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Publishers, psychological tests and greed


There was an intriguing piece in the New
England Journal of Medicine
this week about a commonly used screening test
that indicates if someone is likely to have dementia. The Mini Mental State
Examination (MMSE) is widely used throughout the world because it is quick and
easy to administer. The test is very simple: you need no equipment, and the eleven
items, involving questions to test orientation (e.g. “Where are we?”) and
language (e.g. “What is this?” while showing the patient a wristwatch) are
reproduced at the end of the original
about the MMSE, which was published in 1975.

The problem is that now the authors have taken steps to
license the test, so that it has to be purchased from Psychological Assessment
Resources. The cost is modest, $1.23 per test, but nevertheless more than the
cost of photocopying one side of paper, which is what people have been doing
for years. And of course, if people have to use only officially purchased
copies of MMSE there are the additional costs of raising purchase orders,
postage, storing packs of forms, and so on.

I’ve got a particular interest in this story, as I have
published psychological tests, both off my own bat, and through a test
publishing company. I started out in the late 1970s, when I developed a test of
children’s comprehension called the Test for Reception of Grammar (TROG). This
was more complicated than MMSE in two important respects. It involved lots of brightly
coloured pictures as well as a record form, and in order to decide if a child
had comprehension problems, I needed to establish how well typical children
performed at different ages. The latter process, known as test standardisation,
is not a trivial task, because you have to test lots of children to get a good
estimate of the range of scores as well as the average score at different ages.
This early work was done as part of a study funded by the Medical Research
Council (MRC), but I assumed that, if the project worked out, we’d need a test
publisher, and so I contacted one. The project involved two big costs. First
there was the cost of my time and effort in devising the test, finding reliable
people to test hundreds of children nationwide, analyse the results and write
the manual. The other cost was printing colour test booklets. I had assumed
that the test publisher would be willing to cover this, but they weren’t. They
suggested that the MRC should find another several thousand pounds to cover
printing. Now this made me cross. The publisher would get for free a fully
standardised test that they could sell, no doubt at vast profit, but they
wanted someone else to foot the bill for production costs. MRC were actually
making quite positive noises about finding the money, but I was irritated enough
to explore other options. I found a local printer and learned about the arcane
world of different colour separation processes, and came away with a reasonable
quote. I also discovered something quite interesting. The costs were all in the
initial process of creating plates: the actual printing costs were trivial.
This meant that it cost no more to print 1,000 picture books than the 100
copies I needed. And the costs of printing record forms were trivial. I
returned to MRC and suggested we left the publisher out of the equation, and
they agreed. All proceeded very smoothly, but once the standardisation was
completed, I had a problem. There were 900 unused copies of the picture book. I
discussed with MRC what we should do. They suggested I could give them away,
but this would mean the test would become obsolete as soon as all the copies
were used up. In the end, we reached an agreement that I could sell the test in
a kind of cottage industry, and share any profits with MRC. And so I did for
about the next 15 years. I didn’t bother to copyright the test because it was
cheaper to buy it from me than to photocopy it. Nevertheless, I made a nice
profit, and took considerable pleasure in telling the publisher to piss off
some years later when they approached me expressing interest in TROG.

My next foray into test publishing was with a four-page
questionnaire, the Children’s Communication Checklist (CCC). As with TROG, I
hadn’t set out to devise an assessment: it came about because there wasn’t
anything out there that did what I wanted, so I had to make my own instrument.
I published a paper
on the CCC
in 1998, and listed all the items in an Appendix. I had a
problem, though. I was getting busier all the time. For some years I had been
paying graduate students to look after TROG sales: the weekly trip to the post
office with heavy parcels had become too much of a chore. And every time I
moved house, there was the question of what to do with the stock: boxes of
picture books and record forms. I also realised that TROG was getting out of
date - it’s well recognised that tests need restandardising every ten years or
so. I also wanted to develop a test of narrative language.  And the CCC was far from perfect and needed
revamping and standardising. So I took the big step: I contacted a test
publisher. A different one from before. To cut a long story short, they put
money into the standardisation, covered production costs, and offered highly
professional editorial support. There are now three of my tests in their

The upside for me? The tests are actually marketed, so sales
are massive compared with my cottage industry activities. And I no longer have
to keep a cellar full of cardboard boxes of stock, or concern myself with
organising printing and despatching tests, or dealing with complaints from
someone whose finger was cut by an injudiciously placed staple. There is a
downside, though. The tests are far more expensive. Having done the publishing
myself, I know a little secret of the test publishing business: they don’t make
their profits from actual test materials such as coloured picture books or IQ
test kit. The profits are all in the record forms. These cost peanuts to
produce and are sold at a mind-boggling mark-up.

I went into the deal with the publisher with my eyes open.
They are a business and I knew they’d make profit from my academic work - just
as journal publishers do
. I reckon they’ve done more to deserve that profit
than most journal publishers, as they put money into test development. That
involved taking a gamble that the tests would sell. I have benefited from
having a large professional organisation promoting my work, and I do get
royalties on the tests. I recycle these back to a relevant charity, and there’s
something pleasing about profits from testing children’s language being
ploughed back into helping children with language problems.

But my publisher’s situation is very very different from the
situation with MMSE. The only people who could plausibly argue they deserve to
make money from the test are its authors: the publisher has put no money into
development of the test and taken no risks. The authors appear to be claiming
that the test items are their intellectual property, and that anyone who
attempts to develop a similar test is infringing their copyright. But where did
the MMSE items come from? A quick read of the introduction to the 1975 paper
gives an answer. Most of them are based a longer assessment described in a 1971 article by Withers
and Hinton
. It would seem that the main contribution of Folstein et
al was to shorten an existing test. I wonder if the British Journal of
Psychiatry should go after them for copyright infringement?

Newman, J., & Feldman, R. (2011). Copyright and Open Access at the Bedside New England Journal of Medicine, 365 (26), 2447-2449 DOI: 10.1056/NEJMp1110652

P.S. Another post that includes some information on how MMSE was developed.

You can read more by scrolling down to "The Mini Exam with Maximal Staying Power" on this site from 2007.

Chanel No.5

Some of you may have completed your gift-buying weeks ago, but Debenhams has revealed a rise in sales of Chanel No. 5 represents the start of men's Christmas shopping for the year.


"It's like a starting pistol going off, " Debenhams spokesperson Ruth Attridge told The Daily Mail. "As soon as we see sales of Chanel No. 5 rising, we know that men have begun the race to get their Christmas shopping done. Men just want to get into store, pick up the items they want as quickly as possible - and leave".


The high street store revealed that the famous fragrance is the most popular perfume bought by men each year, signalling the beginning of "The Male Sale" - the frantic period of present-buying culminating in a Christmas Eve peak.

Sienna Miller Style

See the latest Sienna Miller style, fashion, trends, wardrobe and accessories. View ratings and vote on Sienna Miller style and fashion.
Check out the latest Sienna Miller style and fashion trends on Coolspotters. Browse and shop for all the latest style and fashion choices of today's hottest ...

Kate Middleton’s sapphire and diamond earrings from Diana’s collection

On her first royal Christmas, Duchess of Cambridge was spotted wearing a gift from her husband. The diamond and citrine drops were an elite choice for such a grand and religious occasion. But this was not the first time she was spotted wearing jewels given by her husband.

Diana-Kate Earrings

She already wears the sapphire engagement ring presented by Prince William. The ring was once belonged to William’s mother Princess Diana. After wedding Prince William also presented his mother’s sapphire and diamond studs to Kate which she wore for the first time when she attended a tennis match at Wimbledon. The studs were among Diana’s most prized and favorite jewels and she wore them quite frequently before her death.

Sapphire and Diamond Earrings

Princess Kate followed suit by wearing the earrings more often during her trips to Canada and the United States. The fashionista has given a modern touch to the earrings by having them remodeled into hoop earrings.

The earrings hold heirloom sapphire in the center surrounded by diamond rounds in a halo style and are the perfect match with her sapphire engagement ring that has the same design.

Duchess of Cambridge, Princess Catherine loves to carry simple and stylish flair. She has a very classic and trendy wardrobe and knows exactly what she should don for a particular event. This sense of her has made her the most photographed female of England. There is no surprise that the jewels in her collection are adding the substantial quality to her already photogenic fashion forward yet classic style.

Varvatos Approaching Independence Through VF Corp

Following 8 many years underneath the possession associated with VF Corp., Steve Varvatos is actually lastly near to becoming free of it's corporate-minded mother or father organization. However possible suitors doing some fishing in order to click upward Varvatos' somewhat grubby, tousled, music-influenced manufacturer will have to have a quantity: based on the Ny Publish, buyer Ron Burkle as well as Birmingham buyout organization Lion Funds tend to be each within foretells obtain Varvatos. The actual manufacturer may be available because '09, as well as last year, Varvatos had been went after with a proposed 4 company suitors.

However VF Corp., that matters Wrangler, Shelter, as well as Timberland amongst it's manufacturers, thwarted just about all feasible purchasers because of strict needs how the Varvatos manufacturer end up being bought from it's complete share worth. Underneath the Northern Carolina-based corporation's business outdoor umbrella tend to be numerous denim manufacturers comprising the actual range through Shelter as well as Wrangler in order to 7 For those Humanity, back pack purveyors such as Jansport, Kipling, as well as Eastpak, as well as modern outlines Ella Moss as well as Marvelous, amongst others. Varvatos had been initially possessed through Nautica, that was purchased away through VF Corp. within 2003.

Lion Capital's present style qualities consist of opportunities within United states Apparel—to the actual melody associated with $80 zillion within second-lien debt—and Just about all New orleans saints, the actual second option which had been committed to earlier this Might. This is not the very first time which Los Angeles-based Burkle as well as Lion Funds possess clashed on the preferred purchase: Within Oct, Burkle targeted to improve their risk within United states Clothing in order to $90 zillion, which may provide him or her the biggest reveal from the Spandex-spangled corporation's line of credit.

Creation of Gods-NS Harsha

NS Harsha was created within 1969. He or she life as well as functions within Mysore, Indian. Symbolized within Birmingham through Victoria Miro Gallery, he's famous with regard to their capability to fresh paint using the finest preciseness the actual family portrait of various people. Their artwork may be proven in several exclusive locations, for example Indian native Freeway in the Serpentine Gallery and also the Astrup Fearnley within Oslo, and also the 26th Sao Paulo Biennale. Following a single display from Maison Hermès within Tokyo within 08, he's already been asked to style the headband for that France manufacturer.

1. Exactly how can you link style in order to style?
Can one state style 'inspires' style? Style celebrates timelessness during comparison style celebrates a specific second associated with history. Style produces marriage in between materials as well as entire body, whilst style can make ‘materials’ function round the entire body.

two. What's the actual part associated with background as well as artwork background inside your conceiving associated with style?
The conversation is definitely upon. Within Indian all of us possess a powerful romantic relationship in between background as well as clothes. For instance, Gandhi’s Khadi motion nevertheless includes a substantial part in order to perform with regards to modern style. Individuals attempt to avoid this in order to support this however they continue to be using a conversation using the motion in either case. The greater style is designed in order to create, the greater this must be knowledgeable concerning the previous I suppose? Therefore, personally, Style as well as background proceed together...

3. Can you explain style like a vocabulary along with a discourse, because Barthes made it happen?
Obviously style is really a vocabulary! I'm unaware associated with Barthes' textual content. However indeed, certainly, fashion/clothing is really a powerful system in order to express/communicate one’s values, politics placement and so forth.... Personally i think the visible conversation begins in between a couple prior to the spoken trades. It's a deal with whenever we encounter the marriage associated with clothes, talk as well as words and phrases within an person, you could phrase this because sophistication or even style. In comparison, often all of us run into style that's totally misinterpreted that leads to the actual projection associated with lack of knowledge.

four. The term "intellectual" had been coined inside a period associated with excellent politics stress. Will style possess a politics part? As well as by which method?
Mentionened above previously over presently there might not be a much better instance compared to Gandhi’s Khadi Motion that provides clothes as well as national politics towards the exact same system. Style could be a powerful device expressing one’s public placement as well as appeal to such as oriented individuals as well as simultaneously maintain away particular additional people. ‘Statement’ is really a popular term within the style neighborhood, in which the term includes a politics high quality inlayed involved with it.

5. Exactly how can you connect the idea of style towards the among design?
Design may become really repeated or even flat. We are able to notice a few individuals/societies reside having a particular design almost all their existence, this particular In my opinion functions from the primary from the human being nature. However style offers space in order to perform, to increase and also to agreement; to produce dialogues using the altering occasions.

Men's Sneaker: New Balance 574 Dragon Pack for 2012

In commemoration of the 2012 Chinese Zodiac’s year of the dragon, New Balance has crafted a unique pack to celebrate the heralded occasion. The set utilizes one of the brand’s most readily released silhouettes, the 574. The collection highlights a variety of colorways, as each will be most notably set off by branding of the mythical creature throughout each edition.

The sneakers will be optioned in three schemes of black, yellow and red, while additional limited edition offerings of gold color will  also be available. You can expect the thematic footwear to be available by the end of December, through select New Balance stock lists throughout Asia.  

Source: Streething

NHS research ethics procedures: a modern-day Circumlocution Office

In Little Dorritt, Charles Dickens rails against the
stifling effects of bureaucracy:

No public business of
any kind could possibly be done at any time without the acquiescence of the Circumlocution
Office.… the Circumlocution Office was down upon any ill-advised public servant
who was going to do it, or who appeared to be by any surprising accident in
remote danger of doing it, with a minute, and a memorandum, and a letter of
instructions that extinguished him.

 Substitute “NHS research ethics procedures” for
Circumlocution Office, and “researcher” for public servant, and you have a
perfect description of a contemporary problem.

December 2010

My programme grant has been running now for over a year, and
it’s time to gird up my loins to tackle NHS ethics. I’ve had plenty of other
research to keep me busy, but I’m aware that I’ve been putting off this task
after earlier aversive experiences. “Come on,” I tell myself, “you deal with
unpleasant and bureaucratic tasks regularly - reviewing grants, responding to
reviewer comments, completing your tax return. You really just have to treat
this in the same way.”

It starts well enough. I track down a website for the Integrated Research Application
IIRAS). I start to have misgivings when it tells me that it’ll take
approximately an hour to work through its e-learning training module. To my
mind, any web-based form that requires training in its use needs redesigning. But
I bite the bullet and work through the training. Not too bad, I think. I can
handle this. I start to complete the form. I’m particularly happy to find
little buttons associated with each question that explain what they want you to
say. A definite improvement, as in the earlier versions you spent a lot of time
trying to work out what the questions were getting at. It also cleverly adapts
so that it excludes questions that aren’t relevant to your application. This
turns out to be a two-edged sword, as I discover some weeks later. But at
present I am progressing and in a cheerful mood.

The process is interrupted by need to travel from Australia to UK, Christmas, snow, massive
revision to do to address reviewer comments on a paper, etc.

January 2011

Input more information, design information sheets, consent
forms, etc, etc. Still feeling buoyant. The form is virtually complete, except
for some information from collaborators and bits that need to be completed by
Oxford R&D. I realise we want an information video for kids who can’t read,
but it’ll need to be approved, but we don’t want to go to all the trouble and
expense of making it before getting approval. Discuss with helpful person from
Oxford R&D, who suggests I write a script for approval. I also book in the
film crew, shortlist and interview candidates for research assistant posts on
the project, send draft to all collaborators for approval, and ask geneticist
collaborator for help with some details. Am finding that progress is slower and
slower, because navigating the form is so difficult: it displays one page at a
time and does not scroll. You can specify a question to go to, but it’s not
easy to remember which questions correspond to which numbered item, and so you
end up repeatedly printing out the whole form and shuffling through a mountain
of paper to find the relevant question. Keeping things consistent is a big

February 2011

Two weeks’ holiday, then enter final details that were sent
to me by collaborators and send the whole lot off to R&D.

The dynamic form starts to reveal its diabolic properties
when I enter a new collaborator from Cardiff,
only to find that the form now pops up with a new question, along the lines of
“How will you meet the requirements of the Welsh Language Act 1993?”. I won’t.
We’re studying language, and all our tests are in English, so only English
speakers will be recruited. Explain that, and hope it works out.

But now it gets seriously worse. I’ve entered lots of
clinical colleagues as “NHS Sites”, but it turns out they aren’t sites. They
are Patient Identification Centres. I have to delete them all from the form.
Well, I think, at least that makes life simpler. But it doesn’t. Because now
they aren’t sites any more, new questions pop up. Who will do the patient
recruitment, and how will we pay for it? This one is a Catch 22. Previously our
research assistants have been supervised by a consultant to go through records
to find relevant cases. Some places required that you get honorary NHS status,
and that could necessitate fulfilling other requirements. I actually had to get
vaccinated for tetanus as part of getting an NHS contract some years ago. They
said it was in case I got bitten by a child, something that has not happened to
me in 35 years of researching. But I digress.  Now, it seems, even a fully vaccinated, child-proofed,
police-checked researcher is not allowed to go through medical records to
identify cases unless patients have given prior consent. Which, of course, they
won’t have, since they don’t know about the study.

“Help!” I say to my lovely clinical colleagues. “What do we
do now?”. Well, they have a suggestion. If I can register with something called
CLRN, then they can help with patient recruitment. I’m given contact details
for a research nurse affiliated with CLRN who soothes my brow and encourages me
to go the CLRN route. I have to fill in something called a NIHR CSP Application
Form which apparently goes to a body called the “portfolio adoption team” who
can decide whether to adopt me and my project. All of these forms want a
project start date and duration. I did have early April as notional start date,
but that’s beginning to look optimistic.

Late February: comments back from R&D. Have been through
application with a fine toothcomb and picked up various things they anticipate
won’t be liked by the ethics committee. Impressed with the thoroughness and
promptness of the response, and found the people at R&D very helpful over
the phone, but my goodness, there is a lot to cope with here:

First, it seems I am still in a muddle about the definition
of NHS sites, so have filled in bits wrongly that need to be entered elsewhere.
Am also confused about the distinction between an “outcome” and an “outcome

Then there is the question of whether I need “Site specific
forms”. The word “site” is starting to cause autonomic reactions in me. Here’s
what I’m told: “Please supply an NHS SSI form for each research site; Please
note for Patient Identification Centres (PICs) 
R&D approval is required but you do not need an SSI form for these
provided no research activity takes place on that site – taking consent to take
part in the project is a research activity, giving out information on the
study/advertising the study is not considered a research activity.”

I also baulk at the suggestion that I should add to the
information sheet: “The University has arrangements
in place to provide for harm arising from participation in the study for which
the University is the Research Sponsor.
NHS indemnity operates in
respect of the clinical treatment with which you are provided.”  Since I don’t understand what this means, I
doubt my participants will, and the participants aren’t receiving any clinical
treatment. Out of curiosity, I paste these two sentences into a readability
index website
. It gives the passage a Flesch-Kincaid Grade Level of 22,
with readability score of 4 (on a scale of 0 to 100, where 100 is easy). I try
to keep my information sheets at maximum 8th grade level, so reword the bits I
do understand and delete the bits that seem irrelevant or incomprehensible.

I reluctantly went along with the idea that I should
devise an “Assent form” for children. This is like a kiddie consent form, but
with easier language, to be signed by both child and researcher. They seem to
be a blanket requirement these days, regardless of the level of risk posed by
research procedures. I dislike the Assent form because I am not sure what
purpose it serves, other than to make children nervous about what they are
getting themselves into. It has no legal status, and we can’t gather
psychological test data from unco-operative children. Others share my view that
this requirement is incoherent
and wrong
. But I want to do this study, so feel I have no choice. I had a
look on the web and NHS guidance sites to look at suggested wordings, and did
not like them, so did a modified and simplified version I hoped would be
approved. It would be interesting to do some research on Assent forms to see
how they are perceived by children.

March 2011

Hooray! By the start of March, I’m ready to submit my
forms. Since  IRAS is all electronic, I
had assumed I would do it with a button press, but that would be too simple. Multiple
copies must be sent by snail mail within a specific time frame. There has been serious research on the
environmental impact of this. But first there is the question of booking an
appointment with an ethics committee. There’s a whole centre devoted to this
task, and they have standard questions that they ask you about the nature of
the research. I was doing well with these until we got to the question about
children. Yes, I was going to do research with children. Ah, well then I
couldn’t go to any old ethics committee, I had to go to one with a
paediatrician. And, unfortunately, there weren’t any slots on committees in
Oxfordshire with paediatricians. But, said the helpful girl on the phone, I
could try calling the Oxfordshire people directly and they might be able to
book me in. At 12.05 I call the number I’ve been given, only to get an automated
message saying the office is only open from 10 to 12. Since the following
morning I’m busy (I am trying to do my regular job through all this), despair
starts to set in. But I break out of a meeting to call them the next morning.
The phone rings. And rings. Back to my meeting. Break out again, repeat
experience. Eventually I get through. Person at end of phone takes me through
the same list of questions about type of research, and finds a convenient slot
with an Oxfordshire committee, which I can make if I move an appointment. Move
the appointment. Get called back to say that committee can’t unfortunately take
me, because they don’t do proposals with children. Am offered another slot on a
day when I have arranged to examine a PhD in London. Next one in Oxford is a month later, well after the
proposed start date for the research. Best they can do is to offer me a slot
with a Berkshire committee, who do have a paediatrician and are just one hour’s
drive away, and which is later than the original slot, but sooner than the
Oxford one. I decide to go for it. I then receive a remarkable document with a
lot of multicoloured writing, which gives me a booking confirmation number, and a
lot of instructions.

This triggers a frantic process because you then have
seven days to get all the material delivered to the ethics committee. This may
not seem difficult, except that all the information sheets and consent forms
need to have little header put on them with the booking number and date, and
they also want copies of things like a CV, copies of test forms and suchlike,
and worse still, there have to be signatures not just from me but also from
R&D, who are in a hospital a couple of miles away up a hill. Unfortunately
coincides with a period when my PA is absent, and so I rush around like a
demented cockroach getting this all together. I’d not budgeted much time for
this bit, as I’d assumed submission would involve pressing a button on my
computer and uploading some attachments and my diary was full. Somehow I had to
find a couple of hours for fiddling with forms, a trip up the hill for a
signature the next day, and a journey to the post office to ensure it would all
get delivered on time.

I also needed to get the documents to CLRN. This could be
done by email, but that soon bounced back. Once more the critical distinction
between sites and centres eluded me, and I was told that I had to submit
corrected documents because:

Part C, if the only research site is the University of Oxford and the other organisations
listed are Participant Identification Centres (PICs), there should be listed
under the heading Participant Identification Centre(PIC)Collaborator/Contact
immediately below the University of Oxford entry, and not separately.”

So back to the form again to
alter this bit. At last it is accepted. But this now triggers new emails,
including one from London

“We have been notified that you
may be participating in the above study. If the Chief Investigator or Study
Coordinator confirms this, Central and East London CLRN will be supporting you
locally through the NIHR CSP process and we look forward to working with you on
this project.

If this is confirmed, please
email all relevant documents to me when you submit your SSI Form through IRAS.
The documents you need to submit are listed on the Checklist tab within your
SSI Form in IRAS…..etc etc”

The SSI form was one I thought I
didn’t have to complete, so I phoned the number given on the email, who said
they couldn’t comment and I should ask Oxford, so I asked Oxford, who agreed I
didn’t need to do anything.

Meanwhile, there’s yet another
form that has popped up that wants to know what training in ethics the
researchers have had. Since I haven’t had formal training, I’m told I can
either go on a half-day course, or take an on-line course in five modules, each
lasting around 45 minutes. I try the online course, but find most of the
material is not relevant to me. It starts with pictures of concentration camp
victims to emphasise why people need to be protected from reseachers, then goes
on to give information focussed on clinical trials. I’m not doing a clinical
trial. The quizzes at the end of each module don’t seem designed to check
whether you have mastered the subtleties of ethical reasoning, so much as
whether you know your way around the bureaucratic maze that is involved in
ethical approval, and in particular whether you understand all the acronyms.

April 2011

The six weeks from early March
to mid April were joyfully free from communications with ethics people, and
normal life resumed. My new staff took up their posts and we made a start on
filming for an information DVD for the project, and decided that we would delay
the editing stage until after the Berkshire
meeting. The day of the committee meeting dawned sunny and bright and I drove
off to Berkshire, where I had a perfectly
reasonable chat with the ethics committee about the project for about 15
minutes. The Paediatrician was absent. I explained I wanted to assemble the
information video, but was told I had to wait until I received a letter
documenting changes they’d want me to make. When this arrived, about a week
later, they wanted some minor rewording of one sentence. This would be trivial
for a written information sheet, but entailed some refilming and careful
editing. In addition, the committee raised a point that had not been discussed
when I met with them, namely that they were concerned at a statement we had
made saying we would give feedback to parents about their children’s language
assessment if we found difficulties that had not previously been detected.
This, I was told, was an incentive, and I should “soften” the language. This
was seriously baffling, as you either tell someone you’ll give them feedback or
you don’t. I could not see how to reword it, and I also felt the concern about
incentives was just silly. I sent them a copy of a paper on this topic
for good measure.

May 2011

Oh frabjous day! At last I receive a letter giving consent
for the study to go ahead. I think my troubles are over, and we swing into
action with those parts of the project that don’t involve NHS recruitment. But
joy is short-lived. I am only just beginning to understand the multifarious
ways in which it is possible to Get Things Wrong when dealing with the
Circumlocutions Office. I now start to have communications with the CLRN, who
want copies of all documentation (including protocol, consent forms, the
information video, etc etc - a total of 15 documents) and then tell me:

“The R&D Signature pages
uploaded to the doc store on 27th June 2011 do not marry up with the R&D
Form uploaded on 15th March 2011”

Requests for new form-filling also
come in from the CCRN Portfolio. I’m getting seriously confused about who all these
people are, but complete the form anyway.

And, worst still, in August I
get a request from TVCLRN for a copy of  the
letter I sent to Berkshire in which I
responded to their initial comments. I had written it at a time when my computer
was malfunctioning so it’s not with other correspondence. I spend some time
looking on other computers for an electronic copy.  It seems that without a copy of this letter,
they will not be satisfied. Anyhow, I think this will be simple to sort out,
and phone the Berkshire ethics committee to
ask if they could please send me a copy of the letter that I had written to
them. Amazingly, I’m told that
“due to GCP guidelines” the Berkshire ethics committee cannot give me a copy.
Stalemate. I can’t actually remember how we dealt with this in the end, as my
brain started to succumb to Circumlocution Overload.

The last 6 months

We have a meeting with the clinical geneticists with whom
we’re collaborating, and I find that most of them are as confused as I am by
the whole process. We discuss the Catch 22 situation whereby we aren’t allowed
to help go through files to identify suitable patients because of ethical
concerns, which means they have to take time out of their busy schedules to do
so. This is where the CLRN is supposed to help, by providing research nurses
who can assist, but only if we complete loads more paperwork. And having done
this, after months of to-ing and fro-ing with requests for documentation or
clarification, one of the CLRN centres has just written this week to say they
can’t help us at all because they are a Patient Identification Centre and they
need to be a PI, whatever that is. I’m currently trying to unravel what this
means, and I think it means that they have to become an NHS Site - which was
what I  had originally assumed when I
started filling in the forms. But in order for them to do so, there are yet
more forms to complete.

Meanwhile, in October, I had a request from the UKCRN
saying I needed to upload monthly data on patient recruitment in a specific
format, and sending me a 35 page manual explaining how to do this. Fortunately,
after several exchanges on email, I was able to establish that we did not need
to do this, as the hospitals we were dealing with were Patient Identification
Centres rather than Sites. But now we have a PIC that wants to become a Site,
who knows what new demands will appear?

And then, this week, a new complication. The geneticists
who are referring to our study need to check with a child’s GP that it is appropriate
to send them the recruitment materials. But an eagle-eyed administrator spotted
that this letter “was not an ethically approved form”. I was surprised at this.
This is not a letter to a patient; it is a standard communication between NHS
professionals. Nevertheless, my R&D contact confirmed that this letter
would need approval, and that I’d have to fill in a form for a “substantial
amendment”, which would then need to be approved by all the R&D sites as
well as the Berkshire ethics committee.

When I expressed my despair about the process on Twitter,
I had some comments from ethicists, one of whom said “If you're doing research
on ppl then someone has to look after them, no?” Of course, the answer is
“yes”, and in fact the project I’m working on does raise important ethical
issues. As another commentator pointed out, the problem is not usually with the
ethics procedures, and it is true that the IRAS form is much better  than its predecessor and guides you through
issues that you need to think about and offers good advice. But the whole
process has got tangled up in bureaucratic legal issues and most of my problems
don’t have anything to do with protecting patients and have everything to do
with protecting institutions against remote possibilities of litigation.

Concluding thoughts

1. In the summer, I was contacted by a member of the public
who was concerned about the way in which a medical project done at Oxford University
was being used to promote unproven diagnostic tests and treatment for a serious
medical condition. I recommended that my contact should write to the relevant
person dealing with ethics in the University. I was sanguine that this would be
taken seriously: here was an allegation of serious infringement of ethical
standards and all my dealings with our R&D department indicated they were
sticklers for correct procedures. A month or so passed; they didn’t reply to
the complainant. I was embarrassed by this and so wrote to point out that a
serious complaint had gone uninvestigated. After a further delay we both got a
bland reply that did not answer the specific questions that had been raised and
just reassured us the matter was being investigated. This just confirms my
cynicism about the role of our systems in protecting patients. As Thomas Sowell
pointed out: You
will never understand bureaucracies until you understand that for bureaucrats
procedure is everything and outcomes are nothing

2. The current system is deterring people from doing
research. The problem is not with the individuals running the system: they’ve
mostly been highly professional, helpful and competent, but they are running a
modern Circumlocution Office. I’ve interacted with at least 27 people about my
proposal, and that’s not counting the Research Ethics Committee members. I’m a
few years off retirement and I’ve already decided that I won’t tangle with NHS
Ethics again. I’m in the fortunate position that I can do research studies that
don’t involve NHS patients, and I want to spend the time remaining to me
engaged in the activity I like, rather than chasing pieces of paper so that someone
somewhere can file them, or waiting for someone to agree that an innocuous
letter from a Consultant to a GP is ethically acceptable.

3. To end on a positive note: I think there is another
way. The default assumption seems to be that all researchers are unscrupulous
rogues who’ll go off the rails unless continuously monitored. The system should
be revamped as a mechanism for training researchers to be aware of ethical issues
and helping them deal with difficult issues. For research procedures that are
in common use, one can develop standard protocols that document how things
should be done to ensure best practice. On this model, a researcher would
indicate that their research would follow protocol X and be trusted to do the
research in an ethical fashion. The 
training would also ensure that researchers would recognise when a study
involved ethically complex or controversial aspects that fell outside a
protocol, and would be expected to seek advice from the Research Ethics
Committee. The training would not revolve around learning acronyms, but would
rather challenge people with case studies of ethical dilemmas to ensure that
issues such as confidentiality, consent and risk were at the forefront of the
researcher’s mind. This is the kind of model we use for people engaged in other
activities that could pose risks to others - e.g.,  medical staff, teachers, car-drivers. Life
would come to a standstill if every activity they undertook had to be scrutinised
and approved. Instead, we train people to perform to a high standard, and then
trust them to get on with it. We need to adopt the same approach to researchers
if we are not to stifle research activity with human participants.

Further reading

Kielmann T, Tierney A, Porteous R, Huby G, Sheikh A, & Pinnock H (2007). The Department of Health's research governance framework remains an impediment to multi-centre studies: findings from a national descriptive study. Journal of the Royal Society of Medicine, 100 (5), 234-8 PMID: 17470931

Knowles, R. L., Bull, C., Wren, C., & Dezateux,
C. (2011). Ethics, governance and consent in the UK: implications for research into
the longer-term outcomes of congenital heart defects. Archives of Disease in
Childhood, 96(1), 14-20.

Robinson, L., Drewery, S., Ellershaw, J., Smith, J.,
Whittle, S., & Murdoch-Eaton, D. (2007). Research governance: impeding both
research and teaching? A survey of impact on undergraduate research
opportunities. Medical Education, 41(8), 729-736.

Warlow, C. (2005). Over-regulation of clinical
research: a threat to public health. Clinical Medicine, 5(1), 33-38.

Wilkinson, M., & Moore, A. (1997). Inducement in
research. Bioethics, 11, 374-389.

Holiday gift guide - the boho babe

In today's installment you'll find some gift ideas for the bohemian girl.
You can't go wrong with statement jewelry or a long scarf.
- Statement necklace (House of Harlow 1960, available in Romania here)

- Large ring (Kenneth Jay Lane @revolveclothing)

- Gold stack bangles (House of Harlow 1960)

- Headband (Deepa Gurnani @shopbop)

- Scarf (Theodora & Callum @shopbop)

- H&M faux fur vest

Lauren Conrad Style Fashion

See the latest Lauren Conrad style, fashion, trends, wardrobe and accessories. View ratings and vote on Lauren Conrad style and fashion. Follow Lauren Conrad style and see what trends that style has started. Be the first to wear Lauren Conrad fashion after you get a sneak peak in that celebrity

Louis Vuitton Spring/Summer 2012 Ad Campaign | Daria Strokous & Kati Nescher by Steven Meisel

louis vuitton 2012 spring summer campaign womens

Daria Strokous & Kati Nescher photographed by Steven Meisel for Louis Vuitton Spring/Summer 2012 Ad Campaign 

louis vuitton 2012 spring summer campaign womens

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Look of the day - Olivia Palermo

I know I've been missing in action lately, but I'll be back in a few days with lots of interesting and inspiring posts.
In the meantime, check out Olivia Palermo's casual chic outfit, which I think is perfect for the current weather here in Romania.

Man Fashion Tips: Men Dress Shirts for Skinny and Short Man

If you are short and thin, dressing up can be quite the hassle. You are going to look like you are drowning in a shirt if it is not made to fit your figure. Despite having a small frame, there are a few ways on how to look great in a dress shirt.

Short height does best with slim, streamlined details. Pick narrow collars whose points aim downward over wide spread collars as broad collars make you look stouter than you really are.

It is important to have the length of the sleeve and the shirt adjusted to suit your body measurement. Nothing looks more awkward than having the sleeves that hang down too far or shirt that is too wide at the waist. A trim fitted dress shirt with the pocket and collar in the right size will stop you from looking like a flying squirrel.

This is a little optical illusion that you could use well to your advantage. Vertically-oriented patterns on dress shirts compliment short figures. Horizontal line going across will only make you look wider instead of taller. However if you are aiming to look broader, vertically striped patterns such as plaid or windowpane patterns make flattering choices. Do not go overboard with loud plaids and windowpane designs, choose more subtle tonal varieties. Dressing in dark colors from head to toe will only emphasize your skinny body frame. If you wish to avoid emphasis on your small body frame, add in a splash of white or light gray to break the whole one colored outfit. Avoid anything with over excessive stripes in varying colors and sizes as it can be a little overbearing to the eyes. Thin, simple stripes make you look elegant and taller than you actually are.

Another piece of advice for a man of short height is to remember that dress shirt is to always be kept tucked in. Shirttails that are let loose shorten your legs dramatically. Un-tucked dress shirts will cut your body in half and make you look particularly stumpy. Tucking in your dress shirt makes sure your leg line is maximized. Men with longer leg lines naturally give the illusion of being taller.

Regardless of what kind of body shape Mother Nature gave you, making the most of what you were given will make you look better and help you feel more confident.

Mens Fashion Jeans: Burberry Prorsum Dark Indigo Jean

We are sure slim fitting dark indigo jeans have a place in every man's wardrobe, more so for this pair from Burberry Prorsum, that has minimal detailing that makes them a go-to option for any stylish look. Made with raw denim and 100% cotton, these jeans will soften with use for a unique patina that will develop as you wear them.

Come with five pockets, button closure and fly and layered perspex plaque on the back engraved with the Burberry Prorsum logo, Burberry Prorsum Dark Indigo Slim Fit Jean is a "Must Have" item in your wardrobe. You can find one from

5 Designer Watches for Your Girlfriend this Christmas

The mention of a perfect gift and while most men will think gold, most women will think of Swiss and diamonds. Those sparkling fashion gems are always a good gift idea but this year, why not buy your sweetheart something that is both quality and a fashion statement?

Rolex Datejust Special Edition

Rolex recently just released a new collection of their sensual, dazzling and enchanting watches. What better way to impress her with this special Everose gold model edition produced with brilliant-cut diamonds elegantly showcased in an 18 carat white gold setting?

TAG Heuer Women’s Aquaracer Diamond Pink Mother-of-Pearl Dial Watch

If your love one adores watches and diamonds, TAG Heuer may just be the right choice. This luxury timepiece is made up of jewel-encrusted stainless steel strap with a bezel full of diamonds surrounding the radiant complements to the pink mother-of-pearl dial. The design is feminine and elegant and has jewels as hourly markers.

Michele Tahitian Ceramic Watch

This luxury sporty watch will make her the envy of her friends. A ceramic bracelet with a hundred sparkling master diamonds that circle around the Tahitian Ceramic timepiece, this gorgeous trendy white watch is a gift that will definitely have her eating out of your hands.

Cartier Baignoire Watch

This simple yet elegant small Cartier timepiece is bound to please any women. Instead of the usual round dial, this timepiece was designed in an oval shape with roman numerals and is surrounded by round diamonds. The unique feature about this watch is the blue sword-shaped steel hands and it is water resistant to 100 ft! No need to worry about water ruining your precious gift.

OMEGA De Ville Ladymatic

Worn by Nicole Kidman, this unique red gold timepiece has a transparent case back making it possible for her to admire the movement inside of the watch. The diamonds on this OMEGA is the hardest, most luminous precious stone whose value is calculated according to the 4C criteria; cut, carat, clarity and color. It is class and beauty at the same time.

Designer watches are appropriate for many occasions and are not only beautiful but practical pieces of accessories as well. Believe it or not, women today are starting to pay attention to the technical and mechanical aspects of a watch. Just paying attention to the outlook of that wrist accessory can be a flaw. The most important thing is observing her fashion preference to make better gift choices. Good luck guys!

Winter 2011-2012 Fashion. SKIRTS. What skirts are in fashion this season.

Skirt is an indispensable thing in the wardrobe of every woman. This winter you'll be plenty to choose from. Fashion designers represented a big variety of colors, styles, textures, variations of detail, so that we can say that the skirt in the cold season will be one of the most stylish woman's wardrobe items.

Now is the time to get rid of jeans and pants and put on a skirt and heels.

Leaher skirts.
The fashion hit of this season. A leather skirt is an amazing way to turn heads and get noticed. It can turn a woman into a lady vamp, and it can turn a teenage girl into a woman. It's one piece of clothing that can look cold and hard in a closet, but warm and sexy when it's worn right way.
Leather skirts from Jean Paul Gaultier, Ports 1961, Tommy Hilfiger, Aigner, Holly Fulton, Chanel and Hermes

Warm skirts.
This season you don't have to choose between beauty and health. This winter designers advise to wear fur skirts.
Fur skirts seen at Betty Jackson, Matthew Williamson and Albino.

High waist skirts.
You should wear high waist skirt with thin polo-neck sweater or blouse tucking it into your skirt.
Seen at Temperley London, Badgley Mischka, Antonio Marras, Sonia Rykiel, Nicole Farhi and Roccobarocco.

Pencil skirts.
Designers refreshed classical models with bright prints, appliqué, flounces and patch pockets.
Pencil skirts from Zac Posen, DKNY, Donna Karan, Ports 1961, J. Saunders, Tsumori Chisato and Elie Saab.

Mini skirts.
Mini skirts are extremely fashionable this season. But fashion designers advise to forget about tight-fitting skirts and choose trapezoid cut.
Seen at Issa London, Acne, Ungaro, Thakoon, Tibi and Herve Leger