Background: Institutional requirements for training of individuals engaged in human subjects research pose a barrier to PCOR teams inclusive of patient stakeholders with intellectual and developmental disabilities (IDD) affecting cognition. Existing trainings are inaccessible to these patient stakeholders due to high literacy, working memory, and abstract thinking demands. Further, they are not tailored to the specific roles of patient stakeholders with IDD. As a result, people with IDD are excluded from full engagement in PCOR or subject to training that feels overwhelming and does not facilitate learning.
Proposed Solution to the Problem: Using stakeholder engagement, the project team will develop, evaluate, and disseminate an open-access capacity-building resource: a research ethics training that is relevant, accessible, and acceptable to patient stakeholders with IDD, IRBs, and researchers. PCOR teams will be able to use the training to support patient stakeholders with IDD to conduct human subject research activities.
Objectives: (a) Identify research ethics training learning outcomes and content tailored to the roles of PCOR/CER patient stakeholders with IDD; (b) develop a cognitively accessible research ethics training for PCOR/CER patient stakeholders with IDD; (c) disseminate and refine the socially valid and cognitively accessible research ethics training.
Activities: Using stakeholder engagement, the team will: (a) identify educational content and learning outcomes for patient stakeholders with IDD by cross-walking existing research ethics training content and learning outcomes with common PCOR patient stakeholder roles; identify unique ethical dilemmas for PCOR with adults with IDD; and engage stakeholders to reach consensus on priority learning content, outcomes, and applications; (b) iteratively develop the cognitively accessible research ethics training with patient stakeholders with IDD; the training will include online and real-life, hands-on learning activities corresponding to learning outcomes and ethical dilemmas; (c) optimize accessibility and acceptability by demonstrating the training with PCOR research teams with patient stakeholders with IDD and broader networks of researchers, IRBs, and patient stakeholders with IDD.
Projected Outcomes and Outputs: The team will produce and disseminate a freely available, accessible research ethics training that can be adopted by teams collaborating with patient stakeholders with IDD. Consequently, teams will be able to include research partners with IDD in a broader range of roles, including those that require IRB-approved training, thereby expanding their influence over research, leading to more relevant and valid research on health outcomes for adults with IDD.
Patient and Stakeholder Engagement Plan: The project will be led by a steering committee, comprised of the co-leads, patient stakeholders with IDD, IRB administrators/members, and PCOR researchers. The steering committee will meet regularly to develop and refine the research training using power-sharing and consensus decision-making approaches. In addition, stakeholder councils will provide feedback at key stages. Councils include: the University Council (IRB members, researchers) and the Community Council (individuals with IDD and individuals who support them).
Project Collaborators: This project is a collaboration of Co-Leads Katherine McDonald, PhD (Syracuse University) and Ariel Schwartz, PhD (MGH Institute of Health Professions), researchers and IRB administrators, and patient stakeholders from across the United States.