Axiom Research Compliance

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PREPARE, PRESENT, AND POLISH THE CONSENT FORM

A study recently crossed my desk where a researcher wanted to understand if Parkinson’s disease patients would experience improved swallowing after a four-week exercise regime of techniques used by singers in training. These exercises included a facial muscle strengthening routine of: (1) vocalized yawn, (2) jaw stretch and hum, (3) the pucker and lip smack, and (4) sing “Doe-Ray-Me-Sew-La-Tea-Doe” three times.

 

The researcher was going to compare this “singing exercise regimen” with a typical Parkinson’s exercise regimen of (1) purse lips and shove them outward, (2) blink deliberately, (3) close and open eyes, (4) move cheeks from side-to-side.

 

While the effects of these exercise techniques are still unknown, my involvement in this work started when I read the researchers’ consent form.

 

The consent form this researcher prepared for this study was convoluted. For instance, the introduction of the consent form described the literature surrounding the use of Fiberoptic Endoscopic Evaluation of Swallowing (“FEES”), and its importance for measuring swallowing among Parkinson’s patients. The researcher did not describe the parameters of the study until page two of the consent form. The researcher wrote in full paragraphs without breaking up text to ease the reading load, as well as used inconsistent font sizes; there were typos, grammatical errors, and jargon. Overall, the consent form needed editing.

 

I met with the researcher and walked through the issues of the consent form and we developed an action plan to improve the document.

 

Above all, the goal of this action plan was to ensure the consent form was easy to understand. The action plan was organized in three ways: (1) Prepare, (2) Present, and (3) Polish.

 

PREPARE:

  • Follow American Psychological Association (APA) formatting: Double-space, use standard-sized paper (8.5” x 11”) with 1” margins on all sides, 12 point, Times New Roman font. Using other serif fonts like Courier, New Century Schoolbook, and Palatino also work because they tend to be easier to read than sans-serif fonts.
  • Ensure adequate white space between paragraphs. Try to keep the sentences as short and simple as possible. Use bullet points, or numbered lists to break up long lists of text.
  • Know the usage of each tense and be aware of shifting tenses.
  • Bold paragraph headers to make the consent form easier to read and understand.
  • Include page numbers and the total number of pages in the footer of the document. For example, “1 of 2” or “1 of 5.”

 

PRESENT:

  • Include the institution’s name, address, and phone number as the document header.
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  • The first page of the consent form should include the protocol title, type of consent form (e.g., informed consent, parental permission, or child/student assent form), the primary investigator’s name, title, and contact information. Also include the purpose of the research and how much time is expected of each participant.
  • Write in the second person using “you/your” pronouns.
    • For example: “You are being invited to participate in this research study called….” or “You may qualify to take part in this research study because….” or “Your personal information will be kept confidential….”
  • However, do not use assumptive statements such as: “You will understand that ...” or “You have been directed to....” or “You will benefit from…”

 

POLISH:

  • The consent form should introduce the study to participants using common, ordinary language instead of technical, academic terms. A good rule of thumb is writing consent forms for an 8th grade reading level. Reading levels are often determined using Flesch (1948) Reading Ease metric. Above all, tailor the materials so they are appropriate for the target population both linguistically and culturally. 
  • Avoid jargon and do not use unnecessary complicated phrasing. Use examples, whenever possible (e.g., “anxiety,” means to “worry”).
  • Spellcheck the entire document. Double-check words like, “principal,” and “principle.” (I have even seen a consent form about “public speaking,” where the writer forgot the “L” in “public.” That misspelling made for a totally different interpretation of the work!)
  • Read the document from the last paragraph to the first paragraph. Switching up this reading pattern may help researchers catch errors they may have missed otherwise.
  • And it is always a good idea to have someone else read the consent form or at least read it out loud word-for-word.

 

The consent form is one of the first documents participants experience within a study. Therefore it is important to make a good first impression; to show the participant this study is well prepared, thoughtfully presented, and polished.

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