There is strong recognition of the importance of partnering with people with developmental disabilities in research. This group includes people with a range of life experiences and diagnoses, such as intellectual disability, autism, cerebral palsy, Down syndrome, and other genetic conditions. The disability community, researchers, and funders note that these partnerships reduce individual and group harms and enhance scientific rigor and knowledge translation.1, 2, 3, 4 Despite advances, institutional research ethics training requirements are a persistent barrier for all community research partners but especially those with developmental disabilities.5 Without disability-accessible research ethics trainings that are accepted by institutions, community research partners maybe not be able to serve in research roles that involve participant recruitment and enrollment, data collection, and analysis of individually identifiable data.6
We worked with an academic-community partnership to develop Research Ethics for All (https://re4all.org), a free disability-accessible social-behavioral research ethics training (masked). We identified and selected educational content for Research Ethics for All through a review of other research ethics trainings, a scoping review of ethical, legal, and social issues in developmental disabilities research and for community research partners with developmental disabilities, and robust academic-community partnership engagement (masked). Research Ethics for All is designed to be delivered synchronously by an academically-trained researcher with experience in research with adults with developmental disabilities and research ethics, and can be delivered virtually or in-person.Across 5 units, Research Ethics for All addresses ethical, legal, and social issues in research with adults with developmental disabilities and for individuals serving as a community research partner including: (1) community-engaged research; (2) regulations; (3) participant enrollment (i.e., recruitment and consent/assent); (4) risks and safeguards; and (5) researcher safety, conflicts of interest, and authorship (masked). The website provides information on how educational content is aligned with CITI Social-Behavioral-Educational Foundations (link masked). Generally, Research Ethics for All has strong overlap with CITI's content. Exceptions include: Research Ethics for All includes some content specific to people with developmental disabilities and researcher safety and rights not contained in these CITI modules, and does not include some topics covered by CITI Social-Behavioral-Educational Foundations, including: other populations designated as potentially vulnerable, and specific elements required in consent processes.
Research Ethics for All includes didactic materials (video and written options) to ensure standardized content. These materials include images of, a narrator, and actors with developmental disabilities. For each topic, the didactic materials include descriptions of how a fictional research team applied that topic's content. After reviewing didactic material (video or written content), learners engage in discussion and active learning (e.g., role plays, script generation) to reinforce and apply content. Teams can also use “add-on” activities to support direct application of learned content to their active research project(s). Example add-on activities are a review of their research team's consent form for specific information, development of a Community Research Partner Rights and Responsibilities document with agreements specific to the research project (e.g., confidentiality in their research study, ways the team will ensure voluntary, informed, and ongoing consent). After completion of Research Ethics for All, learners complete an individual certification process, facilitated by an academic researcher. Certification includes appropriately answering 9/9 open-ended questions 2/2 sorting questions (total required score: 11/11) that require application of the primarily learning objectives (e.g., what research is, safeguards, vulnerability, consent/assent, privacy and confidentiality, mandatory reporting). Learners can refer to Research Ethics for All training materials (e.g., list of research words with definitions and images, main ideas summarizing each topic, etc.) during certification, and facilitators have discretion over how many opportunities community research partners have to provide an acceptable response, based on their role(s) and responsibilities. Certification instructions include standardized prompts to support responses and a list of acceptable responses.
While our robust engagement with academic and community partners should enhance the quality of Research Ethics for All, adoption of new resources requires social validity, or that users accept its goals, procedures, and outcomes.7,8 In the context of research ethics education, researchers are more likely to use a research ethics education training when they believe that it addresses essential content relevant to the roles of community research partners (i.e., training goals); does so in a more disability-accessible way than other available trainings (i.e., acceptable procedures); and leads to successful certification and is determined by their Institutional Review Board (IRB) to meet researcher training requirements (i.e., acceptable outcomes). As a critical next step in the ongoing development of Research Ethics for All, we examined social validity from the perspectives of academic researchers and community research partners to identify strengths and areas in need of further refinement. Specifically, we studied the extent to which the goals, procedures, and outcomes of Research Ethics for All were acceptable to academic researchers and community research partners. We describe specific criteria for evaluation in Table 1.
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