Partnering in Research: A National Research Trial Exemplifying Effective Collaboration With American Indian Nations and the Indian Health Service

American Journal of Epidemiology © The Author 2014. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: . Vol. 180, No. 12 DOI: 10.1093/aje/kwu246 Advance Access publication: November 11, 2014 Practice of Epidemiology Partnering in Research: A National Research Trial Exemplifying Effective Collaboration With American Indian Nations and the Indian Health Service * Correspondence to Jennifer Q. Chadwick, Native American Programs Coordinator, University of Oklahoma Health Sciences Center, 1200 NE Children’s Avenue 4D, Oklahoma City, OK 73104 (e-mail: ). Initially submitted March 19, 2014; accepted for publication August 15, 2014. Despite the fact that numerous major public health problems have plagued American Indian communities for generations, American Indian participation in health research traditionally has been sporadic in many parts of the United States. In 2002, the University of Oklahoma Health Sciences Center (Oklahoma City, Oklahoma) and 5 Oklahoma American Indian research review boards (Oklahoma City Area Indian Health Service, Absentee Shawnee Tribe, Cherokee Nation, Chickasaw Nation, and Choctaw Nation) agreed to participate collectively in a national research trial, the Treatment Options for Type 2 Diabetes in Adolescence and Youth (TODAY) Study. During that process, numerous lessons were learned and processes developed that strengthened the partnerships and facilitated the research. Formal Memoranda of Agreement addressed issues related to community collaboration, venue, tribal authority, preferential hiring of American Indians, and indemnification. The agreements aided in uniting sovereign nations, the Indian Health Service, academics, and public health officials to conduct responsible and ethical research. For more than 10 years, this unique partnership has functioned effectively in recruiting and retaining American Indian participants, respecting cultural differences, and maintaining tribal autonomy through prereview of all study publications and local institutional review board review of all processes. The lessons learned may be of value to investigators conducting future research with American Indian communities. American Indians; American Indian health; collaborative research; community-based research Abbreviations: IRB, institutional review board; MOA, Memorandum of Agreement; OUHSC, University of Oklahoma Health Sciences Center; P&P, Presentations and Publications; TODAY, Treatment Options for Type 2 Diabetes in Adolescents and Youth. academic investigators (2–4). In some cases, American Indian communities have experienced abuse of trust, misinterpretation or misrepresentation of data, and failure by investigators to share new knowledge with them (2, 4–8). In other cases, academic researchers have ignored or failed to acknowledge valuable contributions made by tribal community members (8). In the past, researchers entered American Indian communities with preconceived notions of the communities’ problems, without knowledge of the culture or an appreciation of what the communities themselves viewed as their problems (4, 6, 8). At times, American Indian communities learned of studies’ results only after seeing them in print or in the media, leading the communities to believe they were HISTORICAL BACKGROUND American Indian communities have dealt with numerous public health–related issues for decades. Of all US racial/ ethnic groups, the American Indian population continues to have the lowest attained levels of education, the highest unemployment rates, and the lowest income levels (1). American Indians have higher mortality rates, including mortality from tuberculosis, diabetes, and pneumonia, than all other US racial/ ethnic groups (1). Even with these health concerns, historically there have been significant barriers to conducting research with American Indian communities, including a lack of understanding of tribal culture, sovereignty, and research priorities by non-Native 1202 Am J Epidemiol. 2014;180(12):1202–1207 Jennifer Q. Chadwick*, Kenneth C. Copeland, Mary R. Daniel, Julie A. Erb-Alvarez, Beverly A. Felton, Sohail I. Khan, Bobby R. Saunkeah, David F. Wharton, and Marisa L. Payan Research Partnering With American Indian Nations Tribal sovereignty American Indian tribes and nations have a unique legal status known as tribal sovereignty. In the 1800s, the US Supreme Court recognized the ability of Native tribes and nations to regulate their own internal affairs but limited this power by recognizing them as domestic dependent nations (13). Tribal sovereignty is derived from complex and frequently changing treaties that were negotiated with the US government (6). The 1975 Indian Self-Determination Act, along with the passage of the Indian Self-Determination and Education Assistance Act Amendments in 1988, allowed Native tribes and nations to take control of their health programs and reclaim traditional practices (14, 15). As a result of these acts and treaties, tribal sovereignty must be recognized and respected while partnering with American Indian tribes and nations in academic research (6). Oklahoma tribal and Indian Health Service institutional review boards As a result of previous concerns related to health research, many tribes have begun exerting their sovereign authority by developing tribal institutional review boards (IRBs) or research ethics boards that monitor research activities within their jurisdiction. In Oklahoma, 4 American Indian IRBs— the Oklahoma City Area Indian Health Service IRB and 3 tribal IRBs, the Cherokee Nation, Chickasaw Nation, and Choctaw Nation IRBs—are registered and have their own unique Federalwide Assurance agreements with the Department of Health and Human Services’ Office of Human Research Protection. The Oklahoma City Area Indian Health Service and tribal IRBs provide human subject protections for the respective American Indian populations they serve, with the Oklahoma City Area Indian Health Service IRB serving those tribes that do not have an IRB. Although these IRBs represent independent, sovereign entities, they often collaborate closely with one another. Designed to promote research collaboration while preserving the rights of tribal citizens and protecting them from research harms, the boards also strive to protect tribal cultural Am J Epidemiol. 2014;180(12):1202–1207 values and sensitivities. The characteristics of tribal IRBs are unique, and these IRBs have a broader scope than a traditional academic IRB (7). American Indian IRBs typically: 1) require that approved research be relevant to tribal community priorities, 2) reserve the right to approve publications, and 3) claim sole or joint ownership of data generated by the research. American Indian IRBs promote community-engaged research and work closely with the researchers throughout the duration of a project (16). Prior to c (...truncated)