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 and 32 women, 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 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. (shrink)

Researchers are required to seek consent from Indigenous communities prior to conducting research but there is inadequate information about how Indigenous people understand and become fully engaged with this consent process. Few studies evaluate the preference or understanding of the consent process for research with Indigenous populations. Lack of informed consent can impact on research findings. The Picture Talk Project was initiated with senior Aboriginal leaders of the Fitzroy Valley community situated in the far north of Western Australia. Aboriginal people (...) were interviewed about their understanding and experiences of research and consent processes. Transcripts were analysed using NVivo10 software with an integrated method of inductive and deductive coding and based in grounded theory. Local Aboriginal interpreters validated coding. Major themes were defined and supporting quotes sourced. Interviews with Aboriginal leaders were facilitated by a local Aboriginal Community Navigator who could interpret if necessary and provide cultural guidance. Participants were from all four major local language groups of the Fitzroy Valley; aged 31 years and above; and half were male. Themes emerging from these discussions included Research—finding knowledge; Being respectful of Aboriginal people, Working on country, and Being flexible with time; Working together with good communication; Reciprocity—two-way learning; and Reaching consent. The project revealed how much more there is to be learned about how research with remote Aboriginal communities should be conducted such that it is both culturally respectful and, importantly, meaningful for participants. We identify important elements in community consultation about research and seeking consent. (shrink)

The consent and community engagement process for research with Indigenous communities is rarely evaluated. Research protocols are not always collaborative, inclusive or culturally respectful. If participants do not trust or understand the research, selection bias may occur in recruitment, affecting study results potentially denying participants the opportunity to provide more knowledge and greater understanding about their community. Poorly informed consent can also harm the individual participant and the community as a whole. Invited by local Aboriginal community leaders of the Fitzroy (...) Valley, the Kimberley, Western Australia, The Picture Talk project explores the consent process for research. Focus groups of Aboriginal community members were conducted to establish preferences for methods of seeking individual consent. Transcripts were analysed through NVivo10 Qualitative software using grounded theory with inductive and deductive coding. Themes were synthesised with quotes highlighted. Focus groups with Aboriginal community members were facilitated by a Community Navigator as a cultural guide and interpreter and a researcher. Participants were recruited from all main language groups of the Fitzroy Valley – Gooniyandi, Walmajarri, Wangkatjungka, Bunuba and Nikinya. Participants were aged ≥18 years, with 5 female groups and one male group. Themes identified include: Reputation and trust is essential; The Community Navigator is key; Pictures give the words meaning – milli milli versus Pictures; Achieving consensus in circles; Signing for consent; and Research is needed in the Valley. Aboriginal communities of the Fitzroy Valley recommend that researchers collaborate with local leaders, develop trust and foster a good reputation in the community prior to research. Local Aboriginal researchers should be employed to provide cultural guidance throughout the research process and interpret local languages especially for elders. Pictures are preferred to written text to explain research information and most prefer to sign for consent. The Fitzroy Valley welcomes research when collaborative and for the benefit of the community. Future research could include exploring how to support young people, promote health screening and improve understanding of medical knowledge. (shrink)

Recruitment of study participants from marginalized populations present unique challenges for researchers and associated institutions. Researchers must be aware of the specific adaptations required in the research process in conducting research within and Indigenous populations. Cultural consciousness is key with any research conducted within these populations to understand the past issues that can influence present and future willingness to participate in research. This article aims to provide context and examples where increasing cultural awareness of specific ethical principles during the recruitment (...) phase can affect the study process as well as the researcher themselves. Integrating Indigenous cultural concepts within the recruitment and study design process can help to lay the groundwork for a positive research process as a whole and facilitate an appropriate study environment for all involved. (shrink)

COVID-19 is compromising all aspects of society, with devastating impacts on health, political, social, economic and educational spheres. A premium is being placed on scientific research as the source of possible solutions, with a situational imperative to carry out investigations at an accelerated rate. There is a major challenge not to neglect ethical standards, in a context where doing so may mean the difference between life and death. In this paper we offer a rubric for considering the ethical challenges in (...) COVID-19 related research, in the form of an ethics toolkit for global research developed at the University of Edinburgh in collaboration with more than 200 global researchers from around the world. This toolkit provides a framework to support confrontation of ethical conflicts through the integrated and iterative analysis of Place, People, Principles and Precedents, throughout the research journey. Two case analyses are offered to exemplify the utility of the toolkit as a flexible and dynamic tool to promote ethical research in the context of COVID-19. (shrink)

La presencia e integración de la investigación cualitativa a los protocolos de investigación biomédica ha cobrado cada vez mayor relevancia, por la importancia de la antropología cultural. El caso particular de la etnografía adquiere aún más preeminencia en relación con la definición de riesgo para el sujeto de investigación. El presente artículo expone las principales características de la investigación etnográfica que deben ser evaluadas por un comité de ética de la investigación, y define una serie de recomendaciones para la evaluación (...) del riesgo para los sujetos que se someten a este tipo de estudio. Los miembros de los Comités de Ética en Investigación deben tener en cuenta la etnografía para realizar a cabalidad su función. (shrink)