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A New Era of Indigenous Research: Community-based Indigenous Research Ethics Protocols in Canada.

ABSTRACT: Indigenous communities across Canada have established principles to guide ethical research within their respective communities. Thorough cataloging and description of these would inform university research ethics boards, researchers, and scholars and facilitate meaningful research that respects Indigenous-defined ethical values. A scoping study was conducted of all relevant peer-reviewed literature and public-facing Indigenous research ethical guidelines from First Nations, Metis, and Inuit communities and organizations in Canada. A total of 20 different Indigenous research ethics boards, frameworks, and protocols were identified. Analysis resulted in three key themes: (1) balancing individual and collective rights; (2) upholding culturally-grounded ethical principles; and (3) ensuring community-driven/self-determined research. Findings demonstrate how employment of Indigenous ethical principles in research positively contributes to research outcomes.

SUBMITTER: Hayward A

PROVIDER: S-EPMC8458667 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature

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A New Era of Indigenous Research: Community-based Indigenous Research Ethics Protocols in Canada.

Hayward Ashley A Sjoblom Erynne E Sinclair Stephanie S Cidro Jaime J

Journal of empirical research on human research ethics : JERHRE 20210609 4

Indigenous communities across Canada have established principles to guide ethical research within their respective communities. Thorough cataloging and description of these would inform university research ethics boards, researchers, and scholars and facilitate meaningful research that respects Indigenous-defined ethical values. A scoping study was conducted of all relevant peer-reviewed literature and public-facing Indigenous research ethical guidelines from First Nations, Metis, and Inuit comm ...[more]

PMID: 34106784

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Project description:ObjectivesTo assess the completeness of reporting of sample size determinations in unpublished research protocols and to develop guidance for research ethics committees and for statisticians advising these committees.DesignReview of original research protocols.Study selectionUnpublished research protocols for phase IIb, III, and IV randomised clinical trials of investigational medicinal products submitted to research ethics committees in the United Kingdom during 1 January to 31 December 2009.Main outcome measuresCompleteness of reporting of the sample size determination, including the justification of design assumptions, and disagreement between reported and recalculated sample size.Results446 study protocols were reviewed. Of these, 190 (43%) justified the treatment effect and 213 (48%) justified the population variability or survival experience. Only 55 (12%) discussed the clinical importance of the treatment effect sought. Few protocols provided a reasoned explanation as to why the design assumptions were plausible for the planned study. Sensitivity analyses investigating how the sample size changed under different design assumptions were lacking; six (1%) protocols included a re-estimation of the sample size in the study design. Overall, 188 (42%) protocols reported all of the information to accurately recalculate the sample size; the assumed withdrawal or dropout rate was not given in 177 (40%) studies. Only 134 of the 446 (30%) sample size calculations could be accurately reproduced. Study size tended to be over-estimated rather than under-estimated. Studies with non-commercial sponsors justified the design assumptions used in the calculation more often than studies with commercial sponsors but less often reported all the components needed to reproduce the sample size calculation. Sample sizes for studies with non-commercial sponsors were less often reproduced.ConclusionsMost research protocols did not contain sufficient information to allow the sample size to be reproduced or the plausibility of the design assumptions to be assessed. Greater transparency in the reporting of the determination of the sample size and more focus on study design during the ethical review process would allow deficiencies to be resolved early, before the trial begins. Guidance for research ethics committees and statisticians advising these committees is needed.

Project description:BackgroundBiomedical 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.MethodsWe 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.ResultsA 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.ConclusionClinical 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.

Project description:BackgroundSocial epigenomics research investigates links between social experiences and epigenetic modifications, which may ultimately impact health. Such research holds promise for precision medicine and addressing health disparities based on social conditions, but also brings unique ethical challenges. The linking of social experiences to biological changes risks pathologizing experiences, potentially leading individuals and communities to be seen as 'damaged.' This stigmatization or stereotyping based on experiences also risks placing disproportionate personal responsibility for health. These risks are likely to be amplified in historically marginalized communities already facing discrimination. It is therefore essential to engage members of historically marginalized communities to explore attitudes about social epigenomics research. This study focuses on the Black and African American (B/AA) population in the USA, studying perceptions of social epigenomic research participants, research decliners, and broadly representative community members to identify perceived benefits and risks of social epigenomic research as well as strategies to maximize benefits and lower risks for both participants and communities.ResultsBoth research participants and community members perceived potential benefit of social epigenomic research for the B/AA population. While most research participants did not perceive research related risks, community members identified risks both specific to social epigenomic research and more generalized to medical research. Several of the risks identified, and a belief that the likelihood of harms was greater than the likelihood of benefits, were based on past research injustices to B/AA research participants and mistrust in the medical and research enterprise. However, community members provided concrete strategies for maximizing the chance of benefits and lowering risk of harms including acknowledging and addressing biases and past injustices, ensuring transparency and understanding, positive framing of research, thorough research and dissemination, and engaging with communities before, throughout, and beyond the research process.ConclusionsWhile B/AA community members identified risk of both individual and community harm from social epigenomic research, they also perceived potential health benefits for the B/AA community. Through concerted efforts to apply community recommendations to lower risks and enhance benefits, researchers can conduct ethical and valid epigenomic research that aims to address health disparities with historically marginalized communities.

Dataset Information

A New Era of Indigenous Research: Community-based Indigenous Research Ethics Protocols in Canada.

Publications

A New Era of Indigenous Research: Community-based Indigenous Research Ethics Protocols in Canada.

Similar Datasets

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