Quote
……while Durham has fallen 30 places to 103

Unfortunately, I can’t find the table which this is based upon – the detailed statistics are at www.dfes.gov.uk/performancetables/ but I can’t find an overview.

Dear Mr. Dinsdale,

Thank you for your recent letter refusing my request for information under the Freedom of Information Act 2000.

I would like to appeal against the refusal on the following grounds:

1) In determining the request as vexatious, you have pointed out the sudden increase in FOI requests between 11th and 26th November. I note that there were 106 requests. If the trials you have done have been performed in a scientific manner, then the information I require should already be in a convenient format, for example a pdf file, or easily rendered into such a format. Emailing this information to one or a hundred and six recipients should not therefore be an issue for you. My own computer is used regularly to email information to thirty or more recipients, and usually does not take longer than fifteen minutes to do so. I cannot see that the number of people wanting the information should place a significant burden on your council’s computers.

2) Your assumptions about the purpose of my request aggregates the emails you have received into one body and fails to take into account the reasons I clearly stated on my original email. I said “As a concerned member of the public I am interested to know that there is adequate supporting information for scientific claims made directly to the media.” Why does it make a difference that the information about your trials was conveyed to me and others by a third party?

3) I believe that your description of the purpose of my email as a “form of protest” is an attempt to twist my intentions into a framework that makes it easy for you to refuse my request under a provision of the Act. My email was sent for the reasons stated in (2) above, and I resent your implication that it was otherwise.
I find the tone of your email to be both condescending and disapproving. Your council has acted as though a newspaper columnist is the only person interested in obtaining information from you.

I would be very grateful if you would send me confirmation of this email.
Yours Faithfully,
Chris

Here is the reply I received from the Assistant Head of Legal Services (curly brackets are mine):

2 January 2007

Dear {Chris}

Re Request for Information Under the Freedom of Information Act

The complaint arises out of your appeal against a response from Peter Dinsdale, the Freedom of Information/Data Protection Coordinator indicating the Council considered your request to be vexatious and refused it under Section 14(1) of the Freedom of Information Act 2000.

The response, was not however a blanket refusal to provide information and acknowledging, that there is a public interest in disclosure of information relating to the fish oil trials, supplied information regarding the studies and in particular, three papers.

Freedom of Information Act

Section 14(1) of the Act removes the obligation of a public authority to reply with a request for information if the request is “vexatious”.

Mr Dinsdale quoted guidance note 22 from the information commissioner. Within paragraph 2 of that guidance, the Commissioner states the following:

“The Commissioner considers that the exception in the Act for vexatious and repeated requests is important, especially as no fee would be charged for most requests. His approach will be influenced by the desirability of keeping compliance costs to a minimum and to avoiding damage to the credibility or reputation of the Freedom of Information framework”.

Whilst stressing that Authorities should not conclude that a request is vexatious or repeated unless there are sound grounds for such a decision, the guidance goes on to say:

“While giving maximum support to individuals, genuinely seeking to exercise the new right to know, the Commissioner’s general approach would be sympathetic towards Authorities where a request, which may be the latest in a series of requests, would impose a significant burden and clearly does not have any serious purpose or value, is designed to cause disruption or annoyance, has the effect of harassing the Public Authority or can otherwise be fairly characterised as obsessive or manifestly unreasonable.”

There is no definition of vexatious request. Whilst referring to a case of Attorney General -v- Barker in 2000 which suggested a definition of:

“Designed to subject a Public Authority to inconvenience, harassment or expense.”

-The guidance goes on to say that a wide approach is necessary in the context of FOI requests “made without charge and with the minimum of formality to Public Authorities”. It suggests that effect needs to be considered as well as intention.

Thus, although it may not be the intention of the enquirer to cause inconvenience or expense, if a reasonable person would conclude that the main effect of the request would be disproportionate inconvenience or expense, then it will be appropriate to treat the request as being vexatious.

Your request for information was one of 106 requests for information on this subject received between the 11th and 26th November. Within that period, this Authority received 18 further e-mails of support for Ben Goldacre.

On 11th November 2006, Mr Goldacre’s Bad Science contained an article advising readers that this Authority had declined a Freedom of Information request that he had made and advising, if not encouraging readers, to make their own application and refers them to the Consort Guidelines. At one point he states:

“I suggest that each person requests just two or three sections each, going through them in order to avoid confusion, plus what they requested and ideally the full e-mail request they sent in the comments below, so everyone can see how far we have got and what is left to be requested. Remember, for each request to say that you want the information for each and every one of the many different trials or studies into Omega-3 fish oils that have been performed in children by Durham employees in the last five years, God knows how many there really are.”

Later, he adds:

“Good luck, have fun and don’t forget to post the replies you get from Durham in the coming weeks. Don’t worry about doubling up with what other people have requested. It’s better to be belt and braces …”

Peter Dinsdale advised in his response to you the reasons for regarding your request as vexatious.

It needs to be stressed that the reasons are based upon the fact that yours was one of many requests for information about this matter within a short period of Mr Goldacre’s article and that in the year 2005, the County Council received only 165 requests in total under the Freedom of Information Act. This influx of enquiries, all on the same subject was an unusual pattern and I do not consider it unreasonable for Mr Dinsdale to have concluded that they were sent in pursuance of a campaign.

When giving reasons for finding your claim to be vexatious, Mr Dinsdale took into account the purposes of the request, comments in the e-mails themselves and the bad science website and reached the following conclusions:

1. This was an attempt to circumvent the fees regulations as Mr Goldacre’s second FOI request had been refused because of the costs of compliance and that in his article he had suggested that readers might like to send questions, albeit in smaller parts.

2. That its purpose was to pressurise Durham County Council into disclosure of information in response to Ben Goldacre’s second FOI request, even though a legitimate refusal notice had been forwarded to him and at that stage no appeal had been lodged against that refusal.

3. That the campaign appears to be solely concerned with pressurising the Council into providing information to Ben Goldacre, it was apparent that the requests had been sent as a form of protest against the decision and were designed to cause disruption or annoyance and that they have the effect of harassing the Public Authority.

When he reached that conclusion, Mr Dinsdale informed you that his response was a refusal notice under Section 17 of the Freedom of Information Act.

Having considered: -

• The circumstances in which the requests were received
• Their apparent purpose
• Their effect
• That your request was one of that of a large number of applications previously described

- I uphold Mr Dinsdale’s view.

I note your view that the information you requested should be easily accessible and your objection to your request being aggregated with e-mails from other enquiries. I also note that you found the tone of Mr Dinsdale’s e-mail to be both condescending and disapproving.

Having looked carefully at Mr Dinsdale’s response, I do not consider it to be condescending and disapproving. In my view it carefully explained why the request was being turned down and included some published information; signposts for any remaining enquiries that you had with an explanation why currently unpublished information would not be revealed prior to being published in a peer review magazine.

This is not to suggest that Durham County Council considers you to be vexatious, but Mr Dinsdale’s approach of taking into account the contents of the bad science website; the intensity of the requests in a short period of time immediately following publication of the article, supports the view that this was part of a campaign instigated by the article and had the apparent purposes set out by Mr Dinsdale in his response as the reasons for deciding that the applications were vexatious.

I would also add that regardless of the apparent purpose, taking into account the information Commissioner’s advice, the effect of the requests in total were to cause disproportionate inconvenience and expense to a Public Authority dealing with FOI requests without charge and the minimum formality.

I therefore regret to inform you that your appeal is not upheld.

If you are dissatisfied with the outcome of this appeal, you have a right to appeal to the Information Commissioner at:

Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire, SX9 5AF, telephone 01625 545 745, website www.informationcommissioner.gov.uk.

Yours sincerely

Colette Longbottom
Assistant Head of Legal Services

I agree with TimW. Perhaps the words “form of protest” are mentioned in the Act as being valid reasons for an information holder to refuse to disclose. Obviously receiving a number of requests in one go in response to a plea in a national newspaper is going to look fairly “protesty” on the face of things – if you don’t want to look too deeply into it.

The reality is completely different: I didn’t send in my request as a way of protesting against DCC. I sent it because I genuinely want to know what data they have on the trials they conducted; data that any organisation that had conducted their trials responsibly would have at their fingertips, no matter how great the number of requests.

We’ve been sold short here. Perhaps skjg has a point (posting #181): one of us should make a request in a few months’ time, when DCC can’t use the same excuse. I’d be happy to do it.

“it is apparent that the requests have been sent in as a form of protest against the decision to refuse Ben Goldacre’s second FOI request. They are designed to cause disruption or annoyance and they have had the effect of harassing the public authority.”

That’s not true though, is it? It’s not a protest; the requests have been sent in to find out what trials Durham have any info about. And the requests are not “designed to cause disruption or annoyance”; they’re designed to obtain the information, bit by bit.

The “apparent purpose” of the requests is one of the reasons the FoIs were refused, and it seems a flakey excuse to me.

Durham’s long reply (#175) is surely a partial victory for the ‘mass FOI’ approach, even if is a grudging PS to a ‘vexed’ formal response (unless they had already sent all that to you, Ben)? Anyway, the Portwood paper to the World Autism Conference is new.

Some stock-taking:

- one real beef is that Durham/Equazen plug the product on the basis of research which isn’t ready for publication yet (the Midlesbrough study) – which suggests an ASA approach about inappropriate advertising – the code is on the ASA website and is useful on these kinds of issues (#165 and passim)

- a second concern is that Portwood is quick to say what she’s found, but slow to back it up. Does her paper to the World Autism Conference relate only to children with autism – or does it make wider claims ? Since Durham seem to know a lot about this work, maybe FOI for the protocol and data for that should be pursued.

Anyway, we now have the money pledged now to meet Durham’s charge for responding to Ben’s original request (£790! – though worryingly my name seems to be there twice). So why not call in the money, Ben, and send them a cheque? (On second thoughts, probably best to ask DCC first since if they won’t take the money, you’ll spend it getting it back to us). That will pull the rug (morally, at least) from under ‘vexatious’ and ‘harrassment’.

The Department for Education and Science’s “SCHOOL FOOD & HEALTHY SCHOOL’S TEAM” (punctuation as per original!) wrote me today saying:

“I refer to your request received on 11 November under the Freedom of Information Act 2000 for information provided by Durham County Council (DCC) to the Department for Education and Skills (DfES) since January 2005 about the studies conducted by DCC into the effect of the consumption of fish-oil supplements by children.

I am writing to advise you that following a search of our paper and electronic records, I have established that the information you requested is not held by this Department.”

So its not just the public DCC don’t want to know the detail- they don’t want central government dealing with school food to know anything about it!

No reply yet to other FOI requests to central government departments.

Thank you for your e-mail and its attachments.

I am intrigued by your statement that:

“Between 11th and 26th November 2006, Durham County Council received 106 requests for information as a result of this campaign, along with 18 further emails of support for Ben Goldacre. In 2005 as a whole, Durham County Council only received 165 requests under the FOI Act. This clearly demonstrates that these requests have imposed a significant burden on the Council”.

and would be most interested in knowing – as a measure of the general interest in these trials (about which, as the mother of a main-target child, I am extremely interested in) – what the 2006 total of the requests for information was as at 26th November 2006.

Do they have a year-on-year, month-by-month clause somewhere?

“Between 11th and 26th November 2006, Durham County Council received 106 requests for information as a result of this campaign, along with 18 further emails of support for Ben Goldacre. In 2005 as a whole, Durham County Council only received 165 requests under the FOI Act. This clearly demonstrates that these requests have imposed a significant burden on the Council. ”

Come again?

2006 – 106 + 18 = 124. Definitely vexatious

2005 – “as a whole” “ONLY” 165. ? …………………….

I think that there is a definite improvement in the burden imposed on Durham Council in the last year, all things considered.: 41 fewer requests, to be exact. So it should be a piece of cake for them this year. No?

So what now?

I looked at the attachments to the e-mail – and they are no help. The autism paper and the recruitment and protocol for trials have no data from results in them. The Bryan, Stevens and Richardson papers only deal with children with ADHD, the Fontani paper looks promising, but gives no details of who was tested (except that they were “healthy”), the other Richardson paper looked at children with DCD, the Morale, Auestad, Helland and Colombo papers looked at infants or very young children (NOT year 11!), the Hamazeki paper looked at aggression, the Portwood study says they got good results but gives no details.

Would it be possible for one person to ask Durham, politely, how we can get this information in a way that they do not find “harassing”?

My concern is with “has the effect of harassing the public authority” by that means any sustained campaign for information would be harassment.

“Where a request, which may be the latest in a series of requests, would impose a significant burden and:
· Clearly does not have any serious purpose or value;
· Is designed to cause disruption or annoyance;
· Has the effect of harassing the public authority; or
· Can otherwise fairly be characterised as obsessive or manifestly unreasonable.”

I am more than vexed by this I am positively irritated. I feel the need to contest their judgement with an appeal.

FREEDOM OF INFORMATION ACT 2000 – REQUEST FOR INFORMATION

Your request for information on the fish oil trials / studies / initiatives at Durham has been considered.

It has become apparent that the recent influx of requests received by Durham County Council on this subject is as a result of an article by Ben Goldacre, published in The Guardian (11 November 2006) and on the website www.badscience.net. It is also apparent that these requests have been sent by different persons who are acting in concert or in pursuance of a campaign. We consider these requests to be vexatious, and they are therefore refused under section 14(1) of the Freedom of Information Act 2000 (“the FOI Act”).

Section 14(1) of the FOI Act states that:
“Section 1(1) does not oblige a public authority to comply with a request for information if the request is vexatious.”

In his guidance note No. 22 on Vexatious and Repeated Requests, the Information Commissioner gives further detail as to what may constitute a vexatious request:
“Where a request, which may be the latest in a series of requests, would impose a significant burden and:
· Clearly does not have any serious purpose or value;
· Is designed to cause disruption or annoyance;
· Has the effect of harassing the public authority; or
· Can otherwise fairly be characterised as obsessive or manifestly unreasonable.”

Between 11th and 26th November 2006, Durham County Council received 106 requests for information as a result of this campaign, along with 18 further emails of support for Ben Goldacre. In 2005 as a whole, Durham County Council only received 165 requests under the FOI Act. This clearly demonstrates that these requests have imposed a significant burden on the Council.

In determining that these requests are vexatious we also had regard to what appeared to be the purposes of these requests, which became evident from comments in the emails themselves and on the Bad Science website:
· As an attempt to circumvent the Fees Regulations, as Ben Goldacre’s second FOI request had been refused as the cost of complying exceeded the appropriate limit of £450. In his article in The Guardian he had suggested that readers might send in parts of his request under their name, as he believed that this might enable the information to be fully disclosed, albeit in small parts to several individuals;
· To pressure Durham County Council into disclosure of information in response to Ben Goldacre’s second FOI request, even though a legitimate refusal notice had been issued and, at the time, no appeal had been received against this refusal notice;
· As the campaign appears to be solely concerned with pressuring the Council into providing information to Ben Goldacre, it is apparent that the requests have been sent in as a form of protest against the decision to refuse Ben Goldacre’s second FOI request. They are designed to cause disruption or annoyance and they have had the effect of harassing the public authority.

It is for these reasons, taking into account the effect of the requests in imposing a significant burden on the Council and the apparent purposes of the requests, that we consider your request to be vexatious. This is therefore a refusal notice under section 17 of the FOI Act.

While we are refusing your request for information under the FOI Act, we do recognise that there is an interest in the disclosure of information relating to these studies. Attached is a document that outlines published scientific studies into dietary polyunsaturated fatty acids. This information was provided to Ben Goldacre on 16 October 2006 in full response to the first of his two requests for information under the FOI Act. This clearly sets out all of the studies that have been undertaken by Durham County Council. You will note from the details that there have been three randomised controlled trials and other open label studies carried out using fatty acid supplements by staff employed by Durham County Council.

The Oxford-Durham Trial – Dr AJ Richardson (a Research Fellow at Mansfield College, Oxford University) published the preliminary results: – Clinical trials of fatty acid supplementation in dyslexia and Dyspraxia: in Glen AIM, Peet M, Horrobin DF. (eds.) Phospholipid Spectrum Disorder in Psychiatry and Neurology. Carnforth: Marius Press, October 2003: 491-500.

The first peer-reviewed results were published by Dr Richardson and Dr Paul Montgomery (Lecturer, Department of Social Policy and Social Work, Oxford University): – The Oxford-Durham study: a randomized, controlled trial of dietary supplementation with fatty acids in children with developmental coordination disorder. Pediatrics. 2005 May;115(5):1360-6

In accordance with scientific protocol, you should address any requests for further details on this study to the authors of the paper, at Mansfield College.

Sunderland – Dr Madeleine Portwood presented the first paper on 31st October 2006 at the World Autism Conference, Cape Town, hence the details of this study are now in the public domain. Please find attached a copy of the paper.

Middlesbrough – It is intended that details of this study will be submitted for publication next year. In common with accepted scientific practice, we will not release unpublished detailed information, as that would prejudice its ultimate publication in a peer-reviewed journal. We are, however, attaching a copy of the recruitment and trial protocol.

Greenfield / SureStart open label studies – The paper detailing the results of these two studies has now been published (Nutrition and Health, 2006, Vol. 18(3), pp233-247), hence the details of this study are now in the public domain.

Ethical approval was sought before any of the three randomly controlled trials were carried out: the protocol of the Oxford-Durham Study was approved by the Durham Local Research Ethics Committee; the protocols of two further trials completed last year were submitted to the University of Sunderland and Sunderland Primary Care Trust ethics committees, and the Middlesbrough Primary Care Trust research ethics committee respectively. The former was approved by those two committees, and the response of the second was that ‘as this trial was being implemented by the education authority it would not require their ethical approval and that the trial could simply proceed’.

The respective research ethics committees did not at any time instruct the investigators of these trials to make a clinical trial application to the Medicines and Healthcare Products Regulatory Agency (MHRA), regarding the use of supposed ‘investigational medicinal products’ in human trials. Therefore as the researchers of the trials believed that they were using safe levels of nutritional supplements, the need for registration to trials databases was not deemed essential at the times that they commenced, as they are in the case of drug trials. In addition, the researchers believe that publications resulting from these trials will be considered for peer-review publication because the International Committee of Medical Journal Editors’ published policy (2004) states that only clinical trials starting patient enrolment on or after 1st July 2005 would not be considered. Each of the three trials started enrolment before this date and should therefore still be publishable without the existence of a EUDRACT code or equivalent.

In addition to these, Ben Goldacre was also supplied with the details of many other studies that are detailed in the attachment that outline the rationale for Durham’s support and involvement in research and initiatives relating to fatty acids and learning.
If you are dissatisfied with the handling of your request please contact me at the address below, or by telephone (0191 370 8803) or e-mail (peter.dinsdale@durham.gov.uk) to appeal under the County Council’s Corporate Complaints Procedure.

After you have exhausted our internal appeals procedure you also have a right of appeal to the Information Commissioner at:
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Telephone: 01625 545 745
Fax: 01625 524 510
Email: enquiries@ico.gsi.gov.uk

Most of the documents that we provide in response to Freedom of Information Act requests will be subject to copyright protection. In most cases the copyright will be owned by Durham County Council. The copyright in other documents may be owned by another person or organisation, as indicated on the documents themselves.

You are free to use any documents supplied for your own use, including for non-commercial research purposes. The documents may also be used for the purposes of news reporting. However, any other type of re-use, for example, by publishing the documents or issuing copies to the public will require the permission of the copyright owner.

For documents where the copyright is owned by Durham County Council, please contact me for details of the conditions on re-use.

For documents where the copyright is owned by another person or organisation, you would need to apply to the copyright owner to obtain their permission.

Yours sincerely

Peter Dinsdale
Freedom of Information / Data Protection Coordinator
Durham County Council
Culture & Leisure
Rivergreen Centre
Aykley Heads
Durham
DH1 5TS

FREEDOM OF INFORMATION ACT 2000 – REQUEST FOR INFORMATION

Your request for information on the fish oil trials / studies / initiatives at Durham has been considered.

It has become apparent that the recent influx of requests received by Durham County Council on this subject is as a result of an article by Ben Goldacre, published in The Guardian (11 November 2006) and on the website www.badscience.net. It is also apparent that these requests have been sent by different persons who are acting in concert or in pursuance of a campaign. We consider these requests to be vexatious, and they are therefore refused under section 14(1) of the Freedom of Information Act 2000 (“the FOI Act”).

Section 14(1) of the FOI Act states that:
“Section 1(1) does not oblige a public authority to comply with a request for information if the request is vexatious.”

In his guidance note No. 22 on Vexatious and Repeated Requests, the Information Commissioner gives further detail as to what may constitute a vexatious request:
“Where a request, which may be the latest in a series of requests, would impose a significant burden and:
· Clearly does not have any serious purpose or value;
· Is designed to cause disruption or annoyance;
· Has the effect of harassing the public authority; or
· Can otherwise fairly be characterised as obsessive or manifestly unreasonable.”

Between 11th and 26th November 2006, Durham County Council received 106 requests for information as a result of this campaign, along with 18 further emails of support for Ben Goldacre. In 2005 as a whole, Durham County Council only received 165 requests under the FOI Act. This clearly demonstrates that these requests have imposed a significant burden on the Council.

In determining that these requests are vexatious we also had regard to what appeared to be the purposes of these requests, which became evident from comments in the emails themselves and on the Bad Science website:
· As an attempt to circumvent the Fees Regulations, as Ben Goldacre’s second FOI request had been refused as the cost of complying exceeded the appropriate limit of £450. In his article in The Guardian he had suggested that readers might send in parts of his request under their name, as he believed that this might enable the information to be fully disclosed, albeit in small parts to several individuals;
· To pressure Durham County Council into disclosure of information in response to Ben Goldacre’s second FOI request, even though a legitimate refusal notice had been issued and, at the time, no appeal had been received against this refusal notice;
· As the campaign appears to be solely concerned with pressuring the Council into providing information to Ben Goldacre, it is apparent that the requests have been sent in as a form of protest against the decision to refuse Ben Goldacre’s second FOI request. They are designed to cause disruption or annoyance and they have had the effect of harassing the public authority.

It is for these reasons, taking into account the effect of the requests in imposing a significant burden on the Council and the apparent purposes of the requests, that we consider your request to be vexatious. This is therefore a refusal notice under section 17 of the FOI Act.

While we are refusing your request for information under the FOI Act, we do recognise that there is an interest in the disclosure of information relating to these studies. Attached is a document that outlines published scientific studies into dietary polyunsaturated fatty acids. This information was provided to Ben Goldacre on 16 October 2006 in full response to the first of his two requests for information under the FOI Act. This clearly sets out all of the studies that have been undertaken by Durham County Council. You will note from the details that there have been three randomised controlled trials and other open label studies carried out using fatty acid supplements by staff employed by Durham County Council.

The Oxford-Durham Trial – Dr AJ Richardson (a Research Fellow at Mansfield College, Oxford University) published the preliminary results: – Clinical trials of fatty acid supplementation in dyslexia and Dyspraxia: in Glen AIM, Peet M, Horrobin DF. (eds.) Phospholipid Spectrum Disorder in Psychiatry and Neurology. Carnforth: Marius Press, October 2003: 491-500.

The first peer-reviewed results were published by Dr Richardson and Dr Paul Montgomery (Lecturer, Department of Social Policy and Social Work, Oxford University): – The Oxford-Durham study: a randomized, controlled trial of dietary supplementation with fatty acids in children with developmental coordination disorder. Pediatrics. 2005 May;115(5):1360-6

In accordance with scientific protocol, you should address any requests for further details on this study to the authors of the paper, at Mansfield College.

Sunderland – Dr Madeleine Portwood presented the first paper on 31st October 2006 at the World Autism Conference, Cape Town, hence the details of this study are now in the public domain. Please find attached a copy of the paper.

Middlesbrough – It is intended that details of this study will be submitted for publication next year. In common with accepted scientific practice, we will not release unpublished detailed information, as that would prejudice its ultimate publication in a peer-reviewed journal. We are, however, attaching a copy of the recruitment and trial protocol.

Greenfield / SureStart open label studies – The paper detailing the results of these two studies has now been published (Nutrition and Health, 2006, Vol. 18(3), pp233-247), hence the details of this study are now in the public domain.

Ethical approval was sought before any of the three randomly controlled trials were carried out: the protocol of the Oxford-Durham Study was approved by the Durham Local Research Ethics Committee; the protocols of two further trials completed last year were submitted to the University of Sunderland and Sunderland Primary Care Trust ethics committees, and the Middlesbrough Primary Care Trust research ethics committee respectively. The former was approved by those two committees, and the response of the second was that ‘as this trial was being implemented by the education authority it would not require their ethical approval and that the trial could simply proceed’.

The respective research ethics committees did not at any time instruct the investigators of these trials to make a clinical trial application to the Medicines and Healthcare Products Regulatory Agency (MHRA), regarding the use of supposed ‘investigational medicinal products’ in human trials. Therefore as the researchers of the trials believed that they were using safe levels of nutritional supplements, the need for registration to trials databases was not deemed essential at the times that they commenced, as they are in the case of drug trials. In addition, the researchers believe that publications resulting from these trials will be considered for peer-review publication because the International Committee of Medical Journal Editors’ published policy (2004) states that only clinical trials starting patient enrolment on or after 1st July 2005 would not be considered. Each of the three trials started enrolment before this date and should therefore still be publishable without the existence of a EUDRACT code or equivalent.

In addition to these, Ben Goldacre was also supplied with the details of many other studies that are detailed in the attachment that outline the rationale for Durham’s support and involvement in research and initiatives relating to fatty acids and learning.
If you are dissatisfied with the handling of your request please contact me at the address below, or by telephone (0191 370 8803) or e-mail (peter.dinsdale@durham.gov.uk) to appeal under the County Council’s Corporate Complaints Procedure.

After you have exhausted our internal appeals procedure you also have a right of appeal to the Information Commissioner at:
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Telephone: 01625 545 745
Fax: 01625 524 510
Email: enquiries@ico.gsi.gov.uk

Most of the documents that we provide in response to Freedom of Information Act requests will be subject to copyright protection. In most cases the copyright will be owned by Durham County Council. The copyright in other documents may be owned by another person or organisation, as indicated on the documents themselves.

You are free to use any documents supplied for your own use, including for non-commercial research purposes. The documents may also be used for the purposes of news reporting. However, any other type of re-use, for example, by publishing the documents or issuing copies to the public will require the permission of the copyright owner.

For documents where the copyright is owned by Durham County Council, please contact me for details of the conditions on re-use.

For documents where the copyright is owned by another person or organisation, you would need to apply to the copyright owner to obtain their permission.

Yours sincerely

Peter Dinsdale
Freedom of Information / Data Protection Coordinator
Durham County Council
Culture & Leisure
Rivergreen Centre
Aykley Heads
Durham
DH1 5TS

Or are you just a bunch of cynics who think the council will delay any response as long as legally possible?