Imaginator Study - Ethics Approval and Recruitment Protocol

Richard Taylor made this Freedom of Information request to Medical Research Council

This request has been closed to new correspondence from the public body. Contact us if you think it ought be re-opened.

The request was successful.

Dear Medical Research Council,

Could you please release the ethics approval documentation for the "Imaginator Study" which is currently recruiting subjects via the @imaginatorstudy twitter account at https://twitter.com/imaginatorstudy

If not present in the ethics approval documentation I would also like to request the recruitment protocol and information on any arrangements for protecting the interests of prospective and accepted subjects.

I expect the response may include an application to one or more ethics committees and a record of their feedback.

I am aware of the material published at

http://www.hra.nhs.uk/news/research-summ...

and wish to exclude that from the scope of my request.

If this request would be better directed to another public body please do provide me with relevant advice and assistance.

Regards,

--

Richard Taylor
Cambridge
http://www.rtaylor.co.uk

Dear Mr Taylor,

 

MRC Reference FOI 2017-003

 

Thank you for your Freedom of Information request. We will investigate
what information is available and respond in due course.

 

Yours sincerely,

 

Michael Cherrington

Information Officer

Knowledge and Information Management Team

Medical Research Council

 

www.mrc.ac.uk

show quoted sections

4 Attachments

Dear Mr Taylor,

 

MRC Reference FOIA 2017-003

 

Thank you for your Freedom of Information request of 19 January 2017 in
which you asked:

Could you please release the ethics approval documentation for the
"Imaginator Study"  which is currently recruiting subjects via the
@imaginatorstudy twitter account at [1]https://twitter.com/imaginatorstudy

If not present in the ethics approval documentation I would also like to
request the recruitment protocol and information on any arrangements for
protecting the interests of prospective and accepted subjects.

 

Please find attached the following documents:

-      R - 16 LO 1311 SL14 Favourable Opinion on further information

-      R - 208173 Letter of HR Approval 22.09.2016

-      Imaginator Protocol submitted 020716

-      Imaginator Full PIS

 

You will see that a small amount of information has been redacted from the
first two documents.  This has been done under Section 40 of the Freedom
of Information Act which states that:

40 Personal information.

1)    Any information to which a request for information relates is exempt
information if it constitutes personal data of which the applicant is the
data subject.

2)    Any information to which a request for information relates is also
exempt information if—

a)    it constitutes personal data which do not fall within subsection
(1), and

b)    either the first or the second condition below is satisfied.

3)    The first condition is—

a)    in a case where the information falls within any of paragraphs (a)
to (d) of the definition of “data” in section 1(1) of the Data Protection
Act 1998, that the disclosure of the information to a member of the public
otherwise than under this Act would contravene—

                                         i.    any of the data protection
principles, or

                                        ii.    section 10 of that Act
(right to prevent processing likely to cause damage or distress), and

b)    in any other case, that the disclosure of the information to a
member of the public otherwise than under this Act would contravene any of
the data protection principles if the exemptions in section 33A(1) of the
M2Data Protection Act 1998 (which relate to manual data held by public
authorities) were disregarded.

 

I have consulted with the HRA and they have confirmed that they do not
consent for this personal data to be published therefore to do so would go
against the Principles of the Data protection Act in that the disclosure
would not be fair.  Further information on the application of Section 40
can be found at:
[2]https://ico.org.uk/media/for-organisatio...

 

Further information on the Imaginator Study is available from the study
website ([3]https://surveys.mrc-cbu.cam.ac.uk/imagin...), and the
clinical trials registration website
([4]https://clinicaltrials.gov/ct2/show/NCT0...

 

I hope that this information answers the questions that you have.  Please
do contact me if you require any clarification, or have any further
questions.

 

I hope you are satisfied that this response has been handled
appropriately; if not you may appeal using the MRC's complaints procedure.
Details are on the MRC website at:
[5]http://www.mrc.ac.uk/about/information-s... You may
contact the MRC Complaints Officer at:

 

The Complaints Officer,

Medical Research Council,

14th Floor, One Kemble Street.

London,

WC2B 4AN.

email: [6][email address]    

 

If you remain dissatisfied with the handling of your request or complaint,
you have a right to appeal to the Information Commissioner at:

 

The Information Commissioner's Office,

Wycliffe House,

Water Lane,

Wilmslow,

Cheshire,

SK9 5AF.

Telephone: 0303 123 1113.

Website: [7]www.ico.org.uk   

 

There is no charge for making an appeal.

 

Yours sincerely,

 

Tiffany Lay

 

Senior Information Officer

Knowledge and Information Management Team

Medical Research Council

 

[8]www.mrc.ac.uk

 

Dear Medical Research Council,

 

Could you please release the ethics approval documentation for the
"Imaginator Study"  which is currently recruiting subjects via the
@imaginatorstudy twitter account at [9]https://twitter.com/imaginatorstudy

 

If not present in the ethics approval documentation I would also like to
request the recruitment protocol and information on any arrangements for
protecting the interests of prospective and accepted subjects.

 

I expect the response may include an application to one or more ethics
committees and a record of their feedback.

 

I am aware of the material published at

 

[10]http://www.hra.nhs.uk/news/research-summ...

 

and wish to exclude that from the scope of my request.

 

If this request would be better directed to another public body please do
provide me with relevant advice and assistance.

 

Regards,

 

--

 

Richard Taylor

Cambridge

[11]http://www.rtaylor.co.uk

 

-------------------------------------------------------------------

 

Please use this email address for all replies to this request:

[12][FOI #383152 email]

 

Is [13][Medical Research Council request email] the wrong address for Freedom of
Information requests to Medical Research Council? If so, please contact us
using this form:

[14]https://www.whatdotheyknow.com/change_re...

 

Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:

[15]https://www.whatdotheyknow.com/help/offi...

 

For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:

[16]https://www.whatdotheyknow.com/help/ico-...

 

If you find this service useful as an FOI officer, please ask your web
manager to link to us from your organisation's FOI page.

 

 

show quoted sections

Richard Taylor left an annotation ()

It is interesting there is so much more material available on request than has been pro-actively published.

The released material does not give a clear assurance that those whose first attempt to seek help in relation to self-harm is to respond to tweets inviting them to sign up for the trial will be pointed to established routes for seeking help. The project protocol does though state willingness for the project team to contact a participant's GP and other clinicians is an inclusion criteria.

There appears to be an inconsistency between the documents, the Health Research Authority letters say the only role for GPs is displaying the study poster, whereas the protocol says referral by clinicians responsible for routine primary care (GPs) is a recruitment route; the latter sounds more active, and personal, than putting a poster up.

The names of the chair and alternate-vice chair, of the Health Research Authority's Bromley Research Ethics Committee have been redacted citing a personal information exemption, as has the name of the "assessor" who issued the letter of approval. I think these are senior decision makers in the public sector acting in a public capacity and it would have been fair to release their names. Some information on committee membership, but not specific roles, will perhaps become available when the committee's next annual report is published.
http://www.hra.nhs.uk/about-the-hra/our-...

It's interesting that all this effort is going into a project which the released documents show has an aimed sample size of just forty participants.