Ethics approval of IRAS 308194 Outcomes for children referred to Gender Identity Development Service
Dear Health Research Authority,
This is a request for information under the Freedom of Information Act 2000.
In August 2023, the East of England – Cambridge East Research Ethics Committee (REC) approved the Cass Review Quantitative Research study "Assessment, Management and Outcomes for children and young people referred to a National Gender Identity Development Service" (IRAS ID 308194) with reference 24/EE/0062.
Please could you supply, subject to any necessary redactions to omit personal information which is not pertinent, copies of:
1. The minutes of any meetings of the REC in which this study was discussed.
2. Any communication from the REC about the approval of the study, including the approval of the study itself.
3. Any communication that was received by the REC or HRA about the approval of the study.
4. Any other internal documentation of the REC or HRA pertinent to the ethical assessment and ethical approval of the study. (Note I am not requesting information about the Confidentiality Advisory Group (CAG) approval, which is already public.)
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,
Jeni Tennison
Dear Jeni Tennison,
Thank you for your email dated 17 May 2024.
Before I formally acknowledge your request, it would be helpful to obtain
clarification from you regarding point 3 of your email. Could you please
confirm whether this point relates to all external correspondence received
by the REC/HRA about the approval of the study? This would include all
communications with the sponsor/study team and any other external
stakeholders that have contacted us about the study’s approval.
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
Hello Emma,
If it helps narrow things down, I'm particularly interested in the communication received by the HRA from external stakeholders that contacted you about the study’s approval, rather than administrative back-and-forth emails with the sponsor/study team, which I imagine will reflect information that will be apparent in the REC minutes. From the CAG minutes I know at least two letters were received and passed on to the chairs of the CAG and REC, one from Mermaids, and I'd like to see any others.
Thanks for your help,
Jeni Tennison
Dear Jeni,
Freedom of Information (FOI) Act request
Thank you for your email to the Health Research Authority (HRA) dated 20
May 2024, where you requested the following information regarding the
study titled, Assessment, Management and Outcomes for children and young
people referred to a National Gender Identity Development Service (IRAS ID
308194):
1. The minutes of all REC meetings which discussed the approval of the
study.
1. All REC correspondence regarding the approval of the study, including
the REC ethics opinion letter.
1. A copy of any correspondence submitted to the CAG/REC by external
stakeholders related to concerns about the approval of the study.
1. Any other internal documentation of the REC or HRA pertinent to the
REC’s ethical review 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 18
June 2024.
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 Jeni,
Freedom of Information (FOI) Act request
Thank you for your email to the Health Research Authority (HRA) dated 20
May 2024, regarding your request for information under the FOI Act. You
have requested the following information regarding the study titled,
Assessment, Management and Outcomes for children and young people referred
to a National Gender Identity Development Service (IRAS ID 308194):
1. The minutes of all REC meetings which discussed the approval of the
study.
2. All REC correspondence regarding the approval of the study, including
the REC ethics opinion letter.
3. A copy of any correspondence submitted to the CAG/REC by external
stakeholders related to concerns about the approval of the study.
4. Any other internal documentation of the REC or HRA pertinent to the
REC’s ethical review and approval of the study.
Our response is as follows:
1. Please see attached PDF document which contains the minutes of all REC
meetings which discussed the approval of the study at each stage of
the process. We ask you to note that all personal information has been
redacted in line with the requirements of the Data Protection Act.
◦ (1.1) Minutes of the full REC meeting where the initial review took
place.
◦ (1.2) Minutes of the Sub-Committee which reviewed the provisional
response.
◦ (1.3) Minutes of the Sub-Committee which reviewed the "response
incomplete" response.
2. All formal REC correspondence regarding the approval of the study has
also been provided. This includes the following:
◦ (2.1) Email confirmation of submission of a valid research
application.
◦ (2.2) REC provisional opinion status update email.
◦ (2.3) REC ‘response incomplete’ status update email.
◦ (2.4-7) Final outcome email, including the REC favourable opinion
letter, the CAG support letter and the HRA Approval letter which were
provided as attachments.
3. The HRA received two letters of concern from external stakeholders
prior to the approval of the study which have been provided as part of
this response. You can read our response to concerns about the study on
our [1]website and in our follow up news [2]post.
o (3.1) Mermaids letter
◦ (3.2) TransActual letter
4. We do not hold any further documentation pertinent to the REC’s ethics
review and approval of the study in addition to what has been provided
in response to points 1 and 2.
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 [3][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
[4]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. [5][email address]
W. [6]www.hra.nhs.uk
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