CAG requests from Our Future Health
Dear HRA,
Under the Freedom of Information Act, can you please provide copies of all documents provided to the Confidentiality Advisory Group since 1st January 2021 to inform decision making of support for a) any initial request, and b) any later modifications from:
i) "Our Future Health", and
ii) "UK Biobank".
Personal information, and material already published by HRA/CAG can be excluded from scope of this request.
Yours faithfully,
Sam Smith
Dear Sam,
Freedom of Information (FOI) Act request
Thank you for your email dated 31 May 2023 requesting the following
information regarding Our Future Health and UK Biobank:
• A copy of all documents submitted to the Confidentiality Advisory
Group since 1 January 2021 to inform decision making of support for
any initial request and any later modifications.
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 28
June 2023.
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 Sam,
Freedom of Information (FOI) Act request
Following a search of our records, we have identified that UK Biobank have
not submitted an application to the Confidentiality Advisory Group for
consideration. However, we did receive a UK Biobank application for
Research Ethics Committee review, which received a favourable opinion in
2021. If you would like to request further details about this application,
then please advise us of the nature of the information you require and we
will amend your request.
Kind regards,
Emma
Dear HRA,
Thank you for confirming there was no application in the relevant period from Biobank.
In respect of Our Future Health, can you please provide a copy of documents supplied by OFH to inform the CAG opinion they received.
If a cost limit may be reached, please provide a full list of documents first, and the documents that can be met within the cost limit.
Yours sincerely,
Sam Smith
Dear Sam,
Freedom of Information (FOI) Act request
We are writing in response to your request for information, under the FOI
Act, dated 31 May 2023. Thank you for your enquiry. You requested the
following information regarding Our Future Health and UK Biobank:
▪ A copy of all documents submitted to the Confidentiality Advisory
Group since 1 January 2021 to inform decision making of support for
any initial request and any later modifications.
Our response is as follows:
• As set out in our email dated 7 June 2023, we did not receive an
application to the Confidentiality Advisory Group from UK Biobank and
therefore we are unable to provide the requested information.
• With regard to Our Future Health, please see attached PDF files
containing the documents set out in the table below. Please note that
personally identifiable information has been redacted in line with the
requirements of the Data Protection Act.
• We ask you to note that the below information does not include outcome
letters issued by CAG or CAG meeting minutes, which are publicly
available on our [1]website. Equally, this does not include any email
conversations between Our Future health and the CAG team, other than
instances where Our Future Health were providing further information
to be shared with CAG. This also does not include any documents that
were reviewed as part of a pre-application advice service given to Our
Future Health as anything submitted as this part of the process was
not shared with the CAG.
Portfolio Submission Documents
March 2022 March 2022 ▪ CAG_RTB_Form_04MAR2022_signed
Initial CAG initial CAG ▪ Protocol v3.2
Application application ▪ Data Protection Registration_Z8959110
▪ OFH-Ethics_Governance_Letter of Support
▪ 22CAG0051 CAGSF1 CAT advice form
OFH_FINAL
▪ 4372 OFH – Consent Form_June_print
▪ OFH_PIS_booklet_v1.1
▪ 293316_21EE0016_(RTB)_Favou
▪ Appendices 1-5 OFH Comm plan
▪ Appendix6
▪ Appendix 7_Detailed Data Production
Flow 1.1
Amendments 1 May 2022 ▪ NHS Digitrials invitation_V3.2
Amendment
notification only
November 2022 ▪ CAG 22AG0051 Our Future Health
Amendment Amendment Application
Feb 2023 ▪ [CLEAN] 3 protocol V4.0 FINAL_15DEC022
Amendment ▪ 22CAG0051 CAG Amendment request Jan
2023
▪ CAG Amendment Application ADDENDUM on
opt out and PPIE Feb 23
▪ Clarification on proportions
▪ CAG response from Our Future Health
07032023
March 2023 ▪ CAG-Interim Amendment Application March
Amendment 2023
Amendments 2 April 2023 ▪ CAG Application April 2023 ADDITIONAL
Amendment INFORMATION
▪ CAG response regarding letter variant
testing May 2023 FINAL
▪ CAG-Amendment-Application April 2023
FINAL
▪ Response to questions raised by CAG
amendment Application April 2023
April 2023 Annual ▪ CAGSF6-Annual-review-April 2023 FINAL
Review
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 [2][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
[3]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. [4][email address]
W. [5]www.hra.nhs.uk
Dear Sam,
Freedom of Information (FOI) Act request
It has come to our attention that the Confidentiality Advisory Group
received an application from UK Biobank in 2006 (reference: PIAG4-06(b)).
We apologise for our oversight in identifying this.
We are currently reviewing whether any of the documents fall within the
requested timeframe and we anticipate that we will be in a position to
provide you with a full response within the next 10 days.
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
Sent: Wednesday, June 28, 2023 2:25 PM
To: Sam from medConfidential <[FOI #985894 email]>
Subject: HRA response to FOI request - 2324/FOI/010
Dear Sam,
Freedom of Information (FOI) Act request
We are writing in response to your request for information, under the FOI
Act, dated 31 May 2023. Thank you for your enquiry. You requested the
following information regarding Our Future Health and UK Biobank:
▪ A copy of all documents submitted to the Confidentiality Advisory
Group since 1 January 2021 to inform decision making of support for
any initial request and any later modifications.
Our response is as follows:
• As set out in our email dated 7 June 2023, we did not receive an
application to the Confidentiality Advisory Group from UK Biobank and
therefore we are unable to provide the requested information.
• With regard to Our Future Health, please see attached PDF files
containing the documents set out in the table below. Please note that
personally identifiable information has been redacted in line with the
requirements of the Data Protection Act.
• We ask you to note that the below information does not include outcome
letters issued by CAG or CAG meeting minutes, which are publicly
available on our [3]website. Equally, this does not include any email
conversations between Our Future health and the CAG team, other than
instances where Our Future Health were providing further information
to be shared with CAG. This also does not include any documents that
were reviewed as part of a pre-application advice service given to Our
Future Health as anything submitted as this part of the process was
not shared with the CAG.
Portfolio Submission Documents
March 2022 March 2022 ▪ CAG_RTB_Form_04MAR2022_signed
Initial CAG initial CAG ▪ Protocol v3.2
Application application ▪ Data Protection Registration_Z8959110
▪ OFH-Ethics_Governance_Letter of Support
▪ 22CAG0051 CAGSF1 CAT advice form
OFH_FINAL
▪ 4372 OFH – Consent Form_June_print
▪ OFH_PIS_booklet_v1.1
▪ 293316_21EE0016_(RTB)_Favou
▪ Appendices 1-5 OFH Comm plan
▪ Appendix6
▪ Appendix 7_Detailed Data Production
Flow 1.1
Amendments 1 May 2022 ▪ NHS Digitrials invitation_V3.2
Amendment
notification only
November 2022 ▪ CAG 22AG0051 Our Future Health
Amendment Amendment Application
Feb 2023 ▪ [CLEAN] 3 protocol V4.0 FINAL_15DEC022
Amendment ▪ 22CAG0051 CAG Amendment request Jan
2023
▪ CAG Amendment Application ADDENDUM on
opt out and PPIE Feb 23
▪ Clarification on proportions
▪ CAG response from Our Future Health
07032023
March 2023 ▪ CAG-Interim Amendment Application March
Amendment 2023
Amendments 2 April 2023 ▪ CAG Application April 2023 ADDITIONAL
Amendment INFORMATION
▪ CAG response regarding letter variant
testing May 2023 FINAL
▪ CAG-Amendment-Application April 2023
FINAL
▪ Response to questions raised by CAG
amendment Application April 2023
April 2023 Annual ▪ CAGSF6-Annual-review-April 2023 FINAL
Review
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 [4][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
[5]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. [6][email address]
W. [7]www.hra.nhs.uk
Dear Sam,
Freedom of Information (FOI) Act request
As set out in our previous email, we apologise that our original response
did not include this information regarding UK Biobank.
We can confirm that one document relating to the UK Biobank has been
submitted to the Confidentiality Advisory Group since 2021 (see attached
PDF document). This document is an end of study report which was submitted
inform us that CAG support was no longer required.
Please note that personal identifiable information has been redacted in
line with the requirements of the FOI act.
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
Sent: Wednesday, June 28, 2023 2:58 PM
To: Sam from medConfidential <[FOI #985894 email]>
Subject: RE: HRA response to FOI request - 2324/FOI/010
Dear Sam,
Freedom of Information (FOI) Act request
It has come to our attention that the Confidentiality Advisory Group
received an application from UK Biobank in 2006 (reference: PIAG4-06(b)).
We apologise for our oversight in identifying this.
We are currently reviewing whether any of the documents fall within the
requested timeframe and we anticipate that we will be in a position to
provide you with a full response within the next 10 days.
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
From: FOI
Sent: Wednesday, June 28, 2023 2:25 PM
To: Sam from medConfidential
<[5][FOI #985894 email]>
Subject: HRA response to FOI request - 2324/FOI/010
Dear Sam,
Freedom of Information (FOI) Act request
We are writing in response to your request for information, under the FOI
Act, dated 31 May 2023. Thank you for your enquiry. You requested the
following information regarding Our Future Health and UK Biobank:
▪ A copy of all documents submitted to the Confidentiality Advisory
Group since 1 January 2021 to inform decision making of support for
any initial request and any later modifications.
Our response is as follows:
• As set out in our email dated 7 June 2023, we did not receive an
application to the Confidentiality Advisory Group from UK Biobank and
therefore we are unable to provide the requested information.
• With regard to Our Future Health, please see attached PDF files
containing the documents set out in the table below. Please note that
personally identifiable information has been redacted in line with the
requirements of the Data Protection Act.
• We ask you to note that the below information does not include outcome
letters issued by CAG or CAG meeting minutes, which are publicly
available on our [6]website. Equally, this does not include any email
conversations between Our Future health and the CAG team, other than
instances where Our Future Health were providing further information
to be shared with CAG. This also does not include any documents that
were reviewed as part of a pre-application advice service given to Our
Future Health as anything submitted as this part of the process was
not shared with the CAG.
Portfolio Submission Documents
March 2022 March 2022 ▪ CAG_RTB_Form_04MAR2022_signed
Initial CAG initial CAG ▪ Protocol v3.2
Application application ▪ Data Protection Registration_Z8959110
▪ OFH-Ethics_Governance_Letter of Support
▪ 22CAG0051 CAGSF1 CAT advice form
OFH_FINAL
▪ 4372 OFH – Consent Form_June_print
▪ OFH_PIS_booklet_v1.1
▪ 293316_21EE0016_(RTB)_Favou
▪ Appendices 1-5 OFH Comm plan
▪ Appendix6
▪ Appendix 7_Detailed Data Production
Flow 1.1
Amendments 1 May 2022 ▪ NHS Digitrials invitation_V3.2
Amendment
notification only
November 2022 ▪ CAG 22AG0051 Our Future Health
Amendment Amendment Application
Feb 2023 ▪ [CLEAN] 3 protocol V4.0 FINAL_15DEC022
Amendment ▪ 22CAG0051 CAG Amendment request Jan
2023
▪ CAG Amendment Application ADDENDUM on
opt out and PPIE Feb 23
▪ Clarification on proportions
▪ CAG response from Our Future Health
07032023
March 2023 ▪ CAG-Interim Amendment Application March
Amendment 2023
Amendments 2 April 2023 ▪ CAG Application April 2023 ADDITIONAL
Amendment INFORMATION
▪ CAG response regarding letter variant
testing May 2023 FINAL
▪ CAG-Amendment-Application April 2023
FINAL
▪ Response to questions raised by CAG
amendment Application April 2023
April 2023 Annual ▪ CAGSF6-Annual-review-April 2023 FINAL
Review
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 [7][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
[8]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. [9][email address]
W. [10]www.hra.nhs.uk
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We have decompressed the archives and made all the files available here:
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