Ethical Issues

Guest Expert: Jane Ganter - Writing Informed Consents: Advice from an Editor

Last Updated: Aug 30, 2012

Please welcome Jane Ganter as this month's AccrualNet Guest Expert!  Jane spent the last decade of her publishing career as Editor-in-Chief of Applied Clinical Trials after serving as associate editor of Pharmaceutical Executive and editor of BioPharm. Jane brings a wealth of insight and perspective to her chosen topic today on informed consent.

Jane Ganter's Post:

Research professionals who write consent documents often share a characteristic with experts who write for their fellow professionals. Both groups are more likely than their readers to have advanced academic degrees. They spend most of their time with similarly educated colleagues. Both groups tend to assume that their readers share the vocabulary and basic knowledge of the topic at hand. That assumption may be understandable, but it is rarely -- if ever -- accurate. When you prepare a consent document, knowledgeable readers are not your target audience.

A clinical research professional I worked with had an effective method of determining readability. She used pizza to reward groups of middle school students for reading a consent document, then answering her questions about how well they understood it.

A statement found in a publication years ago haunts me yet: "Unlike those of us involved in clinical research, most patients do not distinguish the difference between clinical care and clinical research." A critical part of the consent process is ensuring that volunteers understand the difference between standard patient care and an experimental treatment governed by a study protocol.

The first step toward making your consent document inviting is the advice every editor gives every writer: Know your audience. A clinical investigator chooses formal medical language (insider jargon) to communicate with colleagues, then switches to lay language for explanations in a consent form.Say you are writing about a Phase 3 study. You need to explain the study in a way that's accessible to a middle-school reader -- one who could be ill, stressed, and medically naive. You can consult one of the glossaries available to translate technical terms into familiar everyday expressions. Most everyday people understand drawing blood, for example, but never heard of phlebotomy. A bit of research will yield other resources. Today, I ran across a recent Ohio State University study that looked at strategies for explaining randomization in a way that can increase the likelihood that a person will volunteer for a study.

Making your document easy to read is a start. How about making it a compelling read? One the reader just can't put down. That's a tall order, but it's a worthy goal.

References

  1. Moench, E. The Partially Involved Principal Investigator: How PIs Can Affect Study Success.
  2. Krieger JL, Parrott RL, Nussbaum JF. Metaphor use and health literacy: a pilot study of strategies to explain randomization in cancer clinical trials.

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