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Emerging ethical issues raised by highly portable MRI research in remote and resource-limited international settings.

ABSTRACT: Smaller, more affordable, and more portable MRI brain scanners offer exciting opportunities to address unmet research needs and long-standing health inequities in remote and resource-limited international settings. Field-based neuroimaging research in low- and middle-income countries (LMICs) can improve local capacity to conduct both structural and functional neuroscience studies, expand knowledge of brain injury and neuropsychiatric and neurodevelopmental disorders, and ultimately improve the timeliness and quality of clinical diagnosis and treatment around the globe. Facilitating MRI research in remote settings can also diversify reference databases in neuroscience, improve understanding of brain development and degeneration across the lifespan in diverse populations, and help to create reliable measurements of infant and child development. These deeper understandings can lead to new strategies for collaborating with communities to mitigate and hopefully overcome challenges that negatively impact brain development and quality of life. Despite the potential importance of research using highly portable MRI in remote and resource-limited settings, there is little analysis of the attendant ethical, legal, and social issues (ELSI). To begin addressing this gap, this paper presents findings from the first phase of an envisioned multi-staged and iterative approach for creating ethical and legal guidance in a complex global landscape. Section 1 provides a brief introduction to the emerging technology for field-based MRI research. Section 2 presents our methodology for generating plausible use cases for MRI research in remote and resource-limited settings and identifying associated ELSI issues. Section 3 analyzes core ELSI issues in designing and conducting field-based MRI research in remote, resource-limited settings and offers recommendations. We argue that a guiding principle for field-based MRI research in these contexts should be including local communities and research participants throughout the research process in order to create sustained local value. Section 4 presents a recommended path for the next phase of work that could further adapt these use cases, address ethical and legal issues, and co-develop guidance in partnership with local communities.

SUBMITTER: Shen FX

PROVIDER: S-EPMC8382487 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Stepped-wedge cluster randomized trials (SW-CRTs) are increasingly popular in health-related research in both high- and low-resource settings. There may be specific ethical issues that researchers face when designing and conducting SW-CRTs in low-resource settings. Knowledge of these issues can help to improve the ethical conduct of SW-CRTs in a global health context. METHODS:We performed an ethical analysis of two studies using SW-CRT designs in low-resource settings: the Que Vivan Las Madres study conducted from 2014 to 2017 in Guatemala and the Atmiyata study conducted from 2017 to 2018 in rural parts of India. For both case studies, we identified and evaluated the classification of the study as research or nonresearch and the ethical issues regarding the justification of the design, including the delayed rollout of an intervention that had a promising effect. RESULTS:In our case studies, some minor ethical issues surfaced about the registration and stakeholder pressure on the order of randomization, but both included good justification for the design and delayed rollout. Our analysis did, however, demonstrate that careful consideration of the role of randomization and registration of the trials is important. DISCUSSION:SW-CRTs can provide an opportunity for rigorous evaluation of interventions destined to be rolled out on the basis of limited evidence. Furthermore, in SW-CRTs, the underlying objective is often to provide a robust evaluation of the effectiveness for generalized dissemination, and this makes the SW-CRT no less a research study than any other form of cluster randomized trial. CONCLUSION:The design and conduct of stepped-wedge cluster randomized trials raises at least two ethical issues that need special consideration in both high- and low-resource settings: the justification for using the design, specifically the delayed rollout of the intervention to the control group, and the classification of the study as research or nonresearch. In our case studies, these issues did not seem to raise special ethical scrutiny in low-resource settings. Further ethical evaluation will hopefully result in specific ethical guidelines for the use of SW-CRTs in both high- and low-resource settings to contribute to responsible functioning of these trials and adequate protection of participants.

Project description:BackgroundAlthough laparoscopic surgery has made remarkable progress and become the standard approach for various surgical procedures worldwide over the past 30 years, its establishment in low-resource settings, particularly in public hospitals, has been challenging. The lack of equipment and trained expertise has hindered its widespread adoption in these settings. Cholecystectomy is one of the most commonly performed procedures using laparoscopy world wide AIM: The aim of the study is to determine whether laparoscopic cholecystectomy is feasible in a resource challenged setting METHODS: The research focused on individuals who underwent laparoscopic or open cholecystectomies at Yekatit 12 Hospital in Addis Ababa, Ethiopia, over a one-year period. Comprehensive data collection was conducted prospectively, encompassing both intraoperative and postoperative parameters. Follow-up was carried out via phone calls. The surgical procedures employed innovative techniques, including the reuse of sterilized single-use equipment and the utilization of local resources. The evaluation involved a comparison of demographic information, intraoperative details (such as critical view determination and operative duration), and postoperative complications, including assessments of pain and wound infections RESULTS: From August 2021 to September 2022, 119 patients were assessed. Among these patients, 65 (54.6%) underwent open cholecystectomies, while the remaining 54 (45.4%) underwent laparoscopic cholecystectomies. The average duration of the laparoscopic cholecystectomies was 90.7 min, which is 17.7 min behind the open. Patients in the laparoscopy group had significantly shorter hospital stays than the open group, and 94% were discharged by post operative day 2. The conversion rate from laparoscopic to open surgery was determined to be 3.3% CONCLUSION: To sum up, the safe execution of laparoscopic cholecystectomies is feasible in public hospitals and settings with limited resources, given adequate training and resource distribution. The study findings showcased superior outcomes, including reduced hospitalization duration and fewer complications, while maintaining comparable levels of operative duration and patient satisfaction in both groups.

Project description:IntroductionAccurate measurement of adherence is necessary to ensure that therapeutic outcomes can be attributed to the recommended treatment. Phone-based unannounced pill counts were shown to be feasible and reliable measures of adherence in developed settings; and have been further used as part of medication adherence interventions. However, it is not clear whether this method can be implemented successfully in resource-limited settings, where cellular network and mobile phone coverage may be low. Our objective is to describe operational issues surrounding the use of phone-based unannounced pill counts in Lesotho and Ethiopia.MethodsPhone-based monthly unannounced pill counts, using an adaptation of a standardized protocol from previous US-based studies, were utilized to measure anti-TB and antiretroviral medication adherence in two implementation science studies in resource-limited settings, START (Lesotho) and ENRICH (Ethiopia).ResultsIn START, 19.6% of calls were completed, with 71.9% of participants reached at least once; majority of failed call attempts were due to phones not being available (54.8%) or because participants were away from the pills (32.7%). In ENRICH, 33.5% of calls were completed, with 86.7% of participants reached at least once; the main reasons for failed call attempts were phones being switched off (31.5%), participants not answering (27.3%), participants' discomfort speaking on the phone (15.4%), and network problems (13.2%). Structural, facility-level, participant-level, and data collection challenges were encountered in these settings.DiscussionPhone-based unannounced pill counts were found to be challenging, and response rates suboptimal. While some of these challenges were specific to local contexts, most of them are generalizable to resource-limited settings. In a research study context, a possible solution to ease operational challenges may be to focus phone-based unannounced pill count efforts on a randomly selected sample from participants who are provided with study phones and rigorously ensure that call attempts are made for these participants.

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Emerging ethical issues raised by highly portable MRI research in remote and resource-limited international settings.

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