Consent Form: The Number and the Qualifier Disagree
You are translating a 900-word Spanish informed-consent form for a multinational vaccine trial into English for a US IRB. Deadline: three days; your CAT tool shows 62% leverage from an earlier study. The source contains «riesgos poco frecuentes (pueden afectar hasta 1 de cada 100 personas)», uses «el/la participante» 14 times, and carries a handwritten marginal note on the scanned page reading «pendiente de aprobación del CEIC». The footer shows version 4.2 with a date. The sponsor's project manager writes: “Just translate what's there - don't add anything and don't leave anything out.” The IRB requires plain language at roughly an 8th-grade reading level, and trial coordinators will read the English aloud to participants.
1. «Riesgos poco frecuentes (pueden afectar hasta 1 de cada 100 personas)» - what do you do with the tension between the qualifier and the number?
Read the worked answer
Do not harmonize. Standard frequency banding (CIOMS/EU) puts uncommon / poco frecuente at ≥1/1,000 and <1/100. A stated ceiling of 1 in 100 sits at the boundary of common, not uncommon. The qualifier and the figure cannot both be standard, and you are not the person who decides which one the subject should see.
What to do:
- Translate both elements faithfully and keep them adjacent: “uncommon side effects (may affect up to 1 in 100 people).”
- Do not convert to “1%” - the 1-in-100 form is more concrete for a listener and matches the source's register.
- Do not silently change poco frecuentes to common to make the text self-consistent.
- Query the sponsor in writing and log the query with the delivery.
Why it matters: this is a consent document. Quantity and probability are exactly the content a participant uses to decide. A translator who “fixes” the inconsistency has edited the risk disclosure; one who flags it has done the job. Keep the query separate from the file so the 62% leverage does not quietly propagate the same issue into the next study.
2. How do you handle the handwritten marginal note, given “don't add anything and don't leave anything out”?
Read the worked answer
The instruction is actually satisfied by treating the note as what it is.
Analysis: the note is physically on the page but is not part of the approved consent text. Omitting it breaches completeness - a reviewer comparing page images will see it. Folding it into the body would misrepresent an internal annotation as adopted content. Either choice is a distortion.
Do: reproduce it in place, marked as annotation - [handwritten note: pending approval by the IEC] - and mention it in the delivery email.
Then raise the larger issue: if the form is pendiente de aprobación, the version you were given may not be the approved version, and the footer version number and date are the way to check. Tell the sponsor before they print 400 copies. This is a completeness question that turns into an ethics question the moment you notice it, and noticing it is the job.
Also: do not let the CAT tool's 62% leverage pull the earlier study's wording over the marginal note position or over the version footer. Placeables must be verified, not inherited.
3. How do you render «el/la participante» (14 occurrences) into English at an 8th-grade level, and what do you tell the sponsor about “don't add anything”?
Read the worked answer
The options:
- “the participant” - formal, longest, flattest when read aloud 14 times.
- “he or she” - clunky, and it foregrounds gender in a document that does not.
- singular “they” - plain, idiomatic, accepted in US plain-language health writing.
- “you” - standard in US consent forms, shortest, most audible, but it changes grammatical person and may clash with the sponsor's template.
The decision rule: consistency and the surrounding text decide, not preference. If the Spanish elsewhere addresses the reader with «usted», “you” is coherent and best serves the read-aloud requirement. If the form is written in third person throughout, singular “they” preserves distance. Mixing them is the only real error. Record the choice in a note so the next linguist does not flip it.
On “don't add anything”: the IRB mandate for plain language requires syntactic rewriting - splitting sentences, unpacking nominalizations. That is not addition; addition is new content. Say this explicitly: you will change form, not meaning. Where a source phrase cannot be simplified without loss (e.g. a legal qualifier), you will leave it dense and flag it rather than trim it.