Improving information for research participants

What’s the problem we’re addressing?

Deciding to take part in a research study can be a big decision and people need good information to be able to make that decision, whether that information is written, verbal or in a video. Whilst many research teams produce great participant information, others produce information that is too complicated, missing key facts or presented in a way that is hard to absorb.

Ethics committees play an important role in reviewing how people will be informed about the study they are being asked to take part in. However, they respond to unsuitable participant information in lots of different ways, causing researchers confusion in what ethics committees expect.

Working with our partners across the UK over the past two years we have been developing guidance to make participant information better and to make the way that committees review that information more consistent.

This work is still on-going and we will keep you updated on the ideas we have developed so far and let you know when we are ready to implement them.

How we're developing our guidance

We heard from more than 200 people from across the UK who took part in workshops earlier this year to give their views about our ideas for improving participant information.

We’ve used this feedback to develop ideas for new guidance to make sure people invited to take part in research receive clear and concise study information which has been designed with and for patients and study participants.

Read on to find out more about how we are developing our ideas. We'll let you know when we're ready to implement them.

What is Think Ethics?

The point of Think Ethics is to find ways to make research ethics review more innovative, efficient, and trusted. When we’ve done this work, there should be some big changes which make a real difference to how ethics review works.

One of the things we’ve wanted to improve is how the information that researchers give people helps them decide whether to take part in research. These pages will explain why that’s important, what the problem is, how we’ve come up with ideas to fix it, and what we’ve decided to do.

Why is participant information important?

People can’t make a proper decision about whether to take part in research unless they know enough about what taking part would mean for them. Participant information is the information researchers share about a study so that people can make that decision. They can share that information through a written document, a website, a film, an app, or in other ways. Having someone to talk to about the research and what taking part would mean is also important.

Research Ethics Committees decide whether plans for a research study are ethically acceptable. Among their considerations, they think carefully about whether researchers will give people the right information, at the right times, in the right ways. Taking part in any research involves some amount of risk and takes time and effort. It isn’t fair or right to ask people to decide whether to take part without giving them the right information clearly.

Research normally can’t happen unless people agree to take part. If people can’t tell what taking part in a study is going to be like then they might decide not to take part. Or they might start taking part but then drop out once the research has started if they realise it’s not right for them.

Research organisations are legally responsible for the welfare of people who take part in the research they run. They need to help people understand what that means when they agree to take part. This is especially important to make sure they treat people taking part in research properly.

What’s the problem we’re trying to fix?

Sometimes research organisations create long winded participant information

Communicating clearly about research is something lots of people find difficult. Not everybody learns how to do it, and it can take a lot of time and effort to learn how to do it well.

The main official record of what researchers tell people about a study so they can decide whether to take part is often a participant information sheet to read and a consent form to sign afterwards. If someone is harmed through taking part in a study, those documents are important for checking whether they really understood the risks involved in the research, as well as the benefits, when they decided to take part.

Some research organisations put lots of detailed information and use specific legal wording into participant information documents. Many organisations (particularly private companies) end up with long templates that they use and adapt for each study they run.

Worries about the legal risks of carrying out research mean participant information ends up being too long and complicated for it to be useful for people considering taking part in a study.

Different Research Ethics Committees tell researchers different things about how to improve it

Ethics committees spend a lot of time and energy thinking carefully about the participant information designed for new studies. They often need researchers to make changes to it before they can give a favourable ethical opinion to let research get started. They take that very seriously because informed consent is vital for (most) research to be ethical.

But ethics committees respond to unsuitable participant information in lots of different ways. Some committees spend a lot of their time discussing participant information in detail, and agreeing specific wording researchers need to use. Others just give general advice that the information needs to be checked or rewritten more simply.

When participant information needs lots of improvement it takes everyone a lot of time to discuss, describe, make, and check the changes the need to happen. Sometimes the changes committees ask for are more about advice than ethical issues.

It can be difficult for researchers to know what ethics committees expect, because different committees ask for different changes in order to make participant information suitable. Sometimes what they ask for contradicts what other committees ask for, which can be confusing. It makes it difficult for researchers to get participant information right before the ethics review.

What do we want to be different?

Aims: what are we trying to do?

1. To improve participant information materials and processes
2. To improve the way ethics committees review them

Outcomes: what will be different if we do it?

• Ethics committees will make decisions about participant information in a more consistent way
• They will be able to issue more favourable ethical opinions at a first view for research to go ahead, faster
• It will be clearer what role public involvement has in how researchers develop participant information and how ethics committees review it. That will mean the public involvement won’t be wasted and can be more meaningful.

Benefits: why will things being different be a good thing?

• Participant information will be better, so more people will be able to make better decisions about whether to take part in research
• Research recruitment and retention will be more efficient and inclusive
• Research will be better and more successful
• Ethics committees, research organisations, regulatory staff, and public contributors will all save time, effort, and resources
• They will have a better experience of being part of the ethics review process

How did we decide what to do?

We did some research

We didn’t want to guess about what matters for participant information. If we did that, we might accidentally make changes that aren’t helpful. We read research about participant information to learn what’s helpful and what’s unhelpful. We also wanted to find out about how different people think about participant information: researchers, ethics committee members, people who ask people if they want to take part in studies, and people who take part in research.

We learned some important things:

• Participant information sheets are already very long, and they’re getting longer. Most people aren’t likely to read and understand very long documents.
• Participant information often uses language which isn’t suitable for the people reading or hearing it. That means it doesn’t help them to make a proper decision about whether to take part in a study.
• When people can choose how much information to have about a study, a lot of them (41%) pick very basic information. A lot of them (41%) don’t choose to read anything at all before making their decision.
• People also only want to know about between a quarter and a half of the topics usually covered in participant information. That means that lots of the templates and guidance about how to make good participant information ask people to include a lot more topics than people want.
• When participant information is shared through a video or a presentation instead of in a written document it doesn’t help people to understand what the study involves better, but people are generally happier with the way they’re finding out about the research.
• Working with people who have experienced the condition or situation that the research is about is one of the best ways to make participant information better for the people who’ll be asked to make a decision about taking part in research.

We discussed the problem with people

We talked to lots of people who know a lot about participant information in different ways.

We listened to:

• People who have taken part in research or who use their lived experience to help design research
• People who are members of Research Ethics Committee
• People who work for organisations that set up and run research (either as part of the NHS, charities, universities, or private companies)

People who work as part of research teams that carry out research

People who work for UK regulators

We asked people what makes it difficult to create excellent participant information, and what problems come up when Research Ethics Committees decide whether or not it’s ok for the research to go ahead.

We also wanted to know about any ideas people had for how we could make things better.

What people told us:

• There are problems with how researchers make participant information and ethics committees review it. People want that to change.
• It’s not clear what excellent participant information should be like, and that means the people who make it and review it sometimes don’t feel confident.
• People who work for research organisations want it to be much clearer what ethics committees look for when they review participant information, and how they make their decisions about whether it’s ok or not.
• There’s too much emphasis on participant information paperwork and not the whole process of how people find out about a study over time and build relationships with members of the research team.
• Lots of people think that participant information is often too long and complicated because pharmaceutical companies’ legal departments say researchers have to use particular wording. They’re worried that this will be difficult to change.

We asked people to help us choose the right solutions

We thought about what we’d learned from reading research and listening to people. The people we discussed the problem with had some great ideas for how to fix it.

We ended up with about 25 ideas, and we discussed these with the Think Ethics Advisory Group and a team of experts at the Health Research Authority. We discussed the pros and cons of each idea, and how likely we thought each one was to work.

We agreed on 10 top ideas to think about more seriously. To do that, we needed to put our heads together with lots of other people. First, we invited all ethics committee members in the UK to tell us what they thought would work the best, what wouldn’t work at all, and why. After that we held two big workshops to ask lots of other people the same questions. The people who came to work with us were a mixture of patients and the public, research organisation representatives, researchers, and ethics committee members. They voted on what they thought would be the best way forward, and took part in discussion groups and an online survey to tell us why.

Because the problem we’re trying to fix is complicated, people told us that we should pick several ways to try to make things better. They encouraged us to be ambitious and to think creatively, because it’s really important to change things. People warned us that small changes won’t make enough difference!

The Health Research Authority can change things in three main ways: we can change what we expect researchers to do, we can change how ethics committees review research before it begins, and we can change how we provide support to them both.

People told us that it was really important that we should share any advice for researchers about participant information with ethics committees, and anything for ethics committees with researchers so that that they could have a transparent, shared understanding of what matters.

What have we decided to do?

We’ve decided that a package of changes, improving the whole process from information design to committee review, is the best way to make serious change. Those changes are:

• Set minimum quality standard for participant information
• Require public involvement in participant information design
• Develop a participant information review framework for ethics committees to use
• Develop a participant information design framework for researchers to use

Set minimum quality standard for participant information

What

There will be a clear, measurable minimum standard that all participant information has to meet before an ethics committee looks at it. We’ll base the standard on the evidence about what matters. It will be specific enough that it’s straightforward to know when participant information meets the standard. For example, it might cover using UK spelling, terminology, and grammar, and meeting well-established accessibility or plain language standards. It could mean providing information which isn’t about the specific study elsewhere instead. Participant information that doesn’t meet the quality standard won’t be able to continue through the ethics review process.

Why

People from research organisations told us that it would really help for everyone to have a shared understanding of exactly what ‘good enough’ looks like. That will help make sure participant information basics are always covered before ethics review. The ethics review process will be more efficient if there is a clear standard that it’s straightforward to check the same way every time. It will help ethics committees to focus on more complex ethical considerations about participant information instead of losing time asking researchers to make basic improvements to it.

How

We’ll work together with ethics committees, research organisations, experts, research participants, and regulatory staff to decide the quality standard. We need to make sure it’s practical and prioritises the needs of people taking part in research. We’ll make sure that research organisations know all about the standard well before they begin planning a study. We’ll create training and guidance that helps researchers to meet the standard and helps staff and ethics committees to use it.

Require public involvement in participant information design

What

Researchers will have to work with people who have lived experience which is similar and relevant to the people who they will invite to take part in the study when they design participant information.

Researchers and ethics committees will have clear guidance about:

• how to do public involvement that makes participant information better
• how to describe public involvement to ethics committees
• how to take public involvement into account during an ethics review

Why

Public involvement improves the quality of participant information. It helps to make sure that the information will make sense to the people it’s for, and that it tells them what they want to know about. Ethics committees told us that knowing that people with relevant lived experience have been involved in designing participant information helps them to be far more confident that it’s suitable.

We already encourage researchers to work with people who have relevant lived experience to make their participant information excellent. However, through this work people have told us it is essential.

How

We’ll make sure research organisations understand why public involvement is important and how it’s helpful. We’ll provide support and guidance for researchers and ethics committees about what good public involvement in participant information development means. We’ll use lots of practical examples. We’ll make sure that ethics committees know how to consider public involvement when they review participant information. We’ll work together to decide whether there are ever any good reasons not to include people with relevant lived experience in participant information designed for people like them.

Develop a participant information review framework for ethics committees to use

What

We’ll create a framework of principles that help ethics committees to focus on what matters the most for participant information. The principles will make it clear what the important ethical considerations are for participant information. They will help ethics committees to be flexible but focused when they review information participant information materials and processes.

Why

We want to support ethics committees to be confident that they are focusing on what matters the most when they review participant information. We particularly want to help committees to review participant information documents within the broader context of how and when researchers will communicate about a study over time.

How

We’ll work with ethics committee members, staff, and public contributors to develop and test the principles. We’ll make sure it’s well integrated across ethics committee training, guidance, and support.

Develop a participant information design framework for researchers to use

What

We’ll create a framework of principles that mirror the principles for ethics committees to help researchers to understand what matters the most for participant information.

Researchers will be able to choose whether to use the principles when they design participant information; the principles will make it clear what the important ethical considerations are for participant information.

Why

People told us we should support researchers to move away from relying on rigid templates for what participant information should include and how it should say it. They said that developing principles would help them to design creative, innovative participant information materials and processes with people with relevant lived experience.

How

We’ll make sure that the principles are flexible and relevant for all different kinds of research. They’ll be based in the evidence for what works well and what doesn’t, and we’ll work with participants, researchers, ethics committee members and staff to create them.

What did we decided not to do?

Some of the ideas we thought about might help to improve participant information a bit, but not enough to be worth doing now. People told us that some of them might accidentally cause other problems, too. That was really helpful to hear! It helped us decide to do the four things we’ve described above.

Limit how long participant information can be

We discussed making a rule that written participant information can’t be more than a few pages long. This could make it easier for people to use participant information to decide about whether to take part in a study. We do think participant information documents should be much, much shorter. But we were worried that making this rule could accidentally make things worse. People might try to squeeze tiny writing onto a couple of pages or not have space to include useful pictures or diagrams. Instead, we’ll make it clearer what information shouldn’t be included in participant information so that it can be more to the point.

Monitor how well information works once participants are using it

We thought about making a rule that researchers have to check how well their participant information is working and then tell the ethics committee about it. Then we could share information publicly about which research organisations make brilliant participant information. Most people didn’t like this idea at all.  It would take a lot of time, money, and planning to collect and share this information. In fact, it could accidentally make things worse. Researchers might not include people in their research if they need different ways of communicating, which would make research less fair and accurate. Designing participant information with people who are similar to the people who will be invited to take part in the study is a better way to make sure it will work well in real life.

Consider other things instead of participant information

Written participant information is just one part of the bigger picture about how people make decisions about whether to take part in research. We talked about asking researchers to make it clearer how they will make sure that people understand what taking part in their study would involve. But doing this won’t improve the long, complicated participant information that researchers sometimes write.

Create a toolkit for people who take part in research

We talked about creating a range of resources which would help people considering taking part in research know what to expect and how to seek support. We would need to work with other health and social care organisations to do this. People deserve to know what to expect when researchers invite them to take part in research. They deserve to know what they can do if they don’t have the right information in the right way. People strongly supported this idea but said that it probably wouldn’t improve the quality of participant information. We still thought this idea was important so we decided to think about whether we should do it as part of a different project instead.

Help research organisations to start doing public involvement

We thought about starting a new service to help research organisations to set up and run their own public involvement groups or networks. This would be so researchers know how to find people with relevant lived experience, and how to work with them well to design participant information. People agreed that there should be lots of support for research organisations to do public involvement. But they were worried that a central, national service like this might accidentally replace existing local public involvement groups. If the Health Research Authority offered a service like this it would need to be able much more than participant information, so we decided to think about this idea outside of this project.

Make an automatic guidance generator

We discussed making a tool that could use an algorithm to help researchers to find the most relevant guidance about participant information for their study. We want to make it as easy as possible for researchers to find helpful guidance about how to create great participant information. But this would take a lot of time and money and could easily end up being too much like the guidance we already have. That wouldn’t make a big enough change to how people create participant information.

What happens next?

We will:

• make sure that participants and ethics are the priority in how researchers develop participant information and ethics committees review it
• develop our solutions in a way that’s practical and based in the evidence for what works
• hold ourselves to a high standard for how we share what we develop – anything we make to help people approach participant information differently has to be easy to navigate and digest and brought to life using real examples
• keep working with all the kinds of people who’ve helped us decide what to do so far, so that we do those things well
• keep you updated about this work as we do it