Extending Research Protections to Tribal Communities.

The history of research in American Indian/Alaska Native (AI/AN) communities has been marked by unethical practices, resulting in mistrust and reluctance to participate in research. Harms are not limited to individual persons-tribal communities experience harmful misrepresentation and generalizations disrespectful of AI/AN groups' heritage, cultures, and beliefs. The Belmont Report's research ethics principles are applied primarily to protect individual research participants. The principles of sovereignty and solidarity are argued to be important concepts in extending Belmont's research protections to tribal communities. Sovereignty, an expression of respect for autonomy at a group level, is the basis for tribal self-determination. The principle of solidarity provides an ethical underpinning for tribes' obligations to protect community interests and culture. Extension of Belmont through these principles should serve to minimize harms to AI/AN groups in research.

Genomic Research and American Indian Tribal Communities in Oklahoma: Learning From Past Research Misconduct and Building Future Trusting Partnerships.

Research misconduct and consequential harms have been inflicted upon American Indian/Alaska Native communities for decades. To protect their people and culture and to retain oversight over research, many Native communities have established tribal health research and institutional review boards. The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study showcases a successful, trusting research collaboration with tribal nations and academic investigators in Oklahoma. In 2006, the TODAY Study investigators proposed a modification of the study protocol to collect biological specimens from participants for genomic analyses and indefinite storage. Partnering American Indian tribal nations elected not to participate in the genomics collection and repository proposal. Reasons included 1) protection of cultural values, 2) concerns regarding community anonymity, 3) a potential threat to tribal services eligibility, 4) broad informed consent language, and 5) vague definitions of data access and usage. The nations believed the proposed genomics analyses presented a risk of harm to their people and nations without clear benefit. Since the 2006 proposal and the advancement of genomics research, many tribal communities in Oklahoma, appreciating the potential benefits of genomic research, are developing policies regarding oversight of/access to data and biological specimens to mitigate risks and provide members and communities with opportunities to participate in safe and meaningful genomic research.

Racial Misclassification in Mortality Records Among American Indians/Alaska Natives in Oklahoma From 1991 to 2015.

OBJECTIVE: The primary purpose of this study was to compare age-adjusted mortality rates before and after linkage with Indian Health Service records, adjusting for racial misclassification. We focused on differences in racial misclassification by gender, age, geographic differences, substate planning districts, and cause of death. Our secondary purpose was to evaluate time trends in misclassification from 1991 to 2015. DESIGN: Retrospective, descriptive study. SETTING: Oklahoma. PARTICIPANTS: Persons contained in the Oklahoma State Health Department Vital Records. MAIN OUTCOME MEASURES: To evaluate the age-adjusted mortality ratio pre- and post-Indian Health Service record linkage (misclassification rate ratio) and to evaluate the overall trend of racial misclassification on mortality records measured through annual percent change (APC) and average annual percent change (AAPC). RESULTS: We identified 2 stable trends of racial misclassification upon death for American Indians/Alaska Natives (AI/ANs) from 1991 to 2001 (APC: -0.2%; 95% confidence interval: -1.4% to 1.0%) and from 2001 to 2005 (APC: -6.9%; 95% confidence interval: -13.7% to 0.4%). However, the trend identified from 2005 to 2015 decreased significantly (APC: -1.4%; 95% confidence interval: -2.5% to -0.2%). For the last 5 years available (2011-2015), the racial misclassification adjustment resulted in higher mortality rates for AI/ANs reflecting an increase from 1008 per 100 000 to 1305 per 100 000 with the linkage process. There were an estimated 3939 AI/ANs in Oklahoma who were misclassified as another race upon death in those 5 years, resulting in an underestimation of actual AI/AN deaths by nearly 29%. CONCLUSIONS: An important result of this study is that misclassification is improving; however, this effort needs to be maintained and further improved. Continued linkage efforts and public access to linked data are essential throughout the United States to better understand the burden of disease in the AI/AN population.

Obesity, Diabetes, and Birth Outcomes Among American Indians and Alaska Natives.

Objectives To examine the relationships between prepregnancy diabetes mellitus (DM), gestational diabetes mellitus (GDM), and prepregnancy body mass index, with several adverse birth outcomes: preterm delivery (PTB), low birthweight (LBW), and macrosomia, comparing American Indians and Alaska Natives (AI/AN) with other race/ethnic groups. Methods The sample includes 5,193,386 singleton US first births from 2009-2013. Logistic regression is used to calculate adjusted odds ratios controlling for calendar year, maternal age, education, marital status, Kotelchuck prenatal care index, and child's sex. Results AI/AN have higher rates of diabetes than all other groups, and higher rates of overweight and obesity than whites or Hispanics. Neither overweight nor obesity predict PTB for AI/AN, in contrast to other groups, while diabetes predicts increased odds of PTB for all groups. Being overweight predicts reduced odds of LBW for all groups, but obesity is not predictive of LBW for AI/AN. Diabetes status also does not predict LBW for AI/AN; for other groups, LBW is more likely for women with DM or GDM. Overweight, obesity, DM, and GDM all predict higher odds of macrosomia for all race/ethnic groups. Conclusions for Practice Controlling diabetes in pregnancy, as well as prepregnancy weight gain, may help decrease preterm birth and macrosomia among AI/AN.

Fostering Ethical, Legal, and Social Implications Research in Tribal Communities: The Center for the Ethics of Indigenous Genomic Research.

Genomic research raises unique ethical concerns among Alaska Native and American Indian (AN/AI) people and their communities. The Center for the Ethics of Indigenous Genomic Research (CEIGR) was created to foster research that takes these concerns into account while considering the sovereign status of AN/AI tribal nations. Relationships developed within CEIGR have allowed for effective, collaborative research among individuals who come from diverse cultures, political and historical backgrounds, and academic disciplines, and who work for organizations with varying resources, capacities, and expectations. The CEIGR framework may inform other groups seeking to conduct social science research related to genomic research with tribal people and their communities.