03 · What You Need to Know
What meaningful simplification actually looks like
The strongest participant information often feels simple to read even when considerable work went into making it that way. The researcher has already decided what matters, removed unnecessary jargon, organized related information, and translated technical concepts into concrete explanations.
That is different from merely deleting words.
Plain language is not the same as childish language
Adults do not need to be spoken to like children merely because they are unfamiliar with research terminology.
Plain language respects the reader by reducing unnecessary interpretive work. It uses familiar words when they are accurate, explains unfamiliar concepts, makes relationships between ideas explicit, and helps readers find information.
OHRP states that informed-consent procedures should communicate with the participant population in terms they can understand. The U.S. Common Rule similarly requires information to be provided in language understandable to the participant or legally authorized representative.
In medical research, the 2024 Declaration of Helsinki requires relevant information to be communicated in plain language and calls for particular attention to individual information and communication needs.
Replace jargon when an ordinary word does the same job
Some technical language survives in consent forms simply because researchers are accustomed to it.
"Venipuncture" can usually become "a blood draw using a needle." "Approximately" can often become "about." "Utilize" can usually surrender gracefully to "use."
These changes reduce linguistic difficulty without sacrificing substantive information.
Unnecessary technicality
"Participants will undergo venipuncture at three study time points."
Plain but accurate
"A trained member of the research team will take blood from a vein in your arm at three study visits."
Explain technical concepts when the concept itself matters
Some terminology cannot responsibly be solved by substitution.
Consider randomization. Replacing the word with "you will be placed into a group" removes an important feature if participants need to know that neither they nor the researcher simply chooses the group.
A better explanation might state that participants will be assigned to one of the study groups by chance, similar to a random process, and then explain any implications relevant to the study.
The principle is simple: remove unnecessary technical vocabulary, but preserve necessary technical meaning.
Concrete descriptions are often simpler than abstract summaries
"You will undergo a series of assessments over the study period" is short, but not especially informative.
"You will complete three online questionnaires: one today, one in four weeks, and one in eight weeks. Each takes about 15 minutes" is longer and considerably easier to understand.
Simplification should therefore not be confused with reducing word count. Sometimes a few additional concrete words remove a great deal of ambiguity.
Short sentences help only when the ideas remain connected
Breaking a complicated paragraph into shorter sentences can improve readability. Breaking every idea into isolated fragments can make relationships harder to follow.
The revised U.S. Common Rule specifically requires consent as a whole to avoid merely providing lists of isolated facts and instead to facilitate understanding of why someone might or might not want to participate.
Participants need relationships between information, not just simpler individual sentences.
Do not simplify away uncertainty
Research often contains uncertainty by definition.
An experimental intervention may or may not help. A risk may be possible but its exact probability may be unknown. Researchers may not know whether a new procedure is better than an established alternative.
Statements such as "This treatment will help your condition" may be easy to understand but ethically misleading when benefit is uncertain.
Clearer wording might be: "We do not know whether this treatment will help you. One reason for doing this study is to learn whether it works."
The second version is simple precisely because it communicates the uncertainty rather than smoothing it away.
Do not simplify away risk
"You may experience some discomfort" sounds accessible, but it may be inadequate if the actual foreseeable risk involves severe pain, significant emotional distress, a meaningful privacy consequence, or another more specific harm.
Plain language should make risk easier to understand, not make it sound smaller.
The nature, seriousness, likelihood, duration, and reversibility of a risk may all be relevant depending on the study and available evidence. Researchers should communicate the dimensions participants reasonably need without manufacturing precision that the evidence does not support.
Do not simplify away choices
Consent becomes less useful when simplification removes the alternatives that make the decision meaningful.
For some research, participants may need to know that ordinary treatment remains available outside the study. In other studies, they may be able to agree to one optional procedure while declining another, depending on the protocol.
If the participant has meaningful choices, simplifying the document should make those choices clearer rather than collapsing them into a single yes-or-no impression.
Prioritize before you simplify
One reason participant information becomes confusing is that every fact receives similar emphasis.
Before rewriting sentences, decide which information is central to the decision. For research governed by the revised U.S. Common Rule, consent must begin with a concise and focused presentation of the key information most likely to help a prospective participant understand why they might or might not want to participate.
Prioritization can make a document feel simpler even when no substantive information has been removed.
Reading grade level is a diagnostic tool, not the definition of plain language
Readability formulas can identify long sentences and difficult words. They cannot determine whether the reader understands a concept.
An integrative review of research consent forms found that consent documents frequently exceeded recommended reading levels. Yet other research has shown that lowering reading level alone does not consistently guarantee improved comprehension.
This distinction matters. You can write "random assignment" using short words and still fail to explain what randomization means.
Use readability metrics, where helpful, to identify possible problems. Do not use them as proof that the document is understandable.
Formatting can support understanding
Plain language is partly visual.
Descriptive headings, manageable paragraphs, adequate spacing, readable typography, and appropriately used lists can help readers locate and process information. Expert consensus guidance for clinical research participant information has similarly emphasized both writing and document design when improving accessibility.
Formatting should reveal structure rather than decorate the page. Bold text loses its usefulness when half the document is bold.
Visuals can help when they explain something real
Some procedures, timelines, probabilities, or study pathways may be easier to understand with diagrams or other visual explanations.
Electronic consent can also incorporate audio, video, graphics, and interactive features. These approaches may be valuable for particular populations or concepts, but multimedia is not inherently superior to well-written text. A systematic review of consent interventions found mixed effects across multimedia approaches, while enhanced forms and extended discussions showed more consistent benefits in the studies reviewed.
Use visuals when they clarify a difficult concept, not because the consent form looked lonely without an infographic.
Translation requires more than translating difficult prose
If the source consent document is dense and confusing, translating it faithfully can produce dense and confusing prose in another language.
Participant information should be understandable in the language in which it is delivered. Researchers should also consider whether examples, concepts, or assumptions transfer appropriately across linguistic and cultural contexts.
Applicable institutional and regulatory requirements may specify how translated consent materials must be prepared, reviewed, or approved.
Accessibility is broader than reading level
Participants may encounter barriers unrelated to vocabulary.
Visual impairment, hearing impairment, dyslexia, cognitive disability, limited digital access, unfamiliarity with research, and other communication needs can influence whether information is usable.
The 2024 Declaration of Helsinki specifically calls for attention to the information and communication needs of individual potential participants in medical research.
Researchers should therefore ask not merely "Is this text simple?" but "Can the people we plan to recruit access and use this information?"
Test the communication, not just the prose
Researchers are poor judges of what their own participants will find obvious. Months spent developing a protocol make specialized concepts feel much more ordinary than they are.
Where feasible, review participant materials with people who resemble the intended audience or with lay reviewers who are unfamiliar with the study. Cognitive interviewing, usability review, participant advisory input, or other forms of pretesting can reveal unclear wording and hidden assumptions.
Such testing does not guarantee comprehension in every future participant, but it can expose problems before recruitment begins.
Watch Out
Never improve readability by changing the substance of the study. If a risk is serious, say so clearly. If benefit is uncertain, preserve the uncertainty. If participants have meaningful alternatives or limitations on withdrawal, explain them. Plain language should remove linguistic barriers, not inconvenient facts.
