The participant information sheet a UK ethics committee will pass

The documents addressed to participants are almost always the ones a UK research ethics committee discusses most in a study application, and the faults it finds in the participant information sheet recur: a sheet too long, too complex and written from the researcher's perspective, details missing or unclear, wording unsuited to the country, and a balance of benefit and risk tilted toward benefit. The committee checks whether each participant-facing document allows true consent. The Health Research Authority's guidance and mandatory quality standards frame the sheet, and the committee always wants six things explained.

How the committee reviews participant-facing documents

In the experience of one member of a UK research ethics committee, the participant information sheet, the consent form and any direct recruitment material almost always raise the most discussion and concern among the documents the committee reviews. ¹ Participant-facing documents, such as the information sheet, the consent form, recruitment posters, diaries and debriefing documents, are scrutinised for comprehensiveness and understandability. ² The committee can send back any it deems inappropriate, and does so until it is satisfied that they allow true consent. ² They are the hardest documents to get right and are almost always sent back for rewriting. ² The committee checks:

• whether the language is one participants can understand and the explanations are clear enough
• whether everything that happens to or is required of participants is explained and logically organised, such as the number of visits, the time needed, what happens at each visit and restrictions such as no alcohol, with this information ideally designed from the participant's point of view
• whether visuals such as diagrams and flow charts augment the text, though not the schedule of events meant for investigators and site managers without adjustment
• whether the content is age-appropriate, given that where several age groups are recruited, each must have its own set of documents
• whether the content suits the UK, since US-centric content prepared for review boards is often reused, with references to the cost of payment, which does not apply under the NHS, and wording common in the US but not the UK
• whether the risks and benefits of the treatment are explained clearly, in enough detail and in balance, which is key information: participants want to know whether others have been exposed to the drug or treatment and what that experience was like
• what happens to leftover samples, such as whether they will be destroyed or stored in tissue banks, since stored samples must not be assumed usable in future studies and consent must be sought for their use
• whether the language is coercive, as in this study needs to be carried out
• how expenses and lost earnings are compensated
• whether participants, who give a lot of time and effort, will be given the overall results

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When applicants resist changing terminology, what matters is whether the committee has made a requirement or a suggestion. ² Requirements are ethical and must be met. ² Suggestions are more subjective and sometimes cannot be taken up for practical reasons, for example where terminology must stay consistent across the sites of a multicentre trial. ² Where no ethical issue is at stake, the committee can be flexible, though it hopes for a better-written application next time. ²

The Health Research Authority's guidance

The Health Research Authority provides comprehensive and detailed guidance for researchers and ethics committees on the sheet and consent documentation, and consulting it before preparing these documents is strongly recommended. ³ It covers recommended content, design and style, example documents and a template with suggested subheadings. ³ The Authority presents it as a framework rather than a rigid template, and says that one size will not fit all. ³ Information requirements can vary greatly between studies: a straightforward questionnaire study, for example, does not need the same detailed sheet and consent form as a complex drug trial. ^{3, 4}

The Health Research Authority has also issued guidance for drafting participant information, the Design and Review Principles, and mandatory quality requirements, the Participant Information Quality Standards, which took effect in December 2023. ⁵ Both contain advice a professional medical communicator designing and writing for a general audience should already be following. ⁶ The Design and Review Principles show applicants and committees the important ethical considerations for participant information, and help applicants meet the Quality Standards. ⁵ The Authority's research ethics staff check each application against the Quality Standards before it goes to a committee, and return any that does not meet all the requirements. ⁵

The Design and Review Principles are:

• Involve public contributors in design and review, so that information is relevant and understandable for the intended audience.
• Keep information succinct and its quantity proportionate to the study's complexity.
• Make the language as clear as possible, so that key points are easily understood.
• Use a format appropriate to the audience.
• Format written information to optimise comprehension.
• Always tailor information to the intended study population.

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The Participant Information Quality Standards require that:

• all acronyms and abbreviations are explained the first time they are used
• British English is used throughout
• the information starts with a summary of the study-specific details
• approved HRA UK GDPR text is used
• contact details for information, support, complaints and concerns are provided
• any adaptation of approved templates is explained
• images and graphics have captions or other appropriate accessible alternatives
• a proposed video comes with a transcript, and all videos are subtitled
• it is clear that people with relevant experience as patients, family members, carers or members of the public were involved in developing the information

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What the sheet must explain

Whatever the study, the committee always wants six things fully explained: ⁹

• what the study is about
• what will happen to the participant if they consent to take part
• what side effects might develop
• what limits taking part imposes on their lifestyle
• what payments, including for expenses, will be made
• what will happen at the end of their involvement in the research

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Some details are often missing or need to be made clearer. ⁹ Among them are which procedures are optional and which are a standard part of the study, and which are part of standard treatment and which are additional procedures done only for the study. ⁹ The distinction matters particularly where patients receive a lot of general testing or monitoring as part of their standard treatment, as in studies of patients with long-term chronic conditions. ⁹ The sheet must make clear what happens to blood and tissue samples at the end of the study, whether they will be retained and, if so, where and what will be done with them. ⁹ It must make clear whether the data are personal or anonymised, where they will go and who will have access to them. ⁹ Where appropriate, it should also say how participants will be informed of the results. ⁹

Simplicity and the participant's perspective

Sheets the committee sees are often too complex and use language that is far too complicated. ¹ The Health Research Authority recommends a reading age of no more than 11 to 12 years. ¹ Short, simple vocabulary and sentence structure should be used wherever possible. ¹

Participants are very rarely involved in reviewing the sheet, and as a result the sheets the committee receives are often written from the researcher's perspective rather than the patient's. ^{10, 1} The committee often asks for changes so that the sheet is understandable to prospective participants and written from their perspective rather than taken directly from the protocol. ¹

Simple pictures, charts or diagrams of what will be done and when are a very useful way of explaining what will happen in the study, and they are generally underused. ¹

Length

The sheet is often far too long, sometimes approaching 35 to 40 pages. ^{11, 1} In particular, parts of some sheets appear to have been taken over by company lawyers, with long, complex sections on liability and compensation. ¹¹ That information needs to be there, but it should always go at the end as supporting information and be kept to the minimum possible, so that, for example, the sheet says how a claim should be initiated but not how the claim process will be carried out. ¹¹ The Health Research Authority suggests splitting a long sheet into three sections (an introduction, what is involved, and supporting or further information), but this advice is rarely followed. ¹¹ The committee often asks for the sheet to be shortened by removing duplicated and unnecessary material. ¹¹ Where it is still too long and cannot be reduced further, the committee suggests moving supporting information to a separate section at the end and opening the sheet with a half-page summary of the important points. ¹¹

Wording for the country

The wording must suit the country. ⁹ Wording is often a problem where a multinational study submits one standard sheet to every country. ⁹ In the UK, for example, a section on the cost of treatment will normally not be appropriate, as treatment is provided under the NHS. ⁹ Some words should be avoided: patients are invited to take part rather than chosen, and studies are reviewed by the committee and given a favourable opinion rather than approved. ⁹

The balance of benefit and risk

The balance of benefit and risk should not be skewed in any way. ⁹ The benefits of taking part are often overstated, which may raise unrealistic hope of successfully treating the disease, and that hope could be seen as coercive. ⁹ The discomforts, disadvantages and risks of all study procedures and treatments must be clearly stated, and the number of patients who have previously received the treatment and the number of adverse events they reported should be given in preference to general terms such as uncommon. ⁹ Where a study asks for potentially distressing information, such as details of incontinence or previous miscarriage, the sheet should mention the potential for distress as an adverse outcome and how it will be dealt with, and should signpost relevant support and resources. ⁹

Separate sheets for different participants

A single sheet for different kinds of participant, such as patients and their carers or adolescents and their guardians, often becomes confusing, because each takes part in the study differently, so a separate sheet for each kind is recommended. ⁹