Janet Wisely is the office newbie at the NHS Health Research Authority. She’s only been the Chief Executive there for two weeks,
but already she’s got to grips with the challenges and potential of the
fledgling body. Speaking at the Kent and Medway Health Partnerships Research Event she outlined the fledgling body’s brief history.
The HRA took over responsibility for the ethical approval
process for NHS research projects in December last year, and you can’t help
feeling it’s been handed a bit of a poisoned chalice. Anyone who has tried
applying for ethical approval will have their own horror stories around delays
and unreasonable demands. As Janet spoke, an academic next to me was whispering
and rolling his eyes.
However, Janet hopes to change all that. As well as a
simplified, unified application system, she hopes to make the HRA more
responsive, to provide constructive advice, and to turn around ‘95% of
applications within 40 days.’
A bold ambition, and already the HRA is being more
transparent in monitoring its performance towards this goal; have a look at the
graphs and data that they have published on their website. As well as speed, Janet wants to adapt the
system so that it is more proportionate. For example, relatively
straightforward projects should go through a light touch assessment that should
see them returned within two weeks. At the same time she wants to improve the quality
and consistency of assessments, which she recognises as somewhat lacking in the
past.
I wish her well in these ambitions, and hope that, by the
time she crests the hill between newbie and old-timer, my eye-rolling neighbour
will be beaming instead.
Those of you who've read my blogpost likening NHS Ethics Procedures to the Circulocution Office will sense my delight at the prospect of a lighter touch review: http://tinyurl.com/74lzdal
ReplyDeleteHowever, the ethics approval is only the beginning. You then have to deal with R&D, which makes the Circumlocution office seem like a model of efficiency and helpfulness. I get more or less weekly communications from them. We made a terrible mistake in thinking that a letter from an NHS consultant to an NHS GP would not need ethical scrutiny. Its purpose was to confirm that it was OK to contact the patient to invite them to take part in research. (We don't want to contact people who have serious medical problems or who are dead). We were told, however, this was a Substantial Amendment, and a letter between two NHS professionals had to go off for scrutiny, during which we were told we could do NOTHING. Time passed. We then got approval, but one of the consultants then noticed that in some cases the child, rather than the mother, would be the patient of the GP, and that we required an alternative communication for the GP in such cases. This minor rewording was construed as another Substantial amendment. Time again passed. After each 'substantial amendment' I get an email like this (dated 18th June):
Dear Professor Bishop
Re: Amendment to [Children with language, reading and communication problems (67197]
Date of submission to REC: 3 May 2012
Sponsor’s Unique Amendment Number: Substantial amendment 3, 4 May 2012
Thank you for submitting the above amendment.
As your Lead CLRN, we have made this amendment available to each participating NHS Trust. As such, local governance review is now under way at each site that has issued NHS Permission. Sites that have not yet issued NHS Permission (if applicable) have also been notified of the amendment and will consider it as part of their overall governance review.
If applicable, please ensure that you send copies of your regulatory approval(s) (REC, MHRA and any other supporting documents) to this e-mail address. We will make these available to all participating sites.
Trusts have 35 calendar days to undertake their local governance review. Accordingly, subject to the three conditions below, you will be able to implement the amendment on [insert date 20/07/2012 at all sites already in receipt of NHS Permission.
• You may not implement this amendment until and unless you receive, and forward to us, all required regulatory approvals (where applicable)
You may not implement this amendment at any site that informs you that they require additional review time, until they notify you that this review has been satisfactorily completed.
• You may not implement this amendment at any site that withdraws its NHS Permission.
NB: you may only implement changes that were described in the amendment notice or letter.
If you receive your regulatory approval/s after this date, and submit the document(s) to us, you may then immediately implement at all sites that have NHS Permission in place and that have not requested additional review time, or withdrawn NHS Permission.
As it is the responsibility of each individual NHS Trust to notify you if you may not locally implement the amendment, you are not required to wait for receipt of the Notification of Continued NHS Permission from the NHS Trust in relation to the amendment before you may implement on the above date.
Please note that as CI/Sponsor, it remains your responsibility to ensure that the PIs at each of your sites (if applicable) are informed of this amendment.
Please contact tvclrn@nhs.net should you require any further assistance.
Kind regards
I love the bit about 'further assistance'. If this is assistance, then I dread to think what this lot would think obstruction looks like. These people seem to regard their role in life as stopping all research in its tracks, while the clock ticks on as they scrutinise minor changes on bits of paper.