Kansas Center for Implementation Science: Human Subjects and Regulatory (ETHICS) Core

University Of Kansas Medical Center, Kansas City KS

Investigators

Linked publications & trials

Abstract

PROJECT SUMMARY/ABSTRACT: HUMAN SUBJECTS & REGULATORY (ETHICS) CORE The purpose of the Human Subjects and Regulatory (ETHICS) Core is to provide COBRE members, and the broader KUMC community, targeted support for conducting implementation research with human subjects. Implementation science is highly consistent with the goals of community-engaged 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 implementation science, the ETHICS Core will assist Research Project Leaders, pilot studies, 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 Research Project Leaders and other KUMC implementation researchers to: a) identify ethical and design-related challenges in their protocols; b) encourage Research Project Leaders to work with the Community Engagement and Outreach Core to get stakeholder input on research design and implementation; and c) develop an Implementation Science in Human Subjects Plan for each study to address the use of innovative research design. The Core will also establish the ETHICS Navigation service, which will provide expertise in regulatory practices and requirements, assist 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. 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 research. 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 Core effectiveness. 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.