New @HRA_Latest @OfficialNIHR data on UK public attitudes to health research highlights need to work with under-represented groups to break down barriers #diversity

White, middle-class and well-connected - and that's just the patients: is this the health research culture we wish to see in the UK? Ever since it was established in 2011, the Health Research Authority (HRA) - the UK regulator of health research whose mission is 'to protect and promote the public interest' - has commissioned... Continue Reading →

The post-Brexit liberalisation of #clinicaltrials could be the way to a bolder ambition for the UK

There is much post-Brexit talk of using our new-found political independence to liberalise clinical trials in the U.K. We can cut ourselves free of all that terrible EU red-tape that has weighed us down. Or so the argument goes. We can be quicker and more efficient than other countries. We will be more attractive to... Continue Reading →

EU issues draft guidelines on providing clinical trial results so you and I can understand them #clinicaltrials

You probably don't need to hear another thing about the EU, do you? (By the way what a terrible EU referendum campaign it is - have you ever heard such hyperb******s from our politicians?) But this really is a good thing. Following the passage of the new EU Clinical Trials Regulation, the European Commission has started... Continue Reading →

Consent for medical research comes under scrutiny yet again: time for ethics committees to stop second-guessing the public?

This is a really interesting study published in PLOS ONE today.  Eessentially it's a survey of the attitudes of 2300 participants in TwinsUK (a national biobank) to giving their consent to medical research.  The full paper can be found here. The results of the survey would seem to highlight what has been a growing theme in the... Continue Reading →

Government pushes forward with review to speed up availability of innovative medicines and treatments

Two posts in one day!  Ah, those were the days when we got two Post Office deliveries a day.... Just to say the Government has published the full terms of reference for its Innovative Medicines and MedTech Review to be headed up by Sir Hugh Taylor who is currently Chair of Guy's and St Thomas's.  Yes, that's... Continue Reading →

Less haste and more speed is better for research and better for patients

The Government has today announced an Innovative Medicines and MedTech Review, beginning in early 2015. The Minister for Life Sciences, George Freeman MP, has set out a bold vision for cutting drastically the time it takes to develop and give patients access to new medicines and innovation. This news release lays out the basic aims... Continue Reading →

Health Research Authority (HRA) draft guidance on sharing trial results with research participants and more!

The Health Research Authority (HRA) is to be congratulated on its draft guidance to researchers on providing information to participants at the end of the study.  The guidance is open for consultation until the end of this month.It takes a common-sense approach to sharing trial results with study participants. I challenge any researcher not to find... Continue Reading →

Sciencewise: 10/10 see you again – I sincerely hope so!

Sciencewise, the Government funded body which aims to improve science and technology policy-making by making better use of public dialogue, is celebrating its tenth birthday this year. Set up in 2004 in the wake of the fiasco that was GM foods, Sciencewise has done much within Whitehall and Westminster to advance the case for a more open,... Continue Reading →

Health Research Authority looks for good practice in identifying research participants – survey.

Excuse my laziness but it is Saturday. Here's a copy of a press release put out by the a Health Research Authority (HRA) on Wednesday about a call (in essence, a survey) they are doing for good practice in identifying potential participants for research studies. The results of the work will be published by HRA... Continue Reading →

An invitation from the Health Research Authority (HRA): #patientsasregulatorypartners

Invitation to contribute to workshops about the Health Research Authority’s  Public Involvement Strategy The Health Research Authority is running two workshops to give people interested in our strategy an opportunity to discuss it and how we put it into action. We would like these to include researchers and research funders as well as patients and... Continue Reading →

New HRA web guidance on consent and participant info sheets open for review

Yep, it is a double whammy from the Health Research Authority (HRA) via me.  Earlier I blogged about the HRA's new public involvement strategy.  Now I am passing on the following which is self explanatory I think...and I am sure they would welcome your input if you have time. One of the good things about the revised... Continue Reading →

Health Research Authority makes its pitch to patients and the public

Now, how does the famous saying go? Some are born regulators, some become regulators, and some have regulation thrust upon them. Yesterday our medical research regulator - the Health Research Authority (HRA) - set out its strategy for public involvement: http://www.hra.nhs.uk/patients-and-the-public-2/how-the-hra-works-with-patients-and-the-public/our-strategy-for-public-involvement/ Regulators are the modern tool by which Governments operationalise law. Years ago it used... Continue Reading →

OECD wades into clinical trials debate, but statement on public involvement goes awol

The Organisation for Economic Co-operation and Development (OECD) yesterday waded into the increasingly feverish debate about the regulation of clinical trials with a strongly worded recommendation calling on its members to harmonise approval processes.  The recommendation which is worded with the minimum of fuss, is backed by a more detailed explanatory memorandum. But I am... Continue Reading →

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