a clinical and academic perspective in the UK, highlighting the early challenges encountered, and consider implications for patients and staff at research sites, sponsors, research ethics committees, funders, and regulators. We also offer potential solutions both for now and for when we enter a recovery phase from the pandemic.

Regulating impact on bystanders in clinical trials: An unsettled frontier.

This article informally reviews key research ethics guidelines and regulations, academic scholarship, and research studies and finds wide variety in how they consider risk to bystanders in medical research (namely, non-participants whom studies nevertheless place at risk). Some of these key sources give no or very little consideration to bystanders, while others offer them the utmost protection (greater than they offer study participants). This unsettled frontier would benefit from a deeper investigation of the ethics of protecting research bystanders.

Transnational policy migration, interdisciplinary policy transfer and decolonization: Tracing the patterns of research ethics regulation in Taiwan.

Research ethics regulation in parts of the Global North has sometimes been initiated in the face of biomedical scandal. More recently, developing and recently developed countries have had additional reasons to regulate, doing so to attract international clinical trials and American research funding, publish in international journals, or to respond to broader social changes. In Taiwan, biomedical research ethics policy based on 'principlism' and committee-based review were imported from the United States. Professionalisation of research ethics displaced other longer-standing ways of conceiving ethics connected with Taiwanese cultural traditions. Subsequently, the model and its discursive practices were extended to other disciplines. Regulation was also shaped by decolonizing discourses associated with asserting Indigenous peoples' rights. Locating research ethics regulation within the language and practices of public policy formation and transfer as well as decolonization, allows analysis to move beyond the self-referential and attend to the social, economic and political context within which regulation operates.

Postpolitical Careers: How Politicians Capitalize on Public Office

Former government officials have many different opportunities to cash in on their public service, but most academic research and government ethics regulations focus on lobbying. We argue that this ...

Stakeholder views regarding ethical issues in the design and conduct of pragmatic trials: study protocol

BackgroundRandomized controlled trial (RCT) trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action of treatments under ideal conditions (efficacy), whereas a pragmatic approach emphasizes testing effectiveness of two or more available treatments in real-world conditions. Interest in, and the number of, pragmatic trials has grown substantially in recent years, with increased recognition by funders and stakeholders worldwide of the need for credible evidence to inform clinical decision-making. This increase has been accompanied by the onset of learning healthcare systems, as well as an increasing focus on patient-oriented research. However, pragmatic trials have ethical challenges that have not yet been identified or adequately characterized. The present study aims to explore the views of key stakeholders with respect to ethical issues raised by the design and conduct of pragmatic trials. It is embedded within a large, four-year project that seeks to develop guidance for the ethical design and conduct of pragmatic trials. As a first step, this study will address important gaps in the current empirical literature with respect to identifying a comprehensive range of ethical issues arising from the design and conduct of pragmatic trials. By opening up a broad range of topics for consideration within our parallel ethical analysis, we will extend the current debate, which has largely emphasized issues of consent, to the range of ethical considerations that may flow from specific design choices.MethodsSemi-structured interviews with key stakeholders (e.g. trialists, methodologists, lay members of study teams, bioethicists, and research ethics committee members), across multiple jurisdictions, identified based on their known experience and/or expertise with pragmatic trials.DiscussionWe expect that the study outputs will be of interest to a wide range of knowledge users including trialists, ethicists, research ethics committees, journal editors, regulators, healthcare policymakers, research funders and patient groups. All publications will adhere to the Tri-Agency Open Access Policy on Publications.

Developing a framework for the ethical design and conduct of pragmatic trials in healthcare: a mixed methods research protocol

BackgroundThere is a widely recognized need for more pragmatic trials that evaluate interventions in real-world settings to inform decision-making by patients, providers, and health system leaders. Increasing availability of electronic health records, centralized research ethics review, and novel trial designs, combined with support and resources from governments worldwide for patient-centered research, have created an unprecedented opportunity to advance the conduct of pragmatic trials, which can ultimately improve patient health and health system outcomes. Such trials raise ethical issues that have not yet been fully addressed, with existing literature concentrating on regulations in specific jurisdictions rather than arguments grounded in ethical principles. Proposed solutions (e.g. using different regulations in “learning healthcare systems”) are speculative with no guarantee of improvement over existing oversight procedures. Most importantly, the literature does not reflect a broad vision of protecting the core liberty and welfare interests of research participants. Novel ethical guidance is required. We have assembled a team of ethicists, trialists, methodologists, social scientists, knowledge users, and community members with the goal of developing guidance for the ethical design and conduct of pragmatic trials.MethodsOur project will combine empirical and conceptual work and a consensus development process. Empirical work will: (1) identify a comprehensive list of ethical issues through interviews with a small group of key informants (e.g. trialists, ethicists, chairs of research ethics committees); (2) document current practices by reviewing a random sample of pragmatic trials and surveying authors; (3) elicit views of chairs of research ethics committees through surveys in Canada, UK, USA, France, and Australia; and (4) elicit views and experiences of community members and health system leaders through focus groups and surveys. Conceptual work will consist of an ethical analysis of identified issues and the development of new ethical solutions, outlining principles, policy options, and rationales. The consensus development process will involve an independent expert panel to develop a final guidance document.DiscussionPlanned output includes manuscripts, educational materials, and tailored guidance documents to inform and support researchers, research ethics committees, journal editors, regulators, and funders in the ethical design and conduct of pragmatic trials.

Enriching the concept of vulnerability in research ethics: An integrative and functional account.

The concept of vulnerability is widely used in research ethics to signal attention to participants who require special protections in research. However, this concept is vague and under-theorized. There is also growing concern that the dominant categorical approach to vulnerability (as exemplified by research ethics regulations and guidelines delineating vulnerable groups) is ethically problematic because of its assumptions about groups of people and is, in fact, not very guiding. An agreed-upon strategy is to move from categorical towards analytical approaches (focused on analyzing types and sources of vulnerability) to vulnerability. Beyond this agreement, however, scholars have been advancing competing accounts of vulnerability without consensus about its appropriate operationalization in research ethics. Based on previous debates, we propose that a comprehensive account of vulnerability for research ethics must include four components: definition, normative justifications, application, and implications. Concluding that no existing accounts integrate these components in a functional (i.e., practically applicable) manner, we propose an integrative and functional account of vulnerability inspired by pragmatist theory and enriched by bioethics literature. Using an example of research on deep brain stimulation for treatment-resistant depression, we illustrate how the integrative-functional account can guide the analysis of vulnerability in research within a pragmatist, evidence-based approach to research ethics. While ultimately there are concerns to be addressed in existing research ethics guidelines on vulnerability, the integrative-functional account can serve as an analytic tool to help researchers, research ethics boards, and other relevant actors fill in the gaps in the current landscape of research ethics governance.