ObjectivesMembers of racially and ethnically diverse groups have been persistently underrepresented in biomedical research in general, possibly due to mistrust with the medical and research community. This article describes the perceptions, understandings, and expectations of Alaska Native people about research involving the collection and storage of biological specimens.Study designStratified focus groups.MethodsTwenty-nine focus groups with Alaska Native people (n = 178) were held in 14 locations using a semi-structured moderator guide. ATLAS.ti was used for thematic analysis through iterative readings and coding. Alaska Native peoples’ perceptions, understandings, and expectations of researcher beneficence, informed consent processes, and provision of research findings were elicited.Results and conclusionsAlaska Native people desired extensive disclosure of information beyond that typically provided in consent and results dissemination processes. Information germane to the motivation and intent of researchers and specifics of specimen storage and destruction were specifically requested. A clear and extensive process of informed consent and continued improvements in sharing results may enhance the transparency of research intent, conduct, and use of obtained results among Alaska Native people. Meeting expectations may improve relationships between researchers and the Alaska Native population which could result in increased research participation. Our findings offer a guide for researchers and communities when planning and implementing research with biological specimens.

National Institutes of Health data-sharing policies aim to maximize public benefit derived from genetic studies by increasing research efficiency and the use of a pooled data resource for future studies. While broad access to data may lead to benefits for populations underrepresented in genetic studies, such as indigenous groups, tribes have ownership interest in their data. The Northwest-Alaska Pharmacogenetic Research Network, a partnership involving tribal organizations and universities conducting basic and translational pharmacogenetic research, convened a meeting to discuss the collection, management, and secondary use of research data, and of the processes surrounding access to data stored in federal repositories. This article reports on tribal perspectives that emerged from the dialogue and discusses the implications of tribal government sovereign status on research agreements and data-sharing negotiations. There is strong tribal support for efficient research processes that expedite the benefits from collaborative research, but there is also a need for data sharing procedures that take into account tribal sovereignty and appropriate oversight of research ¬ such as tribally-based research review processes and review of draft manuscripts. We also note specific ways in which accountability could be encouraged by National Institutes of Health as part of the research process.

Background Alaska Native and American Indian people (AN/AIs) have high incidence of colorectal cancer (CRC) and CRC-related mortality. Screening can prevent death from CRC, but screening rates are low in racially and ethnically diverse populations. We conducted a randomized controlled trial using text messaging to increase CRC screening among unscreened AN/AIs in a tribal healthcare system in Anchorage, Alaska. Methods The intervention entailed up to three text messages one month apart. We randomized 2,386 AN/AIs aged 40–75 years old who were eligible for CRC screening to the intervention or usual-care control conditions. Screening status was ascertained from electronic health records three and six months after the last message. We estimated hazard ratios (HR) to evaluate the intervention’s effectiveness, stratified by age and sex. Results The intervention increased CRC screening for people ages 50–75 (HR = 1.42, 95% CI = 0.97–2.09) and ages 40–49 (HR = 1.24, 95% CI = 0.95–1.62). Within both age groups the HRs were higher for women (HR = 1.69, 95% CI = 1.02–2.80; and HR = 1.37, 95% CI = 1.01–1.88) than for men (HR = 1.09, 95% CI = 0.59–1.99; and HR = 0.90, 95% CI = 0.54–1.53). Interaction analysis yielded p values of 0.55 and 0.09 for age and sex, respectively. Conclusions A simple text messaging intervention increased CRC screening in AN/AIs, a group with high CRC morbidity and mortality. Text messaging may be a cost-effective means of reducing CRC screening disparities in AN/AIs and other populations.

Objectives Pharmacogenetic testing is projected to improve health outcomes and reduce the cost of care by increasing therapeutic efficacy and minimizing drug toxicity. American Indian and Alaska Native (AI/AN) people historically have been excluded from pharmacogenetic research and its potential benefits, a deficiency we sought to address. The vitamin K antagonist warfarin is prescribed for prevention of thromboembolic events, although its narrow therapeutic index and wide inter-individual variability necessitate close monitoring of drug response. Therefore, we were interested in variation in CYP2C9, VKORC1, CYP4F2, CYP4F11, and GGCX, which encode enzymes important for the activity of warfarin and synthesis of vitamin K dependent blood clotting factors. Methods We resequenced these genes in 188 AI/AN people in partnership with Southcentral Foundation (SCF) in Anchorage, AK and 94 Yup'ik people living in the Yukon-Kuskokwim Delta of southwest Alaska to identify known or novel function-disrupting variation. We conducted genotyping for specific SNPs in larger cohorts of each study population (380 and 350, respectively). Results We identified high frequencies of the lower-warfarin dose VKORC1 haplotype (−1639G>A and 1173C>T) and the higher-warfarin dose CYP4F2*3 variant. We also identified two relatively common, novel, and potentially function-disrupting variants in CYP2C9 (M1L and N218I), which, along with CYP2C9*3, CYP2C9*2 and CYP2C9*29, predict that a significant proportion of AI/AN people will have decreased CYP2C9 activity. Conclusions Overall, we predict a lower average warfarin dose requirement in AI/AN populations in Alaska than that seen in non-AI/AN populations of the US, a finding consistent with clinical experience in Alaska.

PURPOSE This study describes key elements of the transition to a patient-centered medical home (PCMH) model at Southcentral Foundation (SCF), a tribally owned and managed primary care system, and evaluates changes in emergency care use for any reason, for asthma, and for unintentional injuries, during and after the transition. METHODSWe conducted a time series analyses of emergency care use from medical record data. We also conducted 45 individual, in-depth interviews with PCMH patients (customer-owners), primary care clinicians, health system employees, and tribal leaders. RESULTSEmergency care use for all causes was increasing before the PCMH implementation, dropped during and immediately after the implementation, and subsequently leveled off. Emergency care use for adult asthma dropped before, during, and immediately after implementation, subsequently leveling off approximately 5 years after implementation. Emergency care use for unintentional injuries, a comparison variable, showed an increasing trend before and during implementation and decreasing trends after implementation. Interview participants observed improved access to primary care services after the transition to the PCMH tempered by increased staff fatigue. Additional themes of PCMH transformation included the building of relationships for coordinated, team-based care, and the important role of leadership in PCMH implementation.CONCLUSIONS All reported measures of emergency care use show a decreasing trend after the PCMH implementation. Before the implementation, overall use and use for unintentional injuries had been increasing. The combined quantitative and qualitative results are consistent with decreased emergency care use resulting from a decreased need for emergency care services due to increased availability of primary care services and same-day appointments.

Alaska Native (AN) and American Indian (AI) people are underrepresented in health research, yet many decline to participate in studies due to past researcher misconduct. Southcentral Foundation (SCF), an Alaska Native-owned and operated health care organization, is transforming the relationship between researchers and the tribal community by making trust and accountability required features of health research in AN/AI communities. In 1998, SCF assumed ownership from the federal government of health services for AN/AI people in south central Alaska and transformed the health system into a relationship-based model of care. This change reimagines how researchers interact with tribal communities and established community oversight of all health research conducted with AN/AI people in the region. We describe the SCF research review process, which requires tribal approval of the research concept, full proposal, and dissemination products, as well as local institutional review board approval, and a researcher-signed contract. This review evaluates research through the lens of tribal principles, practices, and priorities. The SCF example provides a framework for other tribes and organizations seeking to reshape the future of health research in AN/AI communities.

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Pharmacogenetic research offers the potential to improve the safety and efficacy of drug prescribing. Assuring that the benefits of this research reach indigenous and other medically underserved people is an important justice concern. First, however, a legacy of mistrust, derived from traditional research practices that disempower communities, must be overcome. Linking pharmacogenetic research to collaborative, power-sharing research partnerships provides a valuable opportunity to develop new and positive precedents for genetic research in indigenous communities.