Participant Information Design and Review Principles

Last updated on 21 Aug 2023

The Design and Review Principles have been created to show researchers and Research Ethics Committees (REC) what the important ethical considerations are for participant information. They also make clear to researchers what the RECs will consider as part of the review of participant information and will support them to create information that meets the new Quality Standards.

1. Involve public contributors in the design and review process to ensure that participant information is relevant and understandable for the intended audience

a. Involving people with relevant experience as patients, family members, carers or members of the public in your research is the best way to make sure that participant information is relevant and understandable.

b. Meaningful public involvement when developing participant information should follow our four principles for public involvement:

1. Involve the right people

2. Involve enough people

3. Involve those people enough

4. Describe how it helps

c. Sometimes people will have been involved outside of the UK. For instance, where the study sponsor is based abroad. In these cases, the involvement should be assessed against our principles above. Public involvement does not need to be repeated in the UK provided it meets these principles.

d. Contract research organisations and commercial sponsors conduct lots of very similar studies, such as Phase 1 clinical trials with healthy volunteers. In these cases, it may be appropriate to use template participant information. These templates are informed by public involvement in different ways, such as surveys and other evaluation activities (for Phase 1 clinical trials with healthy volunteers the ‘right’ people to involve are those who have experience as healthy volunteers in such trials). Any activity used to develop the templates should be assessed against the public involvement principles.

e. Participant information developed without public involvement will not normally receive a favourable opinion from an NHS Research Ethics Committee. If the public involvement described in the Integrated Research Application System (IRAS) application does not meet our principles, we will normally request further involvement before a study is given a favourable opinion.

2. Information provided should be succinct, and the quantity proportionate to the complexity of the study

a. Participant information can be lengthy, and this deters people from reading it. Long participant information materials can also be burdensome for the health and social care professionals seeking consent. This can put some health and social care professionals off taking part in recruitment.

b. The quantity of information provided should be enough to make an informed choice about taking part, and no more.

c. How much information you should provide will vary depending on the type of study. For some studies, such as complex clinical trial designs with multiple arms or device studies, a participant will have more to consider before taking part. Therefore, a longer section explaining the procedures and risks may be needed.

d. However, this does not mean every section of information should be longer. There may be too much detail on topics participants are not interested in, and not enough detail on topics they consider more important. Public involvement can tell you which topics are most important and where to include more information.

e. You should ask public contributors about different ways of presenting information. Consider how to layer information so that people can choose how much detail they are interested in. For example, ‘layering’ information through links to webpages with more information or signposting to wider resources. Using a lay summary at the beginning can help people make sense of the information.

Some potential participants might want more information. These participants should be catered for in other ways. For example, information can also be provided verbally through discussions between the potential participant and staff seeking consent.

3. Language should be as clear as possible so that the key points of the information are easily understood

a. Participant information is often written at a higher reading age and level of knowledge than most potential participants understand.

b. You should write in plain language. Our guidance on writing lay information provides some general principles about how to write for a general audience. If information has been prepared outside the UK, make sure that the correct spelling and terms are used for UK audiences. If you are getting information translated, make sure plain language principles apply to these too.

c. Do not assume that the reader will understand specific research, medical, or legal terminology. Avoid using technical language and jargon or, where it is necessary, make sure you explain it.

d. There are several tools available to help you assess how clear and useable your participant information is, such as Flesch-Kincaid, SMOG, or Hemingway Editor. However, you should also test your information through public involvement as well.

e. It may be more useful to explain very complex terms, interventions, or numbers with visual aids such as diagrams or pictures as well as words.

f. Explain technical details or measurements with reference to everyday comparators. Such as ‘a teaspoon of blood’ rather than ‘5ml of blood’.

g. All participant information should be proofread. Focus on removing repetition of information and clarifying unclear or inaccurate language. The proof reader should not be familiar with the study or its subject matter.

h. Write participant information to address the reader directly using the personal pronoun (‘you’) and in the active voice. For example, ‘Record your blood pressure twice a day’ rather than ‘Blood pressure should be recorded twice a day’. Information for parents, carers or representatives should use appropriate terms when referring to the participant.

4. The format of the information should be appropriate for the intended audience

a. Participant information is often provided in writing on paper. Many potential participants would prefer to receive information in a non-paper format and would find this easier to understand.

b. Consider alternative ways to present information, such as videos, websites, and apps. Electronic media may be particularly helpful and more engaging for certain groups. For example, children and adolescents, adults lacking capacity, and those with low literacy levels. Consider whether an Easy Read version would be appropriate.

c. Consider where it would be inappropriate to use electronic media. This may include study populations with low technology literacy or reduced access to the internet. Make sure you provide alternative formats for different people.

d. Do not make assumptions about your population group and their preferred format of information. For instance, do not assume that older populations do not want to use technology. Public involvement can help you establish the most suitable format.

5. Written information should be formatted to optimise comprehension

a. Written information should be as accessible as possible for the intended population group. Information presented in unsuitable formatting may be difficult to follow, particularly for dyslexic or other neurodiverse readers. This may deter potential participants from reading it.

b. Information should be well spaced on the page, usually using a sans serif font (for example, Helvetica, Verdana, Tahoma, Arial, Calibri) no smaller than 12 point, with larger fonts used where appropriate.

c. Use bullet points or numbered lists instead of lists in continuous prose.

d. Avoid using very long paragraphs. Break up chunks of text using headings and subheadings.

e. Present particularly important information in bold text rather than text boxes. Text boxes can encourage the reader to skip through other text on the page.

6. Participant information should always be tailored to the intended study population

a. There is no ‘one size fits all’ approach to the information given to potential participants. Different participant groups will need different types of information. We do not offer a template participant information sheet as we recommend a bespoke approach.

b. If you have developed templates that will apply across a range of similar studies, make sure you still consider the information for each study carefully, and tailor where you need to. Not all headings and content on a generic template will be relevant or useful for every study design or population.

c. It is particularly important to think about different content needs when working with people who will be making participation decisions on behalf of others. For example, research involving children and their parents, or adults lacking capacity and their consultees and or legal representatives. The participant may need different information to the decision maker.

d. When writing or reviewing participant information, carefully consider what information is really required.

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