Documents informing HRA's response to the SciTech Committee on clinical trial transparency
Dear Health Research Authority,
On 5 February 2019 the SciTech Committee received the Health Research Authority’s response to the report on Research integrity: clinical trials transparency.
HRA response here:
https://publications.parliament.uk/pa/cm...
This FOI response is filed on behalf of TranspariMED: www.TranspariMED.org
Please provide the following information:
1. The HRA states that it has "costed a possible model" for clinical trials auditing.
Please provide the complete costing model, including the calculations used to arrive at the final cost estimate.
2. The HRA states that "We have sought legal advice on the extent of our powers, including whether any change to legislation might be necessary", and that "we have already sought legal advice on the extent of those powers and the steps we could take to enforce requirements, including whether the powers extend to the HRA (as opposed to research ethics committees) and their scope beyond England to the devolved nations".
Please provide all documents (or email messages, in case no formal document(s) exist(s)) containing the legal advice referred to in the two passages above.
Thank you for your time - I do realise that HRA is extremely busy.
Yours faithfully,
Till Bruckner
Dear Mr Bruckner,
Freedom of Information (FOI) Act request
Thank you for your email dated 22 February 2019 requesting the following
information in relation to the Health Research Authority’s response to the
SciTech Committee’s report on Research integrity: clinical trials
transparency.:
o A copy of the complete costing model, including the calculations used
to arrive at the final cost estimate, for clinical trials auditing.
o A copy of all documents (or email messages, in case no formal
document(s) exist(s)) containing the legal advice the HRA refers to in
the statements that "We have sought legal advice on the extent of our
powers, including whether any change to legislation might be
necessary", and that "we have already sought legal advice on the
extent of those powers and the steps we could take to enforce
requirements, including whether the powers extend to the HRA (as
opposed to research ethics committees) and their scope beyond England
to the devolved nations".
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 22
March 2019.
Kind regards,
Susannah
Freedom of Information
Health Research Authority
HRA | Skipton House, 80 London Road | London | SE1 6LH
T. 0207 972 2487
E. [HRA request email]
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Dear Mr Bruckner,
We are writing in response to your request for information, under the
Freedom of Information Act (FOIA), dated 22 February 2019. Thank you for
your enquiry. You requested the following information:
1. The HRA states that it has "costed a possible model" for clinical
trials auditing.
Please provide the complete costing model, including the calculations used
to arrive at the final cost estimate.
2. The HRA states that "We have sought legal advice on the extent of our
powers, including whether any change to legislation might be
necessary", and that "we have already sought legal advice on the
extent of those powers and the steps we could take to enforce
requirements, including whether the powers extend to the HRA (as
opposed to research ethics committees) and their scope beyond England
to the devolved nations".
Please provide all documents (or email messages, in case no formal
document(s) exist(s)) containing the legal advice referred to in the two
passages above.
Our response is as follows:
1. Please find attached a document dated 23 November 2018 which estimated
the cost of monitoring the registration and publication of clinical
trials. Please note that this is a rough estimate which will change as
the methodology for monitoring is developed and finalised. The staff
time estimates in the model are extrapolated from the time taken to
carry out previous registration audits.
2. Please note FOIA section 42 (1) exemption, Legal Professional
Privilege (LPP) has been applied in relation to the second part of
your request. As detailed in the Information Commissioner’s Office
(ICO) guidance, LPP protects confidential communications between
lawyers and clients and is made up of two types of privilege;
litigation and advice. Advice privilege applies in this instance as
this covers confidential communications between the client and lawyer,
made for the dominant (main) purpose of seeking or giving legal
advice.
Please note this exemption is a qualified exemption and as such requires a
public interest test to be undertaken. The public interest test requires
an organisation to consider the public interest in maintaining the
exemption versus the public interest in disclosure. The FOIA allows a
reasonable extension of time for the public authority to consider the
public interest test. The ICO guidance details this should not normally be
greater than an extra 20 working days and any extension beyond this time
should be exceptional and justified. We will therefore aim to provide you
a response no later than 18 April 2019. This response will either provide
the requested information or explain why we have found the public interest
test is in favour of maintaining the exemption.
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 mailto: [1][HRA request email]. 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]http://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,
Stephen Tebbutt
Head of Corporate Governance & Risk
Freedom of Information
Health Research Authority
HRA | Skipton House, 80 London Road | London | SE1 6LH
T. 0207 972 2487
E. [3][HRA request email]
W. [4]www.hra.nhs.uk
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Dear Mr Bruckner,
Further to my email on the 21 March the HRA has now had the opportunity to
consider the public interest test with regard to our decision to apply
FOIA section 42 (1) exemption, Legal Professional Privilege to the
following request:
2. The HRA states that "We have sought legal advice on the extent of our
powers, including whether any change to legislation might be
necessary", and that "we have already sought legal advice on the
extent of those powers and the steps we could take to enforce
requirements, including whether the powers extend to the HRA (as
opposed to research ethics committees) and their scope beyond England
to the devolved nations".
Please provide all documents (or email messages, in case no formal
document(s) exist(s)) containing the legal advice referred to in the two
passages above.
As detailed in the Information Commissioner’s Office (ICO) guidance, LPP
protects confidential communications between lawyers and clients and is
made up of two types of privilege; litigation and advice. Advice privilege
applies in this instance as this covers confidential communications
between the client and lawyer, made for the dominant (main) purpose of
seeking or giving legal advice. As this is a qualified exemption a public
interest test must be undertaken. The public interest test requires an
organisation to consider the public interest in maintaining the exemption
versus the public interest in disclosure.
In favour of disclosure the HRA has noted the general public interest in
transparency, accountability and promoting understanding of how the HRA
operates. It also considers that there is a public interest in
understanding the legislative process and the principle of being
transparent with regard to the subject of research transparency.
The HRA has also considered the factors in favour of withholding the
information. It considers that there is a strong public interest in
decision-makers having a "safe space" to develop and consider policy. The
HRA has committed to review its approach to research transparency in 2019
with the development of a new strategy. As part of this approach, the HRA
is seeking input from a range of independent experts through its
[1]Research Transparency Strategy Group. The HRA has committed to seeking
comments on its draft strategy by putting it out to consultation in the
summer 2019 therefore will be transparent in its approach before
finalising any strategy. Whilst the HRA is developing its policy into this
area it is important it is able to consider the appropriate legal advice
alongside expert advice before seeking wider input.
There is also a public interest in the HRA being properly briefed about
its legal powers pertaining to its statutory function of promoting
transparency in health and social care research when considering the
recommendations from the House of Commons Science and Technology Committee
as there may be an impact on how the HRA operates in the future.
The HRA has concluded that on balance the greater public interest lies in
the information being withheld. Therefore, the HRA is withholding the
legal advice under section 42 (1) exemption, Legal Professional Privilege
(LPP).
I hope that this explanation to you of why the HRA has not disclosed the
information you have sought is clear.
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 mailto: [2][HRA request email]. 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]http://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,
Stephen Tebbutt
Head of Corporate Governance & Risk
Freedom of Information
Health Research Authority
HRA | Skipton House, 80 London Road | London | SE1 6LH
T. 0207 972 2487
E. [4][HRA request email]
W. [5]www.hra.nhs.uk
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Freedom of Information
Health Research Authority
HRA | Skipton House, 80 London Road | London | SE1 6LH
T. 0207 972 2487
E. [8][HRA request email]
W. [9]www.hra.nhs.uk
Our latest guidance on how the upcoming GDPR affects health research is
[10]now live
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From: FOI, HRA (HEALTH RESEARCH AUTHORITY)
Sent: 21 March 2019 16:43
To: '[FOI #555277 email]'
<[FOI #555277 email]>
Subject: Freedom of Information request - 1819/FOI/065 HRA response
Importance: High
Dear Mr Bruckner,
We are writing in response to your request for information, under the
Freedom of Information Act (FOIA), dated 22 February 2019. Thank you for
your enquiry. You requested the following information:
1. The HRA states that it has "costed a possible model" for clinical
trials auditing.
Please provide the complete costing model, including the calculations used
to arrive at the final cost estimate.
2. The HRA states that "We have sought legal advice on the extent of our
powers, including whether any change to legislation might be
necessary", and that "we have already sought legal advice on the
extent of those powers and the steps we could take to enforce
requirements, including whether the powers extend to the HRA (as
opposed to research ethics committees) and their scope beyond England
to the devolved nations".
Please provide all documents (or email messages, in case no formal
document(s) exist(s)) containing the legal advice referred to in the two
passages above.
Our response is as follows:
1. Please find attached a document dated 23 November 2018 which estimated
the cost of monitoring the registration and publication of clinical
trials. Please note that this is a rough estimate which will change as
the methodology for monitoring is developed and finalised. The staff
time estimates in the model are extrapolated from the time taken to
carry out previous registration audits.
2. Please note FOIA section 42 (1) exemption, Legal Professional
Privilege (LPP) has been applied in relation to the second part of
your request. As detailed in the Information Commissioner’s Office
(ICO) guidance, LPP protects confidential communications between
lawyers and clients and is made up of two types of privilege;
litigation and advice. Advice privilege applies in this instance as
this covers confidential communications between the client and lawyer,
made for the dominant (main) purpose of seeking or giving legal
advice.
Please note this exemption is a qualified exemption and as such requires a
public interest test to be undertaken. The public interest test requires
an organisation to consider the public interest in maintaining the
exemption versus the public interest in disclosure. The FOIA allows a
reasonable extension of time for the public authority to consider the
public interest test. The ICO guidance details this should not normally be
greater than an extra 20 working days and any extension beyond this time
should be exceptional and justified. We will therefore aim to provide you
a response no later than 18 April 2019. This response will either provide
the requested information or explain why we have found the public interest
test is in favour of maintaining the exemption.
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 mailto: [12][HRA request email]. 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 [13]http://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,
Stephen Tebbutt
Head of Corporate Governance & Risk
Freedom of Information
Health Research Authority
HRA | Skipton House, 80 London Road | London | SE1 6LH
T. 0207 972 2487
E. [14][HRA request email]
W. [15]www.hra.nhs.uk
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now live
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Dear Health Research Authority,
Please pass this on to the person who conducts Freedom of Information reviews.
I am writing to request an internal review of Health Research Authority's handling of my FOI request 'Documents informing HRA's response to the SciTech Committee on clinical trial transparency'.
Specifically, I am asking for an internal review of the public interest test related to the HRA's decision to withhold legal advice under section 42 (1) exemption, Legal Professional Privilege
(LPP).
CONTEXT
On 5 February 2019 the SciTech Committee received the Health Research Authority’s response to the report on Research integrity: clinical trials transparency. The HRA's relevant response reads as follows:
"Recommendation: We recommend that the HRA introduce a system of sanctions to drive improvements in clinical trials transparency, such as withdrawing favourable ethical opinion or preventing further trials from taking place. The Government should consult specifically on whether to provide the HRA with the statutory power to fine sponsors for non-compliance.
"We accept the need to make better use of our powers under existing legislation to tackle non-compliance around clinical trials registration and publication. We are committed to taking steps to address poor performance.
"Following receipt of the Committee’s report, we have already sought legal advice on the extent of those powers and the steps we could take to enforce requirements, including whether the powers extend to the HRA (as opposed to research ethics committees) and their scope beyond England to the devolved nations. We will seek views on how we should use those powers as part of the development of our strategy."
HRA'S ARGUMENTS
HRA argued that there is a "general public interest in transparency, accountability and promoting understanding of how the HRA operates. It also considers that there is a public interest in understanding the legislative process and the principle of being transparent with regard to the subject of research transparency."
HRA concluded that this interest is outweighed by "a strong public interest in decision-makers having a 'safe space' to develop and consider policy."
ANALYSIS
HRA's arguments understate (and arguably misrepresent) the public interest for disclosure, and overstate (and arguably misrepresent) the public interest in non-disclosure.
Framing this legal advice as a case of giving decision-makers a 'safe space' to develop policy ignores the context. Parliament explicitly recommended that HRA "introduce a system of sanctions" and that "Government should consult specifically on whether to provide the HRA with the statutory power to fine sponsors for non-compliance," and the legal advice in question was sought as a direct consequence of this parliamentary recommendation. Thus, the legal advice was obtained to support not routine internal deliberations by HRA, but in order to guide HRA actions in response to parliamentary recommendations. In this specific context, to argue that there is "a strong public interest in decision-makers having a 'safe space' to develop and consider policy" is misplaced.
HRA further argues that:
"HRA has committed to review its approach to research transparency in 2019 with the development of a new strategy. As part of this approach, the HRA is seeking input from a range of independent experts through its Research Transparency Strategy Group. The HRA has committed to seeking comments on its draft strategy by putting it out to consultation in the summer 2019 therefore will be transparent in its approach before finalising any strategy. Whilst the HRA is developing its policy into this area it is important it is able to consider the appropriate legal advice alongside expert advice before seeking wider input."
In essence, the HRA argues that the development of an effective transparency strategy that responds to parliamentary and public expectations is furthered by keeping non-transparent the legal advice that the HRA obtained to determine the possible legal parameters affecting the nature and scope of such a strategy. The HRA further argues that it is in the public interest for HRA itself to be able to "consider the appropriate legal advice alongside expert advice before seeking wider input," i.e. for the HRA to define and delimit the parameters of debate prior to initiating the process of wider public consultation.
Note that the HRA seems not to have provided the members and staff of the Science and Technoogy Committee, the members of the Research Transparency Strategy Group, or the experts it plans to informally consult prior to launching a formal public consultation with a copy of the legal advice that HRA obtained. This runs directly counter to established democratic principles, and in the context of developing a transparency strategy is, at best, ironic.
The planned consultation on how to strengthen clinical trial transparency in the UK can only be meaningfully prepared and conducted if all stakeholders - experts, parliament, NHS patients and the general public - have access to the legal advice obtained by HRA.
In sum, in this specific case, there is no public interest in non-disclosure of the legal advice received by HRA, while there is an overwhelming public interest in disclosure of the legal advice.
Please note that I will refer this case to the Information Commissioner's Office (ICO) in case HRA's internal review process does not result in the release of "all documents (or email messages, in case no formal document(s) exist(s)) containing the legal advice" referred to in my original FOI request within the 20 working days set out by law.
A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/d...
Yours faithfully,
Till Bruckner
Dear Mr Brucker,
Many thanks for your email. Your email is being reviewed internally and a full response will be issued shortly.
Kind regards,
Freedom of Information
Health Research Authority
HRA | Skipton House, 80 London Road | London | SE1 6LH
T. 0207 972 2487
E. [HRA request email]
W. www.hra.nhs.uk
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Dear Mr Bruckner,
Please find attached signed letter from Teresa Allen, HRA Chief Executive
for your attention.
Kind regards,
Hilary Tulloch
PA to Chief Executive
Health Research Authority
Skipton House | 80 London Road | London | SE1 6LH
T. 020 7972 2537
E. [1][email address]
W. [2]www.hra.nhs.uk
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