Communicating study findings to participants: guidance

Why it’s important to communicate findings

Research participants have a right to know the findings of the research study they took part in. Sharing research findings should go beyond publishing results in registries or academic journals, where technical or academic language is used that participants may not understand. Sharing findings directly with participants helps to build trust, show respect, and helps participants to feel valued.

Why it’s important to plan it early on

How you’ll share findings with your participants should form part of the study plan. You may need to factor it into your funding application. You’ll also need to include information about your proposed approach in your application for approvals and participant information sheets. When planning, you’ll need to consider the following:

a) Public Involvement

You should involve relevant people early in the design of your study. This may mean involving patients, service users, carers, other advocates or members of the public. Engaging with relevant people early on will help you to decide how to share findings with participants. Our public involvement webpages have lots of information and guidance to help you.

b) Funding

Sharing findings with participants may require additional funding and resources. You may need to include these in grant or fund applications. You may prefer to consider low cost options, such as sharing information electronically. Discuss this with your public involvement group.

c) Including information in your participant information sheets and approval application

Though the material used for sharing study findings does not need to be submitted for regulatory review, your research application should include an outline about how you plan to share findings to participants.

You should set out your plans to communicate findings to participants in the participant information. Make participants aware of the likely timing of communication about findings so that they know when and how to expect this information.

It is important that you comply with UK GDPR and data protection legislation. To meet the transparency principle, you should explain to participants how you will collect, store and use their contact details, and how and when you will communicate findings.

Participants should not be surprised by receiving study findings or how they have been sent to them. To comply with the legislation, you should make sure you minimise the amount of personal data you use. That means you should only use another organisation to manage communication if other methods are not feasible. If you are using another organisation to manage communication to participants, you should make sure that this is explained to participants. This should include clear information about how and why the other organisation will use their data, and what controls are in place.

You should also make participants aware of their right to object to the processing of their personal data for the communication of research findings.

Participants should have a choice as to whether they receive findings and should be allowed to record if they change their mind during the study.

If you later change your plan for communicating findings to participants, or if you didn’t include details in your initial application but later decide to, then you’ll need to submit an amendment. The amendment should include:

• details of how and when you plan to communicate findings,
• a process to record participants’ choice about receiving findings or not,
• if the study is still recruiting, then you will also need to update the general consent form and participant information.

What to consider when communicating findings to participants

The following information outlines the different aspects to consider when planning your communication of findings. Discuss these aspects with your public involvement contributors at the planning and design stage of your study.

a) who will receive the findings

You should offer a summary of study findings directly to participants. This is in addition to any findings made publicly available.

In some instances, it may be expected that participants could die or lose capacity during the study. In these cases, it may be appropriate to share findings with participants’ relatives or carers. Give immediate family members/carers the choice. Plan early for this to ensure you receive the appropriate consent for storing contact details for this purpose or have put other appropriate mechanisms in place to allow you to share results with participants.

If your participants are children you should also consider how you’ll adapt your communication to ensure it is accessible for them and their family members/carers.

b) how you’ll communicate the findings

There are various ways to share findings with participants. It’s valuable to discuss the options with your public involvement group. Commonly used methods are:

• end of study information sheet or newsletter
• verbal information provided at study visits
• study websites
• study social media accounts

The way you communicate will depend on the type of study and your audience. For example, digital options may not be accessible for everyone – some participants may not be computer literate or may not want to use technology to access findings. Where using a digital option, it may be beneficial for participants if this is also supplemented with hard copy information.

You should consider who your audience is so that you can tailor your communication to be effective. To ensure the findings will be understood by your audience, consider using different versions for different audiences, such as children or adults lacking capacity. You might want to adjust how much detail you provide on your findings depending on the audience.

Where your research study does not collect contact details of participants, it may not be possible to share findings directly to participants. You may wish to include details in the participant information sheet about where findings will be published, so participants can choose to read the findings if they want to. For other types of studies, it may be appropriate to collect email addresses and provide updates that way. Alternatively, you may, with appropriate consent, arrange for a third party to hold contact details solely for the purpose of communicating study updates and findings. For in-person studies, you may decide to share updates and findings during study visits.

Regardless of the type of study and your audience, write your findings in lay language. We provide further guidance on how to write a plain language summary of your research findings.

c) giving participants a choice

While most participants/their relatives or carers will want to receive study findings, some may not. Those who might not wish to receive findings or updates should be given a choice at the start of the study and again during it. You should plan for how people can indicate their choice during the study.

Your participant-facing information should include details about how and when you’ll share study findings. Use the consent form to record the choice participants/their relatives or carers make about receiving findings. You’ll need to take this into consideration when deciding your method for communicating findings.

You need to take three different aspects into account when thinking about how participants or their relatives or carers can make choices about receiving study findings.

1. Common law duty of confidentiality – people’s contact details are part of their health and care data when used alongside information about their health or care. That means that you need to get their consent to use these details for sending information about study findings.
2. UK GDPR and other legislation – you do not need to obtain GDPR-compliant consent, because your organisation can rely on public task or legitimate interests to send out research findings. That means that the consent for sending study findings can be kept simple and does not need to meet all the legal requirements for consent under GDPR. Communicating findings to individuals about research they have been involved in is not direct marketing if such an activity falls within your organisation’s task or function. Therefore, you don’t need to comply with the direct marketing consent requirement or other rules under the Privacy and Electronic Communications Regulations (PECR).
3. Ethics – it’s important that people feel that they can make choices, and that they can change their mind at any time.

The choices about receiving study findings should be separate from the choices about participating in the study. You should consider whether to offer people choices about how they will be contacted, for example by text, email or post as appropriate.

Participants might change their minds as the study progresses. It’s important that you plan to give participants another opportunity to either receive study findings or not. You should make it clear how people can change their choices about receiving study findings, and you should make sure that you can add or remove people from your communication system in accordance with their wishes. Consider also what you’ll do if a participant withdraws during your study. They may decide that they no longer want to receive study findings.

d) responsibility for communicating findings

This will depend on the way you’re sharing the findings. If sharing findings in-person during a study visit, the site team or usual care team may need to take responsibility for this process. If sharing findings via email or post, we recommend that the central study team takes responsibility. When planning your study, decide who is taking responsibility for sharing findings and how this will be funded and resourced. Where you will rely on local teams to provide findings to participants, you should discuss the logistics with representative parties. You can formalise arrangements in study site agreements and contracts.

Your public involvement group may have a preference about who is best placed to communicate study findings. Some findings could be upsetting to participants, for example if they find out that the intervention had no effect, or that study findings were negative or inconclusive. You should still offer to share these findings to participants, explaining that their contribution was important and worthwhile. If you’re communicating findings that may distress or upset participants, consider communicating more individually, such as through a discussion with a research nurse or doctor. When you communicate findings, make sure to include the details of someone that participants can get in touch with if they have any questions or want to discuss the findings in more detail. That person should also be able to point people directly to the sponsor’s Data Protection Officer, or the latter’s details should be provided at the bottom of each communication (along with a reminder of how to withdraw consent from receiving future communications of the same type).

e) exceptions

There may be occasions where it isn’t possible to share study findings directly to participants. For example, a study using anonymised tissue samples or a study using patient identifiable data without consent (approved by the Confidentiality Advice Group under section 251 of the NHS Act 2006) may not be able to share findings to participants. Where you cannot provide findings to participants directly, you should make this clear in your participant-facing information or patient notification materials. Where it’s not possible to share findings directly to participants, you should still publish findings. It may be possible to provide a website link to where the findings will be shared, and include this in participant-facing information at the start of the study.

f) when to communicate findings

When and how often you communicate findings depends on the type of research. For some studies, it will be possible to share interim findings or updates throughout the duration of the study, whereas other studies will only have findings right at the end. For a study with several phases or lots of endpoints, you may want to share findings for each of these as the study progresses. If doing so, it’s important to consider how sharing of results at multiple timepoints may influence the overall study design.

You might want to stagger information, giving participants some information when their involvement in the study is over and some at the end of the study. Keeping in contact with participants in this way helps them feel connected to the research even though their involvement has ended. You should discuss this with your public involvement group.

g) evaluate your communication

More research is needed to evaluate communication of findings strategies and determine best practice. Where possible, you should evaluate your communication methods (ideally in a randomised Study Within a Trial) to establish how effective your strategy is, and whether it has had the impact that you wanted. Depending on when you feedback results to participants, your strategy could become a retention intervention in and of itself.

Useful Resources

1. Parkinson’s UK has a research communications toolkit developed with the HRA and our Research Ethics Committees. The Staying Connected Toolkit is a resource for research teams to use to achieve gold standard practices for communicating with participants throughout the course of the study.

This toolkit covers:

• general principles and timelines for communicating with participants throughout their research journey
• how to plan research communications ahead of time
• simple standardised tools and templates to help researchers to easily communicate with participants during the study
• guidance on how to build a sustainable relationship with the research participant community

2. The RECAP project provides stakeholder-informed guidance on sharing summaries of trial findings

3. The Show RESPECT study looks at the best ways to share study findings with participants

4. The Knowledge Mobilisation Alliance have created an infographic sharing 10 recommendations for communicating research findings to patients and the public

5. Our guidance on developing a plain language summary of your research findings

6. Our guidance on consent and UK GDPR

7. Guidance on What is and isn’t direct marketing? by NHS Transformation Directorate (england.nhs.uk).