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The development of a promising COVID-19 vaccine has been put on hold due to an adverse reaction in a trial participant. A spokesman for AstraZeneca, the company working with a team from Oxford University, told the Guardian the trial has been stopped to review the “potentially unexplained illness” in one of the participants. The spokesman stressed that the adverse reaction was only recorded in a single participant and said pausing trials was common during vaccine development. “As part of the ongoing randomised, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee,” the spokesman said. “This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials. In large trials illnesses will happen by chance but must be independently reviewed to check this carefully." “We are working to expedite the review of the single event to minimise any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standards of conduct in our trials.” Read full story Source: The Guardian, 9 September 2020

Hi there, I represent a team of researchers in Reading, who are submitting ethical approval for a project investigating pain research and knee surgery. Part of this process is receiving feedback from an NHS ethics committee and addressing this for the benefit of the science, patients and clinicians involved. One suggestion they have made is that we involve patients within the review of our information sheets, which detail the procedures (both medical & research) that they may consent to. There is no requirement of expertise or experience from any patient who wishes to be involved, we are just very eager to make sure our information is clear, free of jargon and doesn't come across as confusing or intimidating. The committee have indicated this is an optional recommendation, but it is one that I am very keen to engage with. As it's optional, we are unable to shift our deadline for this, and I would unfortunately need the documents reviewed and submitted by Thursday 26th November. If this is something that anybody would be willing to help us with, I'd be very grateful. One information sheet is 2 pages, and the other is 7 pages, if this offers a good idea of how much time it may require. My hope it it would take no more than 30 minutes. If you are able to volunteer your time, please contact me on rich.harrison@reading.ac.uk, and I will forward you the documents for your review. Once again, thank you in advance! Richard