The Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by the FDA and Duke University, has unveiled a new model for the informed consent process designed to improve the ability of patients to make educated decisions about clinical research participation.
Other initiatives have proposed revising lengthy and complex informed consent forms, which have been widely considered a deterrent to participation in clinical trials. Yet CTTI’s new framework is unique in that it calls for establishing informed consent as a process that centers on personal conversations between the study volunteer and researcher, rather than making the informed consent document the primary focus, and customizing the process to meet the particular needs of individual study participants. In addition, research staff should be trained to effectively communicate trial-specific information and respond to the needs and concerns of study participants in order to support the process.
“Our evidence-gathering activities told us that ultimately the conversation between potential participants and researchers—whether it be the investigator or a research nurse—was what really helped them make a decision, what affected their level of satisfaction and comprehension, and what really made the difference for them,” said Annemarie Forrest, senior clinical project manager at CTTI, who has managed the Informed Consent Project since it began two years ago. “We should really focus on the process and think about ways to support a better process.”
Jane Perlmutter, Ph.D., a long-term cancer survivor and patient advocate, said patients who really understand what they are agreeing to when they sign an informed consent document are more likely to adhere to trial requirements and successfully complete the trial, which can lead to a more efficient and less costly process.
“Not only is excellent consenting better for patients, it will also lead to more efficient and less costly trials,” said Perlmutter, who runs her own consultancy company called the Gemini Group.
The recommendations also call for restructuring and simplifying the informed consent form as a tool and guide for the overall discussion in the informed consent process. In particular, CTTI proposed using a “tiered approach” for creating informed consent documents that would allow patients to receive the amount of study information they want. The first tier would contain information that all participants must receive about critical study information and the elements of informed consent required by federal regulation; the other two would contain optional study summaries and more detailed information about study-related issues. The approach also could be used with electronic informed consent.
“The idea was to tailor a document and to allow participants to take out more information when and how they thought it was valuable to them,” said Forrest. “This is not a one-size-fits-all process. Every potential participant is different and has different needs, as far as what they need to understand to make an informed decision.”
The new recommendations, which can be found on the CTTI website, include tools and templates that sponsor companies, investigative sites and institutional review boards (IRBs) can use to revamp their informed consent processes. The tools include a list of suggested items that an investigator or a research staff member could discuss with a potential research participant as part of the consent process, including the purpose of the research, the voluntary nature of participation and whom to contact with questions or concerns; the document could be used by research staff as a checklist to ensure key elements of the trial are reviewed and to document the process with each participant. The tool, which is not intended as a required regulatory compliance document, also gives direction to tailoring the process to the individual’s needs.
The CTTI recommendation also states that study participants should be given educational materials about clinical trials and sample questions to ask about the benefits and risks of participation.
Now that CTTI has launched the recommendations publicly, it plans to collect public feedback that can be incorporated into an implementation project planned for next year.
Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP), said his organization supports the recommendations and believes they will result in a more efficient and higher-quality informed consent process conducted by clinical research professionals.
“A clear understanding of the risks and expectations clinical trial participants face will enhance their experience and drive better quality research,” he said.
The recommendations, which are all aligned with current federal regulations, outline areas that ideal research staff training programs should include, but do not encourage a standardized training program for the informed consent process. Instead, CTTI recommends that training programs be determined by individual research sites and are tailored to local and organizational needs; in addition, patients should be included in the development and implementation of the training program.
“We didn’t want to suggest that there was one cookie-cutter program that would address everyone’s needs and we didn’t want to create a sense of additional burden on research sites. Sites should figure out what works for them,” said Forrest. “What is important here is not just the regulations and how you conduct a compliant informed consent. We want to take that a step further and think about how staff members, new research nurses and new investigators can be given tools to really think about how they engage with the participant and how they can tailor some of their communication in a way that will be beneficial to everyone.”
Karyn Korieth has been covering the clinical trials industry for CenterWatch since 2003. Her 30-year journalism career includes work in local news, the healthcare industry and national magazines. Karyn holds a Master of Science degree from the Columbia University Graduate School of Journalism. Email firstname.lastname@example.org.
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