Have you ever been on the receiving end of your work? I have. Last year, after arriving to the delivery room for the birth of my daughter, I was approached by a doctor with a request to take part in a clinical trial. Although it was very late at night and I was preoccupied with the business at hand, I took her up on her offer. For one, it provided a distraction from contractions. But beyond that, after handling innumerable clinical trial documentation projects over the years, I welcomed the opportunity to find out first hand what it was really like to be a “human subject.”

The experience was an eye-opener.  Despite my extensive language training, complete lack of stress (the study focused on a screening test), and thorough familiarity with the format, it took determination to get through the seven or so pages of the Informed Consent Form (ICF) and questionnaire. If this is the experience of a human subject under ideal condition, I asked myself, what was happening to real study participants who were not as fortunate as I was.

In reality, although US federal guidelines require ICFs to be understandable to people who have not graduated from high school, studies have shown that many researchers fail to abide by these guidelines. At the same time, over 90 million Americans have low medical literacy levels, meaning they have difficulty comprehending complicated medical information. Moreover, even fairly educated patients lose some of their reading comprehension abilities when placed under stress. When confronted with complex forms full of medicalese and legalese, potential participants may shy away from enrolling in a study or worse, go ahead with it without fully understanding its implications and requirements.

Consider, for example, a hypothetical clinical trial participant with limited schooling, who suffers from a debilitating, life-threatening disease. Would it be fair to present him with a tightly typed, 10-page document comprised of pearls such as this (taken from a genuine Informed Consent Form)?

The aforesaid change of mind in respect to your participation in the DNA study will not carry any effect on your participation in the main part of the research study or on the routine medical care provided to you by your study doctor. Furthermore, said change of mind will not lead to any punitive action against you or to any loss of benefits that may be allowed to you by law.

The rule of thumb is gearing Informed Consent Forms to 4-8^th grade reading level. If you write texts for clinical trial participants, the following tips will help you create more understandable documents. Translator working on such projects can also benefit from these ideas, but consult your client or project manager before changing the style or register of the text.

1. Think short. Shorter words, sentences, and sections make for easier reading and comprehension. Choose one or two-syllable words whenever possible and aim for 15 to 20 words per sentence.

Examples:

Please read the explanation provided below carefully and do not hesitate to request any explanations or clarifications from the staff member, who had approached you with the request. (28 words)

Please read the following explanation carefully (6 words). Feel free to ask the staff member who approached you to explain or clarify anything that is not clear (19 words).

2. To the extent possible use, use verbs instead of nouns.

Example:

Such change of mind regarding your participation in the DNA study will not affect your participation in the main part of the study or the routine medical care given you by your study doctor.

If you change your mind about taking part in the DNA study, you may still take part in the main part of the study and receive routine medical care given by your study doctor.

3. Write in active rather than in passive.

Example:

The results of your tests will not be provided to you.

You will not receive the results of your tests.

4. Whenever possible, use lay terms instead of medical jargon. Why should the patient guess at the meaning of “subcutaneous” when it is possible to write “under the skin?”  The following glossaries may be helpful in finding the right alternatives  to medicalese:

http://humansubjects.stanford.edu/general/glossary.html

http://www.sparrow.org/irrc/irrcpolicies/consent/ic701_d.pdf

Finally, do not forget to check the readability of the document. Word processing programs, such as MS Word, include readability statistics tools.

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