Writing Informed Consent

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Writing Informed Consent

• Yvonne Kellar-Guenther
• This training is part of the Clinical Trials
  Curriculum for Investigators and Coordinators
  (CTTIC) (PI, Yvonne Kellar-Guenther, Ph.D.). The
  CTTIC is part of the Colorado Clinical
  Translational Sciences Institute (CCTSI) grant. 
  This grant was awarded to the University of
  Colorado Denver by National Institutes of Health,
  Principle Investigator is Ronald Sokol, MD.

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What Is Informed Consent?

• The Participant
• Understands the Risks Involved
• Can weigh the reward/risk ratio
• Understands the Alternatives
• Understands the Procedures What is Expected of
  Them
• Understands they are free to leave the study

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What Is Assent

• Cannot give informed consent
• Children over 7 but less than 18 years
• Person with Cognitive Impairment if have legal
  guardian regardless of age if can process
  information at least at 7 year old level (e.g. IQ
  over 40)
• Guardian consents

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What is Informed Assent?

• Participant Understands
• Understands the Procedures What is Expected of
  Them
• Understands they are free to leave the study
• Payment/Incentives

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Informed Consent Pieces

• Informed Consent Paper
• Template for Consent and Assent at COMIRB website
• http//comirbweb.uchsc.edu/portal/downloadcomirb.c
  fm
• Informed Consent Process

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Reducing Reading Level of Consents
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Why Do I Need to Know This?

• More likely to get informed consent
• Can use for all written research material
• Helps with verbal communication

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Exercise
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Tips to Reduce Reading Level

• Hard words are those with more than two
  syllables.
• To get to a fourth-grade readability level
• you need to write with an average sentence length
  of eight words and/or
• no more than one out of 50 words having three or
  more syllables.

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Tips

• The more simplistic the idea, the lower the
  reading level.
• Break up a complex idea into one or two
  sentences.
• Make sure a concept has been introduced first if
  another concept has to build on it.
• Start with an overview of study/task/etc.
• Avoid complex sentences
• One idea per sentence
• Minimize the use of compound sentences

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Tips

• Minimize difficult and complex words
• Replace some unfamiliar words with common words
  (e.g. change recruit to try and get people to
  join or wash out vs. irrigate).
• Choose a word with fewer syllables
• Look at decodability of the word
• Can the words pronunciation be predicted by its
  spelling?
• Can you break down the word to get at its
  meaning?

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Exercise

• Rewrite one sentence
• Find a sentence that is too long
• Make sure a majority of the words are two
  syllables or less.

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Ways to Minimize Confusion

• Pronoun reference should be clear.
• Use the noun first, then the pronoun when
  possible.
• Have pronoun as close to noun as possible.
• Avoid references in parentheses (e.g., another
  name, etc.). Readers with low skills will not
  know how to treat this information.

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Ways to Minimize Confusion

• White space is helpful to the reader (text
  variables).
• Use white space between steps so that they stand
  out
• Putting things in a list (even as complete
  sentences) makes reading level lower using the
  Flesch-Kincaid
• Numbered steps are helpful
• Do periods after bulleted clauses

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Example

• There are other things you can do for your
  ltlist disease or medical problem heregt. These
  treatments are ___________. You may choose not
  to get treatment. Talk to your doctor about other
  treatments. If you stop being in the study you
  can use other treatment. Before you choose to be
  in the study you should understand all your
  choices. (4.8 for section)
• There are other things you can do for your
  ltlist disease or medical problem heregt. These
  treatments are ___________.
• You may choose not to get treatment.
• Talk to your doctor about other treatments.
• If you stop being in the study you can use other
  treatment.
• Before you choose to be in the study you should
  understand all your choices. (3.8 for section)

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Ways to Minimize Confusion

• Avoid Passive Voice
• What is Passive voice?
• The person doing the object is the direct object,
  not the noun
• The story book is kept by her
• vs. She keeps the story book
• It is inferred who is doing the action
• Insert the tube
• vs You need to insert the tube into your arm

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• Use Active Voice
• The person who performs the action is the subject
  of the verb.
• The subject is clearly identified

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Exercise

• Making a passive sentence active
• Attached is a Desk Guide that can be used to help
  you distinguish between SSDI and SSI.

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Tips for using Flesch-Kincaid to Check Reading
Level

• Flesch-Kincaid formula does not like large
  numbers or phone numbers. Check your reading
  level without these.
• If the title of something will not be clear even
  when it is spelled out, use the acronym (COMIRB)
• The use of COMIRB is a lower reading level than
  spelling it out.

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Informed Consent Process

• Think of the formulas as predictors of
  readability, not measures of readability
• There are tricks to get the score lower without
  improving the readability.
• Dont underestimate the interaction when consent
  is given

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Informed Consent Process

• Strategy Variables
• How do you engage the reader?
• Task Variables
• What is the mode of presentation?
• What is the rate of the presentation?
• Reader Variables
• What vocabulary are they used to?
• What is experience do they bring to interpret?

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Tips on Consent Process

• Have the participant explain things to you
• Have them define
• Medical terminology
• The term voluntary
• The term confidential
• Define all clinical terms, even those that are
  common or seem self-explanatory
• What does nauseate mean? Ambulate?
• Make the reader as comfortable as possible
• Think about using different modes to present the
  information

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Tips on Consent Process

• Know your intended audience
• If your audience is general population, write
  to the lowest reading of understanding within the
  group.
• Use common type-faces
• Times-New Roman, Century School-Book

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Tips - General

• Sometimes the lowest reading level isnt always
  the clearest.
• Longer sentences with connectives may make the
  text clearer than shorter sentences without
  connectives. The reading level may be higher,
  but in the text will actually be easier to
  understand.

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Tips General

• Try the cloze procedure
• Delete the 10th word of the text and see if
  someone (similar to participant in your study)
  can fill in the words (or close to the words).
  The more correct the inserts, the easier the
  texts.
• Whenever possible, test your wording on someone
  not familiar with the study to see if they
  understand what you are asking them to do.
• Answer questions to what if (improves clarity)
• Balance level of information
• Too much is as bad as too little
• What do they need to know

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Tips General

• Simple Graphs/Time Tables can also make things
  clearer
• Make consent forms free from grammatical and
  typographical errors
• Allow the participant to ask questions
• Ask questions to make sure participant really
  understands and is giving informed consent

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Resources for Written Consent Language

• Go to COMIRB Website to get most recent
  Consent/Assent templates
• http//comirbweb.uchsc.edu/portal/downloadcomirb.c
  fm -- click on Consent Forms
• Go to COMIRB Website to get recommended standard
  language
• Covers all types of procedures, use of DEXA
  scans, X-rays, etc.
• http//comirbweb.uchsc.edu/portal/downloadcomirb.c
  fm -- click on Consent Forms

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Contact Information

• Yvonne Kellar-Guenther, Ph.D.
• University of Colorado Denver, Anschutz Medial
  Campus
• Yvonne.kellar-guenther_at_ucdenver.edu