Over the past few weeks, you may have heard about a research study called PATHWAYS.
PATHWAYS is a programme (a series of studies linked to a common purpose) of research that aims to test how the NHS can best support people with gender dysphoria.
The research was recommended as part of a review by Dr Hilary Cass which said that this is an area where more research and evidence is needed.
Healthcare for transgender people is something that has become a topic of public debate, with strong views being expressed from multiple different perspectives.
As with all research studies and clinical trials taking place in the NHS, before they can begin recruiting patients, they must first have the proper approvals in place.
When a study is submitted to the Health Research Authority we assess the governance and legal compliance of the research.
We also co-ordinate a review by a Research Ethics Committee (REC) that is independent of the research and the sponsor.
A REC is made up of a range of people with professional and life experience so that they can make an informed decision over whether a proposed study is safe and ethical to invite people to take part in.
Sharing concerns with a Research Ethics Committee
When it comes to high profile research programmes, we often receive requests for information about the research as it goes through the approvals process. PATHWAYS is no different.
We have been asked for information about how and when the study is being reviewed, had requests to share feedback with the REC reviewing the study, and been asked to share the protocol (the full description of the research, including the methods the study will follow).
We have also had requests for the study to be paused or cancelled altogether, or for us to refuse to review it using our usual processes.
Public scrutiny of research is something that we welcome, and is one of the reasons the HRA and Research Ethics Committees exist.
Our role is to consider all of these questions and decide on the right balance between disclosing information and protecting the integrity of the independent review process. We do this through our complaints process and following our duties under the Freedom of Information Act.
Below we look at some of the requests we often receive about research that has been submitted to us, and explain the processes we follow when considering these requests.
What information can we share about a study whilst our review is ongoing?
When a study is submitted to the HRA the documentation is still in draft.
This enables the REC to make recommendations, or requests, to change documents such as the protocol based on the feedback they give.
A protocol or participant information being reviewed by a REC is not the final research tool that would be used during the research or to recruit participants.
Prematurely sharing a research protocol or participant information could unfairly influence any potential participant’s willingness to participate based on incorrect information.
Sharing documents at this stage would undermine the review process and mean that research was not being independently reviewed in line with the UK’s legal and policy frameworks for the review of research.
In some studies, other regulatory bodies may also request changes to the research and its associated documentation.
Identifying which Research Ethics Committee is reviewing an application
The independence of the REC review is a crucial aspect of the checks and balances all health and social care research in the NHS must go through.
A REC must be allowed to review a study free from outside influence that may prejudice any decision they make.
Similarly to how a jury would consider a verdict in a court case, a REC must make an independent decision.
We therefore do not identify REC committees or members to third parties who are not involved in the process until their decision has been made.
Once the decision has been made and the final opinion on a study has been shared with the applicant, we publish the outcome in the research summaries section of our website within 90 days of the final opinion.
Sharing concerns with a REC before or during the review process
We have an established process for sharing concerns about a study before or during the review process.
These concerns are reviewed by the HRA in the first instance to decide whether they raise a clear and specific issue that might not reasonably be identified by the REC in their review which follows a nationally agreed framework for reviewing the ethics considerations within a study.
It is very rare that third party concerns raised would likely not be considered by the REC in their review.
If, however, we decide this is the case, information would then be shared with the REC Chair, or the whole REC.
Sharing the outcome of a review
Every study that is reviewed by the HRA or a UK REC, whether it is approved or rejected, is published in the research summaries section of our website.
Summaries are published within 90 days of a final opinion being shared with the applicant, though sometimes we will publish results sooner if a sponsor wants to formally announce the approval of their research.
Sometimes we are asked to confirm whether we have received an application for a study, or whether a final opinion has been shared.
We can confirm whether or not we have received an application, but we will always share the final opinion with the applicant in the first instance before it is shared publicly.
If someone is unhappy with the outcome for a particular study application we have a well established complaints procedure. Where someone is unhappy with our decision not to disclose information about a study they can also escalate their concerns to the Information Commissioner’s Office.
Balancing transparency and due process
We know that transparency about our processes is really important for people to be able to have confidence in the decisions that we make.
We always have to balance our commitment to transparency, with the due processes we have to follow to protect the integrity of the ethics review of research.
Publishing information about research proactively can help prevent misinformation about an issue.
However, it can also create more confusion if draft information that has not received proper scrutiny is used out of context.
We will continue to share information about all research applications we receive in a timely and transparent manner, following the processes we have outlined above to protect the integrity of the ethics review.