This post builds on my previous one about public involvement and ethical review. It follows the publication in April 2018 of new guidance by the Health Research Authority (HRA) to help applicants for ethical review better identify and report where they have involved the public in their research applications and the difference that made. The intention is to make obtaining approval by a Research Ethics Committee (REC) easier on the basis that involving patients and the public in the design and conduct of a research study addresses many of the things that a REC looks at in reviewing whether the study respects the rights, safety, dignity and well-being of the potential participants. This matters on a number of fronts including helping to reduce waste in research [see the Lancet Series on Research: increasing value, reducing waste] by improving the chances of a study getting ethical approval more quickly and or with fewer conditions. And it matters to patients because as well as potentially helping the research to start sooner it will also help to ensure that studies recruit enough participants to obtain a reliable answer to the research questions and so reduces the chances of another form of research waste. After all if a study does not recruit enough participants then it is potentially my favourite acronym, a WOMBAT, i.e a Waste Of Money Brains And Time!
Several weeks ago I did a guest blog for the Association of Medical Research Charities (AMRC) on the HRA’s new guidance and the Test Beds it is trying to set up to systematically use the new guidance and generate evidence that it works. The HRA hopes that this guidance will make sense and offer a win-win opportunity to researchers. However, it will only do that if they read and apply the guidance and the RECs look for and use the information it generates to help assure them of the ethical issues the involvement of the public has addressed.
The European Patients Academy on Therapeutic Interventions (EUPATI) has just published a series of four papers to highlight guidance it has produced on a number of aspects of patient involvement in medicines development. One of these papers covers “Guidance for Patient Involvement in Ethical Review of Clinical Trials”. The publication of this paper is timely as it complements what the HRA is currently doing.
Most importantly the paper covers not just the review of studies by RECs but three aspects of the design and conduct of studies which are the responsibility of researchers and research funders and sponsors:
- trial concept where the research questions and design concepts are developed;
- trial design where the details of what will be done to participants are developed; and
- after the end of the trial where the results are communicated to different audiences
In doing that the paper very helpfully makes the link between public involvement and ethical review very clear. Design your study well with the involvement of patients and the public and you will most likely address many if not most of the ethical issues a REC is likely to be concerned about and therefore make the ethical review process more straightforward.
I recently attended an NHS REC meeting as an observer and was struck by three things:
- The first was that almost all of the ethical issues the lead discussant and then other members raised about each of the applications were things that good involvement of the public could have addressed and had to an extent in some of them.
- The second was that two of the five applicants had clearly seen the HRA’s new guidance and used it to provide the REC with information that really helped it. Both had an easier time than the others because the issues raised were more minor than for the other applications as a result of having addressed anything more major through their involvement of relevant patients and or carers.
- And the third was that those two applicants had also clearly seen and taken note of the HRA’s “Top tips for public involvement in your research application” and followed one of the two bonus tips by bringing with them one of the public contributors they had worked with (well one of them brought two!). That had a big impact on the REC and further helped to assure them that those studies had been designed with the interests of potential participants in mind. Job done!
I recently read a blog promoting patient advocacy in medicines development in the USA that highlighted what it referred to as “Pharma’s 50 Shades of Gray”. What that consisted of was a rather depressing list of 50 lame excuses for not involving the public, which were illustrative of many similar answers I have seen in applications for ethical review. Whilst there are some important and encouraging initiatives in industry like Patient Focused Medicines Development to support and promote the involvement of patients in medicines development those who make these sort of statements really are missing a trick as the HRA said in announcing the paper I published last December with Kristina Staley. Or given how much money it costs to develop a drug and how little it costs to involve the public they are “spoiling the ship for a ha’peth of tar”.
So I hope the above helps to show the links between involving the public in designing and conducting health and social care research and ethical review and that involvement can help to make the research more ethical and acceptable to potential participants. This is one of the many reasons why public involvement matters so much.