Conducting research with tribal communities: sovereignty, ethics, and data-sharing issues.
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ABSTRACT:
SUBMITTER: Harding A
PROVIDER: S-EPMC3261947 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Humanitarian agencies are increasingly engaged in research in conflict and post-conflict settings. This is justified by the need to improve the quality of assistance provided in these settings and to collect evidence of the highest standard to inform advocacy and policy change. The instability of conflict-affected areas, and the heightened vulnerability of populations caught in conflict, calls for careful consideration of the research methods employed, the levels of evidence sought, and ethical requirements. Special attention needs to be placed on the feasibility and necessity of doing research in conflict-settings, and the harm-benefit ratio for potential research participants.
| S-EPMC2717053 | biostudies-literature
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Project description:Indigenous Peoples have historically been targets of extractive research that has led to little to no benefit. In genomics, such research not only exposes communities to harms and risks of misuse, but also deprives such communities of potential benefits. Tribes in the US have been exercising their sovereignty to limit this extractive practice by adopting laws and policies to govern research on their territories and with their citizens. Federally and state recognized tribes are in the strongest position to assert research oversight. Other tribes lack the same authority, given that federal and state governments do not recognize their rights to regulate research, resulting in varying levels of oversight by tribes. These governance measures establish collective protections absent from the US federal government's research oversight infrastructure, while setting expectations regarding benefits to tribes as political collectives. Using a legal epidemiology approach, the paper discusses findings from a review of Tribal research legislation, policy, and administrative materials from 26 tribes in the US. The discussion specifies issues viewed by tribes as facilitators and barriers to securing benefits from research for their nations and members/citizens, and describes preemptive and mitigating strategies pursued by tribes in response. These strategies are set within the framing of the CARE Principles for Indigenous Data Governance (Collective Benefit, Authority to Control, Responsibility, Ethics), a set of standards developed to ensure that decisions made about data pertaining to Indigenous communities at the individual and tribal levels are responsive to their values and collective interests. Our findings illustrate gaps to address for benefit sharing and a need to strengthen Responsibility and Ethics in tribal research governance.
| S-EPMC9691892 | biostudies-literature
Project description:Stem cell research and related initiatives in regenerative medicine, cell-based therapy, and tissue engineering have generated considerable scientific and public interest. Researchers are applying stem cell technologies to chest medicine in a variety of ways: using stem cells as models for drug discovery, testing stem cell-based therapies for conditions as diverse as COPD and cystic fibrosis, and producing functional lung and tracheal tissue for physiologic modeling and potential transplantation. Although significant scientific obstacles remain, it is likely that stem cell-based regenerative medicine will have a significant clinical impact in chest medicine. However, stem cell research has also generated substantial controversy, posing a variety of ethical and regulatory challenges for research and clinical practice. Some of the most prominent ethical questions related to the use of stem cell technologies in chest medicine include (1) implications for donors, (2) scientific prerequisites for clinical testing and use, (3) stem cell tourism, (4) innovation and clinical use of emerging stem cell-based interventions, (5) responsible translation of stem cell-based therapies to clinical use, and (6) appropriate and equitable access to emerging therapies. Having a sense of these issues should help to put emerging scientific advances into appropriate context and to ensure the responsible clinical translation of promising therapeutics.
| S-EPMC4364318 | biostudies-literature
Project description:Numerous arguments have been advanced for broadly sharing de-identified, participant-level clinical trials data, and trial sponsors and journals are increasingly requiring it. However, data sharing in pragmatic clinical trials presents ethical challenges related to the use of waivers or alterations of informed consent for some pragmatic clinical trials and corresponding limitations of informed consent to guide sharing decisions; the potential for data sharing in pragmatic clinical trials to present risks not only for individual patient-subjects, but also for health systems and the clinicians within them; sharing of data from electronic health records instead of data newly collected for research purposes; and researchers' limited capacity to control sensitive data within an electronic health record and potential implications of such limits for meeting obligations inherent to Certificates of Confidentiality. These challenges raise questions about the extent to which traditional research ethics governance structures are capable of guiding decisions about pragmatic clinical trial data sharing. This article identifies and examines these ethical challenges for pragmatic clinical trial data sharing. We suggest several areas for future empirical scholarship, including the need to identify patient and public attitudes regarding pragmatic clinical trial data sharing as well as to assess the demand for pragmatic clinical trial data and the correspondingly likely benefit of such sharing. Further conceptual work is also needed to explore how requirements to respect patient-subjects about whom data are shared in the context of pragmatic clinical trials should be understood, particularly in the absence of informed consent for initial research activities, and the appropriate balance between promoting the generation of socially valuable knowledge and respecting autonomy.
| S-EPMC10267884 | biostudies-literature
Project description:BackgroundAmerican Indians/Alaska Natives have the highest commercial tobacco use in the United States, resulting in higher tobacco-caused deaths and diseases than the general population. Some American Indians/Alaska Natives use commercial tobacco for ceremonial as well as recreational uses. Because federally recognized Tribal lands are sovereign, they are not subject to state cigarette taxes and smoke-free laws. This study analyzes tobacco industry promotional efforts specifically targeting American Indians/Alaska Natives and exploiting Tribal lands to understand appropriate policy responses in light of American Indians'/Alaska Natives' unique sovereign status and culture.MethodsWe analyzed previously secret tobacco industry documents available at the Truth Tobacco Documents Library (https://industrydocuments.library.ucsf.edu/tobacco/).ResultsTobacco companies used promotional strategies targeting American Indians/Alaska Natives and exploiting Tribal lands that leveraged the federally recognized Tribes' unique sovereign status exempting them from state cigarette taxes and smoke-free laws, and exploited some Tribes' existing traditional uses of ceremonial tobacco and poverty. Tactics included price reductions, coupons, giveaways, gaming promotions, charitable contributions, and sponsorships. In addition, tobacco companies built alliances with Tribal leaders to help improve their corporate image, advance ineffective Youth Smoking Prevention programs, and defeat tobacco control policies.ConclusionsThe industry's promotional tactics likely contribute to disparities in smoking prevalence and smoking-related diseases among American Indians//Alaska Natives. Proven policy interventions to address these disparities including tobacco price increases, cigarette taxes, comprehensive smoke-free laws, and industry denormalization campaigns to reduce smoking prevalence and smoking-related disease could be considered by Tribal communities. The sovereign status of federally recognized Tribes does not prevent them from adopting these measures.ImplicationsAmerican Indians/Alaska Natives suffer disparities in smoking prevalence and smoking-related diseases as compared with other groups. The tobacco industry has used promotional tactics including price reductions, coupons and giveaways, casino and bingo promotions, charitable contributions and sponsorships, and so-called Youth Smoking Prevention (YSP) programs to specifically target American Indians/Alaska Natives and exploit Tribal sovereignty, which likely contribute to disparities in tobacco use and related diseases and deaths among this population. Tribal and public health policy makers should consider rejecting ineffective YSP programs and instead consider adopting proven policy interventions including tobacco price increases, cigarette and casino taxes, comprehensive smokefree laws, and anti-industry denormalization campaigns to reduce smoking and smoking-related disease.
| S-EPMC6588391 | biostudies-literature
Project description:Yoga and meditation-based interventions have been extensively utilized in the field of contemporary complementary and alternative medicine for various physical and mental health conditions. Ongoing COVID-19 pandemic has rekindled the interest of researchers in yoga and meditation for its preventive and therapeutic utilities. However, the available literature in this area has several methodological concerns, limiting formers' clinical utility. A comprehensive literature on this topic would stimulate researchers and guide them to conduct research on this topic with robust methodologies. The current review highlights the methodological issues with the yoga and meditation-based Research (henceforth, MBR), discusses some of the contentious issues, and provides future directions. The PubMed, Medline, and google scholar databases were searched to screen records dealing with the methodological issues on MBR. The search yielded 299 records, upon screening, only 24 articles were found suitable for the current study. Common methodological issues with MBR: lack of the consensus definitions of the yoga and meditations, interventions lacking theoretical framework of meditation; inadequate description of the study design; difficulty with participants recruitment, setting up the control groups, and blinding; difficulty in assessing the baseline characteristics of the participants, and validity issues with the outcome measures. A few research, however, have also highlighted the potential measures to overcome these methodological challenges. Yoga and meditation-based interventions are promising for several health conditions. However, literature suffers from considerable methodological issues, thus, limiting its utility in modern clinical practice. The study findings can stimulate and guide future research on this topic.
| S-EPMC9451492 | biostudies-literature
Project description:Background:Research around humanitarian crises, aid delivery, and the impact of these crises on health and well-being has expanded dramatically. Ethical issues around these topics have recently received more attention. We conducted a systematic literature review to synthesize the lessons learned regarding the ethics of research in humanitarian crises. Methods:We conducted a systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines to identify articles regarding the ethics of research in humanitarian contexts between January 1, 1997 and September 1, 2019. We analyzed the articles to extract key themes and develop an agenda for future research. Results:We identified 52 articles that matched our inclusion criteria. We categorized the article data into five categories of analysis: 32 were expert statements, 18 were case studies, 11 contained original research, eight were literature reviews and three were book chapters. All included articles were published in English. Using a step-wise qualitative analysis, we identified 10 major themes that encompassed these concepts and points. These major themes were: ethics review process (21 articles, [40.38%]); community engagement (15 articles [28.85%]); the dual imperative, or necessity that research be both academically sound and policy driven, clinical trials in the humanitarian setting (13 articles for each, [25.0%)]; informed consent (10 articles [19.23%]); cultural considerations (6 articles, [11.54%]); risks to researchers (5 articles, [9.62%]); child participation (4 articles [7.69%]); and finally mental health, and data ownership (2 articles for each [3.85%]). Conclusions:Interest in the ethics of studying humanitarian crises has been dramatically increasing in recent years. While key concepts within all research settings such as beneficence, justice and respect for persons are crucially relevant, there are considerations unique to the humanitarian context. The particular vulnerabilities of conflict-affected populations, the contextual challenges of working in humanitarian settings, and the need for ensuring strong community engagement at all levels make this area of research particularly challenging. Humanitarian crises are prevalent throughout the globe, and studying them with the utmost ethical forethought is critical to maintaining sound research principles and ethical standards.
| S-EPMC7245798 | biostudies-literature
Project description:In response to community concerns, we used the Tribal Participatory Research framework in collaboration with 5 American-Indian communities in Washington, Idaho, and Montana to identify the appropriate criteria for aggregating health data on small tribes. Across tribal sites, 10 key informant interviews and 10 focus groups (n = 39) were conducted between July 2012 and April 2013. Using thematic analysis of focus group content, we identified 5 guiding criteria for aggregating tribal health data: geographic proximity, community type, environmental exposures, access to resources and services, and economic development. Preliminary findings were presented to focus group participants for validation at each site, and a culminating workshop with representatives from all 5 tribes verified our final results. Using this approach requires critical assessment of research questions and study designs by investigators and tribal leaders to determine when aggregation or stratification is appropriate and how to group data to yield robust results relevant to local concerns. At project inception, tribal leaders should be consulted regarding the validity of proposed groupings. After regular project updates, they should be consulted again to confirm that findings are appropriately contextualized for dissemination.
| S-EPMC4929243 | biostudies-literature
Project description:Background: Genomic and biobanking research has increased in Africa over the past few years. This has raised pertinent ethical, legal, and societal concerns for stakeholders such as sample or data ownership, commercialization, and benefit sharing. There is limited awareness of the concept of benefit sharing by stakeholders in sub-Saharan Africa. Objective: This study aimed to explore the perceptions of researchers and research ethics committee members on benefit sharing in international collaborative genomic and biobanking research. Methods: Qualitative in-depth interviews were conducted with 15 researchers and 19 research ethics committee members. A thematic approach was used to interpret the results. Results: Six themes emerged from the data and these included perceptions on the benefits of genomic and biobanking research; discussion of benefit sharing with participants during the informed consent process; legal implications of benefit sharing and the role of material transfer agreements; equity and fairness in sharing the benefits of genomic research; perceived barriers to fair benefit sharing; and recommendations for fostering fair and equitable benefit sharing in genomic and biobanking research. Most respondents clearly understood the various forms of benefits of genomic and biobanking research and opined that such benefits should be fairly and equitably shared with low and middle-income country researchers and their institutions, and research communities. The perceived barriers to the fair benefit sharing unfavorable include power disparities, weak research regulatory frameworks, and lack of scientific integrity. Conclusion: Overall, respondents believed that the distribution of the advantages of genomic and biobanking research in North-South collaborative research was not equitable nor fair, and that the playing field was not leveled. Therefore, we advocate the following for fair and equitable benefit sharing: Building the capacities and empowering research scientists in developing nations; strengthening regulatory frameworks and extending the purview of the research ethics committee in the development and implementation of material transfer agreements; and meaningfully involving local research communities in benefit sharing negotiations.
| S-EPMC9714451 | biostudies-literature