Participant Information Sheet (PIS) : The Essentials

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All research trials involving humans must adhere to rigorous ethical standards, and in order to work with participants or patients we must ensure that they are protected at every stage. Protection should be extended not just to health, but to wellbeing and personal data, too. While a Research Ethics Committee (REC) will certainly review your PIS comprehensively to ensure adherence to ethical and quality standards, this can be a time-intensive process taking weeks or even months. Avoiding confusion and being clear from the get-go by addressing key considerations in the PIS developmental process is essential.

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To get started, here are our pointers on the basics of Participant Information Sheet (PIS) structure as outlined by the NHS Health Research Authority (HRA). For more information, check out the HRA guidance here:

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• Section 1: Title
• Section 2: Invitation & Summary
• Section 3: Details of What's Involved
• Section 4: Supporting Information

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Section 1: Title

Key features that the title page document must address are summarised as: Intervention, Population, Outcome and Comparator (IPOC). (i) What is the intervention that is being tested? is it a supplement? a medicine? a medical device or behavioural intervention? (ii) What population will the study work with? young or elderly? male, female or non-binary individuals? (iii) What are the desirable or expected outcomes? (iv) Is there a comparator? for example, something known to have an effect which we would like to make a comparison with?

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Section 2: Invitation & Summary

A brief description of the trial in the form of an invitation is sufficient (in writing - paper or digital) to first introduce the participant to the concept of the trial. This is typically followed by a short summary of the research. Themes in the summary should cover: (i) What the research is and how it relates to people, participants or patients, (ii) What area is under investigation in the trial, what is being tested and what it means, briefly, for a participant to be involved in this particular study, (iii) Who will be eligilbe, (iv) Where will the study be undertaken, and (v) What is the duration of the study.

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At this stage, the participant is being introduced to the overall aims and objectives of the trial without swamping them with too much information. Two main target outcomes of this section should be (i) to prevent the participant from being overwhelmed (this can drastically reduce recruitment), and (ii) to give them the opportunity to become interested or informed enough to read more in later sections should they wish to.

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Section 3: Details of What's Involved

This section allows the researcher to expand with a much more comprehensive overview of the study and will ideally address any additional questions the participants might have after reading the brief introduction. With enough information these can go a long way in reducing the need for lengthy phonecalls or conversations and queries with research staff.

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What is the right amount of information? Here are our top pointers:

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Keep your background interesting but simple

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Too many details might confuse a participant. Avoid flowery and decorative text and just open with the basics: (i) What is the nature and purpose of the study? What do we already know and how will this study help gather more knowledge? Assume the participant knows nothing of the study and avoid terms that are too technical - including excessive acronyms - and inform them in simple terms of the wider implications of the work. Reiterate to the participant why they have been approached for this study, how many others might be involved and explain any background to any condition or treatment which is pertinent to the study design.

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‍Explain how things might be different for them

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Participants might often show an interest in trials through personal experience. Perhaps they - or loved ones - have struggled with a particular condition and have interest in contributing to science and research which will benefit everyone in the future. Whatever the case, they may or may not be familiar with current therapeutic strategies. For example, does the study involve pain relief? What are the current standards of care for this particular condition? How might this trial and/or this intervention be different to what pain relief care they might routinely expect to receive from their healthcare provider/s? If the participant is currently undertaking treatment, it's important that they are told how this study might integrate with that healthcare. Make it clear that participation, or not, will not affect the healthcare they will receive going forward.

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‍What does "taking part" mean exactly?

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This facet of the trial design and protocol weighs heavily on chances of success of the trial from the researchers' perspective: participant compliance. Depending on the nature of the study the participant might be required to perform daily, weekly or monthly actions for a defined period of time. Be explicit and fully outline the commitments which would be required. Will they need to take time off work? Is it likely that they have lifestyle commitments which interfere with the trial in any way? Will they need site visits - with researchers, nurses, doctors, healthcare professionals (HCPs) or GPs? Where might these be? Is transportation required? If the study is not observational it might involve taking an intervention and the provision of biological samples. If the participant is currently receiving care, will the trial affect this? or blend with this in some way? What might the repercussions of this be and will any follow-ups or long-term monitoring be required. With the best intentions, participants might be unable or unwilling to engage in a trial if expectations and demands are too high.

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‍Data and all things personal

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Data protection is the cornerstone of any ethical study in the 21st century. While trials management has certainly been digitised quite radically in recent years, paper-based data protection is also a major consideration in PIS transparency. Inform the participant of all the data you will be collecting from them. They might presume to be anonymised, however, some studies will require consent and specific approvals for unblinding of participants. Be sure to define the data controller, where the data will be held and who might access this data in the future. As the general population is becoming more aware of their digital identity in others' hands, full transparency in this section is crucial. Whatever data regulation policies might come into play, you will need to be clear of the participants rights surrounding data sharing, submission and processing. As research now also evolves into an era where genomic testing and sequencing is affordable and commonplace, it must also be made clear what tissue samples might be given, stored, processed and what might be carried out with this data in the future.

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‍Manage expectations

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By being truthful and honest you will not be creating an illusion that might suggest that the participant will guarantee some benefit from the study. Fair monetary remuneration is acceptable and can definitely be constituted as a 'gain' for any willing participant, however, be sure to avoid suggesting any guarantees. After all, you do not know the outcomes of your study, hence the reason for the trial in the first place. Be clear when stating what the benefits of the study are. You cannot guarantee the outcomes, but involvement in the study could help provide outcomes which will educate the participant, and maybe have positive knock-on therapeutic implications for people in the future. If the study is blinded and placebo-controlled, there will also be no guarantees that they will take anything other than a placebo as an intervention.

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‍Unmask the risks

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Perhaps the most important part of the PIS - always be clear about the risks. Any known information about the nature of the intervention, particularly from any intervention manufacturers data-sheets, should be stated very clearly. It doesn't matter if the chances of negative side effects are extraordinarily rare. Informing the participant with all the information they need to make a reasonable and well-informed decision which is evidence-based is crucial to any consensual partnerships between a participant and a trial study team. Side-effect complications aside, additional risks also frequently overlooked could be data breaches of their personal information. Are you obtaining information from them from other sources - such as the Office for National Statistics (ONS) or their GP? Would they be happy for you to do this? If you obtain personal data for them (e.g. genomics), what is the risk that this may become available to unintended persons?

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Be aware of special circumstances

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Specific types of studies will involve some special considerations, particularly in vulnerable people. These might include adults without capacity to consent themselves, pregnant or breastfeeding women and so on. More information on this can be found on the NHS HRA website. Learn more about this here in the HRA guidelines.

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Section 4: Supporting Information

Consider this section similar to a Frequently Asked Questions (FAQ) forum. What information can you provide to put the participant at ease? Are there any things they might not necessarily ask about but are good to cover off for completeness in your PIS document?

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‍Catastrophe planning

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Everyone wants to know that they will be kept safe and looked after. In the event (unlikely as it may be) that something catastrophic happens to the participants health or data, be clear in the PIS that this has been considered and that there are actions to tackle every expected eventuality.

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Rights to withdraw

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Reinforcing to the participant that they are in control is essential. Be clear that they may withdraw should they wish to at any time. State that their choices will not be influenced, questioned or challenged and, once again, repeat that whatever their decision/s may be during the trial, it will not affect their future healthcare.

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Extra information and contact details

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In these supporting footnotes it is useful to add some trials metadata. Who is sponsoring the study? Who is organising the study? Ensure that there is always a point of contact, whether this is email, phone or by a web or mobile app. Who has reviewed the study? and what will happen with the results once the study has completed?