The Art of Conducting an Effective Informed Consent Discussion

Beth Harper
President, Clinical Performance Partners, Inc.
October 11th, 2013

The mere mention the word sales or salesmanship in the context of informed consent discussions causes many a clinical research professional to cringe. The image of a used-car salesman pressuring a potential research participant into signing up for a clinical trial violates all basic tenets of good clinical practice. But if we can take a step back and look at what “selling” means and how it has evolved, there may be some opportunities to apply the art of salesmanship to the informed consent process in a way that protects and preserves all of the ethical and regulatory requirements. Better yet, applying some of the principles of needs-based selling may, in fact, actually enhance the informed consent process.

In addition to learning from the plethora of research and information related to the art of selling, we have much to learn from some of the world’s greatest storytellers. John Steinbeck in East of Eden, writes, “If a story is not about the hearer, he [or she] will not listen…” Brandon Sanderson in The Way of Kings, notes “The purpose of a storyteller is not to tell you how to think, but to give you questions to think upon.” Some say that the ability to weave a tale is among the post powerful elements in any leader’s repertoire.

The Power of Communication

As leaders of clinical research and champions for any specific clinical trial, one of the most essential skills and abilities clinical researchers need is the ability to effectively communicate with prospective study subjects. While new multi-media and e-consents are all the rage these days, these are just tools to help aid the discussion and certainly they can add value in helping to illustrate complex protocol and risk-benefit information in more visually appealing and understandable ways. But high-tech solutions are no match to the high-touch approach that is needed in the informed consent discussion.

In fact, in some groundbreaking research recently published in the July 2013 issue of BMC Medical Ethics, Adam Mishimura and colleagues found some fascinating results from their meta-analysis of 54 interventions aimed at improving understanding in the informed consent process:

Extended discussions and enhanced consent forms were associated with a significant increase in subject understanding whereas, multi-media approaches were associated with a non-significant increase.

What does an “extended discussion” look like in practice?

It’s not simply a matter of more time but the nature and quality of the discussions.  And that’s where the art of salesmanship and storytelling converge to enable more effective informed consent discussions. Given the importance, value and trust that participants place on their relationship with the investigators and research personnel, it is imperative that those in a position to educate research volunteers are well equipped with these skills.

Watch these free, on-demand webinars to learn more methods for improving the informed consent process and reducing the number of consent declines: 

On-Demand Webinar: Making Your Consent Forms Readable

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