Clinical Trial Writing and Design Archives - Imperial Clinical Research Services Blog

A patient-friendly informed consent form (ICF) is a key element for prospective clinical trial participants’ understanding of a clinical research study. In this blog, we delve into tips to ensure the ICF is clear and understandable.

The research ICF document provides potential participants with the necessary information to make an informed decision about taking part in a clinical trial. Current regulations (and good ethics) require that information is presented in a clear, simple, concise, and understandable way that allows individuals to voluntarily decide whether to participate.^1,2

If you are new to writing research consents or need to brush up on the regulations, visit the FDA or U.S. Department of Health and Human Resources for U.S. ICF requirements.^1,6The ICH-GCP guidelines² provide a unified quality standard for the conduct of clinical trials. The standards are observed by the U.S. and adopted by the European Union, Japan, Australia, Canada, Nordic countries, and the World Health Organization. Additional countries have implemented these standards or are working toward adopting them.

Reading level guidelines for a patient-friendly informed consent form

The general recommendation is for informed consent documents to be written at or below an 8th-grade reading level. I have heard of some site populations needing study materials to be at a reading level of 5^th grade or lower.

Checking the Flesch-Kincaid reading level in Microsoft Word is one way to determine the grade level of your ICF.³ Although limited research exists on the association between improved reading levels and comprehension, ICFs that are complicated and include professional jargon and technical terms create barriers to participants’ understanding of the clinical study and the study requirements. This can negatively impact recruitment and retention rates.

Improve health literacy by using plain language

Effective health literacy approaches can significantly enhance the readability of consent forms. The principles of plain language foster the creation of clear and understandable communication with the goal of increased comprehension and engagement for all literacy and educational levels. Using plain language means communicating in a way your audience can understand the information the first time they read or hear it.

Many countries have plain language requirements. The U.S. government’s Plain Writing Act requires federal agencies to communicate in a clear, straightforward, and concise manner.⁴ The plain writing guidelines developed by governmental agencies are largely applicable and helpful for any type of medical communication, including ICFs.

The consensus of these guidelines is that plainly written documents enable the audience to:

Find what they need
Understand what they find
Act appropriately on that understanding

A team of experts representing 25 countries, and 19 languages developed an International Organization for Standardization (ISO) Plain Language standard released in 2023.⁵ This guidance further solidifies and raises awareness about the importance of plain language.

Plain language writing tips

Write text using words familiar to someone not in a medical profession
Use words with as few syllables as possible
Use headers and logical order
State major points before going into detail and make sure the main message is at the beginning of the document
Include only details needed for the reader’s understanding
Stick to one theme per paragraph and one idea per sentence (each sentence <20 words)
Avoid acronyms and abbreviations or explain them the first time used (maybe more than once)
If uncommon terms must be used, define and use them consistently; you may need to lead the audience to understand with a comprehensive definition
Use the most direct, strongest form of the verb possible, preferably in the present tense
- - For example, the word “change” has several meanings: to make something different, convert, exchange, give or get an equivalent amount of money, etc.
  - Using the word “amend” instead, means to alter, improve, or correct faults and is a better choice
Use consistent terminology – for example, pick one term from the examples below to use throughout the ICF:
- - Clinical study, research study, clinical trial
  - Study doctor, trial doctor
  - Research clinic, study site, trial site
Choose words that have a single meaning
- - Use “correct” instead of “right”
Alternative options for common non-medical words
- - Participate: take part
  - Reduce: lower
  - Confirm: make sure
  - Evaluate: find
  - Modify: change
  - Determine: find out

Visual tips

Avoid a wall of text in informed consent forms

Avoid a wall of text that is off-putting to the reader.

Format consent forms in a way that allows for easy reading, using:
- - Adequate white space
  - Size 12 or 14 font
  - Headings/subheadings
  - Bulleted lists
  - Bolding text where needed
Include easy-to-read tables and graphics to enhance understanding
Break text into smaller paragraphs to avoid a wall of text

Keep in mind that CFR 46.116 requires that the ICF must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the study.⁶

Medical terms for a patient-friendly informed consent form

Using medical terms in research consent forms is unavoidable. It’s best to explain medical terms in lay language if you’re unable to replace the term with something simpler. For example, if your study is recruiting sciatica patients, you may want to add an explanation in plain language terms such as sciatica (pain in the back, hip, and outer side of the leg) to ensure clarity. Also, consider if the use of abbreviations or acronyms will be understandable to your audience, and be sure to write them out the first time (e.g., hypertension [HTN]).

Finding an online glossary can be a big help in explaining medical/technical terms. Here are some alternative phrases for common medical terms:

Treatment-resistant: Treatment doesn’t work well
Effectiveness/efficacy: How well the [drug or procedure] works
Titrate: Change the dose of a medicine

It’s OK to retain a big word if it’s necessary – just define it. Here is an example: Shots will be given sequentially (one after the other).

Statistics for a patient-friendly informed consent form

In studies with multiple treatment arms, it’s important to make the statistics of randomization easy for a layperson to understand. For example, if the randomization is 1:1, state you will be randomly assigned (like flipping a coin) to a treatment group. You will have a [50/50 or 1 out of 2] chance of getting the study medicine [experimental medicine] or placebo. Or you can say, the number of people getting the study medicine will be [insert x number] and the number of people getting placebo will be [insert y number].

For studies with three or more arms, characterize randomization as pulling names from a hat or throwing dice. When writing the randomization scheme for participant understanding, have a statistics expert verify the accuracy of how this has been described. At Imperial, we have found inaccuracies in this section of ICF documents. Having an expert review this before regulatory submission can prevent giving incorrect information to potential participants and having to amend and resend the ICF for IRB/EC approval.

Explaining why the study uses a placebo and blinding is important. So is going a step further to explain the purpose of blinding. Here is some sample text:

A placebo looks like the study medicine but contains no active ingredients. Neither you nor your study doctor or study staff can choose the group you will be in or know which group you have been assigned to. The term for this is “double-blind.” For the results of this study to be reliable, it is important that you and the study doctor/staff do not know whether you have been given the study drug or placebo. This is one of the best ways to understand the true effect of the study drug.

Creating a patient-friendly informed consent form: Insights from global oncology patient panels

A study conducted between 2018 and 2022 invited patient advocates to review, edit, and provide recommendations for improving draft ICFs for sponsored clinical trials to facilitate better understanding. Draft ICFs (n=36) were reviewed by 47 advocates in 13 hematology/oncology disease areas and 14 countries.

Researchers interviewed the advocates to obtain in-depth responses and recommendations for improvement. The qualitative analysis identified these five primary themes:

Create easy-to-read documents by simplifying words and using visuals
Clearly communicate participation requirements in patient-friendly terms, including an executive summary or table of logistical, financial, and patient-reported outcomes requirements
Provide transparency: background on the treatment and personnel involved in the study, explain the study’s privacy policies and what happens if the patient is no longer eligible for the trial
Provide supplemental information materials to aid understanding
Provide instructions for the investigator/trial team presenting the patient with the ICF⁷

Based on the identified five primary themes, one recommendation has not yet been covered in this blog. Providing supplemental information to aid patient understanding is an important step in the informed consent process and a principle in which Imperial excels.

Imperial often creates an ICF presentation flipchart as an integral part of study recruitment materials for our clients. Physicians and study teams use this document pre-consent to present detailed study information to potential participants.

The flipchart is double-sided so the physician and patient can review the ICF information at the same time. The patient’s view is written in lay terminology using plain language, and the physician’s view contains more detail, so they are reminded to discuss key critical elements of the study. The flipchart includes visuals to keep the patient engaged and enhance understanding.

Final thoughts

Of course, including the required elements defined by regulatory bodies is essential. However, making the choice and effort to create a patient-friendly ICF that is understandable, organized, and visually appealing builds trust with potential participants. It provides a pathway to understanding by historically underserved and underrepresented research populations and is a solid first step toward making your study patient centric.

The Imperial Advantage

Contact us for more information on how our award-winning creative team can write and design protocol-specific recruitment and retention materials for your study. Imperial also excels at procuring and managing clinical trial ancillary supplies and equipment, customized print and digital production, precise clinical translations, warehousing, and global logistics.

Having one vendor provide multiple services allows tremendous control, consistency, and transparency in the flow of work. This promotes efficiencies resulting in superior quality, timelines, and cost. Visit Imperialcrs.com.