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January 2016 HRPP Newsletter

Volume 2, Issue 1

In this issue:

  • Tip Of The Month: Writing Readable Informed Consent Forms
  • IRB Metrics Update
  • iMedRIS Helpful Hint: Resources

Happy New Year!

2016 will be an exciting year as we continue to build the Human Research Protection Program (HRPP) to enhance efficiency and provide services assisting investigators to meet their research goals. Our continued aim is to support the Institutional Review Board (IRB), while promoting and facilitating the research enterprise. Our collective goal with you and the IRB is to ensure the rights and welfare of our research participants. We look forward to working with you, the IRB, and the UT research community to achieve our most successful year yet! – HRPP Staff

Tip Of The Month: Writing Readable Informed Consent Forms

Requirements

Informed Consent Forms (ICFs) submitted with new applications are rarely approved without required changes. This is most often because, in addition to including the required elements of consent, ICFs must also communicate those elements in a language understandable to the research participant or their legally authorized representative such as a parent or caretaker. This means the document must be written in plain language, in lay terms without jargon or technical language and at a reading level they can comprehend.

Many words and concepts used in research settings are complicated and unfamiliar to the average adult. The use of technical language in consent materials is not limited to biomedical research. All disciplines of research use language that may not be understood by a person unfamiliar with that discipline regardless of their education level. Further complicating the matter, nearly half of American adults read at or below an 8th grade level. For these reasons, we recommend that all participant materials such as ICFs, recruitment materials and study instructions be written at or below an 8th grade reading level.

Plain Language

Plain language uses evidence‐based standards in structuring, writing, and designing materials. When using plain language, the resulting texts are easy to read, user‐friendly, and reader‐focused.

Resources

Translating research or academic terminology into a comprehension level appropriate to the general public is challenging. A variety of resources are available to assist investigators in developing materials that are readable and participant centered.

  • PRISM Readability Toolkit – A free, 81-page plain language handbook illustrating why literacy is important and how to improve the readability of research consent forms and other materials for study participants. It provides a quick reference guide and plan language alternatives to complex terms.
  • PRISM Online Training – A web-based plain language hour-long tutorial created for research professionals, including scientists, research staff, Institutional Review Boards (IRBs), or communications staff. It covers plain language strategies and examples, readability, health literacy and interactive editing examples and exercises. This course is free.
  • Plainlanguage.gov – provides guidance, examples, suggested word usage, etc.
  • MS Word can calculate readability statistics using the Flesch Reading Ease Score. The Flesch-Kincaid Grade Level score rates text on a U.S. grade-school level. Unfortunately, this scale underestimates the reading level of health-related text by one to two grade levels. If the Flesch-Kincaid is used, it is safest to add 2 grade levels.

Tips On Writing Readable ICFs

  • Write in the second person (you), not third person (the participant).
  • Use common, everyday words familiar to the non-academic/non-scientific reader.
  • Avoid abbreviations and acronyms (if using, spell out when first used).
  • Use a conversational tone.
  • Use headings and subheading to group text together.
  • Write short, simple, and direct sentences.
  • Avoid using e.g. or etc., use instead, “for example,” “so forth”.
  • Keep paragraphs short and limited to one idea.
  • Use page numbers, if appropriate.
  • 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 repetition.
  • Avoid large blocks of printed text and embrace “white space”.
  • Use photos or pictures if they will help clarify procedures.
  • Be consistent with use of all terminology, such as procedures, activities and abbreviations.
  • Check the reading level.
  • Ask someone to read the material and provide feedback. Asking someone unfamiliar with research or your area of study can be particularly helpful.

IRB Metrics Update

This first graph highlights the number of submissions received over the last year (December 2014-December 2015). A monthly average of 221 studies and associated requests has been submitted for that period. During the month of December 2015 the IRB received a total of 208 submissions.

Number of Submissions by Month and Review Type

The second graph, below, highlights the average review time per month. The IRB continues to strive to maximize the efficiency of review for full board, exempt and expedited categories. The average review turnaround time for all submissions during the month of December improved by more than two weeks—from 25 days in 2014 to 4 days in 2015—continuing the trend of significant reduction across all review types.

Average IRB Turnaround Time by Month and Review Type

iMedRIS Helpful Hint: Resources

Additional resources may be found under the help button in iMedRIS or on the resource page: https://tiny.utk.edu/imedris-resources. If you have any questions about your submissions please call us at 865-974-7697.

Contact Information

If you have questions or concerns, please don’t hesitate to contact any of our team members.

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