Implementation Science and Equity: Human Subjects & Regulatory (ETHICS) Core

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PROJECT SUMMARY/ABSTRACT: HUMAN SUBJECTS & REGULATORY (ETHICS) CORE The purpose of the ETHICS Core is to provide COBRE members, and the broader KUMC community, targeted support for conducting equity-focused implementation research with human subjects. Implementation science is highly consistent with the goals of community-engaged, equity-focused research. The study designs and methods used in implementation science, however, challenge the current training of investigators and IRB committees. To meet the unique ethical challenges of conducting equity-minded implementation science, the ETHICS core will assist Project Leads, pilot study, and other investigators with understanding and meeting the ethical and regulatory requirements related to their specific implementation projects. Aim 1. Establish the Implementation Research Ethics Consultation Service. Core leadership will conduct Ethics Consultations with Project Leads and other KUMC implementation researchers to: a) identify ethical and design-related challenges in their protocols; b) encourage Project Leads to work with the CEO Core to get stakeholder input on research design and implementation; and c) develop an Implementation Science and Equity in Human Subjects Plan for each study to address aspects of research that involve vulnerable populations and novel research design. The Core will also establish the Ethics Navigation service. The ETHICS Navigator, with expertise in regulatory practices and requirements, will assist Project Leads and other investigators conducting implementation research to develop protocols/consent, interact with the IRB, submit protocols, revise protocols, and remain up to date on all human subjects-related trainings and deadlines. Aim 2. Curate and provide trainings to support ethical research in Implementation Science and Equity. The ETHICS Core will identify relevant internal and external trainings and link researchers with trainings as appropriate. It also will enhance KUMC’s existing Responsible Conduct of Research and Good Clinical Practice trainings to include examples of implementation and disparities research; incorporate evidence regarding structural discrimination, and integrated exercises related to implicit bias. The Core will provide IRB member training in these research approaches to build institutional capacity for appropriate review. Aim 3. Collaborate with the Administrative Core to evaluate ETHICS performance. The ETHICS Core will collect ongoing data required by the Administrative Core to evaluate Core services. In addition, the ETHICS Core will conduct a detailed internal evaluation to address strengths, weaknesses, and areas for improvement for Core services.