Contract with Participants


Applied Clinical Trials

The Plain Writing Act of 2010 (H.R. 946) was signed into law by President Obama on October 13, 2010. Its goal? “To enhance citizen access to Government information and services by establishing that Government documents issued to the public must be written clearly, and for other purposes.”

In light of this, it seems a good time to remind clinical trial professionals to make participant materials easier to read.

The Contract with Participants
We, the researchers, do hereby pledge that we will provide information to you [patient/subject] that is easy to read and understand.

Freedom from Long Words
We will stop using long words when short words say the same thing. “Eligibility Criteria” will now be written “You can be in this study if:” We will keep repeating to ourselves: “One syllable: good. Three syllables: bad.”

Just You and Me
We will use “we” and “us” for everyone on our staff. We trust that you will figure out that at different times we mean the study doctor, nurse, technician, receptionist, etc. When we talk about something that affects all participants, we will write “you.”

The Importance of Being Important
We will no longer write, “It’s important [three syllables] to…” We vow to give you only information that is important. In places where we have an urge to write “It is especially [four syllables!]  important to…”; we will instead write the especially important sentence in bold.

Doctor, Doctor
We will use the term “doctor” because we recognize that 1. “physician” is a bad word from start to finish, with its ph that sounds like f, followed by a y with a short i sound, and ending with “shun” spelled “sician,” and 2. real people don’t say, “I feel sick, I’m going to call the physician.”

The Sheriff Was Shot By Me vs. I Shot the Sheriff
Passive voice will not be used in our documents. Or to put it more clearly: We will use active voice.

Make the Grade
We will learn how to check the reading level of our consent forms and handbooks. In Microsoft Word, we will go to Review and then Spelling & Grammar [depending on your version of Word the placement may be different, but it is within the Spelling & Grammar option]. We will consider eighth-grade reading level to be unacceptable. We will work towards sixth-grade level. We will go to for help.  

Marie McCarren is president of Nomad Research, Inc., located in Maryland. She is a medical writer, an occasional clinical trial participant (and thus has immunity against cholera and bird flu), and a tutor for adults who are improving their reading skills.

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