Writing Patient Consent Information for a Clinical Study

This was initially written to advise trainee oncologists on a training workshop.

Patient Consent Information

There is good guidance available on how to construct a Patient Consent Information leaflet. This includes templates you can follow.  Have a look at the following:

This guidance from the UK has been developed through involvement of patients, ethical committee members and researchers.

Some advice about style (as opposed to content):

  • Use simple language – guidance would be to aim for age 12 capability
  • Use short sentences and short paragraphs
  • Do not join different concepts – abolish “and” if you can
  • Use short words – no more than three syllables in English, if you possibly can
  • Avoid technical jargon – if you have to use them, acronyms MUST be spelled out
  • Do not assume that the reader knows anything about research
  • Do not make reference to other documents unless they are freely available

Within the structure and the constraints of content:

  • Try and tell it a bit like a story – invite the patient to read along with you
  • Start from something the patient understands
  • Remember that all patients are different – you can repeat the story a different way
  • Explain what the study is aiming to demonstrate and why
  • Explain what will happen to them in the study – show empathy
  • Answer the obvious “what if” questions in your text (eg. what if it doesn’t work?)

You take your pick on formatting advice, however:

  • Use diagrams and tables to show issues clearly eg. schedule of hospital visits
  • Use side-boxes to explain issues separately from the main flow of the story if necessary
  • When formatting the sheet make it look inviting and easy to read
  • Put a line space between paragraphs, don’t crowd text tight to the page edge

In the back of your mind:

Remember that the patient will only take one pathway through the study so complex issues like cross-over between arms in an RCT, or choice of successive therapies driven by response, need careful handling. A diagram can often help.

Ethics reviewers will want to see that you:

  • Be clear about side effects – not just short term but any possible long term issues
  • Be clear about reporting and managing side effects, including self-management

Dont rush:

  • Give yourself time.  Draft, read and re-draft. Read it back 24 hours later
  • Get others to read it, especially patients
  • Have you been balanced in your explanation? Maintain equipoise
  • It does not matter if key issues are repeated
  • Remember that anything which appears to incentivise patients to enter the study will be unethical

Other issues:

  • Does the study have a website? Give the URL
  • Explain how to contact the research team – both email and telephone
  • Explain how to act in an emergency, with at least two telephone numbers
  • Have a card or sheet with contact details on it which patients can put on the kitchen noticeboard

Document management:

  • Use document management to control versions until ethics approval is finalised
  • Number the pages

 Passing ethical review:

Every ethical board has its own view of what makes a good patient consent information sheet. Almost everyone is agreed that page after page of legal statements should be at the back and that the first two or three pages is all that a patient will actually take in. Much of the rest will be read by family or friends. These first few pages are where the heart of the story must be told, this is where to place the diagrams they may need to refer to, this is where contact details should be (probably repeated right at the end). My personal view is that the first 2/3 pages should be like an executive summary, this is followed by the full story, then the statutory material. At the very end is a repeat of the contact details so that they can be easily separated from the main document as an aide memoire.

Roger Wilson