Ethical Issues in Research: Perceptions of Researchers, Research Ethics Board Members and Research Ethics Experts.

In the context of academic research, a diversity of ethical issues, conditioned by the different roles of members within these institutions, arise. Previous studies on this topic addressed mainly the perceptions of researchers. However, to our knowledge, no studies have explored the transversal ethical issues from a wider spectrum, including other members of academic institutions as the research ethics board (REB) members, and the research ethics experts. The present study used a descriptive phenomenological approach to document the ethical issues experienced by a heterogeneous group of Canadian researchers, REB members, and research ethics experts. Data collection involved socio-demographic questionnaires and individual semi-structured interviews. Following the triangulation of different perspectives (researchers, REB members and ethics experts), emerging ethical issues were synthesized in ten units of meaning: (1) research integrity, (2) conflicts of interest, (3) respect for research participants, (4) lack of supervision and power imbalances, (5) individualism and performance, (6) inadequate ethical guidance, (7) social injustices, (8) distributive injustices, (9) epistemic injustices, and (10) ethical distress. This study highlighted several problematic elements that can support the identification of future solutions to resolve transversal ethical issues in research that affect the heterogeneous members of the academic community.

Bio-Ethics and One Health: A Case Study Approach to Building Reflexive Governance.

Surveillance programs supporting the management of One Health issues such as antibiotic resistance are complex systems in themselves. Designing ethical surveillance systems is thus a complex task (retroactive and iterative), yet one that is also complicated to implement and evaluate (e.g., sharing, collaboration, and governance). The governance of health surveillance requires attention to ethical concerns about data and knowledge (e.g., performance, trust, accountability, and transparency) and empowerment ethics, also referred to as a form of responsible self-governance. Ethics in reflexive governance operates as a systematic critical-thinking procedure that aims to define its value: What are the "right" criteria to justify how to govern "good" actions for a "better" future? The objective is to lay the foundations for a methodological framework in empirical bioethics, the rudiments of which have been applied to a case study to building reflexive governance in One Health. This ongoing critical thinking process involves "mapping, framing, and shaping" the dynamics of interests and perspectives that could jeopardize a "better" future. This paper proposes to hybridize methods to combine insights from collective deliberation and expert evaluation through a reflexive governance functioning as a community-based action-ethics methodology. The intention is to empower individuals and associations in a dialogue with society, which operation is carried out using a case study approach on data sharing systems. We based our reasoning on a feasibility study conducted in Québec, Canada (2018-2021), envisioning an antibiotic use surveillance program in animal health for 2023. Using the adaptive cycle and governance techniques and perspectives, we synthesize an alternative governance model rooted in the value of empowerment. The framework, depicted as a new "research and design (R&D)" practice, is linking operation and innovation by bridging the gap between Reflexive, Evaluative, and Deliberative reasonings and by intellectualizing the management of democratizing critical thinking locally (collective ethics) by recognizing its context (social ethics). Drawing on the literature in One Health and sustainable development studies, this article describes how a communitarian and pragmatic approach can broaden the vision of feasibility studies to ease collaboration through public-private-academic partnerships. The result is a process that "reassembles" the One Health paradigm under the perspective of global bioethics to create bridges between the person and the ecosystem through pragmatic ethics.

Colombian adolescents' preferences for independently accessing sexual and reproductive health services: A cross-sectional and bioethics analysis.

OBJECTIVE: Our study sought to (1) describe the practices and preferences of Colombian adolescents in accessing sexual and reproductive health services: accompanied versus alone; (2) compare actual practices with stated preferences; and (3) determine age and gender differences regarding the practice and these stated preferences. METHODS: 812 participants aged 11-24 years old answered a survey in two Profamilia clinics in the cities of Medellin and Cali in Colombia. A cross-sectional analysis was performed to compare participants' answers based on the variables of gender and age. RESULTS: A quarter of participants visited the clinic alone (25.4%). Females were more likely to go alone in comparison to males (26.3% vs 14.1%; p = 0.031), and older participants went alone more often than younger participants (p < 0.001). Most participants - 72.7% (95 %CI: 69.3-75.9) - expressed a preference in being accompanied to the clinic, and more than 90% had their preferences met. The preferences of older participants were, however, less likely to be met than those of younger participants (p < 0.001), notably, because they predominantly wanted to be accompanied. CONCLUSION: Contemporary public health and bioethics literature advocates in favor of developing health services that better meet the preferences of adolescents. The present research highlights an apparent blind spot related to the role that others (e.g., parents, friends, partners) can or should play in accompanying adolescent patients when they access sexual and reproductive health services. Respecting adolescents' preferences, and hence their autonomy, is not simply a matter of ensuring freedom from constraints (e.g., their right and ability to go alone). Rather, it should also consider the liberty to choose whether to be accompanied when accessing SHRS and by whom.

Making Decisions about Service Provision for Clients with Low Back Pain: Perspectives of Canadian Physiotherapy Professionals.

Purpose: This study identified the individuals responsible for making decisions about physiotherapy (PT) wait time, frequency of treatment, and treatment duration for persons with low back pain and determined which factors guided these decisions. Method: A cross-sectional survey was sent to Canadian PT professionals treating adult patients with musculoskeletal problems. It included a clinical vignette describing a patient with low back pain. Respondents were asked who made decisions about wait time, treatment frequency, and treatment duration as well as on which factors they based these decisions. Results: Clinicians were most often responsible for making decisions about treatment frequency and duration. Although clinicians and managers or coordinators were mainly responsible for making decisions about wait time, there was more variability depending on sector of care: in the private sector, administrative assistants played a much larger role. Clinical judgment, clinical guidelines, and patients' demands were the predominant factors influencing wait time and frequency decisions. Treatment duration was related to patients' goals, clinical progression, patients' motivation, and patients' return to work. Conclusions: Decisions about service provision for wait times are made by a range of stakeholders, and a wide variety of factors guide Canadian PT professionals' decision making. Identifying these factors is essential for informing a discussion of decisions about evidence-based and equitable service delivery so that the actors involved can reach a consensus.

Objectif : établir quelles sont les personnes responsables de prendre des décisions au sujet des temps d'attente et de la fréquence et de la durée des traitements en physiothérapie pour les personnes souffrant de douleurs lombaires, et déterminer quels facteurs orientent ces décisions. Méthodologie : les professionnels canadiens en physiothérapie qui traitaient des patients adultes atteints de problèmes musculosquelettiques ont reçu un sondage transversal, qui comprenait une mise en situation clinique décrivant un patient souffrant de douleurs lombaires. Les répondants devaient indiquer qui prenait les décisions au sujet des temps d'attente et de la durée et de la fréquence des traitements et sur quels facteurs reposaient ces décisions. Résultats : la plupart du temps, les cliniciens étaient responsables de prendre les décisions relatives à la fréquence et la durée des traitements. Même si la prise de décision sur les temps d'attente incombait surtout aux cliniciens et aux gestionnaires ou aux coordonnateurs, les responsabilités étaient plus variables en fonction du secteur de soins. En effet, dans le secteur privé, les adjoints administratifs jouaient un rôle beaucoup plus important à cet égard. Le jugement clinique, les directives cliniques et les demandes des patients étaient les principaux facteurs qui influaient sur les décisions en matière de temps d'attente et de fréquence. La durée des traitements dépendait des objectifs des patients, de leur progression clinique, de leur motivation et de leur retour au travail. Conclusions : de nombreux intervenants prennent les décisions sur le temps d'attente avant l'obtention des services, et toute une série de facteurs oriente les décisions des professionnels canadiens en physiothérapie. Il est essentiel de connaître ces facteurs pour éclairer les échanges sur les décisions relatives à une prestation de services équitable et fondée sur des données probantes, afin que toutes les personnes visées parviennent à un consensus.

COVID-19 and Moral Imperialism in Multinational Clinical Research.

A TV debate in April 2020 between two French doctors regarding the benefits of testing a coronavirus vaccine in Africa where there are no masks or treatments available has led to international criticism. This case highlights a problematic ethical double standard in multinational clinical research: trials that would be considered unethical in high income countries (e.g., placebo-controlled where there is an existing treatment) are nonetheless justified in low-and-middle-income countries because the existing standards of care are less (i.e., no access to a treatment). Underlying this ethical double standard in some multinational clinical trials is a moral imperialism and persistent colonialist thinking that must be rejected.

Misconduct and Misbehavior Related to Authorship Disagreements in Collaborative Science.

Scientific authorship serves to identify and acknowledge individuals who "contribute significantly" to published research. However, specific authorship norms and practices often differ within and across disciplines, labs, and cultures. As a consequence, authorship disagreements are commonplace in team research. This study aims to better understand the prevalence of authorship disagreements, those factors that may lead to disagreements, as well as the extent and nature of resulting misbehavior. Methods include an international online survey of researchers who had published from 2011 to 2015 (8364 respondents). Of the 6673 who completed the main questions pertaining to authorship disagreement and misbehavior, nearly half (46.6%) reported disagreements regarding authorship naming; and discipline, rank, and gender had significant effects on disagreement rates. Paradoxically, researchers in multidisciplinary teams that typically reflect a range of norms and values, were less likely to have faced disagreements regarding authorship. Respondents reported having witnessed a wide range of misbehavior including: instances of hostility (24.6%), undermining of a colleague's work during meetings/talks (16.4%), cutting corners on research (8.3%), sabotaging a colleague's research (6.4%), or producing fraudulent work to be more competitive (3.3%). These findings suggest that authorship disputes may contribute to an unhealthy competitive dynamic that can undermine researchers' wellbeing, team cohesion, and scientific integrity.

Researchers' Perceptions of Ethical Authorship Distribution in Collaborative Research Teams.

Authorship is commonly used as the basis for the measurement of research productivity. It influences career progression and rewards, making it a valued commodity in a competitive scientific environment. To better understand authorship practices amongst collaborative teams, this study surveyed authors on collaborative journal articles published between 2011 and 2015. Of the 8364 respondents, 1408 responded to the final open-ended question, which solicited additional comments or remarks regarding the fair distribution of authorship in research teams. This paper presents the analysis of these comments, categorized into four main themes: (1) disagreements, (2) questionable behavior, (3) external influences regarding authorship, and (4) values promoted by researchers. Results suggest that some respondents find ways to effectively manage disagreements in a collegial fashion. Conversely, others explain how distribution of authorship can become a "blood sport" or a "horror story" which can negatively affect researchers' wellbeing, scientific productivity and integrity. Researchers fear authorship discussions and often try to avoid openly discussing the situation which can strain team interactions. Unethical conduct is more likely to result from deceit, favoritism, and questionable mentorship and may become more egregious when there is constant bullying and discrimination. Although values of collegiality, transparency and fairness were promoted by researchers, rank and need for success often overpowered ethical decision-making. This research provides new insight into contextual specificities related to fair authorship distribution that can be instrumental in developing applicable training tools to identify, prevent, and mitigate authorship disagreement.

Towards an Integration of PrEP into a Safe Sex Ethics Framework for Men Who Have Sex with Men.

The ethics of safe sex in the gay community has, for many years, been focused on debates surrounding the responsibility (or lack thereof) regarding the use of condoms to prevent HIV transmission, once the only tool available. With the development of Truvada as a pre-exposure prophylaxis (PrEP) for HIV, for the first time in the history of the HIV/AIDS epidemic there is the potential to significantly reduce the risk of HIV transmission during sex without the use of condoms (without taking into consideration 'treatment as prevention' with HIV-positive people). The introduction of PrEP necessitates a renewed discussion about the politics and ethics of safe sex for men who have sex with men (MSM). We present the arguments of authors who hold radically opposite positions with regard to the ethics of condom use by gay men, but who currently both criticize the use of PrEP. We offer a critique of their arguments and advance the position that the use of PrEP, even without condoms, can be acceptable and part of a safe sex ethics framework for MSM.

Conflicts of interest and the (in)dependence of experts advising government on immunization policies.

There has been increasing attention to financial conflicts of interest (COI) in public health research and policy making, with concerns that some decisions are not in the public interest. One notable problematic area is expert advisory committee (EAC). While COI management has focused on disclosure, it could go further and assess experts' degree of (in)dependence with commercial interests. We analyzed COI disclosures of members of Québec's immunization EAC (in Canada) using (In)DepScale, a tool we developed for assessing experts' level of (in)dependence. We found great variability of independence with industry and that companies with the highest vaccine sales were predominantly associated with disclosed COIs. We argue that EACs can use the (In)DepScale to better assess and disclose the COIs that affect their experts. Going forward our scale could help manage risk and select members who are less conflicted to foster a culture of transparency and trust in advisors and policy-makers.

Validation d'un questionnaire auto-administré sur les valeurs en politique publique de santé.

OBJECTIVES: The aims of this article are to describe the development of a self-administered questionnaire assessing the core values in the field of public health ( radardesvaleurs.com ) and to report the results of a study testing the questionnaire's test-retest reliability, internal consistency and construct validity. METHOD: A 24-item questionnaire grounded in the conceptual framework of Shalom H. Schwartz (2000) was developed by a group of international experts in public health. Six scores were generated, each linked to a specific value and put on three axes: individualism-equity, autonomy-conformity and risk-security. The questionnaire was submitted to students attending the School of Public Health of the Université de Montréal (ESPUM) (n = 700). A total of 401 students completed the questionnaire, 52 of whom completed it again one month later. RESULTS: For the test-retest reliability, all percentages of agreement were equal or superior to 60% except for a single question (50%). All Cohen's kappa coefficients of individual items were strong (> 0.60) except for three questions which presented a very high percentage of agreement. The Intraclass Correlation coefficients of the values' scores varied between 0.27 and 0.77. The three axes' internal consistency was estimated by Cronbach's alphas (between 0.46 and 0.74). The exploratory factorial analysis only partially confirmed the questionnaire's theoretical structure. CONCLUSION: Despite the limits of the results, the questionnaire has an interesting level of reliability and validity, which makes its pedagogical use pertinent to pursue. The limitation to four items/value, as well as the representativeness of the sampling (ESPUM students), could explain certain empirical shortcomings of the questionnaire.

Conflicts of interest policies for authors, peer reviewers, and editors of bioethics journals.

BACKGROUND: In biomedical research, there have been numerous scandals highlighting conflicts of interest (COIs) leading to significant bias in judgment and questionable practices. Academic institutions, journals, and funding agencies have developed and enforced policies to mitigate issues related to COI, especially surrounding financial interests. After a case of editorial COI in a prominent bioethics journal, there is concern that the same level of oversight regarding COIs in the biomedical sciences may not apply to the field of bioethics. In this study, we examined the availability and comprehensiveness of COI policies for authors, peer reviewers, and editors of bioethics journals. METHODS: After developing a codebook, we analyzed the content of online COI policies of 63 bioethics journals, along with policy information provided by journal editors that was not publicly available. RESULTS: Just over half of the bioethics journals had COI policies for authors (57%), and only 25% for peer reviewers and 19% for editors. There was significant variation among policies regarding definitions, the types of COIs described, the management mechanisms, and the consequences for noncompliance. Definitions and descriptions centered on financial COIs, followed by personal and professional relationships. Almost all COI policies required disclosure of interests for authors as the primary management mechanism. Very few journals outlined consequences for noncompliance with COI policies or provided additional resources. CONCLUSION: Compared to other studies of biomedical journals, a much lower percentage of bioethics journals have COI policies and these vary substantially in content. The bioethics publishing community needs to develop robust policies for authors, peer reviewers, and editors and these should be made publicly available to enhance academic and public trust in bioethics scholarship.

Big Data in Drug Discovery.

Interpretation of Big Data in the drug discovery community should enhance project timelines and reduce clinical attrition through improved early decision making. The issues we encounter start with the sheer volume of data and how we first ingest it before building an infrastructure to house it to make use of the data in an efficient and productive way. There are many problems associated with the data itself including general reproducibility, but often, it is the context surrounding an experiment that is critical to success. Help, in the form of artificial intelligence (AI), is required to understand and translate the context. On the back of natural language processing pipelines, AI is also used to prospectively generate new hypotheses by linking data together. We explain Big Data from the context of biology, chemistry and clinical trials, showcasing some of the impressive public domain sources and initiatives now available for interrogation.

Getting Digital Assets from Public-Private Partnership Research Projects through "The Valley of Death," and Making Them Sustainable.

Projects in public-private partnerships, such as the Innovative Medicines Initiative (IMI), produce data services and platforms (digital assets) to help support the use of medical research data and IT tools. Maintaining these assets beyond the funding period of a project can be a challenge. The reason for that is the need to develop a business model that integrates the perspectives of all different stakeholders involved in the project, and these digital assets might not necessarily be addressing a problem for which there is an addressable market of paying customers. In this manuscript, we review four IMI projects and the digital assets they produced as a means of illustrating the challenges in making digital assets sustainable and the lessons learned. To progress digital assets beyond proof-of-concept into widely adopted tools, there is a need for continuation of multi-stakeholder support tailored to these assets. This would be best done by implementing a structure similar to the accelerators that are in place to help transform startup businesses into growing and thriving businesses. The aim of this article is to highlight the risk of digital asset loss and to provoke discussion on the concept of developing an "accelerator" for digital assets from public-private partnership research projects to increase the chance that digital assets will be sustained and continue to add value long after a project has ended.

Supporting ethics educators in Canadian occupational therapy and physical therapy programs: A national interprofessional knowledge exchange project.

Ethics education is the cornerstone of professional practice, fostering knowledge and respect for core ethical values among healthcare professionals. Ethics is also a subject well-suited for interprofessional education and collaboration. However, there are few initiatives to gather experiences and share resources among ethics educators in rehabilitation. We thus undertook a knowledge exchange project to: 1) share knowledge about ethics training across Canadian occupational and physical therapy programs, and 2) build a community of educators dedicated to improving ethics education. The objectives of this paper are to describe this interprofessional knowledge exchange project involving ethics educators (with a diversity of professional and disciplinary backgrounds) from Canadian occupational and physical therapy programs as well as analyze its outcomes based on participants' experiences/perceptions. Two knowledge exchange strategies were employed: an interactive one-day workshop and a wiki platform. An immediate post-workshop questionnaire evaluated the degree to which participants' expectations were met. Structured telephone interviews 9-10 months after the workshop collected participants' perceptions on whether (and if so, how) the project influenced their teaching or led to further interprofessional collaborations. Open-ended questions from the post-workshop questionnaires and individual interviews were analyzed using qualitative methods. Of 40 ethics educators contacted, 23 participated in the workshop and 17 in the follow-up interview. Only 6 participants logged into the wiki from its launch to the end of data collection. Five themes emerged from the qualitative analysis: 1) belonging and networking; 2) sharing and collaborating; 3) changing (or not) ways of teaching ethics; 4) sustaining the network; and 5) envisioning the future of ethics education. The project attained many of its goals, despite encountering some challenges. While the wiki platform proved to be of limited benefit in advancing the project goals, the interactive format and collaborative nature of the one-day workshop were described as rewarding and effective in bringing together occupational therapy and physical therapy educators to meet, network, and share knowledge.

Operationalizing wait lists: Strategies and experiences in three hospital outpatient physiotherapy departments in Montreal.

In Canada, limited resources and increasing demand place pressure on the public healthcare system, something that is likely to increase. In this context, wait lists in outpatient physiotherapy departments (OPD) will get longer, system inefficiencies will arise, and frustrations and ethical concerns will be experienced by patients and staff. To better understand the perceptions of OPD staff regarding priority setting, treatment frequency, treatment duration, and wait list management strategies, we conducted an Interpretive Description study involving semi-structured interviews in three OPDs in Montreal. Participants discussed factors that influenced their decision making about who was prioritized to receive care, strategies that were used to respond to an imbalance between needs and resources in the OPDs and procedures to manage wait lists to help improve access to care. While clinical needs are central in approaches to prioritization, other non-clinical factors relating to the patient, the physiotherapist, and the institution also influence decisions. We examine these findings through the lens of complexity theory, providing insight into opportunities and obstacles for the implementation of management strategies in OPDs. These strategies will need to be carefully evaluated in order to create evidence-based guidelines for wait list management in other settings.

Ethical Challenges for Patient Access to Physical Therapy: Views of Staff Members from Three Publicly-Funded Outpatient Physical Therapy Departments.

Demographic change and changing population needs are important drivers of increased demand for rehabilitation. These developments place significant stress on access to physical therapy services, as current resources are insufficient to meet the growing demand. This situation presents ethical challenges for physical therapists and others involved in managing wait lists and prioritizing access to services. The purpose of this study is to explore how outpatient physical therapy department (OPD) staff experience ethical issues relating to access to physical therapy services. We conducted semi-structured interviews with 13 participants who were staff at three publicly-funded OPDs in Montreal, Quebec, Canada. Using interpretive description methodology, we developed four themes related to access to physical therapy services: 1) negotiating access to physical therapy services; 2) navigating a complex system with outside influences and constraints, such as professional regulation and third-party payers; 3) managing wait lists responsibly; and 4) striving to be a good professional in a non-ideal world. Across the four themes, two main sources of tension that influence the staff were identified in relation to the experience of wait list management: responsibility and power. This study highlights how difficult it is for OPD staff to balance competing interests and values, and to respond to outside influences, when making resource allocation decisions. Until resource limitations are addressed, wait lists may be an unavoidable feature of many OPDs in the Canadian public health care system. Improving fairness in the access to and distribution of services is thus important in ensuring that professionals are able to treat patients based on their clinical needs, and in a timely fashion.

Low Back Pain: Investigation of Biases in Outpatient Canadian Physical Therapy.

BACKGROUND: Previous research suggested that physical therapy services can be influenced by patient characteristics (age, sex, socioeconomic status) or insurance status rather than their clinical need. OBJECTIVE: The aim of this study was to determine whether patient-related factors (age, sex, SES) and the source of reimbursement for physical therapy services (insurance status) influence wait time for, frequency of, and duration of physical therapy for low back pain. DESIGN: This study was an empirical cross-sectional online survey of Canadian physical therapy professionals (defined as including physical therapists and physical rehabilitation specialists). METHODS: A total of 846 physical therapy professionals received 1 of 24 different (and randomly selected) clinical vignettes (ie, patient case scenarios) and completed a 40-item questionnaire about how they would treat the fictional patient in the vignette as well as their professional clinical practice. Each vignette described a patient with low back pain but with variations in patient characteristics (age, sex, socioeconomic status) and insurance status (no insurance, private insurance, Workers' Compensation Board insurance). RESULTS: The age, sex, and socioeconomic status of the fictional vignette patients did not affect how participants would provide service. However, vignette patients with Workers' Compensation Board insurance would be seen more frequently than those with private insurance or no insurance. When asked explicitly, study participants stated that insurance status, age, and chronicity of the condition were not factors associated with wait time for, frequency of, or duration of treatment. LIMITATIONS: This study used a standardized vignette patient and may not accurately represent physical therapy professionals' actual clinical practice. CONCLUSIONS: There appears to be an implicit professional bias in relation to patients' insurance status; the resulting inequity in service provision highlights the need for further research as a basis for national guidelines to promote equity in access to and provision of quality physical therapy services.