Dear Medical Research Council,

with reference to the Excel file "2017 MRC Clinical Trials Transparency Review data 050618" on your website (linked at https://mrc.ukri.org/research/policies-a... ) please provide the following information:

1. The name of the institution hosting each clinical trial listed

2. The name of the PI (lead investigator) of each clinical trial listed

3. The email address of the PI of each clinical trial listed

Please provide this information by including the data requested above in the existing Excel spreadsheet by adding three columns (one per question).

This FOI is filed based on the assumption that MRC already holds this data within a consolidated spreadsheet from which institutional affiliations and PI details were removed prior to publication.

In case the above assumption is incorrect, in order to lower the burden required by MRC to respond to this FOI request, it would be acceptable to limit the data provided to only those clinical trials that:
1. were found not to have been registered, and/or
2. whose award had ended >12 months previously and which were found not to have reported results

Please note there is a precendent of a UK public institution releasing this type of data in response to an FOI request:
https://www.transparimed.org/single-post...

Please also note that there is a strong public interest in making this data available:
https://www.transparimed.org/single-post...

Yours faithfully,

Till Bruckner

Dear Medical Research Council,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of Medical Research Council's handling of my FOI request 'Institutions and PIs who failed to register clinical trials and/or report results'. In view of the current post-holiday season, please feel free to extend the normal response timeframe and complete your internal review by Friday 15 February 2019.

I strongly welcome the release of information provided so far, which once again underlines MRC's strong commitment to transparency. I also strongly welcome the evidence provided that MRC is actively following up on studies that appear to remain unregistered and unreported, which again underlines the MRC's excellent performance in this area.

However, MRC is not entitled to withold the remaining data under the Freedom of Information Act:
"The names of the Research Organisations for the 16 awards which were identified in the 2017 review as
not having been registered have not been provided. The names and email addresses of the Principal
Investigators have also not been provided."

Specifically:

(1) SECTION 41

MRC: "The names of 16 Research Organisations identified in the MRC’s 2017 review of clinical trials have not
been provided. ... To provide the information requested without the agreement of the research organisation holding the MRC award would be considered a breach of confidence and Section 41 of the Freedom of Information Act, which relates to information provided in confidence, would apply. "

Disclosure of this information would not constitute a breach of confidence because it was not imparted in circumstances importing an obligation of confidence. The names of institutions receiving public funding via the MRC do not fall into this category. As the ICO has stated, "The contents of a contract between a public authority and a third party [such as funding agreement] generally won’t be information obtained by an authority from another person. This is because the terms of the contract will have been mutually agreed by the respective parties, rather than provided by one party to another":
https://ico.org.uk/media/for-organisatio...

In its previous response, MRC itself recognised that disclosure of this information would not constitute a breach of confidence when it released the names of the other grantees. The MRC's apparent position, that such information is only confidential if a grantee may not appear to comply with MRC funding requirements, has no basis in law.

(2) SECTION 40

MRC argued in its response that "it would not be fair to release information relating to named investigators which could now be considered to be inaccurate". This 'fairness' argument has no basis in law, and does not provide valid grounds for a Section 40 exception.

MRC's own policies require clinical trials to be registered on a WHO Primary Registry. According to the WHO, each such registry entry ***must*** include the names of the Primary Sponsor and Secondary Sponsor(s), and the "Name and title, email address, telephone number, postal address and affiliation of the Principal Investigator":
https://www.who.int/ictrp/network/trds/en/

Thus, when entering into a funding agreement with the MRC, each and every institution and PI intending to undertake a clinical trial recognizes and agrees that their identities and contact details will become publicly available during the course of managing the MRC grant. This clear consent to public disclosure of the information means that this data cannot be considered "personal" under Section 40.

MANAGING MRC CONCERNS WHILE COMPLYING WITH THE LAW

I note that MRC is concerned about the fairness of releasing information that may provide a misleading impression of some grantees' performance. However, the resulting stance adopted by the MRC regarding the release of information has no foundation in law.

I respectfully suggest that the MRC considers managing its concerns by releasing the full information originally requested, while at the same time adding a free text column in the Excel file in which it can provide a brief narrative explanation for selected grants/trials to provide whatever interpretative context MRC wishes to be taken into account by the public when it reviews the data released. MRC may also wish to integrate this approach from the outset into its planned 2019 release of information, to avoid the burden of having to subsequently separatetely prepare and release such data in response to FOI requests.

A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/i...

Yours faithfully,

Till Bruckner on behalf of TranspariMED
www.TranspariMED.org

Dear UKRI FOI Requests,

please note that your response to my request for an internal review, filed on 02 January 2019, is long overdue.

Yours sincerely,

Till Bruckner

Dear UKRI FOI Requests,

I am still waiting for the MRC's response to this FOI request, first filed on 02 January 2019, over two months ago.

Please chase this up with the MRC.

Yours sincerely,

Till Bruckner