Ethics approval for NextCOVE study
Dear Health Research Authority,
This is a request for information under the Freedom of Information Act 2000.
In May 2023, the Berkshire B Research Ethics Committee approved the NextCOVE study (IRAS ID 1007516) sponsored by Moderna.
Please could you supply, subject to any necessary redactions to omit personal information which is not pertinent, copies of:
1. The documentation contained in the initial submission and any additional submissions made to the REC or the HRA which articulated the ethical basis for this study, including in particular any documentation which references the Declaration of Helsinki or the requirements of The Medicines for Human Use (Clinical Trials) Regulations 2004 as amended.
2. A copy of the REC’s approval of the study.
3. Any other internal documentation of the REC or HRA pertinent to the ethical assessment and approval of the study.
Please can you share this information as soon as possible and no later than the end of the statutorily-prescribed timeframe of 20 working days.
Yours faithfully,
Mr B Kingsley
Dear Mr B Kingsley,
Freedom of Information (FOI) Act request
Thank you for your email dated 21 August 2023 requesting the following
information regarding the NextCove trial (IRAS: 1007516):
1. A copy of any NextCove study documentation within the initial
submission and any later submissions made to the HRA/REC which
articulate the ethical basis for the study, including any particular
documentation which references the Declaration of Helsinki or the
requirements of The Medicines for Human Use (Clinical Trials)
Regulations 2004 as amended.
1. A copy of the REC’s approval of the study
1. Any other internal documentation of the REC or HRA pertinent to the
ethical assessment and approval of the study.
Your request is being handled under the Freedom of Information (FOI) Act
and has been referred to the appropriate personnel for investigation. We
will provide you with a response as soon as possible, but no later than 19
September 2023.
We ask you to note that we are currently experiencing unexpected staff
shortages which may cause delays to our response time. In instances where
we are not able to provide you with a response within the 20-working day
deadline, we will contact you to provide you with an update.
Kind regards,
Emma
Freedom of Information
Health Research Authority
Second Floor | 2 Redman Place | Stratford | London | E20 1JQ
T. 0207 104 8249 | 0207 104 8153
E. [1][email address]
W. [2]www.hra.nhs.uk
Dear B Kingsley,
Freedom of Information (FOI) Act request
We are writing to inform you that unfortunately we will no longer able be
able to provide you with a response by 19 September. This is due to
staffing issues that we continue to experience within our team and a
higher than expected current workload. Please accept our sincerest
apologies for this delay. We will endeavour to provide you with a response
by 6 October.
Kind regards,
Emma
Freedom of Information
Health Research Authority
Second Floor | 2 Redman Place | Stratford | London | E20 1JQ
T. 0207 104 8249 | 0207 104 8153
E. [1][email address]
W. [2]www.hra.nhs.uk
_____________________________________________
From: FOI <[email address]>
Sent: Wednesday, August 23, 2023 11:42 AM
To: Mr B Kingsley <[FOI #1016638 email]>
Subject: HRA acknowledgement of FOI request - 2324/FOI/040
Dear Mr B Kingsley,
Freedom of Information (FOI) Act request
Thank you for your email dated 21 August 2023 requesting the following
information regarding the NextCove trial (IRAS: 1007516):
1. A copy of any NextCove study documentation within the initial
submission and any later submissions made to the HRA/REC which
articulate the ethical basis for the study, including any particular
documentation which references the Declaration of Helsinki or the
requirements of The Medicines for Human Use (Clinical Trials)
Regulations 2004 as amended.
1. A copy of the REC’s approval of the study
1. Any other internal documentation of the REC or HRA pertinent to the
ethical assessment and approval of the study.
Your request is being handled under the Freedom of Information (FOI) Act
and has been referred to the appropriate personnel for investigation. We
will provide you with a response as soon as possible, but no later than 19
September 2023.
We ask you to note that we are currently experiencing unexpected staff
shortages which may cause delays to our response time. In instances where
we are not able to provide you with a response within the 20-working day
deadline, we will contact you to provide you with an update.
Kind regards,
Emma
Freedom of Information
Health Research Authority
Second Floor | 2 Redman Place | Stratford | London | E20 1JQ
T. 0207 104 8249 | 0207 104 8153
E. [3][email address]
W. [4]www.hra.nhs.uk
Dear Mr B Kingsley,
Freedom of Information (FOI) Act request
We are writing in response to your request for information, under the FOI
Act, dated 21 August 2023. Thank you for your patience while we have
processed your request. As set out previously, this delay was due to
staffing issues within our team alongside an increase in our current
workload. You requested the following information regarding the NextCove
trial (IRAS ID: 1007516):
1. A copy of any NextCove study documentation within the initial
submission and any later submissions made to the HRA/REC which
articulate the ethical basis for the study, including any particular
documentation which references the Declaration of Helsinki or the
requirements of The Medicines for Human Use (Clinical Trials)
Regulations 2004 as amended.
2. A copy of the REC’s approval of the study
3. Any other internal documentation of the REC or HRA pertinent to the
ethical assessment and approval of the study.
Our response is as follows:
1. We are unable to provide this information as there are no Next Cove
study documents which specifically outline the ethical basis /
rationale of the study. It is the role of the Research Ethics
Committee (REC) to consider the ethical basis of a study during their
review of the application; this is the purpose of REC review. To
ensure that the relevant ethical dimensions have been considered, all
Research Ethics Committees in the UK use the ethics review form as
part of their review. On this basis, we would not expect applicants to
outline their ethical rational within their application.
2. Please see attached PDF document titled, 1007516 Favourable opinion on
further information 04.05.23.
3. Please see attached PDF document titled, Internal documentation
pertinent to ethical assessment of study.
We ask you to note that all personal identifiable information has been
redacted in line with the requirements of the Data Protection Act.
We hope that this information is helpful to you, but should you require
further clarification, please let us know.
If you are unhappy about the way in which your request has been handled,
the HRA has an internal complaints procedure through which you can raise
any concerns. Further details of this procedure may be obtained by
contacting the Complaints Manager via [1][email address]. If you are
dissatisfied with the outcome of the complaints procedure, you can apply
to the Information Commissioner’s Office (ICO), who will consider whether
we, as a public authority, have complied with its obligations under the
Act, and can require the HRA to remedy any problems. You can find out
more about how to do this, and about the Act in general, on their website
[2]www.ico.org.uk. Complaints should be sent to:
FOI Complaints Resolution – Information Commissioner’s Office
Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF
Kind regards,
Emma
Freedom of Information
Health Research Authority
Second Floor | 2 Redman Place | Stratford | London | E20 1JQ
T. 0207 104 8249 | 0207 104 8153
E. [3][email address]
W. [4]www.hra.nhs.uk
Sign up to receive our newsletter [5]HRA Latest.
Dear Emma,
Thank you for your response to my FOI request. The second attachment to your response appears to be a pdf portfolio document of some form which is unfortunately un-openable (the first attachment, also a pdf, opens without problem). Could you please resend that second attachment in another format, or else as a series of smaller pdf files, so that they can be opened? If not, could we please arrange an alternative means for you to provide that document to me?
The second attachment appears to be among the main substance of your response so I would much appreciate if you could please prioritise this re-send for today or early next week so that we can then, I hope, close this FOI request.
Thank you.
Yours sincerely,
Mr B Kingsley
Dear Mr B Kingsley,
Please find attached documents regarding internal documentation relevant to the ethical assessment of the NextCove trial. If you encounter any further difficulties in accessing these then please just let me know.
Kind regards,
Emma
Freedom of Information
Health Research Authority
Second Floor | 2 Redman Place | Stratford | London | E20 1JQ
T. 0207 104 8249 | 0207 104 8153
E. [email address]
W. http://www.hra.nhs.uk/
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