The simple answer to the question, to the surprise of many perhaps, is relatively little. Or to put it another way, many of the benefits that involving the public bring to research address important aspects of the ethical review of research. Both are about making sure that research on people (or their data or samples) is ethical, relevant and acceptable to the people who will take part. And while ethical review includes a number of legal duties that are beyond what involving the public can help with the more you look at the background to both and what they achieve the more similar they are. So, why is it then, you might ask, that this is not more widely known about and made use of, most notably in the ethical review of research? To answer this you need to explore the history and the knowledge and myths that surround both.
In the NHS in the UK, review by an NHS Research Ethics Committee is one of a series of safeguards intended to protect the people taking part in the research, the participants. The ethical principles on which the review takes place come from the Declaration of Helsinki, which was first adopted in 1964 and followed the 1947 Nuremberg Code that was developed in the wake of the abuses of human rights by doctors (among others) during the Second World War (if you are interested in the detail Wikipedia is pretty good on it all along with the Health Research Authority’s web site of course). Research ethics is intended to enable and support research that protects the rights, safety, dignity and wellbeing of research participants but also consider what is in the interests of the public and the researchers themselves.
The reason for involving patients and the public in the design and conduct of research is to help ensure that the research is relevant to and addresses what is important to patients and their families and, for clinical research, is designed in a way that is acceptable to take part in. Or in other words is in the interests of patients and the public. That sounds similar to the purpose of ethical review doesn’t it?
NIHR-INVOLVE and the Health Research Authority have published evidence to show that involving patients and the public in research can benefit research in five broad areas that are part of the ethical review of research by:
- making it relevant to the people it is intended to help;
- helping to ensure what is going to be done to the participants is acceptable to them;
- improving the process of seeking informed consent to participate;
- helping to improve the experience of taking part and;
- helping to communicate the progress and findings to participants, other patients and the wider public.
The evidence shows that public involvement can help to assure RECs about aspects of the design and conduct of studies so it is important to ensure that the information asked for is as helpful as possible and used positively. The benefits of good involvement are more relevant research that is acceptable and easy to participate in and well communicated to those with an interest. But more than that, it should be easier to set up studies that are designed and conducted this way because it should also be easier to obtain ethical approval with fewer or no conditions.
However, unfortunately in practice public involvement rarely makes a useful contribution to ethical review as shown in the work I co-published with Kristina Staley (see also the Health Research Authority news story “Researchers are missing a trick with public involvement”). As discussed in the paper this is for a number of reasons. The main ones are a poor level of understanding among many researchers and members of Research Ethics Committees of what involvement is and how it can address ethical concerns. But that is compounded by the question on the application form not prompting applicants to say anything useful about what their involvement of the public contributed to the design of their study.
In addition to the issues above there are also some unhelpful myths or misunderstandings about ethical review itself. The more I look into ethical review the more I feel that many researchers don’t appreciate that ethics committees are actually trying to help researchers do good research. I think many see ethical review as just another hurdle to jump over. And there are also misunderstandings about involving the public and whether you need ethical approval for that, which you don’t, as covered in guidance on the Health Research Authority’s website.
The Health Research Authority is working to address the situation identified above and will be issuing some guidance soon to help applicants to provide more useful information. In parallel I have produced a short guidance note that can be downloaded from this page to help public contributors to do the same thing. One idea we would like to pursue is to set up some “test beds” to systematically apply the guidance and record the effect it has. Ideally these will be research groups / units / centres / institutes that submit a good number of applications for ethical review each year and involve the public in most or all their research. And even better if some are piloting the national standards for public involvement, either as official test beds or informally, and or are following NIHR-INVOLVE’s new guidance on co-production.
Hopefully I have demonstrated that as well as helping to produce excellent research involving the public in the design of research should help researchers to secure ethical approval more easily. This is an added benefit and impact of involvement that does not require a significant amount of additional work so what’s not to like?