In December 2018, the University of Kentucky Office of Research Integrity (ORI) won an Award of Excellence for Best Practice in Human Research Protection for the “Informed Consent Workshop: From Perception to Process.”
The four-hour, hands-on workshop assists researchers in adopting new informed consent rules. Belinda Smith, an ORI research education specialist and co-creator of the workshop, explained that informed consent is a process that provides individuals with the information needed to make an educated and voluntary decision about whether to participate in research. “Informed consent is a fundamental right for participation in all types of human research,” Smith said.
The workshop was developed by Smith and Ada Sue Selwitz, regulatory support and research ethics co-director at the Center for Clinical and Translational Science (CCTS). Selwitz and Smith tag-team presenting and leading group activities to keep the program lively and engaging.
Workshop participants consider public perception, personal experiences and past participant observations of the research consent process, and they learn about federal regulatory requirements, including the Revised Common Rule that went into effect January 21, 2019. “This new regulation, designed to transform and improve the process, is a shift from relying on boilerplate consent templates overloaded with competing purposes,” Smith explained. “It promotes creating and presenting consent in a way that does not merely provide a list of isolated facts, but instead enables participants to weigh pros and cons. Both the form and process must begin with a concise and focused presentation of the key information to help them understand the reasons why one might or might not want to be in the research study.”
Through this workshop, researchers practice skills and strategies for creating consent documents that translate complex research information into plain language. One exercise is a competition to develop wording with the lowest grade level, fewest passive sentences and best readability scores. Another exercise examines design and format options to fit diverse types of studies.
“But even the best documents are no substitution for two-way communication, so we practice active listening through a consent role-play session,” Smith said. “We task researchers with identifying and addressing the motives, misunderstandings and communication gaps of the ‘mock participants’ played by our staff and Institutional Review Board chair. The scenarios and examples are relevant for both medical and social science researchers. ”
The Health Improvement Institute, a non-profit institute dedicated to improving the quality and productivity of America’s health care, gives three awards in Human Research Protection: Best Practice, Innovation, and Lifetime Achievement.
Smith said, “This Best Practice award affirms our efforts and commitment to protecting the rights and welfare of research volunteers. We’ve conducted consent training for years, but this recognition encourages us to continue to develop innovative and interactive training for research professionals.”