A New Era of Indigenous Research: Community-based Indigenous Research Ethics Protocols in Canada.
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SUBMITTER: Hayward A
PROVIDER: S-EPMC8458667 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectivesTo assess the completeness of reporting of sample size determinations in unpublished research protocols and to develop guidance for research ethics committees and for statisticians advising these committees.DesignReview of original research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.
| S-EPMC3604970 | biostudies-literature
Project description: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.
| S-EPMC7568418 | biostudies-literature
Project description:A novel Protocol Ethics Tool Kit ('Ethics Tool Kit') has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval.
| S-EPMC4819642 | biostudies-literature
Project description:ObjectiveCommunity engagement practices in Indigenous health research are promoted as a means of decolonising research, but there is no comprehensive synthesis of approaches in the literature. Our aim was to assemble and qualitatively synthesise a comprehensive list of actionable recommendations to enhance community engagement practices with Indigenous peoples in Canada, the USA, Australia and New Zealand.DesignIntegrative review of the literature in medical (Medline, Cumulative Index to Nursing and Allied Health Literature and Embase) and Google and WHO databases (search cut-off date 21 July 2020).Article selectionStudies that contained details regarding Indigenous community engagement frameworks, principles or practices in the field of health were included, with exclusion of non-English publications. Two reviewers independently screened the articles in duplicate and reviewed full-text articles.AnalysisRecommendations for community engagement approaches were extracted and thematically synthesised through content analysis.ResultsA total of 63 studies were included in the review, with 1345 individual recommendations extracted. These were synthesised into a list of 37 recommendations for community engagement approaches in Indigenous health research, categorised by stage of research. In addition, activities applicable to all phases of research were identified: partnership and trust building and active reflection.ConclusionsWe provide a comprehensive list of recommendations for Indigenous community engagement approaches in health research. A limitation of this review is that it may not address all aspects applicable to specific Indigenous community settings and contexts. We encourage anyone who does research with Indigenous communities to reflect on their practices, encouraging changes in research processes that are strengths based.
| S-EPMC7703446 | biostudies-literature
Project description: Not available
| S-EPMC4838154 | biostudies-literature
Project description:The international context of Indigenous mental health and wellbeing has been shaped by a number of key works recognizing Indigenous rights. Despite international recognitions, the mental health and wellness of Indigenous Peoples continues to be negatively affected by policies that ignore Indigenous rights, that frame colonization as historical rather than ongoing, or that minimize the impact of assimilation. Research institutions have a responsibility to conduct ethical research; yet institutional guidelines, principles, and policies often serve Indigenous Peoples poorly by enveloping them into Western knowledge production. To counter epistemological domination, Indigenous Peoples assert their research sovereignty, which for the purposes of this paper we define as autonomous control over research conducted on Indigenous territory or involving Indigenous Peoples. Indigenous sovereignty might also be applied to research impacting the landscape and the web of animal and spiritual lives evoked in a phrase such as "all my relations." This narrative review of material developed in the Canadian context examines the alignment with similar work in the international context to offer suggestions and a practice-based implementation tool to support Indigenous sovereignty in research related to wellness, mental health, and substance use. The compilation of key guidelines and principles in this article is only a start; addressing deeper issues requires a research paradigm shift.
| S-EPMC10866143 | biostudies-literature
Project description:BackgroundIndigenous populations are disproportionately affected by traumatic brain injury. These populations rely on large jurisdiction surveillance efforts to inform their prevention strategies, which may not address their needs. We examined the incidence and determinants of traumatic brain injury in an indigenous population in the Terres-Cries-de-la-Baie-James health region of the province of Quebec and compared them with the incidence and determinants in 2 neighbouring health regions and in the province overall.MethodsWe conducted a retrospective population-based cohort study of patients in Quebec admitted to hospital with incident traumatic brain injury, stratified by health region (Terres-Cries-de-la-Baie-James, Nunavik and Nord-du-Québec), from 2000 to 2012. We used MED-ÉCHO administrative data for case-finding. A subgroup analysis of adults in the Terres-Cries-de-la-Baie-James health region was completed to assess determinants of the severity of traumatic brain injury and patient outcomes.ResultsA total of 172 hospital admissions for incident traumatic brain injury occurred in the Terres-Cries-de-la-Baie-James region during the study period. The incidence was 92.1 per 100?000 person-years, and the adjusted incidence rate ratio was 1.84 (95% confidence interval 1.56-2.17) compared with the entire province. The incidence was higher than in the neighbouring nonindigenous population (Nord-du-Québec) but significantly lower than in the neighbouring indigenous population (Nunavik). Determinants of traumatic brain injury in the Terres-Cries-de-la-Baie-James region differed from those in the neighbouring populations and in the entire province.InterpretationWe found that the incidence rates and determinants of traumatic brain injury requiring hospital admission varied greatly between the three regions studied. Community-based surveillance efforts should be encouraged to inform the development of relevant prevention strategies.
| S-EPMC4933602 | biostudies-literature
Project description:Báa nnilah is a chronic illness self-management program designed by and for the Apsáalooke (Crow) community. Arising from a collaboration between an Indigenous nonprofit organization and a university-based research team, Báa nnilah's development, implementation, and evaluation have been influenced by both Indigenous and Western research paradigms (WRPs). Báa nnilah was evaluated using a randomized wait-list control group design. In a WRP, contamination, or intervention information shared by the intervention group with the control group, is actively discouraged as it makes ascertaining causality difficult, if not impossible. This approach is not consonant with Apsáalooke cultural values that include the encouragement of sharing helpful information with others, supporting an Indigenous research paradigm's (IRP) goal of benefiting the community. The purpose of this paper is to address contamination and sharing as an area of tension between WRP and IRP. We describe how the concepts of contamination and sharing within Báa nnilah's implementation and evaluation are interpreted differently when viewed from these contrasting paradigms, and set forth a call for greater exploration of Indigenous research approaches for developing, implementing, and evaluating intervention programs in Indigenous communities. (Improving Chronic Illness Management with the Apsáalooke Nation: The Báa nnilah Project.: NCT03036189), ClinicalTrials. gov: NCT03036189).
| S-EPMC8926935 | biostudies-literature
Project description:Karim Brohi and Martin Schreiber, Guest Editors of the Special Issue on Trauma, describe a new era in exploration of the biology of injury response and translation of new opportunities into clinical practice.
| S-EPMC5526495 | biostudies-other
Project description:The increased use of big data in the medical field has shifted the way in which biomedical research is designed and carried out. The novelty of techniques and methods brought by big data research brings new challenges to institutional review boards (IRBs). Yet it is unclear if IRBs should be the responsible oversight bodies for big data research and, if so, which criteria they should use. A large but heterogenous set of ethics guidelines and normative responses have emerged to address these issues. In this study, we conducted a scoping review of soft-law documents and guidelines with the aim of assessing ongoing normative efforts that are proliferating in this domain. We also synthesize a set of recurrent guidelines that could work as a baseline to create a harmonized process for big data research ethics.
| S-EPMC7814666 | biostudies-literature