Patient Lay Summaries: Meeting the Ethical Obligation to Share Trial Results With Study Volunteers


Description of the Research
Currently, almost all clinical trials fail to comply with the ethical requirement, under the Declaration of Helsinki, that all trial participants “be given the option of being informed about the general outcome and results of the study.” does not meet study volunteers’ lay language needs. In a 2012 survey, 97% of participants indicated they wanted to know the results of their trial, but only 9% reported learning the results after it was posted to the US National Institutes of Health database. 

To address this critically unmet need, a nonprofit organization dedicated to ensuring respectful treatment of the participants who help advance medical science collaborated with research sponsors to develop and implement a program for systematically sharing clinical trial results with study volunteers. The groundbreaking program received a Best Practice in Human Research Protection Award from the Health Improvement Institute in 2013 and was cited by the Institute of Medicine in 2015 when describing sharing trial results with volunteers as “a matter of transparency and respect for participants.”

This poster details benefits, challenges, and best practices with supporting stakeholder perspectives and metrics from qualitative and quantitative program evaluation data collected from patients and investigative sites. The findings demonstrate communicating trial results with study volunteers not only fulfills ethical obligations, but also supports advancing the research enterprise through stakeholder education and engagement. Recommendations are provided for industry-wide program implementation to ensure minimal added burden for research sponsors, investigative sites, IRBs, and other stakeholders. 

Critical learnings from over five years of work are shared, including the role of a patient trusted nonprofit organization to prepare a strictly nonpromotional results summary by convening an objective editorial panel including medical and consumer health communication experts, patient advocates, and specialists who “translate” the technical study findings provided by research sponsors into a lay-language summary that patients can easily understand. Research sponsors have the responsibility to plan for results communication from the earliest feasible point, submit patient materials for ethics review as needed, and perform a final check to ensure the lay summary accurately reflects the scientific findings. Investigative sites are also central to the process, ultimately disseminating fully prepared communications to study volunteers in print and electronic formats. For research studies with sensitive populations or that are not completed for months or years after the first patient last visit, on-going communications should be provided to keep volunteers informed about the status of lay summary preparation.