We've recently launched new Quality Standards and Design and Review Principles to improve the information given to people who are invited to take part in research.
Jonathan Fennelly-Barnwell, HRA Deputy Director of Approvals, blogs about how the new standards and principles will support people to make better decisions about taking part in research.
Deputy Director of Approvals at the HRAJonathan Fennelly-Barnwell
Choosing to take part in research is a different kind of decision for different people. For some it may be an immediate, resounding ‘yes please, sign me up!’ For others it can be a harder decision that takes time to think through whether it is right for that person, and of course there will be a range of views in between these positions, and people’s thinking can change. What is a common factor is that it is a big decision, and we believe that people need to understand any risks involved in the research, as well as the benefits.
Many research organisations provide good quality information, but still too often information is given to potential research participants in a way that is confusing and difficult to understand. Research Ethics Committee (REC) members, and staff still see information about research projects, aimed at participants that uses legal language, long-winded sentences, and complicated medical terms.
For a long time, members of individual RECs have identified where participant information falls short of the standards they expect of ethical research that people can trust, and make good decisions about. RECs have helped individual research organisations improve information and practices. Building on this expertise and experience, our recent Think Ethics programme included a workstream to develop a clear Quality Standard for participant information.
We carried out an exhaustive review of the evidence on what constitutes good information and came up with an initial standard. To help maintain this standard, we’ve created Design and Review Principles which help researchers understand what the expectations are, and support RECs in reviewing participant information against those standards. We think this will help to make participant information better, by providing guidance to researchers on what good participant information should look like. They will also help RECs make decisions about participant information in a more consistent way. To check this, we spent a lot of time talking about our proposals to researchers, REC members, and members of the public, and we talked to colleagues and RECs in Northern Ireland, Scotland and Wales too.
We finalised the Participant Information Quality Standards in April, and let our RECs and staff across the UK know about them, and have since been planning their implementation. We know that researchers may need to change some aspects of how they currently design this information, and that if we have a fixed point of implementing and mandating these standards, applications already in progress may be disadvantaged. We will be implementing the standards, and Design and Review Principles over the coming months, with further information being shared with RECs, researchers and the public. We will ask for and listen to feedback to help us modify our implementation plan if needed, but by the end of 2023, we expect that the Quality Standards will be mandatory.
Ultimately, information of a consistently high standard, and review of this information being approached consistently, will help people to make better decisions about whether to take part in research. This will make participant recruitment and retention more efficient and ultimately lead to more successful research.