This webinar is free to all. Watch it now.
In collaboration with Northwest Indian College
American Indian/Alaska Native (AI/AN) tribal nations are communities with distinctive social, cultural, and spiritual qualities that embody a unique context for the review and conduct of research. AI/AN tribal nations have developed a variety of research review mechanisms that are tailored to specific community needs and interests.
Recently, both the National Institutes of Health (NIH) and the Department of Health and Human Services (HHS) solicited public comments on policy proposals that promote the use of a single Institutional Review Board (IRB) of record for review of multi-site research. The explicit goal of these policies is to reduce procedural inefficiencies and redundancies associated with multiple IRB reviews. According to both the Final NIH Policy on the Use of a Single IRB for Multi-Site Research and the Notice of Proposed Rulemaking (NPRM) to the Federal Policy for the Protection of Human Subjects, exceptions would be permitted in some circumstances, such as when local IRB review is required by federal, tribal, or state laws or regulations.
Policies to promote the use of single IRBs for multi-site research raise important questions related to the oversight of research in AI/AN tribes. A number of public comments were submitted in response to the draft policies by and on behalf of AI/AN tribes, all of which emphasized the importance of maintaining a role for local tribal review of research to ensure appropriate consideration of unique tribal interests. Many commenters called for a more explicit recognition of the legal jurisdiction of tribal nations and their role in protecting human subjects to ensure that they do not become overlooked or marginalized.
Neither the final NIH policy nor the NPRM provide specific guidance on how to identify, operationalize, and enforce exceptions to the proposed rules. It falls upon individual federal agencies and NIH Institutes to develop policies and procedures that are tailored to specific cases.
PRIM&R is pleased to present this complimentary webinar in collaboration with Northwest Indian College, which aims to provide recommendations for future guidance with regards to operationalizing the exceptions clause, and to reinforce the vital role local review plays in AI/AN research. Using case studies, speakers will cover the following:
- The historical and ethical foundations for tribally based review
- Models and mechanisms for review that are unique to tribes, and how they currently fit into multisite research with AI/AN tribal populations
- The final NIH policy and NPRM single IRB mandates, and comments and concerns related to the potential impact of these policies on AI/AN research
- Considerations for future guidance regarding operationalization of the exceptions clause in this new regulatory landscape
What will I learn?
After attending this webinar, attendees will:
- Appreciate the unique and vital role review by tribes and review by tribally-based IRBs plays in research with AI/AN tribes, communities, and individuals
- Understand the potential impact of single IRB policies on tribally based review, and the potential impact of tribally based review on single IRB policies
- Be better equipped to engage in a dialogue about preserving local review via the exceptions clauses
Who should attend?
This intermediate-level webinar will benefit IRB professionals, IRB members, and researchers who are currently responsible for reviewing and conducting research with AI/AN communities, as well as those who may review this type of research in the future. This webinar will also be of interest to program officers from funding agencies and those involved with granting exceptions under single IRB policies.
Webinar participants holding the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP recertification.
PRIM&R is pleased to collaborate with Northwest Indian College (NWIC) to present this complimentary webinar to our constituents. Through education, NWIC promotes Indigenous self-determination and knowledge. For more information, visit www.nwic.edu.
Daniel J. Calac, MD, FAAP, has served as chief medical officer of the Indian Health Council, Inc. located near San Diego, California since 2003. He was raised on the Pauma Indian Reservation and graduated from San Diego State University. He attended Harvard Medical School, and completed his internship and residency at the University of Southern California-Los Angeles County Combined Internal Medicine/Pediatrics Residency Program. He is board-certified in both Internal Medicine and Pediatrics. He also practices hospice/palliative care medicine and is board eligible in this field. He is a member of the Pauma Band of Luiseno Indians and is actively involved in his community. His professional interests include chronic disease and clinical research. Dr. Calac serves as the principal investigator for the California Native American Research Center for Health, which is an NIH-funded project that provides a platform for community-based participatory research in American Indian communities. He is actively engaged in several research projects which aim to improve the health of American Indians and encourage students to pursue careers as scientists and/or health care professionals. Dr. Calac also serves on a variety of committees including the Health Research Advisory Council for the Department of Health and Human Services, the Committee on Native American Child Health, Cal State San Marcos Foundation Board, and the governance board for the All Tribes American Indian Charter School. He also enjoys hiking, backpacking, and spending time with his four children and wife Jacqueline of 24 years.
Malia Villegas, EdD, EdM, is director of the National Congress of American Indians (NCAI) Policy Research Center. She is an enrolled member of the Native Village of Afognak in Alaska, where she also serves on the Tribal Council. The NCAI Policy Research Center was established in 2003 to provide tribal leaders with the best available knowledge to inform their strategic policy decision within a framework of Native wisdom to positively impact the future of Native peoples. Dr. Villegas has extensive experience in tribal research governance and leads projects on building tribal data capacity, improving the translation of diabetes research, strengthening the dissemination of community-based participatory research, and fostering Native youth resilience. She serves on the Editorial Board of the Journal of American Indian Education and previously served as an Editor of the Harvard Educational Review. Dr. Villegas earned her master’s degree and doctorate in Culture, Communities, and Education at Harvard University and completed her undergraduate studies at Stanford University.
Sara Chandros Hull, PhD, received her undergraduate degree in molecular cell biology and genetics from Brandeis University and earned a PhD from the Johns Hopkins Program in Law, Ethics and Health in 1999. As a faculty member in the NIH Clinical Center’s Department of Bioethics, Dr. Hull's research interests focus primarily on the intersection between research ethics and new technological developments. Current projects focus on secondary genomic research findings, informed consent and data sharing for research for genomic research, the role and limits of centralized IRB review of multisite research, diversifying genomic research and clinical/diagnostic tools, and developing research ethics training programs for American Indian and Alaska Native Tribal IRBs and research review committees. Dr. Hull also directs the Bioethics Core of the National Human Genome Research Institute (NHGRI), NIH, which provides bioethics education, consultation, and administrative support to investigators in the intramural research program. She has been a member of the NHGRI IRB since 2003 and currently serves as its chair.
Valery Gordon, PhD, MPH is director for clinical research policy in the Office of Science Policy (OSP) in the Office of the Director at the NIH. At OSP, she works on trans-agency initiatives and priority projects for the NIH that are related to facilitating clinical research and enhancing protections for human research participants. Valery has been at NIH since 1992, and has worked in the Intramural Research Program, the Office of Research Services, the Office of Extramural Research (OER), the National Institute of Biomedical Imaging and Bioengineering (NIBIB), and the Office of Science Policy. She has served as a senior staff fellow, a biosafety officer, the director of the Human Subjects Protections Program and acting program policy officer in OER, the director of the Office of Extramural Policy for NIBIB, and most recently, the director for clinical research policy at OSP. Valery has a Ph.D. in Pharmacology from the University of Virginia, and an M.P.H. focusing on ethics and health policy from the Johns Hopkins University School of Public Health.
Ivor Pritchard, PhD, is the senior advisor to the director of the Office for Human Research Protections (OHRP) in the Department of Health and Human Services. He came to OHRP in 2004 from the Institute for Education Sciences at the US Department of Education, where he was a senior research analyst. He joined the US Department of Education in 1986. Dr. Pritchard has a PhD in philosophy from Boston University. His authored or co-authored publications include “Students as Research Subjects” (with Koski, in The Encyclopedia of Bioethics, 2014); “How Do IRB Members Make Decisions? A Review and Research Agenda” (Journal of Empirical Research on Human Research Ethics, 2011); “Searching for ‘Research Involving Human Subjects’: What Is Examined? What Is Exempt? What Is Exasperating?” (IRB: Ethics & Human Research, 2001); “Travelers and Trolls: Practitioner Research and Institutional Review Boards” (Educational Researcher, 2002); Ethical Standards of the American Educational Research Association: Cases and Commentary (Strike et. al., 2002); and “Power, Truth and Justice in Youth Participatory Action Research: Ethical Questions” (Practicing Anthropology: A Career-Oriented Publication of the Society for Applied Anthropology, 2004). His research interests are in research ethics and federal policy, moral and civic education research and practice, and education policy.
"Creating Research Capacity Through a Tribally Based Institutional Review Board" by Deborah J. Morton, Joely Proudfit, Daniel Calac, Martina Portillo, Geneva Lofton-Fitzsimmons, Theda Molina, Raymond Flores, Barbara Lawson-Risso, and Romelle Majel-McCauley in The American Journal of Public Health, December 2013.