One for you and one for me… COI at IZS Sicily

Conflicts of interest at IZS Istituto Zooprofilattico Sperimentale of Sicily in Palermo

How to divide the funds of public research (that is fed by the taxes of citizens) at the expense of some colleagues and with no need to justify the choice.

The small bucket goes into seven shards,
they divided them in seven cones,
one for you, one for me,
one for the kitchen boy of king,
one to a fairy little mouse
who is raising her tail,
one for the magician Biribò,
one to another I do not know,
one off to whomever you want
shards that I no longer have.
Abstract from an Italian nursery rime

Hat tip Ivan Oransky

 

 

Hat-tip Ivan Oransky

 

 

The research at the IZS of Sicily. In Italy there are ten Experimental Zooprofilattico Institutes for animal health, food safety and zoonosis. One of these is the IZS of Sicily that has 5 branches, (Palermo, Catania, Ragusa, Caltanissetta and Messina). As all other Institutes, it annually receives research funding from the Ministry of Health and from the Sicily region. And they are not just peanuts. From last officially published budget of IZS Sicily we learned that the operating grants for research in 2013 amounted to:

615,792 € from the Ministry of Health for the current research
217,162 € from the Ministry of Health for the specific aimed research
814,554 € from the Region and other public entities
for a total of just over 1.6 million Euros.
Similar amount, 1.5 million euro, was allocated the previous year.

How is this taxpayers money spent? From the results it seems not so well. In the  2010 Report on the assessment of the performance of the IZSs, on the Sicilian Institute we read “The most critical area is that of research measured by three indicators: their timely closure of MIT21 research projects, scientific production MIT17 and ability to raise resources for the current task MIT16 “, as you can see from the attached target, the performance in these three indicators is either very poor (red) or poor (orange).

Valutazione attività IZS Palermo

 

At this point our readers will ask why the performance is so critical?
The answer is very long and complex.
Research funds are distributed based on the assessment of the Scientific Technical Committee or CTS of each IZS, which decides the research projects that are funded for current research and proposes the projects for aimed research to the health ministry.
So the CTS works as a filter.
In short: for the current researches there is no second level of control; for aimed research the ministry applies his control only on the research projects proposed by the CTS, not on what the CTS has excluded. So if the filter works badly no one notices because no verification is in place. And that’s not all.

Risk of conflict of interest. The funding of research, of course, are coveted by everyone, including members of the CTS: grab the money for research means increasing its own scientific H-index and consequently a career. But it is also important to get grants for researchers in your own department, or area which often means the co-authorship in more scientific publications, participating as a speaker at a conference, increase its own reputation as the “expert”.
And you know, without any control, the flesh is weak and man is sinful.

Anticorruption. The risks of conflicts of interests in grants awarding are well known. They are debated in international scientific journals where remedies are proposed, and all positive and negative aspects are weighted. Of course, nothing is perfect and everything can be improved. But at least corrective actions and external controls should be put in place. The Ministry of Health, a provider of a large slice of research grants, indicates appropriate measures in its anti-corruption plan. In this plan research is widely cited and among the preventive measures to be taken it indicates repeatedly and with great insistence, the rotation of committee members and the second-level checks.

And it repeats them in the Annex to the call for the aimed research of 2013. These concerns and these enforcement measures should therefore also enter in the plans for the prevention of corruption of all ancillary institutions of the Ministry of Health, including the IZSs. But in the prevention of corruption plan of IZS of Sicily (Resolution 552 of the IZS of Sicily, dated May 23, 2013), the word “research” is even never mentioned.

Maybe it’s just a chance: How is it possible that a strong suggestion of the ministry of health remains dead letter in the periphery of the empire? Certainly the measures proposed by the Ministry have been adopted but their adoption in the anti-corruption plan was simply not specified.
We checked. Take for example the rotation of the evaluators of grant applications, as recommended by the Ministry. So, in IZS, this means the rotation of members of the CTS, which is the scientific technical committee.

But this rotation is unfortunately never mentioned at the IZS of Sicily. In contrast, the members of the Scientific Technical Committee (CTS), appointed by the resolution 822 of 27 September 2012 are since always the same and even the regulation approved by resolution 832 of 3 October 2012 does not mention any rotation for all the three years engagement and for the, already planned, 3 months extension.

Of course the evaluation of the CTS will be made on the basis of objective parameters. The adoption of guidelines for the assessment is in fact another preventive measure against corruption. The ministry itself adopts guidelines, and it would be enough simply to copy them.

In research 2.0 workflow there are evaluations of Commissioners, i.e. the referees, with the explanation of the criteria to be adopted to make sure that the evaluation of aimed as possible.

In 7 points from scientific quality, value and feasibility of the proposed research objectives it examines in detail the strengths and weaknesses of the proposal.
1-Scientific quality, value and feasibility of the proposed research objectives.
2- Novelty , originality and transferability of the project.
3-Methodologies and detailed description of the development of the project for its entire duration, preliminary data and references.
4-Scientific (general information), research (based on the curriculum and publications, the 5 best articles, the 5 most relevant to the topic of research, taking into account the impact factor of the journals in which the articles are published, the number of citations by publication born of the presentation of the research project and the index h) and the last 5 publications. Experience of the research team.
5-tools, infrastructure and equipment available. Economic adequacy and a detailed list of expenses.
6-If the project is somehow inherent in ideas or industrial products patented or subject to rights protection.
7-General Evaluation.

But the evaluations of the CTS -IZS Palermo are absolutely arbitrary: in the minutes of November 12, 2013 the CTS shows that have not followed these criteria, but they came up with new criteria that apparently do not look a priori but established after the reading of the research projects, which leaves a bitter suspicion that the criteria serve as supporting documents for the a priori exclusions of the projects on the basis of other, maybe not scientific, reasons. But that’s not enough. There are the minutes of the meetings, but it seems that no reports on the assessments and evaluation of the single project exist. In other words we are far from the precise grid given by the Ministry of Health for the evaluation of grant and indeed, we are far from any grid of evaluation and far from a semblance of objectivity, from any detailed assessment. Here the “assessment” is an imprecise “pour parler” without any of the formality grids required for the evaluation of grant…

Moreover sometime the assessment seems to be the result of great scientific unpreparedness. Sometimes the “opinion” is so rough to fall into serious scientific errors. This is the case of the evaluation of a project for the Current Research 2013 presented by Anna Maria Vitale (CV), head of the Genetics of Microorganisms laboratory: a request for funding for 80 000 euros for a two-year project in the thematic area of food safety titled Study of biofilm and new molecules with anti-bacterial biofilms in the veterinary field that involves other research centers of the same IZS and the University of Palermo. The CTS answers (we copy text and paste) “Proposal not related to food safety, if not on the third aim: not to be checked mastitis causing udder germs but Aeromonas, Pseudomonas, etc.” Attached the source.

The response surprised even the humble pen shovel worker author of this blog: searching on pubmed or even google search for bacteria most often associated with food poisoning you will get to US government sites (for example that of the USDA or this one) in which Pseudomonas and Aeromonas are never mentioned. Not surprisingly, the proponent of the research answers with polite irony to the comments of the CTS: “of the main pathogens in food security despite extensive research I cannot find any mention of the same Pseudomonas or Aeromonas as proposed by the above CTS“. But there is nothing to do, the project is now discarded.

What the consequences? This arbitrariness of the evaluations makes judgments of CTS Palermo increasingly inconsistent with the assessments of international and ministerial referees. In fact in Year 2011 aimed research projects presented by IZS Sicily there is only a research entitled “Ecoepidemiology of Mycobacterium bovis infection in the Mediterranean area: a multidisciplinary approach” that has been assessed by independent international referees and had a score of 9 (see Annex). That is no small thing: the best score is 5, the worst is 45: in that round the other projects of IZS Sicily, had assessments much worse, from 19 points up (see page 159 in the first), by international referees.
Is it so peculiar that the IZS Sicily lies so badly within the Italian IZS?

Cui bono? One for you, one for me …. Of course, no one is immune from likes and dislikes, but when you are part of a CTS the rejection of the projects cannot depend on human emotions. One might ask why the CTS regularly rejects projects of some areas? Cui bono? To whom go the funds that would otherwise go to them? But just digging a bit you find that the list of conflicts of interest is really too long to tell them all.
The CTS consists of three external members and four internal members. The three external components are Domenico Rutili IZS Umbria, Paolo Boni and Peter Schembri, a manager at the Veterinary Health Service 9 Dasoe of the Regional Health. The four internal members are the president Rossella Colomba Lelli, Santo Caracappa, Anna Fausta Marino and Vincenzo Ferrantelli.

All components are department heads except the president who is scientific director of the Institute but also has a role as a department head and the role of internal members are to evaluate acts (projects) in which they themselves play the role of scientific responsible or responsible for the operating units. Or the approved projects are submitted by employees of their structure and taking place in one of the laboratories under their jurisdiction. In other words the evaluator is also evaluated.
But let us see conflicts of interest in details.

There are three types of COI: a) COI due to appointments; b) COI due to personal benefits  c) COI due to family benefits

a) COI due to appointments. External member SCHEMBRI Pietro is an executive of the Department of regional health. The department is the controller organ on technical and scientific activities of the IZS Sicily and then Schembri has a dual role of a controller- controlled …He should never have to come into CTS of IZS of Sicily.

b) conflicts due to personal benefits. External member Paolo BONI
Boni Paolo is not just an external member. He has been for years an executive of the IZS, now retired and considered “external member” of the CTS. He was given a coordinated and continuous assignment for 7 months (May through December 2014) paid 30,000 euros. He hasn’t given this assignment by himself: but praiseworthy, was Anna Fausta Marino, a member of the CTS who on 7th May 2014 (471 resolution) has entrusted him a project of which she is scientific responsible titled Interregional Research Center for Food Safety & Health IRC_FISH. Not a bad reward for a role that is (should be) free with only the payment of reimbursement of expenses.

c) conflicts due to family benefits Internal member Caracappa Santo
I have a family! Santo Caracappa was for years the Scientific director of the institute. In 2012 the ever-deserving Anna Fausta Marino, a member of the CTS asked herself for and obtained funding for a research project Current research IZSSI 17/12 entitled: Toxoplasmosis comparison study between classical and innovative diagnostic techniques. As part of the same she entrusts a task to cooperate to the recently graduated daughter of Caracappa. Not satisfied, Dr. Marino on 27th November 2014 (Resolution 1115) asks, always for Giulia Caracappa, veterinary surgeon, the authorization to carry out a 10 days internship at the laboratories of the Centre for Virus Research at the University of Glasgow in Scotland for a total cost of Euro 5,000. Even this resolution is, of course, immediately enforceable and “has characteristics of urgency” otherwise as it is well known “The viruses escape”. Anna Fausta Marino has motivated this trip as “an opportunity to carry out the internship to the temporary collaborator for the fact that the laboratories of the Centre for Virus Research at the University of Glasgow (Scotland) are in possession of equipments with high technological value aimed at the application of the innovative technology of genome sequencing and that in the course of the internship, Dr. Giulia Caracappa will learn more about genetic strains and biological isolates that will be sent at the laboratory “(SIC).

We are really sorry that Dr. Marino is convinced that to sequence a virus we need to go up in Scotland, in Glasgow … Italy in this field is not set back as she believes. Indeed. The Glasgow laboratory is biosafety 3 while Marino does not know that in Rome, at the Institute Lazzaro Spallanzani Laboratory, there’s even a laboratory biosecurity 4, the highest, and the virology laboratory has a system of high-sequencing throughput of the latest generation based on the 454 platform.
And if a laboratory biosafety level 3 is enough, like the one in Glasgow, these in Italy are very, very common.

A consolation is that we are not the only ones perplexed about how the IZS Sicily invests public money. It seems to be also the Statutory auditors that examined and evaluated a sample numbers of resolutions, concerning the above resolution “demands to know the considerations that led the responsible of the research project” (Dr. Anna Fausta Marino) to authorize Giulia Caracappa to go in Glasgow at the expense of the Institute (i.e. Italian citizens paying). It continues “The controlling body, as repeatedly noticed, questions the opportunities to send for a mission in Italy and, even worse, outside Italy, unstructured personnel for educational and training activities” (See Minutes – CoR – 13 – of the December 19, 2014 p. 7).

As you can see the scientific direction of the IZS Sicily, in the last years, has had many shortcomings. It is hoped that the Ministry of Health and the one of Scientific Research may turn a closer look at conflicts of interest in the allocation of funding for research, and that transparency also concerns the resolutions on the formation of the CTS and the research funding to allow a more effective public control.

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