Participant Information Sheets (PIS)
Participant information sheet guidelines 1
(This accompanies the Core Document, Sections C, E, and F)
The informed consent process requires that prospective participants, and/or their legal guardians/advocates, are provided with sufficient information about a research project to make a knowledgeable decision about whether or not they want to take part.
Participant Information Sheets (PIS) are an important part of the informed consent process. This document provides a basic template for researchers when designing information sheets for their research/evaluation projects. The following is a suggested template for participant information sheets. You should adjust and populate the template to suit your project and intended audience. Use clear, simple English at all times and avoid abbreviations and acronyms.
Whilst the PIS does not need to be in written form, and alternatives, such as video, may be appropriate, it does need to be clear to potential participants. If you are planning to use a video format, then it ought to follow the same structure as a written PIS.
This template is designed primarily for those doing qualitative interviews with adults or children (where parental consent is also required) from non-vulnerable populations and dealing with non-sensitive topics. You will need to adapt the different sections and information if doing focus groups or structured interviews. If conducting research with vulnerable populations and/or sensitive topics, please see participant information sheet guidelines and template 2 for further details.
Participant information sheet guidelines 2
(This accompanies the Core Document, Section E, F, and G)
This document provides guidance and a template for those conducting research with vulnerable populations or involving sensitive topics, and those conducting focus groups or structured interviews. For more information about participant information sheets and basic templates, please consult Simplified Participant Sheet Guidelines and Template 1.
For most adults, information is normally provided on a sheet that they can take time to read and consider. However, the procedures will sometimes need to be customised, for example when researchers work with children or people who have learning disabilities, cognitive impairments, low levels of literacy or do not speak English fluently. If no special provision is made for these participants, then they are effectively being excluded from the study, and this must be stated in the research proposal and a justification given.
The design of the information sheet must reflect the research study and be accessible to the intended participants. For example, an information sheet for a complex study, or one that carries potential risks (such as discussion of personal information or family background) will need to be relatively detailed, while an information sheet for children may use graphics or photographs rather than just text.
When working with children or vulnerable adults, you may need to produce two versions of the information sheet: one which is accessible to the participants and one intended for the legal guardian (parent, guardian or caregiver). The two versions must be aligned in terms of content and provide sufficient information, in appropriate detail, such that consent is fully informed.
It is important to ensure that participants are able to ask further questions and are provided with details about where they can find further appropriate information on the specific research area. This applies throughout the research process, even after the information sheet has been read and consent has been obtained.
Working with children
In the UK, people under the age of 18 (16 in Scotland) are classified as children. However, researchers should not assume that all children are vulnerable and incapable of providing consent because of their age. Children under the age of 16 can be capable of making decisions for themselves.
As a consequence of the 1985 Gillick Case, medical practitioners refer to ‘Gillick competency’ to denote when a child is able to understand the proposed treatment and to make an informed choice in their best interests. While not yet tested in law, researchers have adopted the same approach and will normally seek consent from both parents/guardians and a child who is deemed Gillick competent. There is no set age for Gillick competency; it depends upon the maturity and understanding of the individual.
While consent can be sought from a child who is deemed Gillick competent, it is normally in the best interests of the child not to proceed with participation unless consent has also been given by their legal guardian. However, in some circumstances, the researcher may decide that parents do not need to be informed and/or do not need to consent. Such cases must be justified robustly and are considered by the research ethics committee on a case-by-case basis.
Accessibility for all
You may need to make provision for participants who are not fluent in the language of the information sheet and consider how to deal with challenges such as low levels of literacy. For example, you may choose to have information sheets translated into other relevant languages and/or use translators when seeking consent. Rather than relying solely on a written format, information may be also delivered verbally, perhaps as a video.
Such provisions need to be factored into the study design and approved by the research ethics committee prior to recruitment. Given the ethical requirement for fairness and justice in recruitment, the decision to make no provision for these participants must be stated in the research proposal and a justification given.