Informed Consent Documents Editing and Proofreading Services

A person is told that a risk is rare. They nod. Later, asked what rare meant, they say something like "it probably won't happen" — which is true of a one-in-ten risk and of a one-in-fifty-thousand risk, and those are not the same decision. Almost every failure of informed consent is a failure of how likelihood was expressed, and almost all of it is fixable in the wording.

We edit what sponsors, sites and ethics committees produce — participant information sheets and consent forms, risk and burden sections, assent documents for children and young people, consent material for adults who may lack capacity and their consultees, translated and adapted consent documents, re-consent material after protocol amendments, sub-study and optional procedure consent, sample and data use consent including future research, withdrawal explanations, and summary and lay explanations of study purpose. Our editors work on the section where risks are quantified.

The risk section is where consent documents either inform or merely disclose, and the failure is verbal frequency labels applied to numbers people cannot recover from them. "Common", "rare" and "very rare" have regulatory definitions that no participant knows. We work through these so every risk is given as a natural frequency with a consistent denominator — 3 people in 100, 1 person in 1,000 — because percentages and rates are read poorly under stress and a shifting denominator makes risks incomparable; so any verbal label used is accompanied by its number rather than replacing it; so the background rate is given where the risk also occurs without the study, since a participant told of a two per cent risk of a clot needs to know what the rate is anyway; so the seriousness and the reversibility of each risk are stated alongside the likelihood, given that people weigh a permanent harm and a temporary one very differently and frequency alone conflates them; so what would be done about each risk is written, as this is the information people actually want and rarely receive; so risks with unknown frequency are stated as unknown rather than omitted or estimated; and so the most likely burdens — the time, the travel, the extra blood tests — are given equal prominence, because these are what people actually experience. Documents written this way support a decision rather than record one.

Everything you send is treated in confidence, including protocols, consent material and ethics correspondence. We are editors rather than clinicians, ethicists or regulatory advisers, and we offer no view on risks, study design or the adequacy of consent. What we can do is make the numbers say what they mean.