Ethics Protocols Research Articles

Negotiating the practicalities of informed consent in the field with children and young people: learning from social science researchers

The real-world navigation of ethics-in-practice versus the bureaucracy of institutional ethics remains challenging. This is especially true for research with children and young people who may be considered vulnerable by the policies and procedures of ethics committees but agentic by researchers. Greater transparency is needed about how this tension is navigated in practice to provide confidence and effective strategies for social researchers, including those new to the field, for negotiating informed consent. Twenty-three social science researchers with a range of experience were interviewed about their practices for gaining informed consent from children and young people in social research and the development of their ‘ethics in practice’ over time. Main themes focused on navigating ethics protocols within institutions, practices to prepare for data collection, and a critical evaluation of the resources that can be applied to gaining consent and managing relationships. A range of methods and concrete steps that address ethical challenges are outlined to illustrate what can be done in practice to achieve authentic consent and appropriate participation.

Information and Communication Technology Use in Suicide Prevention: Scoping Review.

BackgroundThe use of information and communication technology (ICT) in suicide prevention has progressed rapidly over the past decade. ICT plays a major role in suicide prevention, but research on best and promising practices has been slow.ObjectiveThis paper aims to explore the existing literature on ICT use in suicide prevention to answer the following question: what are the best and most promising ICT practices for suicide prevention?MethodsA scoping search was conducted using the following databases: PubMed, PsycINFO, Sociological s, and IEEE Xplore. These databases were searched for articles published between January 1, 2013, and December 31, 2018. The five stages of the scoping review process were as follows: identifying research questions; targeting relevant studies; selecting studies; charting data; and collating, summarizing, and reporting the results. The World Health Organization suicide prevention model was used according to the continuum of universal, selective, and indicated prevention.ResultsOf the 3848 studies identified, 115 (2.99%) were selected. Of these, 10 regarded the use of ICT in universal suicide prevention, 53 referred to the use of ICT in selective suicide prevention, and 52 dealt with the use of ICT in indicated suicide prevention.ConclusionsThe use of ICT plays a major role in suicide prevention, and many promising programs were identified through this scoping review. However, large-scale evaluation studies are needed to further examine the effectiveness of these programs and strategies. In addition, safety and ethics protocols for ICT-based interventions are recommended.

Amelanotic B16-F10 Melanoma Compatible with Advanced Three-Dimensional Imaging Modalities

Amelanotic B16-F10 Melanoma Compatible with Advanced Three-Dimensional Imaging Modalities

Risk of Secondary Distress for Graduate Students Conducting Qualitative Research on Sensitive Subjects: A Scoping Review of Canadian Dissertations and Theses

Qualitative research, in the methods employed and topics explored, is emotionally demanding. While it is common for ethics protocols to protect research participants from emotional distress, the personal impact of emotional work on the researcher can often go unaddressed. Qualitative researchers, in particular graduate student researchers studying sensitive topics, are at risk of psychological effects. It is unclear, however, how this impact on the researcher is discussed in graduate student work and/or the steps taken to address this risk. To provide an overview of how impact on the researcher is considered in Canadian graduate student research, a comprehensive scoping review of dissertations was conducted. Less than 5% (n = 11) of dissertations reviewed included a plan to mitigate psychological risk to the researcher—suggesting a need for further guidance on minimizing risk of emotional distress. The application of trauma and violence-informed principles to graduate supervision policy and practice is discussed as a promising harm mitigation strategy.

Research Ethics, Open Science and CRIS

The purpose of this paper is to analyze how current research information systems (CRIS) take into account ethical issues, especially in the environment of open science. The analysis is based on a review of the literature on research information management, CRIS, open science and research ethics. The paper provides a framework for the assessment of CRIS on two levels: are CRIS (= their data model, format, functionalities, etc.) compliant with ethical requirements from the research community, funding bodies, government, etc., i.e., can they appropriately process data on research ethics (protocols, misconduct, etc.), and which are the ethical issues of the development, implementation and usage of CRIS? What is the impact of new ethical requirements from the open science movement, such as integrity or transparency? Can CRIS be considered as ethical infrastructures or “infraethics”? Concluding this analysis, the paper proposes an empirical approach for further investigation of this topic. The originality of the paper is that there are very few studies so far that assess the implications of research ethics and open science on the CRIS.

Researching Architecture and Urban Inequality: Toward Engaged Ethics

This paper reflects on approaches to conducting “ethical research” on architecture and urban (in)equality in cities in the global south. It focuses on two themes: the formalization of institutional ethics procedures and protocols for conducting such research, and the need to move away from ethical frameworks that emerge from western structures for knowledge production. The paper will question whether ethical principles are universal or specific, and how they affect the possibility of knowledge co-production and its potential to generate pathways to urban equality. These questions arise from the history of contemporary research ethics procedures, which are rooted in the social norms of western modernity that views researchers and research participants as “autonomous individuals.” The paper will suggest that exploring the relation of the individual to the collective and understanding social existence as relationality, is fundamental in formulating an alternative type of ethics methodology.

Predicting the risk of asthma attacks in children, adolescents and adults: protocol for a machine learning algorithm derived from a primary care-based retrospective cohort

IntroductionMost asthma attacks and subsequent deaths are potentially preventable. We aim to develop a prognostic tool for identifying patients at high risk of asthma attacks in primary care by leveraging...

Relational Autonomy as a Way to Recognise and Enhance Children’s Capacity and Agency to be Participatory Research Actors

ABSTRACTThere has been a marked increase in the active involvement of children and young people in social research. This move is underpinned by rights based arguments that children and young people should have a voice, and that this voice should be listened to. However, concerns have been raised about the appropriateness of children’s and young people’s rights and participation in research. This is primarily due to queries over whether they have enough capacity to enact the individual agency required to be rights holders and participate in research. In addition, a focus on their inherent vulnerability continues to be a key feature of research ethics protocols. In this paper I argue that both capacity and vulnerability should be seen as socially produced, meaning that the scope for capacity to be increased and vulnerability decreased also lies within the social. I draw from notions of relational autonomy or ‘associational presence’ to argue that what children and young people need to be active participants in research is the creation of spaces within which relational agency can be nurtured and sustained. Such techniques and values are found in participatory research approaches and can be used to create such emancipatory environments.

The Caenorhabditis elegans Model of Legionella Infection.

Caenorhabditis elegans can serve as a simple genetic host to study interactions between Legionellaceae and their hosts and to examine the contribution of specific gene products to virulence and immunity. C. elegans nematodes have several appealing attributes as a host organism; they are inexpensive, have robust genetic analysis tools, have a simple anatomy yet display a wide range of complex behaviors, and, as invertebrates, do not require animal ethics protocols. Use of C. elegans as a host model complements cell-based models, providing additional support and consistency of the experimental data obtained from multiple models. The C. elegans innate immune system functions similarly to that of the alveolar macrophage including the apoptosis [a.k.a. programmed cell death (PCD)] pathway located within the germline. The digestive tract of C. elegans is a primary interface between the innate immune system and bacterial pathogens. Thus, the C. elegans host model provides an alternative approach to investigate L. pneumophila immunopathogenesis, particularly in the view of the recent discovery of Legionella-containing vacuoles within the gonadal tissues of Legionella-colonized nematodes supporting the plausible evolutionary origin of the strategies employed by L. pneumophila to counteract macrophage cellular responses.

Ethical Issues in Integrated Health Care: Implications for Social Workers.

Integrated health care has come of age. What began modestly in the 1930s has evolved into a mature model of health care that is quickly becoming the standard of care. Social workers are now employed in a wide range of comprehensive integrated health care organizations. Some of these settings were designed as integrated health care delivery systems from their beginning. Others evolved over time, some incorporating behavioral health into existing primary care centers and others incorporating primary care into existing behavioral health agencies. In all of these contexts, social workers are encountering complex, sometimes unprecedented, ethical challenges. This article identifies and discusses ethical issues facing social workers in integrated health care settings, especially related to informed consent, privacy, confidentiality, boundaries, dual relationships, and conflicts of interest. The author includes practical resources that social workers can use to develop state-of-the-art ethics policies and protocols.

Children's perspectives on the benefits and burdens of research participation

ABSTRACTBackground: Participation in research is associated with benefits and burdens for individual research participants. Children living with a chronic illness are considered particularly vulnerable as they are already burdened with symptoms of their illness. In particular contexts, such as learning health care systems (LHS), where research and clinical care are integrated, children with chronic illnesses may be asked to participate in research related to their illness. A growing body of literature has focused on children's perspectives as research subjects; however, a relatively understudied aspect concerns children's experiences of research in clinics where they are also patients. Methods: We interviewed 25 Canadian children and adolescents living with inflammatory bowel disease (IBD) about their experiences of research participation. Results: Our participants described aspects of the research process and particular experiences as benefits and others as burdens. Benefits included helping others, receiving incentives, receiving the results of previous studies, and participating in fun activities. Burdens included the time required for particular types of research, physical and psychological discomfort, and feelings of obligation. Conclusions: Our study describes the experiences of children participating in research at a site that integrates research and clinical care. Our participants described experiences that often go unreported (such as feelings of obligation); we mention these as important considerations to be mindful of when interacting with children as (potential) research participants in an LHS and when thinking about research ethics protocols or the assent/consent process.

Evaluating innovation and navigating unseen boundaries: systems, processes and people

ABSTRACTThis paper illustrates an evaluation model emerging from Australian research. With reference to a range of contexts, its usefulness is demonstrated through application to two professional development initiatives designed to improve continuity of learning in the context of the transition to school. The model reconceptualises approaches to considering and reporting educational change. Responding to an Australian state government’s recognition that aspects of the transition to school process necessitated changed dialogue between teachers and educators in prior to school and the formal school sector, the research team facilitated two eight-month multi-site explorations of core concepts, philosophies and practices. Ethics protocols were followed throughout the collaborative project. While this research acknowledges Wenger’s (2009. ‘Social learning capability: Four essays on innovation and learning in social systems.’ Social Innovation, Sociedade e Trabalho. Booklets 12 – separate supplement, MTSS/GEP & EQUAL Portugal, Lisbon.) claim that ‘social learning capability’ is ‘the most fundamental aspect of the communities of practice approach’ [Omidvar, O., and R. Kislov. 2014. ‘The evolution of the communities of practice approach: Toward knowledgeability in a landscape of practice- An interview with Etienne Wenger-Trayner.’ Journal of Management Inquiry 23: 266–275., p.268], experience in this cross-sector initiative suggests that the intersections of relationship, facilitative infrastructure and ‘spirals of engagement’ [Fleet, A., and C. Patterson. 2001. ‘Professional growth reconceptualised: Early childhood staff searching for meaning.’ Early Childhood Research and Practice 3 (2), ERIC Number: ED458042.] are also key in educational change, and should thus be visible in an evaluation model.

University research ethics clearances: Safety nets, or a false sense of legal immunity?

Ethics reviews loom large in the world of a researcher at a university. Ethics committees review research project applications meticulously and critically. They attempt to ensure that in all projects that are approved, the human respondents and participants suffer no harm that could have been prevented. However, there seems to be little acknowledgement of the possible legal repercussions of unethical research conduct. This article investigates the protection that ethics review protocols (particularly in the human sciences) offer researchers and their institutions against legal ramifications emanating from research projects where participants do suffer harm. The main finding is that research ethics protocols may offer less protection against legal implications of ethical misconduct than would generally be thought to be the case. I will make some observations on liability, vicarious liability, and the basic rights of subjects in research, after which I will offer a conclusion on the implications of this analysis for ethics reviews.

Sustainable Development Dilemmas of Biofuels Research and Production

Global warming due to greenhouse gas emissions and the growing energy needs of the world, has forced the world into thinking differently about energy sources and sustainable development, giving rise to the field of biofuels. Research and introduction of new technologies do, by their very nature, look to bring about positive change in society. Often though, changes result in unintended, unexpected, unforeseen, unforeseeable and unaddressed consequences. It often becomes the role of ethics protocols to militate against these negative consequences. In trying to establish the levels of awareness among South African researchers and producers of biofuels, to the sustainable development dilemmas brought about by their work; the “Five Capitals Framework” and a research ethics protocol, research was carried out at three South African businesses, generating data from interviews and collaborating with data from company publications. The study concluded that industry was indeed aware of the dilemmas that face their industry albeit that it was not in the context of a defined necessary framework.

Why female sex workers participate in HIV research: the illusion of voluntariness

ABSTRACTThe purpose of this study was to examine factors influencing the motivation for and perceived voluntariness of participation in non-intervention HIV research among female sex workers (FSW) in India. FSW (n = 30) who participated in non-intervention HIV studies in the previous three years were recruited from a local community-based organization. Semi-structured qualitative interviews focused on women’s personal and economic motivations for participation and their perceptions of the informed consent process. Interviews were audio-recorded, translated, transcribed, and reviewed for common themes. Content analysis indicated that while many women reported willing participation, reports of obligatory participation were also a common theme. Obligations included money-related pressures and coercion by other FSW, social pressures, not wanting to disappoint the researchers, and perceiving that they had a contractual agreement to complete participation as a result of signing the consent form. Findings suggest a need for additional efforts during and following informed consent to prevent obligatory participation in HIV research studies among FSW. Findings emphasize the importance of integrating ongoing participant feedback into research ethics practices to identify issues not well addressed via standard ethics protocols when conducting HIV research among vulnerable populations.

The management of the patient with non-variceal upper gastrointestinal bleeding: from evidence to clinical practice

A multidisciplinary group of 7 experts developed this update and expansion of the recommendations on the management of acute non-variceal upper gastrointestinal bleeding (NVUGIH) from guidelines published from 2013. The Appraisal of Guidelines for Research and Evaluation (AGREE) process and independent ethics protocols were used. Sources of data included original and published systematic reviews. Recommendations emphasize early risk stratification, by using validated prognostic scales, and early endoscopy (within 24 hours). Endoscopic hemostasis remains indicated for high-risk lesions, whereas data support attempts to dislodge clots with hemostatic, pharmacologic, or combination treatment of the underlying stigmata. Clips or thermo-coagulation, alone or with epinephrine injection, are effective methods. Second-look endoscopy may be useful in selected high-risk patients, but is not routinely recommended. Intravenous high-dose PPI therapy after successful endoscopic hemostasis decreases both rebleeding and mortality in patients with high-risk stigmata. Although selected patients can be discharged promptly after endoscopy, high-risk patients should be hospitalized for at least 72 hours after endoscopic hemostasis. For patients with UGIH who require a nonsteroidal anti-inflammatory drug, a PPI is preferred to reduce the rebleeding. Patients with NVUGIH needing secondary cardiovascular prophylaxis should start receiving acetylsalicylic acid (ASA) again as soon as cardiovascular risks outweigh gastrointestinal risks (usually within 7 days).

Paying patient and caregiver research participants: putting theory into practice.

To review and discuss the ethical and practical considerations about paying patient and caregiver participants in nursing research and, based on this review, to develop a set of guiding principles about payment of participants. To increase recruitment and retention, it is becoming increasingly common in nursing research to provide some form of payment to participants. The risk is that the promise of a payment may influence a patient or caregiver's decision to participate in research. However, research ethics protocols seldom provide explicit guidance about paying participants. Even where formal policies or fee schedules exist, there is little consistency in determining how payments should be calculated or administered. This has resulted in highly variable payment practices between locations, disciplines and institutions. Discussion paper. PubMed, MEDLINE with Full Text, CINAHL and Health Source (Nursing/Academic Edition) were searched for terms related to paying research participants published between 2000 - August 2016. Nurse researchers must comply with international, national and institutional ethical standards. Important ethical and practical considerations should guide the decision-making process about whether to pay research participants and how to determine the nature or value of the payment. Guiding principles can support researchers by highlighting key factors that may direct their decision-making in this regard. A deeper understanding of the fundamental ethical and practical considerations is needed to support researchers in their deliberations about paying participants in nursing research.

The Development of Research Ethics Involving Indigenous People in Taiwan: A Brief Introduction

Adhering to ethics protocols has become increasingly important in the process of doing research in Taiwan since the introduction of research-ethics mechanisms. Adhering to these protocols affects research on Taiwan's indigenous peoples due to the vulnerability of indigenous groups and to their increasing rights consciousness. The present paper explains the context of group rights from a national self-determination perspective and then discusses the current indigenous research-ethics mechanisms in Taiwan. The ethical guidelines for indigenous research in Canada, TCPS2 2014-Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans are referenced as a model for protocols that may foster positive and mutually trusting relationships between academic researchers and indigenous communities in Taiwan.

Governing Well in Community-Based Research: Lessons from Canada's HIV Research Sector on Ethics, Publics and the Care of the Self.

In this paper, we extend Michel Foucault's final works on the 'care of the self' to an empirical examination of research practice in community-based research (CBR). We use Foucault's 'morality of behaviors' to analyze interview data from a national sample of Canadian CBR practitioners working with communities affected by HIV. Despite claims in the literature that ethics review is overly burdensome for non-traditional forms of research, our findings suggest that many researchers using CBR have an ambivalent but ultimately productive relationship with institutional research ethics review requirements. They understand and use prescribed codes, but adapt them in practice to account for the needs of participating community members, members of their research teams and the larger communities with whom they work. Complying with ethics protocols was seen as only the beginning, a minimum standard; our research suggests that the real ethical work happens in the field, where CBR practitioners encounter community members in diverse public roles and must forge ethical consensus across communities. CBR represents an ethical terrain in which practitioners challenge themselves to work differently, and as a result they care for themselves-and others-in ways that often resist the propensity for domination through public health research. '…there are different ways to "conduct oneself" morally, different ways for the acting individual to operate, not just as an agent, but as an ethical subject of action.' (Foucault, 1985: 26).

MP37-18 EVALUATING PATTERNS OF TESTOSTERONE PRESCRIPTION AMONG 40,878 USERS IN BRITISH COLUMBIA BETWEEN 1997-2013

You have accessJournal of UrologyGeneral & Epidemiological Trends & Socioeconomics: Practice Patterns, Quality of Life and Shared Decision Making IV1 Apr 2016MP37-18 EVALUATING PATTERNS OF TESTOSTERONE PRESCRIPTION AMONG 40,878 USERS IN BRITISH COLUMBIA BETWEEN 1997-2013 Jennifer Locke, Ryan Flannigan, Hao Luo, Mahyar Etminan, Ted Hoyda, and S. Larry Goldenberg Jennifer LockeJennifer Locke More articles by this author , Ryan FlanniganRyan Flannigan More articles by this author , Hao LuoHao Luo More articles by this author , Mahyar EtminanMahyar Etminan More articles by this author , Ted HoydaTed Hoyda More articles by this author , and S. Larry GoldenbergS. Larry Goldenberg More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.1695AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Testosterone therapy (TRT) is FDA approved for symptomatic primary or secondary hypogonadism. However, an increase in off-label TRT supplementation is occurring in men despite lack of efficacy and safety data. Furthermore, the associations between TRT and comorbid diseases such as cardiovascular disease, diabetes and prostate cancer (CaP), have not been well characterized in this population. METHODS All prescriptions for TRT between 1997 and 2013 were identified from the longitudinal British Columbian (pharmacy) PharmaNet database. Descriptive statistics were used to examine demographic and utilization information of men with TRT prescriptions using the longitudinal inpatient (discharge abstract database) DAD and outpatient (medical services plan) MSP databases. This was completed in accordance with UBC ethics protocols. RESULTS 40,878 patients prescribed TRT within the study period of 16 years were evaluated. The majority of TRT were prescribed by general practitioners (92.0%) with few prescriptions by urologists (7.6%), internists (4.7%) and endocrinologists (4.1%),. The number of prescriptions per year increased 7-fold over the 16-year period, specifically in men aged 51-61 (from 2,205 to 16,066) and 61-71 (from 2,025 to 14,541). 74% of men received more than one TRT prescription and most (76%) changed the route of TRT administration over the course of their treatment. Injections were the most common route of administration, followed by capsules, then gels. The mean duration of TRT use was 518 days (SD +/- 821 days). Men prescribed TRTs had a baseline prevalence of CaP in 1.1%, diabetes in 36.9%, myocardial infarctions in 9.9%, and arterial embolism or thrombosis in 0.2% of men. CONCLUSIONS We have characterized the longitudinal TRT patterns in a population of 40,878 TRT users. Despite the lack of efficacy and safety data there were annual increases in the prescription numbers. The most popular route of administration was injections. TRT use occurred in many men with baseline cardiovascular disease and CaP. Future work will aim to investigate TRT use in relation to pre, intra, and post-treatment serum TRT levels, cardiovascular events, diabetes and prostate diagnoses. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e504 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Jennifer Locke More articles by this author Ryan Flannigan More articles by this author Hao Luo More articles by this author Mahyar Etminan More articles by this author Ted Hoyda More articles by this author S. Larry Goldenberg More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...