Guidance

Approval standards and guidelines: lay summary

Updated 2 August 2024

When must this standard be met

This standard must be met for all applications requesting to process UK Health Security Agency (UKHSA) ‘Protected’ data.

Standard

1. All applications must include a plain English summary, in the manner as laid out in questions D2.1 to D2.6 (Section D) of the UKHSA data application form. The summary must be tailored for members of the public, rather than a specialist audience and must meet the following editorial requirements. It must:

• be written for an audience with a reading age of less than 13 years (roughly the same level as a newspaper article), so the subject matter is as easy as possible for everyone to understand
• avoid abstract ideas, jargon, abbreviations and technical terms and using clear language that all readers can understand without needing experience or knowledge of the topic – where this isn’t possible, the technical word or term should be followed by a simplified explanation in parenthesis
• avoid complicated English or uncommon words, instead it is recommended that you use conversational language
• avoid complicated sentence structures
• use headings and subheadings to break up sections of text and create structure.
• use bullet points for all lists of 3 things or more
• avoid first person pronouns (such as I, we or us), instead refer to the organisation making the application, or any other organisation involved
• avoid use of directional text, such as ‘click here’ or ‘the list below’
• use the active voice, not the passive, as it makes sentences shorter and clearer
• include no information attributable to an individual patient or member of the public (such as their name, address or NHS number)
• include no visual aids, such as photographs or graphs

Guidelines

Plain language summaries, often known as ‘lay summaries’ or ‘lay language summaries’, are an important tool for scientific communication and public engagement. They are intended to provide an overview of a project – what, who, where, when, why, and how – in non-specialist language to help communicate with members of the public, rather than researchers or other professionals.

They are not the same as a scientific abstract, which in contrast may be highly technical or contain scientific language. This is because scientific writing is often designed for a narrow professional community, so may not be easily understandable outside that community and would not meet the needs and literacy levels of a general audience.

A well-written summary allows everyone, regardless of their own knowledge or experience, to understand how UKHSA data will be used by describing the project, its aims, methods, and intended impacts.

All applications to process UKHSA protected data must include a lay summary. The format of the summary is set out in questions D2.1 to D2.6 of the UKHSA data application form.

As part of the application assessment, UKHSA will review the summary in line with the editorial requirements set out above and provide feedback. Where the requirements of this standard are not met, applicants will be asked to revise their summary.

Before submitting an application, it is worthwhile to ask someone without a scientific background to read your summary to check its suitability and whether it is successful at communicating your project to a non-specialist audience.

Drafting your lay summary

The UKHSA data application form contains 6 questions which must be answered in accordance with this Standard. These questions are set out below with drafting notes.

Drafting notes

D2.1: Project objectives

Describe the overall aim(s) and objectives of the project.

In response to question D2.1, you are asked to identify the aims and objectives of the project. Aims are general statements concerning the overall goals of the project; whereas objectives are specific stages that must be completed to achieve your aims.

Prompt questions:

• What do you hope to achieve (aims)?
• How will you achieve it (objectives)?

D2.2: Rationale

Explain the rationale for why this project is needed, including citing evidence which supports the need for this work.

In response to question D2.2, you are asked to explain the background and rationale for the project. This is also called ‘purpose’ or ‘justification’ of a project. The rationale should link the background of your project to the specific aims and objectives set out in D2.1. In responding to this question, you should describe the compelling reasons the project is necessary, including earlier evidence or observations.

Prompt questions:

• What is the background to the project (including evidence from literature review)?
• What has happened before?
• Has anyone else done a similar study? Why is your project different?
• Why does this project need to be done now?
• What is the scale of the issue?
• What is the statement of the problem?

D2.3: Methods

Explain the methods you will use in your project, such as how you will obtain the data, how you will analyse it and how you will draw conclusions. Where the project involves data linkage, the instruction of data processors, profiling and/or automated decision making, this must be described.

In response to D2.3, you are asked to explain exactly how UKHSA data will be used in your project. The description that you provide about how the project will be conducted should be a simplified version of the methods set out in the scientific protocol. It is important that in your response you demonstrate transparency of how the data will be managed, by clearly setting out how the data will be used and by whom.

Prompt questions:

• When, where and how are you going to carry out the project?
• What design and methods have you chosen and why?
• Who are your participants (if appropriate)?
• Will other organisations be involved and if so, what role will they play?
• What analysis will you do?

D2.4: Anticipated benefits and impacts

Describe the anticipated benefit(s) and/or impact(s) of conducting this project to public health or the public good, including all direct and indirect beneficiaries.

In response to D2.4, you are asked to explain what you expect the outcomes of the project to be and who is likely to benefit from the project. It is important that you are realistic in your language around impact and expected outcomes. Please avoid exaggerating benefits.

Prompt questions:

• What are the expected outcomes and timeframes?
• Who may benefit from the outcomes of the project?
• Why will conducting this project be worthwhile?

D2.5: Intended outputs

Specify any intended outputs that will communicate the findings from this project with the beneficiaries identified in D2.4 or other relevant audiences. If you are not intending to publish your outputs, UKHSA may ask you to explain why.

In response to D2.5, you are asked to select from a list of options about how the outcomes of the project will be communicated to people or organisations who are likely to benefit from it. This includes publishing peer-reviewed journal articles and press releases. The list provided in the form is not exhaustive, so where the options available do not align to your communications plans, select ‘other’ and describe what you will do in the free text box.

D2.6: Website details

Provide the URL of any websites that will highlight the conduct of the project or the outputs listed in D2.5. If the project does not operate a website, leave blank.

In response to D2.6, you are asked to provide the details of any websites that your project operates to share progress. It is recognised that not all projects will have a website, so it is acceptable for this field to be marked as ‘not applicable’.

Data access approvals register

When data is shared with other organisations for research, clinical audit, service evaluation, or surveillance, UKHSA is committed to improving transparency of data use by publishing information about the type of data it shares, the purpose, date of approval, and name of the organisation or individual using (or receiving) the data. We will do this through a data access approvals register.

For every project that receives approval to process UKHSA protected data, the register will include the project’s lay summary.

Further guidance

Several organisations have published guidelines to assist in the creation of plain English summaries.

The Plain English Campaign has published free-to-download guidance on how to write in plain English and how to write medical information in plain English. There is also an A to Z of alternative words.

The National Institute for Health and Care Research (NIHR) published guidance on writing a clear and concise plain English summary as part of the ‘make it clear’ campaign.

NIHR also published a glossary of definitions of research terms developed with a panel of researchers and members of the public.