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Potential research ethics violations against an indigenous tribe in Ecuador: a mixed methods approach.

ABSTRACT: BACKGROUND:Biomedical and ethnographic studies among indigenous people are common practice in health and geographical research. Prior health research misconduct has been documented, particularly when obtaining genetic material. The objective of this study was to crossmatch previously published data with the perceptions of the Waorani peoples about the trading of their genetic material and other biological samples. METHODS:We conducted a mixed methods study design using a tailored 15-item questionnaire in 72 participants and in-depth interviews in 55 participants belonging to 20 Waorani communities about their experiences and perceptions of participating in biomedical research projects. Additionally, we conducted a systematic review of the literature in order to crossmatch the published results of studies stating the approval of an ethics committee and individual consent within their work. RESULTS:A total of 40 men (60%) and 32 women (40%), with a mean age of 57?±?15 years agreed to be interviewed for inclusion. Five main categories around the violation of good clinical practices were identified, concerning the obtention of blood samples from a recently contacted Waorani native community within the Amazonian region of Ecuador. These themes are related to the lack of adequate communication between community members and researchers as well as the voluntariness to participate in health research. Additionally, over 40 years, a total of 38 manuscripts related to the use of biological samples in Waorani indigenous people were published. The majority of the studies (68%) did not state within their article obtaining research ethics board approval, and 71% did not report obtaining the informed consent of the participants prior to the execution of the project. CONCLUSION:Clinical Research on the Waorani community in the Ecuadorian Amazon basin has been performed on several occasions. Unfortunately, the majority of these projects did not follow the appropriate ethical and professional standards in either reporting the results or fulfilling them. The results of our investigation suggest that biological material, including genetic material, has been used by researchers globally, with some omitting the minimum information required to guarantee transparency and good clinical practices. We highlight the importance of stating ethics within research to avoid breaches in research transparency.

SUBMITTER: Ortiz-Prado E

PROVIDER: S-EPMC7568418 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Potential research ethics violations against an indigenous tribe in Ecuador: a mixed methods approach.

Ortiz-Prado Esteban E Simbaña-Rivera Katherine K Gómez-Barreno Lenin L Tamariz Leonardo L Lister Alex A Baca Juan Carlos JC Norris Alegria A Adana-Diaz Lila L

BMC medical ethics 20201017 1

<h4>Background</h4>Biomedical and ethnographic studies among indigenous people are common practice in health and geographical research. Prior health research misconduct has been documented, particularly when obtaining genetic material. The objective of this study was to crossmatch previously published data with the perceptions of the Waorani peoples about the trading of their genetic material and other biological samples.<h4>Methods</h4>We conducted a mixed methods study design using a tailored ...[more]

PMID: 33069227

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Project description:BackgroundTo describe the ethical issues and experiences of scientists conducting mixed methods health services research and to advance empirical and conceptual discussion on ethical integrity in mixed methods health research.MethodsThe study was conducted with 64 scholars, faculty and consultants from the NIH-funded Mixed Methods Research Training Program (MMRTP) for the Health Sciences. This was a cross-sectional study. Survey results were analyzed using descriptive statistics to characterize responses and open coding to summarize strategies about eight ethical mixed methods research issues. Respondents completed an online survey to elicit experiences related to eight ethical issues (informed consent, confidentiality, data management, burden, safety, equitable recruitment, communication, and dissemination) and strategies for addressing them.ResultsOnly about one-third of respondents thought their research ethics training helped them plan, conduct, or report mixed methods research. The most frequently occurring ethical issues were participant burden, dissemination and equitable recruitment (> 70% endorsement). Despite occurring frequently, < 50% of respondents rated each ethical issue as challenging. The most challenging ethical issues were related to managing participant burden, communication, and dissemination. Strategies reported to address ethical issues were largely not specific or unique to mixed methods with the exception of strategies to mitigate participant burden and, to a lesser degree, to facilitate equitable recruitment and promote dissemination of project results.ConclusionsMixed methods health researchers reported encountering ethical issues often yet varying levels of difficulty and effectiveness in the strategies used to mitigate ethical issues. This study highlights some of the unique challenges faced by mixed methods researchers to plan for and appropriately respond to arising ethical issues such as managing participant burden and confidentiality across data sources and utilizing effective communication and dissemination strategies particularly when working with a multidisciplinary research team. As one of the first empirical studies to examine mixed methods research ethics, our findings highlight the need for greater attention to ethics in health services mixed methods research and training.

Project description:Indigenous and other marginalized racial/ethnic minorities have poorer health status than majority populations, including higher rates of type 2 diabetes. These disparities have typically been addressed using a 'deficit-based' discourse that isolates disease management from the broader social, economic, political context and does not incorporate patient perspectives. We aimed to explore factors affecting glycemic control among Indigenous Arabs with diabetes in Israel using a strengths-based approach that centered participants' knowledge of their context, needs, resources and strengths. We conducted an exploratory sequential mixed methods study, which included 10 focus groups (5 men's, 5 women's) and 296 quantitative in-person surveys. Participants with diagnosed diabetes were randomly drawn from the patient list of the largest healthcare service organization (survey response rate: 93%). Prominent and interconnected themes emerged from focus group discussions, including: diet, physical activity, and social, economic, mental/psychological and political stress. The discussions raised the need for adapting diabetes management approaches to incorporate participants' communal, physical and psychological well-being, and socioeconomic/political realities. The connections between these factors and diabetes management were also reflected in multivariable analyses of the survey data. Women (OR: 2.03; 95% CI: 1.09-4.63), people with disabilities (OR: 2.43; 95% CI: 1.28-4.64), and unemployed people (OR: 2.64; 95% CI: 1.28-5.44) had higher odds of economic barriers to diabetes management. Furthermore, female sex (OR: 2.26; 95% CI: 1.25-4.09), unemployment (OR: 4.07; 95% CI: 1.64-10.10), and suboptimal glycemic control (OR: 1.20, 95% CI: 1.03-1.41 per 1-unit increase in HbA1c) were associated with moderate-to-severe depressive symptoms. A pro-active, team-based healthcare approach incorporating Indigenous/minority participants' knowledge, experience, and strengths has the potential to improve individuals' diabetes management. Healthcare services should be structured in ways that enable providers to listen to their patients, address their key concerns, and foster their strengths.

Project description:IntroductionHospital group models represent an organisational form that aims to bring together multiple provider organisations with a central headquarters and unified leadership responsible for locally managed operating units, standardised systems and a value-set shared across the group. These models seek to improve outcomes by reducing unwarranted variations in care provision and reducing costs through economies of scale. There is limited evidence on the impact and processes of implementing these models, so this study aims to evaluate one case study of a hospital group model.Methods and analysisWe will conduct a formative, mixed-methods evaluation using an embedded research approach to analyse the implementation of the model and its impact on outcomes and costs. We will carry out a multisited ethnography to analyse the programme theory for model design and implementation, the barriers and facilitators in the implementation; and wider contextual issues that influence implementation using semi-structured interviews (n=80), non-participant observations (n=80?hours), 'shadowing' (n=20?hours) and documentary analysis. We will also carry out an economic evaluation composed of a cost-consequence analysis and a return on investment analysis to evaluate the costs of creating and running the model and balance these against the potential cost-savings.Ethics and disseminationThe study protocol was reviewed by the local R&D Office and University College London Ethics Committee and classified as a service evaluation, not requiring approval by a research ethics committee. We will follow guidelines for informed consent, confidentiality and information governance, and address issues of critical distance prevalent in embedded research. Findings will be shared at regular time points to inform the implementation of the model. The evaluation will also generate: an evaluation framework to evaluate future changes; recommendations for meaningful baseline data and measuring improvement; identification of implementation costs and potential cost-savings; and lessons for the National Health Service on implementing these models.

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Potential research ethics violations against an indigenous tribe in Ecuador: a mixed methods approach.

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Potential research ethics violations against an indigenous tribe in Ecuador: a mixed methods approach.

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