Statement in response to BBC Newsnight

RECs are made up of health professionals and members of the public who are not usually expert in all types of research that a committee will consider at its meetings. They do however have access to a range of professional experts and can seek additional advice from several sources including the National Research and Ethics Advisors’ Panel (NREAP). RECs review the application, protocol and related study documents. They are not constituted to provide scientific critique of the design of studies but seek assurance that this has been undertaken by the research sponsor or funder. RECs can only review the information which is provided by the study team and are not able to identify new evidence or uncertainties unless this is provided to them. It is normal practice to invite researchers to attend the REC meeting in person for a detailed discussion about their proposals, and the REC will seek to be assured that the research team has taken account of existing evidence and has explored the relevance of the research question. We have reviewed the application form for this study and it appears to give a credible review of the treatment uncertainties and the existing evidence at the time the study was started.

Participant consent is a crucial aspect that the REC reviews, to ensure that the information provided to potential research participants is comprehensive and clear. This means that a potential participant can have a conversation with the research team and make an informed choice as to whether they want to take part in the study. Unfortunately, as this study was reviewed in 2010, before the formation of the HRA and when applications were submitted in hard copy, we no longer have a copy of any study documentation which was submitted only in hard copy. This includes the Participant Information Sheet (PIS).

The HRA is the appointing authority for RECs in England but does not usually comment in detail on the discussion and decision-making of individual committees, as the opinion provided is that of the committee itself. We have access to the minutes from the meeting where this study was approved which indicate that the REC considered the risks and benefits to participants, and the description of these in the study information which would be shared with potential participants.

RECs consider the rights, dignity and well-being of those who will be taking part in the study when reviewing all research applications, and this is particularly crucial when research involves children or young people. They will consider whether relevant patients have been meaningfully involved in the study design, as it is best practice for there to be patient or public involvement. Committees consider the ethical issues presented by an individual application – which vary depending on each study – but all RECs work within the same robust review principles.

There are no records that any Serious Adverse Events (SAEs) have been reported to the REC or the HRA in association with this study at any time. It should be noted that the requirement for this type of study would only be to report adverse events that were both unexpected and deemed to be related to the study intervention. For example, effects that resulted from administration of the research procedure and which were not listed in the protocol as an expected occurrence. As this was an observational study, other events would be managed by the clinical care team as they would for those not taking part in the study.

The institution sponsoring the study is responsible for the overall conduct of the research project, including ongoing monitoring of conduct and safety in accordance with the UK Policy Framework for Health and Social Care Research. This includes adhering to arrangements for registration, reporting results and feeding back to participants. Once approval has been granted, the chief investigator is responsible for ensuring that the conditions of approval are met.

We can confirm that one of these conditions is that progress reports should be produced for the study, giving researchers continued assurance of independent ethical oversight of their work. Our current approach is to request reports when they become due, but it is not a routine activity of RECs to monitor ongoing studies. The HRA does not usually enforce the requirement to submit progress reports by withdrawing ethical approval if they are not received.  However, if concerns are raised, we would ask either the original REC or a different REC to review the study in the light of this new information to determine whether the original opinion should still stand. This will include further dialogue with members of the research team and others as appropriate.  If the REC is not satisfied that all ethical and safety concerns have been addressed, they can withdraw their approval. In some situations, the REC may feel that a study warrants closer oversight, and in these cases they will explicitly request and follow up progress updates. This did not apply to this study. No concerns or complaints about the study’s conduct or safety have previously been raised to the HRA.

We recently received a third-party complaint about the reporting of this study.  We followed this up with the chief investigator, who indicated that this was in progress and they have now provided a comprehensive end of study report. The report states that the research team completed follow-up in February 2019 and a final report is being prepared, which will be sent to the REC when data analysis has progressed. We have also been informed that interim findings have been placed in the public domain throughout the study.

Thanks to the questions that you have raised about this study and some of the information that you have supplied, of which we are not aware, we feel that further investigation into this particular study would be valuable so that we can see whether there is anything further that the HRA could learn to inform future practice. We constantly review, with our RECs, the ways in which they work to ensure that they remain fit for purpose, and this includes reviewing studies like this one. If your team has access to documents which could help us to do this, we would be grateful to you for sharing them.

The HRA is currently consulting with researchers, participants, sponsors and funders on a new strategy for research transparency which considers how we could ensure better compliance with the requirement to submit reports and to make the findings of studies public. One of the options we are consulting on is taking action where individual research sponsors do not fulfill their transparency responsibilities.

On Monday 15 July we issued a follow-up statement which can be found below:

Investigation of studies when concerns are raised to the HRA is part of our complaints policy and procedure. It does not mean that we have reached a conclusion that there has been any wrongdoing on the part of the researcher or sponsor . We need to investigate further because we do not hold all the information that has been referred to in the concerns that have been raised. The investigation that we refer to is not around a specific point.

We have already started this work. We have looked at the REC minutes to establish what ethical issues were identified by the REC and what advice they gave in the context of this particular type of study.  We have looked at the minutes and documents that we had from the second REC submission to establish whether the researchers had considered advice from the first REC submission in terms of their approach to this study.  We have checked the available records to establish whether any adverse events were reported to us or the REC about this study and we have checked our complaints log to establish the nature of any complaints received and acted upon those findings.  We have reflected the results of this work so far in our response of Friday 12 July.

On the material available to us at present we have not seen anything that raises a specific concern or that we believe has been handled inappropriately. However, the ethics review was undertaken by our predecessor organisation, and we do not have all of the information about the study, including the Participant Information Sheet (PIS). Given that concerns have been raised about the PIS, we would like to consider that to see if there are any lessons to be learnt, or matters to discuss with the research team or sponsor.