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Why have I been chosen to take part?

Participants need to understand why they have been selected, for example ‘you are being asked to take part because you are an adult attending an out-patient appointment in the eye clinic during March’. Sometimes details such as planned sample size are given here too.

Do I have to take part?

To allow informed consent, potential participants should understand that their participation is entirely voluntary and, importantly, that not taking part will not have any negative impact on their care. If participants are allowed to withdraw, this should also be stated. This paragraph may take the following form:

It is up to you to decide whether or not to take part. If you refuse to take part, you will not receive any penalty and it will not affect your routine care. If you do decide to take part, you will be given this information sheet to keep and be asked to sign a consent form. However, you are still free to withdraw at any time without giving a reason

What will taking part involve?

Participants should understand completely the steps that will be involved in participating so that they can decide whether they have enough time available and if they are happy to take part. This section should outline the requirements of both participating in any active component (such as attending workshops, including details about what the workshops will involve, how many people will be taking part together, and when and where they take place) and providing research data (such as completing questionnaires or providing samples, etc.). This will draw on the flow diagram given in the research protocol in Chapter 11 (Figure 11.1), but again full details may be simplified to suit the audience reading the PIS. If participants underestimate how much time participating will take, it could lead to high levels of dropouts from studies, which will have a detrimental effect. It should be clear which elements of participating are simply part of participants’ standard care (e.g. if a blood test is required but this can be carried out at the same time as a routine blood test that will be required for treatment or monitoring purposes anyway), and which will involve additional time. If the study involves travelling for additional appointments where a cost might be incurred, it should be stated whether these costs will be covered by the study or not. If data will be accessed from participants’ medical records, it should be discussed what will be accessed and by whom so participants understand what details will be visible to the study team.

If there are options available for people other than taking part in the study, this should also be explained. For example, if the study is exploring whether community arts workshops could support mental health in people with mild depression, participants should understand that this is not the only option available, and that if they decline to participate they can still explore other options for supporting their depression with their doctor. Similarly, if a study involves randomization into different conditions, participants (where possible) should be informed about what each condition involves so they are prepared for all options and understand how the randomization process will work (a notable exception to this is if the study is ‘blinded’; see Chapter 10).

This section of the PIS often also discusses ‘pre’ aspects of the study, such as how participants’ eligibility for the study will be checked, and ‘post’ aspects, such as if the study involves a therapeutic intervention, what provision will be available for participants to continue receiving support once the study formally stops.

 
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