OHRP Virtual Workshop Thursday, August 26, 2021, 1:00 – 3:00PM EDT Slides Agenda Watch Full Event Summary Report Resources Overview The goal of this workshop is to provide the research community with a practical framework for conducting and reviewing human subjects research involving American Indian/Alaska Native (AI/AN) populations. The panelists will address tribal interests in research, notions of community harm, suggestions for investigators on their research design, including how to balance research interests and indigenous values, and finally, training information for IRBs and ethics review boards. The discussion will focus on the importance of the ethical perspectives of Indigenous Communities in planning, reviewing, and conducting research with their community members. Target audience Investigators, members of IRBs and ethics review boards, and institutional research representatives. Welcome Address Rachel L. Levine, M.D.Assistant Secretary for Health, Department of Health and Human Services Speakers Jyoti Angal, M.P.H., C.I.P.Director, Clinical Research, Center for Pediatric & Community Research, Avera Research Institute, Avera McKennan Hospital & University Health Center Read Bio Ms. Jyoti Angal is the Director of Clinical Research at the Avera Research Institute. Over the past decade, Ms. Angal has provided regulatory oversight and leadership for large scale, longitudinal community-based projects and has conducted extensive work in tribal communities in the Northern Plains. She served as Project Director of the Safe Passage Study, a large multi-site longitudinal study involving multiple tribal committees and IRBs. She also served as the Director of the Regulatory Knowledge Core with the NIMHD-funded Collaborative Research Center for American Indian Health (CRCAIH). The mission of the Regulatory Knowledge Core was to work with tribes in South Dakota, North Dakota and Minnesota to build tribal research infrastructure, develop policies around tribally led research oversight, including issues related to data ownership and sharing. Working closely with the CRCAIH tribal partners, Ms. Angal led the development of the Tribal IRB Toolkit – a comprehensive resource to assist tribes with setting up their own IRBs. In 2019, Ms. Angal was appointed to the Secretary of Health Human Services Advisory Committee on Human Research Protections. Spero Manson, Ph.D. (Pembina Chippewa)Distinguished Professor of Public Health and Psychiatry, Colorado Trust Chair in American Indian Health, and Director, Centers for American Indian and Alaska Native Health, Colorado School of Public Health, CU Anschutz Medical Campus Read Bio Spero M. Manson, Ph.D. (Pembina Chippewa) is Distinguished Professor of Public Health and Psychiatry, directs the Centers for American Indian and Alaska Native Health, and occupies the Colorado Trust Chair in American Indian Health within the Colorado School of Public Health at the University of Colorado Denver's Anschutz Medical Center. His programs include 10 national centers, which pursue research, program development, training, and collaboration with 225 Native communities, spanning rural, reservation, urban, and village settings across the country. Dr. Manson has acquired $268 million in sponsored research to support this work and published 280 articles on the assessment, epidemiology, treatment, and prevention of physical, alcohol, drug, as well as mental health problems over the developmental life span of Native people. His numerous awards include the APHA's Rema Lapouse Mental Health Epidemiology Award (1998) and Award for Lifetime Contribution to the Field of Mental Health (2019), 4 special recognition awards from the IHS (1985, 1996, 2004, 2011), election to the National Academy of Medicine (2002); 2 Distinguished Mentor Awards from the GSA (2006; 2007), AAMC's Nickens Award (2006); George Foster Award for Excellence (2006) and Career Achievement Award (2020) from the Society for Medical Anthropology, NIH Health Disparities Award for Excellence (2008), Bronislaw Malinowski Award from the Society for Applied Anthropology (2019); and CDC Foundation's Elizabeth Fries Health Education Award (2021). He is widely acknowledged as one of the nation's leading authorities on Indian and Native health. Amy Elliott, Ph.D.Chief Clinical Research Officer, Avera Research Institute, Avera McKennan Hospital & University Health Center, Professor & Co-Division Chief, Research, Dept. of Pediatrics, University of South Dakota School of Medicine Read Bio Dr. Amy Elliott is the Chief Clinical Research Officer at Avera Health and a Professor/Co-Division Chief for the Department of Pediatrics, University of South Dakota School of Medicine. Dr. Elliott is a Clinical Psychologist who completed a fellowship in behavioral pediatrics and genetics, with a specialization in early childhood development. Dr. Elliott received her doctorate in Clinical Psychology from Western Michigan University and a Master's degree from North Dakota State University. Dr. Elliott has been the Principal Investigator of numerous large NIH-funded multi-site longitudinal projects focused on maternal and child health, as well as American Indian health initiatives. Throughout her career, she has worked to build longitudinal community-based research projects and regional centers to work in partnership with communities and clinicians to bring cutting edge research in areas of need to the prairie. In total, Dr. Elliott has received over $83 million in external funding to support these community-based research and infrastructure building programs. Dr. Elliott maintains active and productive research teams in Sioux Falls, Rapid City and Pine Ridge, focused on improving infant and childhood health outcomes. Elliott served as the Principal Investigator of the Safe Passage Study Northern Plains Comprehensive Clinical Site, a large multi-site community-based longitudinal transdisciplinary study first funded by the NICHD in 2003, to test the effects of prenatal alcohol exposure on fetal and infant mortality - 'Prenatal Alcohol in Sudden Infant Death Syndrome and Stillbirth (PASS) Network' (U01/HD34935). The PASS study required extensive work with state agencies and tribal governments on reporting requirements for substance use during pregnancy to make sure women participating did not experience adverse legal effects from their participation. Five sites across North Dakota and South Dakota participated in this study, with two locations on American Indian tribal lands. This valuable cohort from the Northern Plains is now being followed as part of the NIH-funded Environmental Influences on Child Health Outcomes (ECHO) (UH3/OD023279), where additional outcomes will be available pertaining asthma and neurodevelopment. Dr. Elliott was also involved in leadership for the collection of Fetal Alcohol Syndrome Epidemiological Research (FASER) prevalence data in the Northern Plains that worked to establish newly accepted prevalence data for Fetal Alcohol Spectrum Disorders in the United States. Elliott was the founding Principal Investigator for the NIMHD-funded Collaborative Research Center for American Indian Health (CRCAIH), funded by NIMHD (U54/MD008164) as the only Transdisciplinary Collaborative Research Center focused on American Indian health. CRCAIH provided a platform that brought together Tribal nations and health researchers, from multiple disciplines, to work together in the development of cutting-edge transdisciplinary research to address the significant health disparities experienced by American Indians in South Dakota, North Dakota and Minnesota. This work, over the past 15 years, has been the cultivation of primarily NIH-funded long-term community-based collaborations with tribal nations, key stakeholders, state agencies, clinicians, and partnering scientists. Dr. Elliott and her teams are very experienced in collaborating across varied locations and vast distances, leading start-up of large-scale community-based research studies, and taking the results of these studies and translating them to intervention research (R01/HD080544) or policy change. Dr. Elliott is well-poised to be the PI and join with other scientists and communities to create a collaborative Phase I proposal and operating structure to lead to successful projects in Phase II. Rachael Tracy, M.P.H.Research Director, National Institutional Review Board, Chair, Division of Planning, Evaluation, and Research, Office of Public Health Support, Indian Health Service Read Bio Rachael Tracy, M.P.H., is a proud member of the Navajo Nation. She received her M.P.H. from the University of Oklahoma and her B.S. from Arizona State University. Currently, Ms. Tracy serves as the Indian Health Service Health Research Director and Chair of the National Institutional Review Board. Her professional career has taken her down the path of 25 years of public service at the Indian Health Service, NIH, the California Rural Indian Health Board, and the Inter-Tribal Council of Arizona, Inc., where she has gained expertise in public health, community health, health education, research translation and implementation science and human subjects research protections. Ms. Tracy has had the honor of working with American Indian, Alaska Native, Native Hawaiian, Filipino, Latino, and African-American communities throughout the United States. Cynthia Pearson, Ph.D.Professor, School of Social Work, Adjunct Professor, American Indian Studies, Director of Research, Indigenous Wellness Research Institute National Center of Excellence, University of Washington Read Bio Cynthia Pearson (she/her), is a Professor at the School of Social Work, Adjunct Professor with American Indian Studies, and Director of Research at the Indigenous Wellness Research Institute at the University of Washington. Dr. Pearson provides oversight for research activities including the development of institute and tribal partnership polices, quantitative and qualitative methods, data-related activities (collection, analyses, storage), as well as human subject protocols. Since 2006, Dr. Pearson, has collaborated with Native American communities in designing and implementing community-based prevention interventions and in the development of tribally approved research polices such as data use agreement, and research and publication guidelines. Her effort has contributed to 47 community and university-led grants. She has over 62 publications: and have contributed to over 100 national and international presentations. Accreditation The program has been approved for 2.0 credit hours towards CIP recertification. Please follow their instructions on how to claim the credit hours. OHRP does not provide certification of attendance.