HSPP – January, February, March, 2022- Newsletter

 

How to Write a Low Literacy Informed Consent Form

Obtaining informed consent in non-exempt research is a process required by federal regulations –the U.S Department of Health and Human Services ( HHS) at 45 CFR 46 and the U.S. Food and Drug Administration (FDA) at 21 CFR 50.   The consent process typically includes providing a written consent document containing the required information along with an oral presentation of that information to prospective participants. However, for a consent process to empower individuals to voluntarily participate in a study or not, the information in the consent document must be presented in a language they can understand.   The readability of a consent form is essential to enable potential participants to have sufficient comprehension of the elements that facilitate a decision. The language used in consent forms should not be complex.   An 8^th grade reading level is the suggested benchmark to use as the readability index.

Investigators conducting clinical trials should consider literacy of potential participants when preparing consent documents.

John Hopkins Office of Human Subjects Research  and Elizabeth Winslow offers the following guidance for preparing consent forms:

 

• Recommendations to lower the reading level of consent forms:

 Words

• Use words familiar to the non-medical reader.
• If possible, keep words to 2- 3 syllables or fewer.
• Use common, familiar words

Sentences/Paragraphs/Print Size & Type:

• Write short, simple, and direct sentences.
• Keep paragraphs short and limited to one idea.
• Use active verbs.
• Use the second person (you) not third person (the participant) to increase personal identification.
• Avoid contractions.
• Use page numbers
• Use at least 12-point font and consider a larger font based on your audience.
• Check the text to see if each idea is clear and logically sequential.
• Avoid large blocks of printed text.

 Avoid Complex Medical Terminology

• Avoid medical Terminology. If a medical term must be used, define /explain it
• Be consistent with use of all terminology, such as drug names and abbreviations.
• Use the appropriate abbreviation the first time a drug name is used in the consent.

 Abbreviations:

• Spell out abbreviated terms the first time you use them
• Abbreviation terms such as DNA, HIV and AIDS that have come to be accepted as standard by your proposed study population need not be spelled out.
• Do not use e.g. or etc., use instead, “for example,” “so forth.”
• Spell out acronyms when first used.

 Pictures

• Use photos, graphics, tables, illustrations or diagrams if they will help clarify procedures.

Numbers

• Use numerals rather than words for numbers, e.g., “10” instead of “ten,” “1 out of 4” instead of “one out of four.”

 

Tips to Describe Study Procedures

• Consent forms for projects that involve collection of blood or other fluids should include the amount(s) to be taken.  Do not use ml. or cc. as a volume measure; give a volume equivalent in teaspoons or tablespoons. Rather than abbreviating such words as teaspoon and tablespoon, please spell them out.
• Do not use symbols such as “>”; use “greater than.”
• Describe study design procedures such as “double blind,” “randomized,” and “placebo/controlled” when the concept(s) is/are first introduced. Example: “A placebo is an inactive substance that looks like the study drug, but contains no medication.”
• Do not use the words “treatment” or “therapy” to describe an investigational drug, device or procedure. Use the term “study drug” not “study medication” when the drug is investigational.  The word “medication” or “medicine” should only be used if the drug is commercially available for that particular condition.
• Do not use the term “treatment” or “therapy”” if one of the study arms will be a placebo. Instead, use words like: “study product”, “study drug or placebo”,  “study regimen” or “study procedure
• Do not describe investigational drugs, devices or procedures as “new.”For investigational drugs or devices, state they are investigational or “experimental” and describe that term (e.g., the word “investigational” means the study drug is not approved by the U. S. Food and Drug Administration (FDA) and is still being tested in research studies.) Be consistent in using “investigational” throughout the consent form.
• Use “research study,” instead of “trial.”
• Use the word “participant” in the consent form instead of “patient” since this is research.  However, you may use “patient” when referring to the person prior to his/her entering the study.
• When describing randomization for 2 groups use, “like the flip of a coin,” for more than 2 groups, use “like drawing numbers from a hat.”

To check the grade level of a consent document, the investigator can implement the following steps. 

For Microsoft Word:

1. on the “File” tab, click the “Options” button;
2. on the “Proofing” tab, under “When correcting spelling and grammar in Word”, make sure “Check grammar with spelling” is selected;
3. under “When correcting spelling and grammar in Word”, select the “Show readability statistics” check box.  Click on OK
4. Click on the “Review Tab”
5. Click on “Spelling & Grammar”

After the grammar check is complete, Word displays a message box showing you the readability grade-level.

 

D- The following websites and word substitution file are helpful for drafting consent forms:

1. a)  Glossary of medical words: (http://kidshealth.org/kid/word/)
   b)  Clinical Research Glossary: (http://www.firstclinical.com/icfglossary/)
   c)  Glossary of lay terms: (http://humansubjects.stanford.edu/general/glossary.html)

 

• The following Checklist for Low Literacy Informed Consent Forms .pdf has been posted in the UCONN Health IRB website

 

 

Checklist How to write a Low Literacy Informed Consent Form
Recommendations to lower the reading level of consent forms	Check
Words
Use words familiar to the non-medical reader
If possible, keep words to 2- 3 syllables or fewer
Use common, familiar words
Sentences/Paragraphs/Print Size & Type
Write short, simple, and direct sentences
Keep paragraphs short and limited to one idea
Use active verbs
Use the second person (you) not third person (the participant) to increase personal identification
Avoid contractions
Use page numbers
Use at least 12-point font and consider a larger font based on your audience
Check the text to see if each idea is clear and logically sequential
Avoid large blocks of printed text
Avoid Complex Medical Terminology
Avoid medical terminology. If a medical term must be used, define/explain it
Be consistent with use of all terminology, such as drug names and abbreviations
Use the appropriate abbreviation the first time a drug name is used in the consent
Abbreviations
Spell out abbreviated terms the first time you use them
Abbreviated terms such as DNA, HIV and AIDS that have come to be accepted as standard by your proposed study population need not be spelled out
Do not use e.g. or etc., use instead, “for example,” “so forth.”
Spell out acronyms when first used
Pictures
Use photos, graphics, tables, illustrations or diagrams if they will help clarify procedures
Numbers
Use numerals rather than words for numbers, e.g., “10” instead of “ten,”  “1 out of 4” instead of “one out of four.”
Tips to Describe Study Procedures
Consent forms for projects that involve collection of blood or other fluids should include the amount(s) to be taken.  Do not use ml. or cc. as a volume measure; give a volume equivalent in teaspoons or tablespoons. Rather than abbreviating such words as teaspoon and tablespoon, please spell them out.

 

Checklist How to write a Low Literacy Informed Consent Form
Tips to Describe Study Procedures	Check
Do not use symbols such as “>”; use “greater than.”
Describe study design procedures such as “double blind,” “randomized,” and “placebo/controlled” when the concept(s) is/are first introduced. Example: “A placebo is an inactive substance that looks like the study drug, but contains no medication.”
Do not use the words “treatment” or “therapy” to describe an investigational drug, device or procedure. Use the term “study drug” not “study medication” when the drug is investigational.  The word “medication” or “medicine” should only be used if the drug is commercially available for that particular condition
Do not use the term “treatment” or “therapy”” if one of the study arms will be a placebo. Instead, use words like: “study product”, “study drug or placebo”
Do not describe investigational drugs, devices or procedures as “new.” For investigational drugs or devices, state they are investigational or “experimental” and describe that term (e.g., the word “investigational” means the study drug is not approved by the U. S. Food and Drug Administration (FDA) and is still being tested in research studies.) Be consistent in using “investigational” throughout the consent form.
Use “research study,” instead of “trial.”
Use the word “participant” in the consent form instead of “patient” since this is research.  However, you may use “patient” when referring to the person prior to his/her entering the study.
When describing randomization for 2 groups use, “like the flip of a coin,” for more than 2 groups, use “like drawing numbers from a hat.”
To check the grade level of a consent document, the investigator can implement the following steps
For Microsoft Word: 1.    on the “File” tab, click the “Options” button; 2.    on the “Proofing” tab, under “When correcting spelling and grammar in Word”, make sure “Check grammar with spelling” is selected; 3.    under “When correcting spelling and grammar in Word”, select the “Show readability statistics” check box.  Click on OK 4.    Click on the “Review Tab” 5.    Click on “Spelling & Grammar” After the grammar check is complete, Word displays a message box showing you the readability grade-level.

 

 

ResearchMatch, an Online Recruitment Tool

 

ResearchMatch.org is a national online recruitment tool for health research, funded by the National Institutes of Health and maintained at Vanderbilt University. ResearchMatch connects health researchers with individuals interested in volunteering through its secure online matching tool, available in English and Spanish. UConn Health is part of the ResearchMatch Network and there is no cost to UConn Health researchers to use ResearchMatch. There are currently over 160,000 (and counting!) registered volunteers across the country.

 

To see if ResearchMatch might be useful to you, register now to conduct a feasibility analysis:

Register here: https://www.researchmatch.org/researchers/. (You do not need to be a Principal Investigator to register.) The registration process takes less than 10 minutes. Registration grants you “feasibility access” to search the current ResearchMatch volunteer population for demographic and health information of volunteers within a designated geographic area.

 Then, if you decide to use ResearchMatch to conduct participant recruitment, you will need IRB approval. Once approved, you may request “recruitment access” in ResearchMatch and upload your IRB approval letter and your IRB-approved contact message. Recruitment access will give you the ability to send your contact message to volunteers that you select. If a volunteer agrees, you will be given access to his/her contact information in order to contact about possible study participation.

 The next ResearchMatch Training is April 14, 2022 at 3:00 pm.

For questions about how to use ResearchMatch for your health research, please contact ResearchMatch Liaison, Ellen Ciesielski eciesielski@uchc.edu or visit https://ovpr.uchc.edu/services/rics/hspp/resources/researchmatch/.

 

 

Office of Human Research Protection (OHRP) – Resources

  

• OHRP New Informational Resource Flyer with its Very Own QR Code!

OHRP’s new Informational Resource Flyer includes a QR code allowing anyone with a smart phone access to a free online library of trusted resources about research and research participation. Print, display, and distribute this flyer at your centers for the benefit of prospective research participants!

Find the flyer here together with other informational materials (in English and Spanish) that you may wish to print and provide for potential research participants! These resources are free and you do not need permission to distribute them.

 

• New Interactive Training Programs on IRB Reviews!

OHRP launched two interactive training programs on considerations for reviewing and designing research involving human participants.

OHRP created these programs to enable investigators and IRB reviewers to be cognizant of the importance of diversity, inclusion, and risk minimization in research participation.

Click here to access our other scenarios!

 

• Recordings of OHRP Presentations on Human Subjects Research and Investigator Responsibilities for Protecting Participants in Research!

 

What is Human Subjects Research? A Review of the Common Rule and its Application provides helpful explanation on the complex concept of human subjects research and how to address related considerations in the NIH grant application process.

 What Investigators Need to Know About IRB Review helps investigators understand the thoughts and considerations needed for writing a successful plan to protect human research participants that would pass the muster of reviewers.

These videos will help investigators with the NIH grant application and IRB review process.

 

 

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