Ethics Approval Processes Research Articles

Barriers and hurdles delaying governance approval for an ethically approved nationwide clinical trial in pancreatic cancer.

Streamlined, expedited clinical research is fundamental to rapidly test, translate and implement novel treatments into routine care to improve patient outcomes. The National Mutual Acceptance (NMA) scheme was designed to expedite the ethics approval process, however, growing concerns exist about the fragmented time-consuming governance process needed to actually commence clinical research in Australia. This study reports hurdles and barriers encountered while seeking governance approval for the SCANPatient trial. SCANPatient is a nationwide multi-centre trial comparing standard narrative radiological reporting of CT scans for suspected pancreatic ductal adenocarcinoma. with an alternative structured approach. SCANPatient was approved by a national Human Research Ethics Committee under the NMA. The documents, time, costs and platforms required to obtain governance approval and open the trial at 30 participating hospitals were analysed. Wide variation exists in research governance office (RGO) requirements for local approval, resulting in extra costs (>$117 000), delays of up to 4 months in commencing the trial at some participating sites, unplanned adjustment of the study design, and ultimately the loss of several potential sites. There were inconsistencies among RGOs minimum requirements and processes across jurisdictions and sites, with delays in obtaining approval signatures, time-consuming processes, differing platforms used to submit governance reviews and inflexibility of RGO processes all contributing to delays in progressing the trial and obtaining governance approval. The current governance process is time- and cost-consuming and undermines the NMA scheme's efforts to streamline the clinical trials review process.

When Ethics Becomes Unethical: An Autoethnographic Account of Gaining Ethics Approval to Conduct Ethnography in a Healthcare Setting

AbstractMany ethnographic researchers have raised concerns over the potential impacts that the institutionalization of ethics review boards can have on social science research, especially within healthcare settings. However, few articles to-date have documented how these norms and practices play out in actuality. This paper, therefore, uses autoethnography to provide an account of three ethical challenges that arose during my process of seeking ethics approval through institutional review boards to conduct ethnographic fieldwork in a healthcare setting. In doing so, I demonstrate how bureaucratic accountability took precedence over my research expertise, making the research that I initially set out to do inaccessible, questionable, and ‘unethical’, despite being carried out in accordance with the current standards governing research involving human participants and their data. I conclude with ways to move beyond this existing ethics structure towards a more collaborative approach between ethics boards, researchers, and research participants grounded within the realities of the field.

Challenges and opportunities of translating animal research into human trials in Ethiopia

Background and objectivesAlthough the goal of translational research is to bring biomedical knowledge from the laboratory to clinical trial and therapeutic products for improving health, this goal has not been well achieved as often as desired because of many barriers documented in different countries. Therefore, the aim of this study was to investigate the challenges and opportunities of translating animal research into human trials in Ethiopia.MethodsA descriptive qualitative study, using in-depth interviews, was conducted in which preclinical and clinical trial researchers who have been involved in animal research or clinical trials as principal investigator were involved. Data were analyzed using inductive thematic process.ResultsSix themes were emerged for challenges: lack of financial and human capacity, inadequate infrastructure, operational obstacles and poor research governance, lack of collaboration, lack of reproducibility of results and prolonged ethical and regulatory approval processes. Furthermore, three themes were synthesized for opportunities: growing infrastructure and resources, improved human capacity and better administrative processes and initiatives for collaboration.Conclusion and recommendationsThe study found that the identified characteristics/features are of high importance either to hurdle or enable the practice of translating animal research into human trials. The study suggests that there should be adequate infrastructure and finance, human capacity building, good research governance, improved ethical and regulatory approval process, multidisciplinary collaboration, and incentives and recognition for researchers to overcome the identified challenges and allow translating of animal research into human trials to proceed more efficiently.

Polymedia Literacy and Other Ethical Considerations for Online Ethnographic Research on Social Networking Sites.

Drawing on the authors' own ethnographic research, this article discusses the importance of developing polymedia literacy as a key step toward ethical online research on social networking sites (SNS). Polymedia literacy entails the ability to critically analyze the vast landscape of SNS, their affordances, and users' social motivations for choosing specific SNS for their interactions. Internet researchers face several ethical challenges, including issues of informed consent, "public" and "private" online spaces, and data protection. Even when research ethics committees waive the need for a formal ethics approval process, researchers of online spaces need to ensure that their studies are conducted and presented in an ethical and responsible manner. This is particularly important in research contexts that pertain to vulnerable populations in online communities.

Exploring the perceptions of faculty members about research courses in undergraduate pharmacy curriculum: A qualitative study.

The commitment of pharmacy graduates to patient care and research is crucial to advancing pharmaceutical science and practice. Consequently, the value of involving undergraduate pharmacy students in research has been increasingly recognized. Given that the College of Pharmacy at Qatar University offers two undergraduate pharmacy research courses, it is relevant to explore the perception of faculty members of the delivery, impact, facilitators, barriers, and suggested improvements in these courses. This exploration will help to improve the existing curriculum and to highlight the prospective impact of student involvement in undergraduate pharmacy research courses on the personal and professional growth of students, as well as on the progressive evolution of the pharmacy profession. A qualitative exploratory case study was performed in which five virtual focus groups were conducted. All eligible faculty members from the clinical pharmacy and pharmaceutical science departments with experience supervising students who had taken one or two undergraduate pharmacy research courses were invited to participate. The focus group questions were based on the Theoretical domain framework of behavioral determinants. Verbatim transcription was performed, and the collected data were thematically analyzed using the computer-assisted coding software NVivo®. Of the 26 eligible faculty members, 21 participated in this study. Five deductive themes were identified: social professional role and influences, beliefs about capabilities, skills, beliefs about consequences and goals, and environmental resources and behavioral regulations. Overall, faculty members identified themselves as assessors and mentors. Participants expected students to possess independence, responsibility, and motivation. They believed that students generally required more practical research skills. Several benefits of incorporating students into undergraduate research have been highlighted, including increased publication productivity and quality. However, several hurdles to undergraduate research in pharmacy have been identified, including limited resources, limited timeframes, and sometimes delayed ethical approval. Faculty members expressed optimism regarding the undergraduate research courses. However, some logistical concerns, including the lengthy ethical approval process and resource availability, must be addressed to optimize the effectiveness of these courses.

Evaluating Diagnostic Clarity: The Comparative Efficacy of BlueStain in Serous Effusion Cytology under the International System for Reporting Serous Fluid Cytopathology Reporting Framework.

This section provides details on the cohort of 237 patients with serous effusions, the ethical approval process, sample collection, and staining procedures with BlueStain, Papanicolaou, and Giemsa. It also describes the microscopic evaluation criteria, scoring system, and statistical methods used to compare the stains. BlueStain demonstrated notable performance, particularly in identifying malignant cells, presenting a competitive alternative to the Papanicolaou stain, which, despite higher quality indices in other categories, requires more resources and time. The study revealed that BlueStain might offer a valuable balance between quality and efficiency, especially in cases where rapid diagnostic turnaround is essential. Our findings suggest that BlueStain is a viable staining method in the context of serous effusions, capable of providing detailed cytomorphological analysis. While traditional stains hold their place for their established diagnostic clarity, BlueStain offers a rapid and resource-optimized alternative. The absence of definitive diagnostic criteria in the atypical category and the inherent sample heterogeneity underscores the necessity for adaptable staining methods like BlueStain. The study highlights the potential trade-offs between detail and practicality in staining techniques, advocating for further research into innovative methods that do not compromise diagnostic precision for cost and time efficiency.

Towards a common European ethical and legal framework for conducting clinical research: the GATEKEEPER experience

This paper examines the ethical and legal challenges encountered during the GATEKEEPER Project and how these challenges informed the development of a comprehensive framework for future Large-Scale Pilot (LSP) projects. GATEKEEPER is a LSP Project with 48 partners conducting 30 implementation studies across Europe with 50,000 target participants grouped into 9 Reference Use Cases. The project underscored the complexity of obtaining ethical approval across various jurisdictions with divergent regulations and procedures. Through a detailed analysis of the issues faced and the strategies employed to navigate these challenges, this study proposes an ethical and legal framework. This framework, derived from a comparative analysis of ethical application forms and regulations, aims to streamline the ethical approval process for future LSP research projects. By addressing the hurdles encountered in GATEKEEPER, the proposed framework offers a roadmap for more efficient and effective project management, ensuring smoother implementation of similar projects in the future.

Ethical challenges in global research on health system responses to violence against women: a qualitative study of policy and professional perspectives

BackgroundStudying global health problems requires international multidisciplinary teams. Such multidisciplinarity and multiculturalism create challenges in adhering to a set of ethical principles across different country contexts. Our group on health system responses to violence against women (VAW) included two universities in a European high-income country (HIC) and four universities in low-and middle-income countries (LMICs). This study aimed to investigate professional and policy perspectives on the types, causes of, and solutions to ethical challenges specific to the ethics approval stage of the global research projects on health system responses to VAW.MethodsWe used the Network of Ethical Relationships model, framework method, and READ approach to analyse qualitative semi-structured interviews (n = 18) and policy documents (n = 27). In March-July 2021, we recruited a purposive sample of researchers and members of Research Ethics Committees (RECs) from the five partner countries. Interviewees signposted policies and guidelines on research ethics, including VAW.ResultsWe developed three themes with eight subthemes summarising ethical challenges across three contextual factors. The global nature of the group contributed towards power and resource imbalance between HIC and LMICs and differing RECs’ rules. Location of the primary studies within health services highlighted differing rules between university RECs and health authorities. There were diverse conceptualisations of VAW and vulnerability of research participants between countries and limited methodological and topic expertise in some LMIC RECs. These factors threatened the timely delivery of studies and had a negative impact on researchers and their relationships with RECs and HIC funders. Most researchers felt frustrated and demotivated by the bureaucratised, uncoordinated, and lengthy approval process. Participants suggested redistributing power and resources between HICs and LMICs, involving LMIC representatives in developing funding agendas, better coordination between RECs and health authorities and capacity strengthening on ethics in VAW research.ConclusionsThe process of ethics approval for global research on health system responses to VAW should be more coordinated across partners, with equal power distribution between HICs and LMICs, researchers and RECs. While some of these objectives can be achieved through education for RECs and researchers, the power imbalance and differing rules should be addressed at the institutional, national, and international levels. Three of the authors were also research participants, which had potential to introduce bias into the findings. However, rigorous reflexivity practices mitigated against this. This insider perspective was also a strength, as it allowed us to access and contribute to more nuanced understandings to enhance the credibility of the findings. It also helped to mitigate against unequal power dynamics.

Involving Young People With Lived and Living Experience of Suicide in Suicide Research.

Background: Research into youth suicide prevention rarely involves young people with lived and living experiences as collaborators. Key barriers include a lack of guidelines or frameworks to inform collaboration, appropriate ethical approval processes, perceived risk, and recruitment. Aim: To develop guidelines for involving young people with lived and living experiences in suicide research as collaborators. Method: A Delphi expert consensus study was conducted with two expert panels: a youth lived and living experiences panel and a traditionally qualified researcher panel. Items rated as essential or important using a five-point Likert scale by more than 80% of both panels were included in the guidelines. Results: Forty-nine experts completed two consensus rounds. The guidelines are organized as follows: (1) preparation, (2) supporting safety and well-being, (3) evaluating involvement, and (4) tips for young people. Limitations: Participants were from English-speaking, Western countries only. Conclusion: These world-first guidelines address the unique challenges and opportunities for involving young people with lived and living experiences in suicide research.

‘Meta’ analysis: considerations when using Facebook within research and evaluation studies: a research note

ABSTRACT The use of social media platforms as a means of data collection for researchers is increasing. With the number of active users of Facebook across the globe exceeding two billion, the platform offers a means to reach and hear from diverse populations and gather information-rich data. Despite an increase of researchers utilising Facebook and publishing their findings, there has been less focus on describing the issues researchers need to think about to undertake their work in line with ethical principles, which is particularly important when engaging people in research. This research note provides a worked example of the practical steps adopted when establishing a Facebook Page and Group to recruit and gather data from individuals receiving care and support. The paper offers guidance for researchers on the issues to consider and provides insights into how using Facebook can be aligned with good research governance practice and ethics approval processes.

Survey of exposure to stranded dolphins in Japan to investigate an outbreak of suspected infection with highly pathogenic avian influenza (H5N1) clade 2.3.4.4(b) in humans

BackgroundA highly pathogenic avian influenza (HPAI) A (H5N1) virus has been detected in domestic and wild animals worldwide. The incidence of HPAI infections in sea mammals has been increasing, as is the number of stranded marine mammals linked to H5N1 viral clade 2.3.4.4(b). In this study, we investigated a stranding event involving dolphins and human–dolphin contact, and investigated the potential risk of animal-to-human H5N1 transmission with a survey of exposure on the Tsurigasaki coast, Japan. MethodsWe performed a non-random, convenient-sample-based, survey on Tsurigasaki beach where around 30 melon-headed whales were stranded on April 3, 2023. Face-to-face (n = 25) and telephone (n = 1) interviews among surfers took place on April 7 and 8. A nasal swab for quick antigen testing was taken from those who wished to be tested (n = 13), to detect infections with influenza A virus. ResultsAlthough there was no confirmatory diagnosis of H5N1 in either humans or dolphins (while n = 3 dolphins were autopsied), we found that a large number of surfers had touched the dolphins with their bare hands while attempting to rescue them, and that some surfers were directly exposed to dolphin blood and body fluids in the ocean. ConclusionsThe adequate communication of risk is required to minimize the threat of viral transmission at this particular human–animal interface. Administrative and legal responses to cross-species transmission, including guidelines via one health frameworks, a rapid evaluation process of ethical approval, and the systematic involvement of experts in infectious disease, must be urgently formulated.

Tanaman Ramah Lingkungan Selei Kolang Kaling dan Strowberi Mengurangi Konstipasi Pada Ibu Hamil Trimester III

This research aims to modify canned kolang ingredients into an innovative product that is mixed with strawberries and made into jam which is useful for reducing constipation for pregnant women in the third trimester in the PB Selayang II Health Center Work Area, Medan in 2023. The method used is quantitative research using quasi-experimental methods. design with one group pretest-posttest design. The research has gone through the USU Faculty of Nursing Health Research Ethics approval process with number 2847/VII/SP/2023. The instrument uses a questionnaire containing respondent data/identity and research observation sheets. The research results showed that the results of the paired t test were obtained with a mean result of 19.34 with a t value of 561,000 and a p value of 0.000 in the group of mothers before eating kolang kaling jam and strawberries and then mothers after eating kolang kaling jam and strawberries. In conclusion, kolang kaling and strawberry jam have benefits and functions that can help prevent constipation from pregnant women.
 
 Keywords: Pregnant Women, Constipation, Jam

Ethical considerations for participatory action research involving people with potential cognitive impairment

AbstractBackgroundThis case study aims to stimulate discussion around ethics approvals for research involving humans that is classified as high‐risk. Emerging research paradigms like participatory action research (PAR) advocate for the inclusion of stakeholders in research design, conduct, and analysis, but ethics approval requires development of the research and analysis plan prior to submission of the application, and approval is needed for all research materials, including consent forms, participant information sheets, and recruiting and marketing materials. How is it then possible to involve consumers in the research design and development phase prior to ethical approval of consent documentation?MethodThis investigation is part of the overall analysis of the COM‐IC SRG (Core Outcome Measures for Improving Care in Dementia Stakeholder Reference Group), the consumer arm of the COM‐IC study. It is a case study investigating the ethical approval process for participatory action research involving people with potential cognitive impairment. Data is sourced through the activities of the COM‐IC investigation team and the subsidiary interim SRG, as well as their communication and interaction with HREC teams from supporting institutions. Documentation pertaining to and reflections on the ethics approval process for the stakeholder reference group are critically analysed within the context and purpose of ethical review.ResultAnalysis of the ethics approval process suggests a paradigm shift is needed if true participatory action research is the goal. Lengthy delays, inconsistencies in panel decisions, poor communication, and different perceptions of rights and capabilities of people labelled high‐risk complicates an already highly emotive process. That said, it remains critical to the integrity of the overall system to have checks and balances against unethical research and ensure the rights of participants are truly protected.ConclusionIt is important for people with cognitive impairment to have the opportunity to contribute to research that is about them. Current ethical approval processes, while advocating for protection of vulnerable groups, are inadvertently impeding and complicating their capacity to be involved. Moving forward requires a collaborative rethink around ways of working that both protect and enhance opportunities for people with cognitive impairment.

Reimagining the researcher-participant ethics relationship: a participant-centred, values-based ethics approach in comparative and international education

ABSTRACT Conventional approaches to ethics in comparative and international educational research often entail researchers seeking institutional ethics approval; attempting to manage fieldwork’s practical ethical dilemmas using institutional and disciplinary protocols; and ‘writing up’ methodology, primarily an account of the institutional ethics approval process. This approach largely excludes participants’ conceptions of ethics, manifested through their ethical values, virtues, worldviews, knowledge, perspectives, traditions, norms, epistemologies, etc. This paper proposes a participant-centred, values-based approach which deepens the conventional approach by positioning participants’ values alongside institutional and disciplinary ones; centring participants’ values during fieldwork’s ethical dilemmas; and articulating a situated ethics account. This alternative approach deepens researchers’ capabilities for situated ethical action, and underscores the need for continuous negotiation of ethics with participants towards meaningful ethical partnerships. Such partnerships are ultimately facilitated by institutional ethics committees’ flexibility in enabling, and even encouraging, researcher-participant ethical negotiations at various stages of research.

International variation in ethics and contract approval processes for a low-risk observational study of mechanical ventilation discontinuation practices

ObjectivesTo describe international variation in ethics and contract processes, identify predictors of approval times, and reasons for nonparticipation in an international observational study of ventilation discontinuation practices. Study Design and SettingA nested cross-sectional survey of research personnel at 111 participating sites (representing 142 intensive care units [ICUs]) from six geographic regions (Canada, India, the United Kingdom, Europe, Australia/New Zealand, and the United States). ResultsWe analyzed responses from 80 sites (72.1% response rate). A single local or central approval was required at 34/80 (42.5%) and 23/80 (28.75%), respectively. Of those requiring central ethics approval, 20/23 (87.0%) sites required an additional approval. Sites with central vs. other ethics approval processes had significantly longer times to ethics approval (176 vs. 42 days; P < 0.0001). The median time to contract execution was 140 days (range: 11–1,215) with sites in India and the United States having the shortest and longest times to contract execution, respectively. We did not identify independent predictors of approval times. Of 190 sites that initially agreed to participate, 78 (41%) sites (89 ICUs) were ultimately unable to participate. ConclusionInternational ethics and contract approval times were lengthy and highly variable. Central ethics review processes significantly increased approval times.

The complexities of human procedural nursing research ethical approval processes in Indonesia

Introduction: Research requires high quality ethical practices. However, research approvals vary between developed and developing countries resulting in additional challenges for researchers wishing to participate in collaborative research projects. The aim of this paper is to describe and discuss three nursing research ethics application processes in different locations in Indonesia that had an Australian university overseeing them. Methods: Three nurse researchers provide a reflective account of the ethics application processes of their qualitative research projects conducted between 2014 and 2021. A collective case-study methodology using descriptive analysis was applied where the information was collated and compared for similarities, differences and challenges. Results: Ethics and site approvals varied at each Indonesian site. The ethical and approval application processes were time-consuming at all levels. which delayed the start of all the projects, which varied from between one to six months. As a result, all three projects experienced delayed completion. Conclusions: Ethical approval is required for medical research prior to any data collection. Approval processes need to be consistent so that delays in the application processes are avoided. Any delays in approval to conduct research has implications for research projects. It is essential that timeframe factors need to be considered when applying for grant funding, gatekeepers are identified early, and payments are identified and planned for. It is recommended that, to improve consistency with ethical application processes, streamlining of applications and approvals in Indonesia needs to be reviewed, particularly since the introduction of the WHO March 2022 Standard Operating Procedures.

The Toy Brick as a Communicative Device for Amplifying Children’s Voices in Research

The Toy Brick as a Communicative Device for Amplifying Children’s Voices in Research

'Snapshot' cohort study design across multi-site research settings: challenges, strategies, and solutions.

Multi-site research studies redefine cohort studies by simultaneously providing a cross-sectional snapshot of patients and monitoring them over time, to evaluate outcomes. However, careful design is crucial to minimize potential biases, such as seasonal variations, that may arise during the study period. Addressing snapshot study challenges requires strategic solutions: implementing multi-stage sampling for representativeness, providing rigorous data collection training, using translation techniques and content validation for cultural and linguistic appropriateness, streamlining ethical approval processes, and applying comprehensive data management for follow-up and missing data. These strategies can optimize the efficacy and ethicality of snapshot studies.

Human body donors at academic institutions in the United States of America: An investigative study.

Work with deceased human bodies to enhance anatomical education was first documented in the 3rd century BCE. However, the development of body donation programs provided many new opportunities for medical education. The aim of this study was to investigate the work supported by human body donors at academic institutions in the United States and to evaluate the ethical oversight process and the preparation methods used. A questionnaire was developed using Qualtrics and sent to 125 body donation programs in the United States. Representatives from a total of 69 institutions completed the questionnaire. The data showed that human body donations across the United States are used in teaching, clinical skills training, research, and educational outreach. Most institutions worked with hard-fixed donors for teaching and some with soft-preserved and unembalmed donors for clinical skills training. Among the participating programs, only 33 representatives reported an ethical approval process for conducting research involving human body donors. These findings raise ethical concerns related to the operation of body donation programs due to the lack of oversight. Furthermore, some institutions allowed faculty and staff to take photographs of donated bodies for educational purposes, which is often not disclosed on the consent form. The data also showed the need for more discussion on anatomical legacy collections housed at these institutions in the United States.

Group cognitive stimulation therapy versus usual care for people with intellectual disabilities and dementia (CST-IDD) in the UK: protocol for a mixed-methods feasibility randomised controlled trial

IntroductionThe prevalence of dementia is almost five times higher in people with intellectual disabilities compared with the general population. However, evidence-based treatments for this population are lacking, as most randomised...