Project Summary/Abstract 30 lines of text With a collaborative approach grounded in Indigenous core cultural values, the Indigenous Innovators Collaborative (IIC) team will engage in community-based participatory research study to address the FDA priorities as outlined in FDA OMHHE Health Equity Innovation Award: Racial and Ethnic Minority Acceleration Consortium for Health Equity (REACH) funding opportunity. The IIC seeks to engage American Indian and Alaska Native (AIAN) communities, stakeholders, researchers in an exploration of clinical trials and promote cultural knowledge in understanding clinical trials in Indian Country. The IIC consists of core partners that form the Administrative Core (AC) of this project, including: (1) Americans for Indian Opportunity (AIO), which serves as the fiscal agent/grant administrator; (2) Co-Investigator 1: Dr. Myra Parker (Three Affiliated Tribes), University of Washington; (3) Co-Investigator 2: Dr. Billie Jo Kipp (Blackfeet), Natives in Philanthropy; (4) Principle Investigator: Stephine Poston (Pueblo of Sandia), Poston & Associates, LLC; and, (5) the United Tribes Technical College (UTTC), an accredited, land-grant tribal college located in Bismarck, North Dakota, that serves the five reservations in ND and tribal members across the U.S. UTTC has provided higher education support to over 10,000 AI students from over 75 tribes. We propose to expand this effort to implement an exploratory study that would employ a mixed methods approach to improve understandings of AIAN perceptions of clinical trials and gene therapy across multiple regions of the U.S. Our aims include: 1. Specific Aim 1 – Partner with local tribal colleges to assess AIAN community knowledge, concerns, and beliefs about clinical trials and gene therapy within the 12 IHS regions using a mixed methods approach. a. Hypothesis 1 – AIAN community knowledge, concerns, and beliefs about clinical trials and gene therapy will vary across IHS regions and will reflect local tribal cultural understandings. 2. Specific Aim 2 – Identify barriers and supports for clinical trials and gene therapy among AIAN within the 12 IHS regions by collecting qualitative data from AIAN providers, researchers, and public health experts. a. Hypothesis 2 – Barriers and supports for clinical trials and gene therapy among AIAN will vary by IHS Region and tribal cultures.

Project Narrative Three sentences With a collaborative approach grounded in Indigenous core cultural values, the Indigenous Innovators Collaborative (IIC) team will engage in community-based participatory research study to address the FDA priorities as outlined in FDA OMHHE Health Equity Innovation Award: Racial and Ethnic Minority Acceleration Consortium for Health Equity (REACH) funding opportunity. The IIC seeks to engage American Indian and Alaska Native (AIAN) communities, stakeholders, researchers in an exploration of clinical trials and promote cultural knowledge in understanding clinical trials in Indian Country. One of the fundamental goals of this study is to aid in identifying perceptions of clinical trials and gene therapy within the Native American population.