Excel Sheet semifinal duplication rev1 - European Commission · duplication may be possible in regulatory testing. However, in basic research proof of reproducibility provided by

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Question IX.Aa.

Question text:

Introduction IX.a) Current provisions of Directive 86/609/EEC Member States shall, as far as possible, recognise the validity of data generated elsewhere, unless further testing is necessary to protect public health and safety. IX.b) Current situation in Member States No specific instruments apart from ethical evaluation are employed at the Member States to reduce duplication of testing. Retesting is a legal requirement for general medical products for human and veterinary use. The only instruments possibly contributing to a reduction of duplication in this area are Mutual Recognition Agreements between exporting countries and the EU. However these instruments only cover specific issues and are thus not able to abolish the requirement to test all products coming from that exporting country. For vaccines there is an option for Member States to retest, which 10 – 15 Member States actually use. IX.c) Trends and implications One of the leading principles of the Three Rs is to avoid unnecessary testing on animals. However, due to the different laws, administrative procedures in authorisation and inspection arrangements in the Member States, it cannot be excluded, that duplication of testing may occur. First evidence shows, that in Europe approximately 160.000 animals are subject to duplication in regulatory testing each year.

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Statistics:

IX.d) Problem dimension Currently, there is no harmonised approach in Europe to ensure an effective exchange of relevant information and data regarding animal experiments. Authorisation and inspection bodies as well as researchers do not have the necessary overview of objectives and results of all experiments carried out each year on more than 10 million animals in the EU 25 alone. Although it can be argued that scientists usually have an excellent overview of the literature within their respective fields of specialisation, negative results (although equally valuable), however, are usually not reported. Only 25% of all Member States have currently a system of automatic data collection in place. IX.e) Potential solutions A significant reduction of duplication in regulatory testing would require changes in numerous legislative requirements at Member State level. This policy approach, however, cannot be addressed by a revision of the given horizontal Directive. Compulsory authorisation of projects and ethical evaluation aims partly to address this problem. However, these are discussed in detail elsewhere in the questionnaire. In view of this situation, the general approach of a revised Directive regarding the reduction of duplication could be setting-up a centralised EU-wide database collecting information on project authorisation and scientific results in each Member State. The database could also provide a discussion platform where scientists and inspectors could exchange their experiences, problems and good practices. As far as possible, information on 3rd countries should be collected. This could contribute in increasing the knowledge, especially in basic research, and provide more transparency on “negative results”, not systematically published so far. The database would not be made public but be restricted to scientists and inspectors only. Do you support this overall analysis?

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83 respondents stated that they support the preliminary analysis.

23 respondents stated that they have no opinion in relation to this question.

101 respondents stated that they do not support the preliminary analysis or components of it. To justifydisagreement, they were asked to provide arguments, facts and figures and if possible indicate the source of information. However, a number of respondents opted for the "No" reply only to supply additional arguments in support of the preliminary analysis.

Comments received:

Name of the expert or organisation

Type of organisation

Activity level of the organisation

Representative- ness

IX.Aa.

Dept. Laboratory Animal Science, Utrecht University, The Netherlands

User of animals -public sector

Worldwide chair of lab. animal sci. recognized by national authorities/responsable for national coordination education and training in lab. animal sci./ leading role in international laboratory animal science

Establishing such a database is not supported by a cost-benefit analysis, as the costs would be high and benefits minimal. See comments on 1.1 below.

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Dezentrale Biomedizinische Einrichtungen der Med. Universität Wien


Local; National yes No, not easily practicable

Gesellschaft zur Förderung der biomedizischen Forschung


National The organisation is representative for the field at the respective activity level.

at IX.e) Potential solutions No Proof of reproducibility of results is imperative in natural science. Avoidance of duplication is only possible for safety testing (REACH).

Hannover Medical School


Local; Regional; National

Hannover Medical School currently ranks highest with respect to research activities and aquired research grants

Proof of reproducibility of results is imperative in natural science. Avoidance of duplication is only possible for safety testing (REACH).

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Hans J. Hedrich User of animals -public sector

Local; Regional; National; European

I am currently President of the European College of Laboratory Animal Medicine (ECLAM) and Vicepresident Gesellschaft zur Förderung der Biomedizinischen Forschung

No Proof of reproducibility of results is imperative in natural science. Avoidance of duplication is only possible for safety testing (REACH).

Prof. Dr. R. Nobiling, University of Heidelberg


Regional; National; European; Worldwide

Biomed research at Univ. Heidelberg is Top - ranked

Proof of reproducibility of results and including control groups is imperative in science. However, this is not a duplication of experiments or projects. This can exluded in a well organized scientific community Duplication, however, can and should be avoided in primary safety testing (e.G. REACH).

Timo Nevalainen User of animals -public sector

Local Yes There is already EU-funded ECVAM, not to mention association based structures. Another important point is that verification and confirmation of experimental results is inherent to good science, thus should not be regarded as duplication.

Torgny Jeneskog, Umeå University, Sweden



Yes, guess so ... I cannot understand why and how - at all - this kind of "EU database" might solve the problem of duplication (in regulatory testing).

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(Name confidential - Respondent 001)


National; European; Worldwide

yes The mentioned database open to all scientists of Europe will in fact be a public database which will cause severe problems with a minority of potentially violent animal rights activists. Avoidance of duplication may be possible in regulatory testing. However, in basic research proof of reproducibility provided by other groups is a necessity to ensure a critical approach! Databases introduced for scientific reasons already exist and are used in the evaluation of projects by authorities too (see Chapter XII).



Local; Regional; National; European; Worldwide

XXX See 1.11




Yes It is not clear that there is a problem with duplication of testing as pharmaceuticals are patented and this prevents duplicate research by another company. There is limited re-testing for shipment of vaccines between member states which could be addressed. There is no evidence that a EU-wide database would be beneficial and could generate a huge burden. There are opportunities for focussed databases, such as that for vehicles, which is being developed by the Industry/Animal welfare dog minimisation project team. For the background to this initiative, which could have positive welfare benefits and ensure no duplication takes place with these materials see Smith D et al, ILAR Journal 43, S39-S42, 2002



Worldwide there are others Proof of reproducibility of results is imperative in natural science. Avoidance of duplication is only possible for safety testing (REACH).

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National Yes, we are representing all physiological researchers in the Netherlands; we have about 300 members

The easiest way to reduce duplication is to allow test results from one country for the same purposes to other EU countries. In this way control is exercised at the level of the regulatory authorities, not the investigators.



Worldwide One of several global pharmaceutical companies

It is unclear what the 160,000 animals refer to. There is some replication necessary for safety reasons. Concerning the nonregulatory situation: There is clear need to replicate results. Reliability and reproducibility are crucial for medical ethics to assure quality. Research has to deal with species and strain differences. In this respect the public opinion is often misled. The impact of data bases is grossly overestimated. The EU contributes a decreasing share of scientific results globally. More results are being generated in US and increasingly in Asian countries, esp. China. Many results would be outdated at time of publication. Results from pharmaceutical industry would hardly contribute to decrease animal numbers since companies typically work on patentable compounds.



Not applicable we are a medical university.

absolutely not. Duplication is important for good science. Scientific studies are not often duplicated exactly. There is no question that duplication, reproduction is absolutely critical for science.



Not applicable yes ] Replication of experiments is the fundament of science. Attempts to prevent duplication can be considered as a serious threat to produce solid and replicable scientific results

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Local; National There are several central laboratory animal facilities at Austrian universities

Avoidance of duplication is possible in regulatory testing. In basic research proof of reproducibility by others is a necessity! A database open to all scientists of Europe is in fact a public database which can cause problems with animal activists.



Local representative Proof of reproducibility is imperative in natural science. Duplication might be avoidable in safety testing.



Local yes No. This is an idealise view concerning this topic. In reality it will not work (see below). How does the database know who is a scientist. There might be also animal right activists who are claiming that they do scientific work.



National no Proof of reproducibility of results is imperative in natural science. Avoidance of duplication is only possible for safety testing (REACH).



National yes Bureaucratic centralized regulation of research goes AGAINST the essence of free research. It is not for the regulator do decide which research is worth wile, but to the scientist. I strongly oppose centralized control.

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National yes First need is the definition of a negative result, to prove the absence of effect is the most difficult task in science. Results are based on statistical approach which can prove that groups are different or that they are not different. Inclusion of negative results in a database also needs a peer review process for the insurance of their validity. Data which are not validated could not be useful for rejection of a procedure. Research project are subjected to peer review by scientific expert. During this review, it is necessary to prove that the project is new and has not been previously done. So there is a control based on scientific up to date information done by experts in the field of interest. Creating a database with validated date conduct to a duplication of these evaluations and waste of time and money.



Regional; National

yes see 1.11



Local Not applicable, I am not an organisation

This will be impractical




yes, we are a major EU HEI for biomedical research

No. The issues here are fundamentally political and will not be assisted by a bureaucratic solution. What is at stake here is whether the judgment of medical doctors in one country is trusted by doctors in another. This is not just an EU problem.



National Some smaller institutes exist in the Netherlands

I think this would only be relevant for regulatory testing. For all other experiments the complications with confidentiality issues would be tremendous, except when dealing with obsolete results. The gain for basic science projects would be small, and be outweighed entirely by the additional costs.



National yes Proof of reproducibility of results is imperative in natural science. Avoidance of duplication is only possible for safety testing (REACH).

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It is a University, the question is meaningless

This is an example of an unnecessary layer of bureaucracy, which would add both financial and temporal constraints beyond its benefits. The current level of duplication identified is low, and unlikely to rise.

Bayer HealthCare

User of animals -private sector

Worldwide organisation is representative for the field

The publication of results from animal experiments in an EU-wide internet-based data platform is often impossible as the data are confidential (e.g. in industry). However, it exists already discussion forums in the internet addressing questions to animal studies (confirmed by login and authentication). Results from basic research are publicized on international conferences and publications in international reviewed journals. These results are publishable only one-time. Thus, there is no benefit to establish an additional discussion platform to prevent duplications of animal studies.

GlaxoSmithKline User of animals -private sector

Worldwide Thre are other international pharamceutical companies. We produce 25% of the worlds vaccines

This analysis confirms, as have others http://www.apgaw.org/userimages/Vaccinetesting.pdf that national governments and the EU cause duplication of regulatory testing. It then says it cannot do anything about this, so proposes the burden of a database to addresses it own deficiencies. This is entirely unreasonable

Protherics Medicines Development Ltd.


Worldwide No - ABPI and EFPIA repesent the pharmaceutical industry in UK/EU

See 1.1

sanofi pasteur R&D


Worldwide Vaccine field Based on previous experiences of central database, those systems are not efficient with limited (no) added-value. Worldwide harmonization of regulations might be more effective to limit duplication of studies.

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National yes The setting of such a database seams to be the solution, but I am not sure if there is so much duplication in research. EU- wide database for all results will be very compact and needs high effort to keep the data updated. Regulations, Agreements between MS could be more effective than such a database. There are also existing databases in EUROPE, like REACH.




Sanofi aventis is the largest pharmaceutical company in Europe and ranks third worldwide

Experience with Industry projects designed to create databases of this type show that it is extremely difficult and represent a significant challenge. The contents of the database could rapidly extend to intellectual property that would need to be excluded.



Worldwide Yes Very bureaucratic and do not address the problem in paragraph b), c) and d).



Worldwide Research and development

no comment



Worldwide Yes There are no evidence that a centralized data base would result in a reduction of “duplication” of experiments, since there are no sound data indicating duplication of experiments today. Private institutions will not perform research studies in areas protected by patents of competitors, e.g. pharmaceutical industry will not do pharmacological studies in areas of patents of others and will perform extensive analysis of patent situation simply for economic reasons. Researchers in public and private institutions active in a field are generally well linked to their colleagues also working in the field and since many animal experiments are highly specialized, the benefit of a such a database is questionable. The efforts for setting up and maintaining such a database will be remarkably high. Therefore, a proper analysis of the actual benefits to be expected is needed first.

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Worldwide other relevant organisations

no comment



Worldwide yes Because it is impossible to give a valid definition who is a scientist, how will this designation be awarded



Not applicable Also other biotech companies have similar animal facilities

In the private sector, confidentiality of data might limit feasibility of this EU database



Worldwide There are many other such organisations in Europe

The key issue for duplication is not duplication of licences but duplication of data sets for regulators. The proposal is not appropriate for matters relating to the protection of intellectual property. In the pharmaceutical industry minor chemical differences in compounds are subject to protection of intellectual property due to their potential to dramatically increase efficacy and or safety parameters. The implementation of such unrefined proposals would bring intolerable risk to the operation of drug discovery paradigms in the pharmaceutical industry. It may also be helpful to better define replication versus duplication (see report of Nuffield Council on Bioethics, report titled “Ethics of Research Involving Animals”, p 264, 279,www.nuffieldbioethics.org/go/ourwork/animalresearch/introduction). and whether the screening of distinct chemical entities in a particular animal model would be considered as duplication of testing.



Worldwide No If there are EU Directives which may result in duplicate testing it is these which should be changed, not the system which authorises tests. Publication of negative results for education of others should be recognised as a good thing and encouraged.

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Worldwide Yes It is difficult to understand how this proposed system will be administered to attempt to avoid duplication of animal experiments. Supplying information to a central database will be problematic as details of experiments are usually commercially sensitive. Drug companies will not want to supply information to such a database as this may give their competitors an advantage. The situation will undoubtedly encourage industrial espionage. It will also be very costly to administer, which will, in turn, favour larger establishments.



Worldwide YES (Safety Assessment)

It is being assumed that there is a problem with duplication of testing. This is not the case. There is limited retesting (eg batch release for polio testing). ICH and mutual recognition agreements would be more useful than any database.



Worldwide Global pharmaceutical research and development

No welfare effect of a central database - scientific DBs already available



Worldwide yes see answers below



Worldwide Representative For the safety assessment of new drug, retesting is only limited to satisfy ICH requirements, and to support/compare new data generated "in-house". The large amount of variables still present at individual Research Centers prevent the possibility to generally adopt data obtained at other facilities. Different perspectives might be adopted for the assessment of the existing chemicals, but these have to be consistent within the REACH Program.



Worldwide yes It is being assumed that there is a problem with duplication of testing. This is not the case. There is limited retesting (eg batch release for polio testing). ICH and mutual recognition agreements would be more useful than any database.

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Worldwide no For reasons of effectivity, this is aiming at a comprehensive, all-embracing database, that is open to nearly everybody. Then, intellectual property protection rights will be violated. In addition, lots of people will have to collect data and put them into the database. Why is this only aiming at an EU wide database? Experiments are performed globally! The prerequisite is, that duplication of animal experiments is really an issue. For our sectors and the entire industry this is not true! In the agrochemical sector as well as in the pharmaceutical sector every company is working on their own active compounds without overlaps. For chemicals, avoiding duplication of experiments is already a prominent part of REACH (information exchange fora must be formed and testing proposals must be submitted to the agency). Overall, this will have a high negative impact on European research and industry and this cannot be the goal. Setting up such a database is neither feasible nor reasonable.



Worldwide Many organisations

It is being assumed that there is a problem with duplication of testing. This is not the case. There is limited retesting (batch release for e.g. polio testing. ICH and mutual recognition agreements would be more useful than any database. Reference documents: EFPIA impact assessment on data bases of experiments and our discussion on who should have access to data and specificity of pharmaceutical research + pilot project on data sharing. Please do not forget requirement to publish data under REACH.



Worldwide Yes Duplication may be a problem in basic research where negative results are hard to publish. In regulatory testing, duplicate experiments will be avoided for economic reasons already. However, management of well-run database will be very cost-intensive.



National representative For basic research such a data bank would only be accepted if intellectual property issues are included. Furthermore, a very actual database must be available. If the data are more than 3 month behind, nobody would use it. For regulatory sensitive data and animal studies a data base could be helpful.



Worldwide Don't understand this question

The proposed solutions do not address the issues identified in paragraphs b. c and d.

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Animal Procedures Committee (APC)

Public authority National The APC provide independent advice to UK Government on the use of animals in scientific procedures. The APC consider science, industry and animal welfare. Members are from a variety of backgrounds.

Scientists will necessarily go to great lengths to avoid duplication for very practical reasons. The availability of any tool to assist in this should be welcomed. Fundamental research, however, may be less amenable to use in a straightforward database and the use of systematic review/meta-analysis techniques in animal-based research should be promoted and encouraged to avoid duplication. Statistical techniques to allow for publication bias may already be available to counter the effects of non-publication of negative results. No reference is given for the statement in IXc: “First evidence shows, that in Europe approximately 160.000 animals are subject to duplication in regulatory testing each year.” However, if the EC were successful in addressing this specific issue, it may be a more effective way of reducing the number of animals used in procedures than introducing a database.

Coordination group for laboratory animal activities

Public authority National Yes There is already EU-funded ECVAM, not to mention association based structures. Another important point is that verification and confirmation of experimental results is inherent to good science, thus should not be regarded as duplication.

DR Achim Klug, Ludwig Maximilians University Munich

Public authority Worldwide; Not applicable

Deutsche Forschungsgemeinschaft - DFG

For funded research, the best way to avoid duplication is the grant review process. For competitive funding, one will not be able to get grants for something that has already be done. Again, grant reviewers (peer reviewers) are usually much more competent at determing this issue than any other governmental regulatory agency even under the most ideal circumstances could.

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Francois Lachapelle INSERM

Public authority National BEA du CNRS, de l'INRA, du CEA

establishing such a database will be extermly time consuming and wont'be supported by the scientific community

Prof. Dr. Bernd Hoffmann, Justus-Liebig-Universität Giessen

Public authority National; European

similar to other universities

Most duplication occurs in industry based research. Succesful attempts have been made to decrease animal experiments. I dont think that another substantial progress can be made. Since has to publish which inherently is against duplication. Above all, published data can also be used for registration purposes.


Public authority Local yes Proof of reproducibility of results is imperative in natural science. Avoidance of duplication is only possible for safety testing (REACH).


Public authority Local yes Proof of reproducibility of results is imperative in natural science. Avoidance of duplication is only possible for safety testing (REACH).Proof of reproducibility of results is imperative in natural science. Avoidance of duplication is only possible for safety testing (REACH).


Public authority National; European; Worldwide

yes The reasons are given below.


Public authority National Yes Neither science nor business works in this way. Who should read it? Companies do not publish these data either.


Public authority Local; Regional no This will be ineffective but very bureaucratic

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Public authority National We are the National Competent Authority

The case has not been made that there is a significant amount of unnecessary duplication. Whist the UK strongly encourages and promotes data sharing, the proposed database would be prohibitively expensive and difficult to establish and maintain if it was ever to be seriously considered as a means of finding sufficient high-quality, comprehensive, accurate and up to date information to be of practical use. It is not clear how any mandated use of such a database would be monitored, or how its value and impact would be judged. It is also important to appreciate that data is often owned by those who commission testing – and not the test labs themselves. What is needed in the context of regulatory testing is, though other directives, better promotion of data-sharing, and mutual acceptance of data.


Public authority National Regulatory authority in UK

see 1.11



Although we are a smaller University, about half of the research groups involving animal experiments belong to leading institutions in their field.

Proof of reproducibility of results is imperative to science. "Replication in science … is a way of being sure that something really exists." (Giles, 2006, "The trouble with replication", Nature 442: 344-347). This implies that scientists have to be able to replicate experiments from other groups. Avoidance of duplication is only possible for safety testing.


Public authority National representative Proof of reproducibility of results is imperative in natural science. Avoidance of duplication is only possible for safety testing (REACH).

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1.Animal Aid Other National Other organisations do exist

There should be a statutory obligation to avoid any duplication. To suggest that it would be too complex to introduce such legislation represents a lack of compassion and a disregard for the suffering of fellow sentient beings. A regime that permits duplication is an affront to the Universal Declaration of Animal Rights (proclaimed in Paris on 15 October 1978 at the UNESCO headquarters, and made public in 1990).

Biosciences Federation

Other National; European

There are other relevant organisations

We cannot see how these suggestions could be workable. First, recent UK history of the development of major national databases has shown that they are very expensive, fraught with technical problems and rarely fit for purpose. Second, the results would need to identify the research group, which is not acceptable for security reasons. Third, issues of IP protection would obstruct the objective, as if competitors in a particular research field are doing similar research they are not going to release information to the other side An objective and evidence-based cost-benefit analysis would need to be undertaken before these proposal should be taken forward.

COST Action B24 “Laboratory Animal Science Welfare” - http://biomedicum.ut.ee/costb24

Other European No No. This is an idealised view concerning this topic. In reality it will not work (see below). How does the database know who is a scientist. There might be also animal right activists who are claiming that they do scientific work. And there is already EU-funded ECVAM, not to mention association based structures. Another important point is that verification and confirmation of experimental results is inherent to good science, thus should not be regarded as duplication.

Medical University of Vienna

Other Local; Regional; National; European; Worldwide

Research in Medicine

see 1.11.

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National Centre for the Replacement, Refinement and Reduction of Animals in Research

Other National Representative Much duplication of animal testing is imposed under EU regulations. A more profitable way of achieving a reduction in animal use would be to address this issue. A database may be onerous and too simplistic to be cost effective on any large scale. Systematic reviews and meta-analyses may be more productive.

Royal Netherlands Akademie of Arts and Sciences

Other National Yes, representative of the scientific community

To our knowledge this database is not a feasible option in basic research. For a start, it would give scientists extra administrative tasks. Secondly, in basic research it is very important to perform experiments yourself, even if they have already been performed elsewhere. Testing conditions might differ substantially, so one prefers not to rely on someone else’s results. Next to that, we are worried about privacy matters. It is not guaranteed that people with false intentions will not abuse the information available.

TNO Quality of Life (The Netherlands)

Other National; Worldwide

Yes A central european database is not achievable and meaningfull, because of: - compulsary input of data, including negative results, and keeping the data base up to date will lead to bureaucracy - for regulatory test data compound names are often propriety; under REACH lower tier test data will probably be publicly available in IUCLID V - several large databases on Alternatives are already available (e.g. ECVAM)


Other National I am the chair of the Hungarian Scientific Ethical Committeeon Animal Experimentation

It is a nice, naiv, unrealistic idea.

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Other Local We are relatively small in terms of usage but our operational organisation is typical

Benefits would not justify costs. Effectiveness of such a body is questionnable.


Other Not applicable other The mentioned database open to all scientists of Europe will in fact be a public database which will cause severe problems with a minority of potentially violent animal rights activists. Avoidance of duplication may be possible in regulatory testing. However, in basic research proof of reproducibility provided by other groups is a necessity to ensure a critical approach! Databases introduced for scientific reasons already exist and are used in the evaluation of projects by authorities too (see Chapter XII). Duplication is largely restricted by the need to publish, which is not possible by duplicate work


Other National Yes It is not the case that there is a problem with duplication of testing. As a result, ICH and mutual recognition agreements would be of more use than a database.


Other Worldwide pharmaceutical industry

When intellectual property right and personal confidentiality are secured, such database cannot lead to an exchange of data between experimentators and many data would be excluded from such database. Therefore, the costs of such database would not be in proportion of the very limited gain, if any.


Other European yes These findings assume that there is a problem with duplication of testing. This is not the case. ICH and mutual recognition agreements would therefore be more useful than a database.

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British Heart Foundation

Non-governmental organisation

National We are a medical research charity, of which there are many in the UK

An EU register os experiments for regulatory testing could be useful, but a register for all experiments would be very expensive, difficult to analyse for duplication, and would not lead to significant reduction in animal use.

Eurogroup for Animal Welfare/EWLA


European Eurogroup/EWLA is made up of animal welfare Member Organisations and Observers in all Member States

The Introduction focuses on duplication in specific aspects of regulatory testing whilst neither fully addressing this issue nor fully addressing the issue of duplication in basic and applied research which is equally important. Some means of preventing duplication is essential, and its cost would be outweighed by the benefits in terms of a) reducing the impact of science on animals and b) economic benefits. A single centralised database may not be the best, or only, answer to address duplication in different areas of research and testing. Different strategies are likely to be required in different sectors of regulatory testing and to cover basic research. The problems of duplication, and possible solutions in basic and applied research, should be assessed separately.

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FELASA (Federation of European Laboratory Animal Science Associations)


European FELASA represents 13 European lab animal sci associations and therefore some 3-4000 members of those associations (scientists, veterinary surgeons, technicians etc.). See www.felasa.org

Establishing such a database is not supported by a cost-benefit analysis, as the costs would be high and benefits minimal. See comments on 1.1 below.

Gesellschaft für Versuchstierkunde - Society for Laboratory Animal Science (GV-SOLAS)


National; European

Yes No. This is an idealise view concerning this topic. In reality it will not work (see below). How does the database know who is a scientist. There might be also animal right activists who are claiming that they do scientific work.

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PETA Europe Ltd.


Worldwide both The impact is not neutral because it will reduce animal use and has the potential to improve science. A statutory obligation to avoid duplication should be required. Regulatory testing can and should also be included. In some instances, sharing of information about failed/negative studies could lead to a reduction in animal use and improved science if more effective non-animal methods are introduced. Repetition of flawed animal research is also less likely to happen, resulting in better use of research funding. The additional cost of setting up the system will be outweighed by the financial benefits, and in any event measures to improve animal welfare should always be introduced regardless of cost, in line with the EU commitment to the 3Rs.

Stichting EDEV - Een DIER Een VRIEND


National; European

We cooperate with animal organisations within the ECEAE

This database shoul be public, why not?

The Physiological Society


Worldwide Many other Learned Societies aer also representative

We cannot see how these suggestions could be workable. The work to get all data into a consistent searchable format would be enormous. To be useful, the results would need to identify the research group, which, as indicated elsewhere, is not feasible on security grounds. Issues of IP protection would obstruct the objective. The central support needed would be considerable and ongoing to maintain the database. An objective and evidence-based cost-benefit analysis would need to be undertaken before such a proposal should be taken forward. In any case, any major duplication of basic research is weeded out on cost grounds and during peer review of project proposals, and, as indicated, regulatory duplication cannot be improved by such means.

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The Royal Society


National Yes. The Royal Society is the independent scientific academy of the UK dedicated to promoting excellence in science. The Society plays an influential role in national and international science policy

Whilst we support the principle of avoiding duplication by setting up an EU wide database where negative data could be published, we believe that there is a risk that the costs and resources required will not be proportional to the benefits to be gained from it. The time and resources need to get all data into a consistent searchable and useful format would be enormous. There are also issues of security, confidentiality and IP protection.

UK Laboratory Animal Science Association (LASA)


National LASA represents animal user community in academic, government & industry sectors.

We disagree that there is a problem with duplication of testing. Active pharmaceuticals are patented and this prevents duplicate research by another company. There is limited re-testing for shipment of vaccines between member states which could be addressed. There is no evidence that a EU-wide database would be beneficial and could generate a huge burden. There are opportunities for focussed databases, such as that for vehicles, which is being developed by the Industry/Animal welfare dog minimisation project team. For the background to this initiative, which could have positive welfare benefits and ensure no duplication takes place with these materials see Smith D et al, ILAR Journal 43, S39-S42, 2002



National yes The mentioned database open to all scientists of Europe will in fact be a public database which will cause severe problems with a minority of potentially violent animal rights activists. Avoidance of duplication may be possible in regulatory testing. However, in basic research proof of reproducibility provided by other groups is a necessity to ensure a critical approach! Databases introduced for scientific reasons already exist and are used in the evaluation of projects by authorities too (see Chapter XII).

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National NO OTHER RELEVANT ORGANISATION

The proposal is not precise enough, especially regarding the content of the database (validation process mandatory)



National YES The setting up of an centralizes EU-data base seem impracticable.



Worldwide No other organisations

Whilst we would support the principles behind setting up a database to share information at the EU level, we believe that the resource requirement necessary to establish such a complex system is out of proportion to the benefits to be gained from it. Any such system would be too cost prohibitive and difficult to run. It would take an enormous amount of time and resources to turn the information into searchable data that would be useful to the research community. Issues of security, confidentiality and IP protection would also prove problematic.



Worldwide - -



National yes The database does not help. It would be very demanding and costly to keep it updated.


Breeder of animals

Worldwide Representative These platforms already exists on the scientific level. Thus a duplication of experiments is excluded. Further database will only increase cost and work.

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Regional; National

Not applicable: response is personal opinion based on personal expertise

Although the concept of an EU wide database for this purpose is reasonable, the practical problems related to collecting, uploading, storage in a meaningful and retrievable manner and maintenance (ensuring database is up to date) seem impossible to overcome without extensive resources.


National; European

There are other organisations

Duplication resulting from regulatory requirements should be addressed by the relevant regulatory authorities, and will not be solved by the proposed database.



Yes see below

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Question IX.1.1.

Question text:

Statistics:




Comments received:





IX.1.1a.

Preliminary assessment shows an overall neutral impact of this element: A centralised EU-wide database can help to prevent duplication of testing by providing neutral, timely and comprehensive information about all non-confidential authorised projects in Europe. This can increase both animal welfare and the quality of science, and could make research funding go further as it would avoid having to carry out those experiments that do not need to be duplicated. However, the resource requirements for establishment, administration and maintenance of such a database coupled with challenges for timely availability of information to ensure usefulness could reduce the efficiency of this option Do you support this overall analysis? Yes/No/No opinion

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The cost-benefit analysis does not support the establishment of a centralised database. True duplication is a very rare event, extremely so in the industrial sector owing to differences in molecular structure of compounds and in formulations and excipients. This analysis is supported by the UK Home Office, based on detailed inspections and licensing system in place in that country. Such a database would therefore have a minimal effect on reduction in animal use. There would also be considerable concern at possible disclosure of information that could be of benefit to competitors, and this could lead to a movement of research outside Europe.



Local; National yes No increase in animal welfare expected




at 1.2 and 1.4 No No welfare effect of central database, sufficient assessable scientific databases exist.

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XXX See 1.11




Such database is not needed; companies know what they have done to comply with regulations in one country and should simply be avble to use the same data for the same purpose in the other country.




The impact of data bases is grossly overestimated. The EU contributes a decreasing share of scientific results globally. More results are being generated in US and increasingly in Asian countries, eg. Japan and China. Most results would be outdated at time of publication. Results from pharmaceutical industry would hardly contribute to decrease animal numbers since companies typically work on patentable compounds. The administrative burden to justify experiments when similar but nort equal experiments have to be discussed would be tremendous. There is clear need to replicate results. Reliability and reproducibility are crucial for medical ethics to assure quality. Research has to deal with species and strain differences. In this respect the public opinion is often misled.

30




Other organisations in Austria: Karl-Franzens-University; Medical University Vienna; Medical University Innsbruck

The publication of negative findings is as time-consuming and costly as positive findings, but negative findings do have very little impact, because they do not prove or disprove a principle: from negative findings it can usually only be inferred that one has to try in a slightly different way. Important and conclusive negative findings are published anyway. The second problem is intellectual property. Publishing negative results would disclose the scope of current work a nd the methods applied. In this respect, most negative findings are confidential. Therefore, publishing negative findings must remain optional.




A centralised EU-wide database will not help to prevent duplication of testing. In addition, the scientific journals provide timely and comprehensive information about all non-confidential authorised projects in Europe. An EU database of this kind will waste a huge amount of money. It will neither increase animal welfare nor the quality of science. The bottomline is that most experiments do need to be duplicated. Who would send in information about their experiments? The ones that worked or conversely the ones that didn’t work? Who would send in results of experiments which are not yet published or are waiting for patents? This does not make sense.




see IX.e

31



National yes. There are other academic medical centres

The value of such a database with regard to its effect on reduction of animal experimentation is questionable. First of all, true duplication of experiments is hard to find. Each (Pharma) company has its own specific compounds, formulations. Almost by definition there is no duplication in academia due to the virtual absence of GLP/ GMP/ SOPs. The publication of ‘negative results’ through such a database will only lead to a reduction if results are accompanied by detailed descriptions of the experimental set up and materials and methods used. There is a scientific need to confirm experimental data, which is a basic to the scientific validation of data in general, as irreproducible data are considered invalid. Also, in case a method from literature is to be used, it is essential that the published method can be reproduced before additional experimental variables are introduced into the modelsystem. The phrasing, if at all included, should be: “unnecessary duplication”.



Local yes No, such a database does neither increase animal welfare nor does quality of science. There are other mechanisms already established (see top IX.e).



Regional; National

yes see 1.11




it will be impractical




No opinion. I think this would only be relevant for regulatory testing. For all other experiments the complications with confidentiality issues would be tremendous, except when dealing with obsolete results. The gain for basic projects would be small, and be outweighed entirely by the additional costs.

32



Worldwide Yes, representative

This is total nonsense, at least when applied to scientific research. We are aware of what our colleagues are doing, often well before publication occurs. In addition, it is often necessary and appropriate to repeat experiments in other labs if their results are difficult to integrate into current theory.



As above this is an unreasonable solution for a policy failure at European level. The primary problem of duplication is with regulatory authorities. This where the problem should be addressed




It is being assumed that there is a problem with duplication of testing. Batch release resting should not really be regarded as duplication, as each test is a specific evaluation of a particular batch, to ensure efficacy and safety of that batch. ICH and mutual recognition agreements would be more useful than any database. Management of such a database would be very difficult and labour/cost intensive. Much data on regulatory studies would be missing because of confidentiality, so it may not help in avoiding any duplication of testing. In the regulatory field, there should perhaps be an obligation on regulatory agencies to inform Companies of data in the public domain that could be used to circumvent repeat testing of products, or to encourage two Sponsors with related/similar products to share data. This would do more to reduce duplication than a central database.





The proposition is based on the assumption that there is something wrong with duplication of testing. Good science is based on reproducibility and that previous projects are duplicated as part of validation prior to moving on to the next step. Duplication could be avoided in product testing and vaccine quality assurance. A database is not going to influence this. ICH and regulatory authority agreement will.

33



Worldwide Yes The database very difficult to keep up to date. Mutual recognition much better.




Actually yes but Duplication of experiments should be limited to specific objectives. Regulations tend to harmonize regukatory request to avoid duplication. + problem of confidentiality



National; Worldwide

yes Actually, it is not a really a "duplication" issue… at least as a first objective. All efforts should be concentrated in priority on the real stake i.e. international harmonisation and recognition of regulatory testing




yes but, Duplication of experiments should be limited to specific objectives. Regulations tend to harmonize regukatory request to avoid duplication. + problem of confidentiality



Worldwide yes Quality of science and animal welfare will not depend on this database

34




It is difficult to support the analysis when there is a presumption that avoiding the duplication of licence approvals will result in avoiding the duplication of data sets. For example, would only one single establishment gain approval to conduct studies to generate safety data for crop protection compounds? This is a very important ambiguity about the practical operation of such proposals which must be resolved and the flawed implementation of this proposal will have many negative repercussions for both the public and private sectors. For example, the pharmaceutical industry invests in projects which are at high risk of not eventually delivering medicines for unmet medical needs and therefore the collective innovation of many players simultaneously working on the same problems is highly desirable. It is not clear if the proposal outlined about would prevent several pharma working on key targets for intervention in diseases such as asthma or HIV/AIDS.



Worldwide No No need to set up such a large and unwieldy database, with potential for misuse of data if the Directives which require duplicate testing are revised.



Worldwide yes Actually yes, but: It is being assumed that there is a problem with duplication of testing. This is not the case. There is limited retesting (batch release for e.g. polio testing. ICH and mutual recognition agreements would be more useful than any database. Reference documents: EFPIA impact assessment on data bases of experiments and our discussion on who should have access to data and specificity of pharmaceutical research + pilot project on data sharing. Please do not forget requirement to publish data under REACH.



Worldwide Yes A central database is for research companies not practicable as the majority of experiments are unique due the different nature of compounds. Duplication must be avoided by adapation of the regulatory requirements of the EU countries and not by the introdcution of a money consuming datbase.



Worldwide no For reasons of effectivity, this is aiming at a comprehensive, all-embracing database, that is open to nearly everybody. Then, all confidentiality and intellectual property protection rights have to be violated. In addition, too many people will have to work on collecting data and putting them into the database.

35




It is being assumed that there is a problem with duplication of testing. This is not the case. There is limited retesting (batch release for e.g. polio testing. ICH and mutual recognition agreements would be more useful than any database. Reference documents: EFPIA impact assessment on data bases of experiments and our discussion on who should have access to data and specificity of pharmaceutical research + pilot project on data sharing. Please do not forget requirement to publish data under REACH.



Worldwide yes There is only limited number of duplications of testing. In addition proof for reproducibility of methods and results is a scientific requirement.



Worldwide Yes If at all, duplicate testing may be an animal welfare problem only for basic research. Adequate management of a useful database would require a high amount of resources.



Worldwide yes ---



National representative For basic research such a data bank would only be accepted if intellectual property issues are included. Furthermore, a very actual database must be available. If the data are more than 3 month behind, nobody would use it. For regulatory sensitive data and animal studies a data base could be helpful.




Mutual recognition agreements would be much more useful than any databases.



yes A database would not be able to perform the function stated even if heavily resourced.

36



Yes The administration, costs and user compliance associated with the database might reduce its efficacy. Private organisations would be unlikely to contribute to this. However, another method of encouraging sharing of animal resources an dminimising duplication might be to minimise the beaurocracy associated with the transport/movement of animals from one authority to another. This would facilitate researchers sharing eg genetically modified rodents.



The case has not been made that there is a significant amount of unnecessary duplication. Whist the UK strongly encourages and promotes data sharing, the proposed database would be prohibitively expensive and difficult to establish and maintain if it was ever to be seriously considered as a means of finding sufficient high-quality, comprehensive, accurate and up to date information to be of practical use.



Negative results are rarely published and establishmetn of an accurate relevant database is unlikley


Public authority National Ministry of VWS is also involved

It would be beneficiary so it is not neutral but positive in my opinion



Yes, together with the National Food and Product safety Authority

I bel;ieve this option will have a higher impact as hier above supposed. A EU- central data is an essential tool to get a real oevrview of infromation available to teke the richt measures ( at EU level) to avoid duplication of researach when not necessary.


Public authority Worldwide yes I would consider the benefit/effort ratio as too little

37


This is not neutral. It falls far short of what is required – a statutory obligation to avoid duplication.




See 1.11 - Justification


Other European No No, such a database does neither increase animal welfare nor does quality of science. There are other mechanisms already established (see top IX.e).




see 1.11.



This idea lacks knowledge on mechanism of science. If there is an ongoing project on – say- the mechanism of Parkinson disease (basic science) then no need for another? Or a project for antiparkinson drugs (pharma industry) makes similar projects unnecessary? A basic rule of science is the replicability of the results. Therefore any new finding must be reproduced before it gains acceptance. On the other hand, journals do not accept simple replication of well established results, each experiment must go at least one step further in the exploration of a problem.

38





see answer above

Austrian Society of Toxicoloy (ASTOX)


National Yes such a database does neither increase animal welfare nor quality of science. There are other mechanisms already to there see top IX.e).




The overall assessment ‘neutral’ assumes balance between the benefits and the costs. Until the design and mode of operation of the database(s) is decided, maximising the benefit/cost ratio, the assessment is premature. Costs at all levels would depend on design factors such as level of detail, and would be counterbalanced by the benefits of reducing the use of animals and avoiding the waste of resources. Additional effort and costs required at the establishment level should not be high since all projects require evaluation and reporting as a matter of good scientific practice. Submission to a database should require little extra effort or cost. Additional costs at the MS and EU levels will be cost-effective in the long term. We would stress that a precise definitions are needed on what are considered “non-confidential” authorised projects or “non-confidential information on authorised projects” to ensure harmonisation between the Member States.

39

European Coalition to End Animal Experiments (ECEAE)


Worldwide Representative (the only EU coalition focusing on animal experiments)

The benefit of this option has been underscored. The benefits of this approach can be immense but only if all experiments are covered by this provision. Regulatory testing, with the exception of batch retesting of vaccines can and should also be included.




The cost-benefit analysis does not support the establishment of a centralised database. True duplication is a very rare event, extremely so in the industrial sector owing to differences in molecular structure of compounds and in formulations and excipients. This analysis is supported by the UK Home Office, based on detailed inspections and licensing system in place in that country. Such a database would therefore have a minimal effect on reduction in animal use. There would also be considerable concern at possible disclosure of information that could be of benefit to competitors, and this could lead to a movement of research outside Europe.



National; European

Yes No, such a database does neither increase animal welfare nor does quality of science. There are other mechanisms already established (see top IX.e).

40

Norwegian Animal Welfare Aliance


National 2 other relevant organisations

A database would be very useful and sufficient resources should be set aside for it.

The National Anti-Vivisection Society



The NAVS is the leading and oldest anti-vivisection organisation in the world. There are a number of other relevant anti-vivisection organisations around the world with expertise in this field.

The NAVS supports a centralised EU-wide database, and believes that the overall outcome would be very positive, since one of the major obstacles for avoiding duplication is the non-publication of negative results. Our organisation has repeatedly pointed out the vast problem of duplication associated with (non-regulatory) animal experiments. This problem will not be solved exclusively by having a thorough ethical review process, since the individuals of an ethical panel cannot be expected to search the scientific literature for examples of previous similar work, even less so to find the results of non-published work (1). In addition the EU is, under REACH, already committing to a level of data sharing. This principle should be expanded as wide as possible. See the ADI/NAVS report "Keep animals out of REACH". (1) Accountability: Animal Experiments and Freedom of Information (1997) NAVS report. http://www.navs.org.uk/downloads/accountability.pdf




Recent UK history of the development of major national databases has shown that they are very expensive, fraught with technical problems and rarely fit for purpose.

41

The Royal Society


National Yes. The Royal Society is the independent scientific academy of the UK dedicated to promoting excellence in science. The Society plays an influential role in national and international science policy

Whilst we support the principle of avoiding duplication by setting up an EU wide database where negative data could be published, we believe that there is a risk that the costs and resources required will not be proportional to the benefits to be gained from it. The time and resources need to get all data into a consistent searchable and useful format would be enormous. There are also issues of security, confidentiality and IP protection.




both The impact of an EU database is underscored as it would be immense – if it included all experiments, including regulatory testing - as it would give the chance to actually compare what has already been done and what hasn't. We have written statements by the regulatory bodies of the Austrian Länder, in which they state that even in a small country like Austria, avoidance of duplicate testing is not always possible. (letters can be provided upon request)



National yes as IX.e


Breeder of animals

Worldwide Representative see IXe

42


Regional; National


The resource implications appear to me to be seriously underestimated. As commented in response to the overall assessment - it is likely that this would be very difficult to maintain and would require several (probably many) dedicated and full time staff to input data and ensure that it could be searched and retrieved.


National; European


There will be an overall negative impact due to increased administrative burden without welfare benefit.



Yes see below

43

Question IX.1.2.

Question text:

Statistics:




Comments received:





IX.1.2a.

1.2 Animal welfare – basic research: An EU database would have moderate positive impacts on animal welfare for animals used in basic research, due to more information available on negative results of previous projects not yet published. Do you support the preliminary findings? Yes/No/ No opinion

44




See comment on 1.1 above.



Local; National yes see above




No welfare effect of central database, sufficient assessable scientific databases exist.

45






Hannu Komulainen


National; European

Is relevant I doubt such a database. Who would maintain it. A lot of bureaurcracy for researchers to send the information (or for somebody else).




No No welfare effect of central database, sufficient assessable scientific databases exist.

46





Proof of reproducibility of results and including control groups is imperative in science. However, this is not a duplication of experiments or projects. This can exluded in a well organized scientific community


Local Yes Basic research has several knowledge bases, which are already used efficiently. Why to double the effort?




Yes, guess so ... I don´t agree to "moderate impact", but rather to "no impact".







National XXX are representative of our scientifi activity (basic research)

No , the info would not be detailed enough to allow for that analysis. In addition, it is in fact quite rare that a new experiment has already been performed under the very same conditions. Any different factor, be it minor, could be invoked to claim that this is a different experiment. No regulation can solve this issue.



Worldwide there are others No welfare effect of central database, sufficient assessable scientific databases exist.

47




see above




The EU contributes a decreasing share of scientific results globally. More results are being generated in US and increasingly in Asian countries, eg Japan and China. Research has often to deal with species and strain differences. The impact of data bases is grossly overestimated.




With all the gigabytes of scientific literature available to us at the keystroke of a computer key, why would we waste time reading about experiments that didn’t work. Even if I did read about experiments that are similar to my own that didn’t work, it doesn’t mean that mine won’t work. Published works are generally NOT exact replicas. We are not discussing exact replicas because the likelihood that two labs do the exact same experiment is very low. In addition, there are many documented experiments in which there were differences in what were thought to be exact replicas in different and often competing laboratories. It has been demonstrated that two labs doing the exact experiment that get different results, DID NOT DO THE SAME EXPERIMENT. It is critical that we don’t accept everything that we see and read, for this would halt our progress. Regrettably, it means doing more experiments, often with animals and it means scientific and medical progress.




Scientific databases already exist. Unnecessary duplication may occur, but in negligible numbers. Scientifically justified retesting must be allowed.

48



Local representative A central data base is a bureaucratic monster without welfare effect on animals. Nowadays all relevant information can be retrieved from scientific databases




See 1.1




No By making negative results available other research groups know that a certain subject/model was already investigated but that it didn't give good results. So it has no sense to try the same experiments again and by that prevent unnecessary use of animals.



Local yes No, it is a prejudice that there is a considerable amount of duplications of experiments in research. Scientists usually have an excellent overview of the literature within their respective fields of specialisation. Especially in basic research also the so-called “negative results” are important results which are published. Scientific journals will no accept results (regardless whether they are “positive” or “negative”) which are already published elsewhere. This prevents already duplication of experiments in research. Furthermore, for authorisation of projects it is necessary to demonstrate that experiments are not doubled. A literature search has to be performed for that reason.



National no No welfare effect of central database, sufficient assessable scientific databases exist.



National yes Negative results need to be validated before implementation in the database. This is very similar to publication. Incitation must be done on publication. In absence of validation false result will be implemented leading to poor science quality.

49



Regional; National

yes see 1.11




No. The gain would be very limited due to confidentiality issues.



National yes No welfare effect of central database, sufficient assessable scientific databases exist.





see 1.1 above

Bayer HealthCare



1.2 See comment above



This analysis implies that such a database becomes a parallel publication process, or even an on-line ‘journal of negative results’. There are several objections to this. Negative results may not be peer reviewed. They may not be place in a framework to communicate significance, as in published work. Information may be confidential or a trade secret. Finally work done in third countries is excluded

50




See 1.1



National yes See comments point A





See above



Worldwide Yes See 1.1




see 1.1



Worldwide Yes See overall analysis. Since most researchers are interested in publishing their data, the amount of useful information on negative results is considered small and since there would always be a time gap, even this information will come too late in most fields, which tend to develop fast in our days.

51



European Representitive I think it would have low benefit for animal welfare, as not most research can be filtered at the grant application stage, and it is not in the private companies interests to supply this information to its competitors too soon.




See 1.1



Worldwide yes The exchange of scientific information and the access to appropriate date is very high at present, negative results of an experiment are not hided and kept under closure




This proposal is entirely counter to the need to have several innovators working in competition on the same projects or problems. The proposal appears to neglect the fundamental difficulties and risks inherent in research, public health and unmet medical need. In the pharmaceutical industry “negative” test results do not carry the same prejudiced connotation as presented in the analysis above. All results in the pharmaceutical and biomedical sector are “decision-making” and enable research to take new directions in an informed manner. All decision-making studies potentially have a role in the protection of intellectual property.



Worldwide Yes There are many variations of individual experiments and, consequently, it will be extremely difficult for a central administrator to determine which are duplications.




No welfare effect of a central database - scientific DBs already available

52



Worldwide yes see comment above



National Yes Please see 1.11



Worldwide Representative See above comments.



Worldwide yes It is being assumed that there is a problem with duplication of testing. This is not the case. Pharmaceutical companies work on their own compounds and patent these at an early stage so that 2 companies would not be working on the same ones. There is limited retesting (batch release for polio testing). ICH and mutual recognition agreements would be more useful than any database.



Worldwide no Why is this only aiming at an EU wide database? Experiments are performed globally!




See comment above



National representative See comment above

53




See 1.1

Coenraad F.M.Hendriksen

Public authority National at the national level: yes

There are many variables that might influence the outcome of an animal experiment which makes it almost impossible to store all this information into a data-base.


Public authority National Yes Basic research has several knowledge bases, which are already used efficiently. Why to double the effort?

Prof. Dr. Bernd Hoffmann, Justus-Liebig-Universität Giessen


similar to other universities

see statements made above


Public authority Local yes No welfare effect of central database, sufficient assessable scientific databases exist.





yes It is extremely unlikely that animal welfare will be impacted in any way by such a database. Negative results are a specific issue which are a concern, but the lklehood that such a database can prevent these is VERY slim.

54


Public authority Local; Regional no the database will not be read by most of the people. Many researchers know what their nearby colleagues investigate. And in the private sectors, secrets remain secrets



Yes It is unlikely that researchers would take the time to publish negative results on a public database.






see 1.11




Doubt of welfare effect due to a central database. Sufficient scientific databases already exist.

55


Public authority National representative No welfare effect of central database, sufficient assessable scientific databases exist.


This is unlikely to have any impact on animal welfare, since many research projects involving basic research are justified on the grounds that they are not repetitious of previous experiments – based on minor modifications in the experimental protocol. A good example of this can be found at www.animalaid.org.uk/viv/curiosity.htm which illustrates the characteristic use of one study to justify the next. In many cases, unanswered (usually unforeseen) questions arising from one study produced the rationale for a later study. In several instances, the team invokes conflicting or erroneous results from previous studies (sometimes their own) to justify another study.


Other European No No, it is a prejudice that there is a considerable amount of duplications of experiments in research. Scientists usually have an excellent overview of the literature within their respective fields of specialisation. Especially in basic research also the so-called “negative results” are important results which are published. Scientific journals will not accept results (regardless whether they are “positive” or “negative”) which are already published elsewhere. This prevents already duplication of experiments in research. Furthermore, for authorisation of projects it is necessary to demonstrate that experiments are not doubled. A literature search has to be performed for that reason.

Cris Iles-Wright Other Not applicable Not applicable Such a database would have to link regulators to current events and the availablity of technology available since the 1960s which has eliminated the need for tests such as those they are approving. Involvement of NGOs would enable this.




see 1.11.

56




Other National Yes It is not the case that there is a problem with duplication of testing.


Other Worldwide These comments originate from a large academic institution in Belgium with a large tradition in biomedical research and were formulated by mutual agreement

The scientific world eliminates the use of duplicates itself by reviewing articles and refusing funding to non-original work. Moreover, filling out a database will be an extra burden, but will also only be done once the work is published to avoid revealing interesting information to other research groups, making the database completely superseded.



see answer at the top

57


Other European yes These findings assume that there is a problem with duplication of testing. This is not the case.



National Yes it is a prejudice that there is a considerable amount of duplications of experiments in research. Scientists usually have an excellent overview of the literature within their respective fields of specialisation. Especially in basic research also the so-called “negative results” are important results which are published. Scientific journals will not accept results (regardless whether they are “positive” or “negative”) which are already published elsewhere. This prevents already duplication of experiments in research. Furthermore, for authorisation of projects it is necessary to demonstrate that experiments are not doubled. A literature search has to be performed for that reason.




No further comment

58







National; European

Yes No, it is a prejudice that there is a considerable amount of duplications of experiments in research. Scientists usually have an excellent overview of the literature within their respective fields of specialisation. Especially in basic research also the so-called “negative results” are important results which are published. Scientific journals will no accept results (regardless whether they are “positive” or “negative”) which are already published elsewhere. This prevents already duplication of experiments in research. Furthermore, for authorisation of projects it is necessary to demonstrate that experiments are not doubled. A literature search has to be performed for that reason.

59





We believe that an EU-wide database would have high positive (+++) impact on animal welfare in basic research, since our investigations have shown that duplication is frequently occurring within this area (1). (1) Access denied 1996. NAVS report http://www.navs.org.uk/publications/reports/c=1




See above comment




60



National NO OTHER RELEVANT ORGANISATION

The info would not be detailed enough to allow for that analysis



Worldwide - -



National yes This will not work.



Worldwide yes No welfare effect by central database, sufficient accessible scientific databases exist.


Breeder of animals

Worldwide Representative It is unrealistic that negative results will be published in such a database


Regional; National


It is extremely unlikely that animal welfare will be impacted in any way by such a database. Negative results are a specific issue which are a concern, but the likelihood that such a database can prevent these is VERY slim.

61


National; European


First, it will not be possible to assimilate and publish on the database all research data in a timely manner to be useful. Second, the premature dissemination of data will be a threat to intellectual property. Third, duplication of basic research is reduced in the peer review process prior to research being funded or conducted. Duplication that occurs due to regulatory requirements will need to be addressed by regulators rather than a database. Fourth, the proposal also seems to focus on project authorisation rather than experimental authorisation – and will not be able to achieve its objectives of avoiding experimental duplication.


Regional; Worldwide

also others see 1.11



Yes see below

62

Question IX.1.3.

Question text:

Statistics:




Comments received:





IX.1.3a.

Animal welfare – regulatory testing: 0 An EU database would have no positive impacts on animal welfare regarding the approx. 160.000 animals used in retesting of e.g. pharmaceutical products for regulatory purposes per year. Do you support the preliminary findings? Yes/No/ No opinion

63








No I agree with your statement that a significant reduction of duplication in regulatory testing would require changes in numerous legislative requirements at Member State level and that the EU wide database dissolves only a small part of the problem. Nevertheless if we can save 20% of the 160.000 animals you mentioned that would be still worthwhile to consider! Moreover I think that we must investigate together with the pharmaceutical industry and the government if retesting of e.g. pharmaceutical products on animals can be considerably decreased




See 1.1

64



European Yes There is little difference in research logic in pharmaceutical products and basic research. Such a database very positively impact both pharmaceutical products and basic research.




This finding is not supported by the arguments presented above as licence and authorisation duplication will not solve the issues of portability of results between regulatory agencies in the EU and third countries.



Worldwide No This issue should be addressed rather than ignored.




It is being assumed that there is a problem with duplication of testing. This is not the case. Pharmaceutical companies work on their own compounds and patent these at an early stage so that 2 companies would not be working on the same ones. There is limited retesting (batch release for polio testing). ICH and mutual recognition agreements would be more useful than any database.




See comment above



Worldwide Yes There is a strong interest for pharmaceutical companies to avoid duplicate regulatory testing for economic reasons.

65


Public authority National SVFA SR is central conpetent authority for approvel for the experiments and inspections animal protection

EU databasa is very necessary. mainly collection of date chemical elemnts, articles( rodenticides, hernicides, .....)



The case has not been made that there is a significant amount of unnecessary duplication. Proprietary and intellectual property considerations essentially prevent unnecessary duplication within this sector. Whist the UK strongly encourages and promotes data sharing, the proposed database would be prohibitively expensive and difficult to establish and maintain if it was ever to be seriously considered as a means of finding sufficient high-quality, comprehensive, accurate and up to date information to be of practical use. It is also important to appreciate that data is often owned by those who commission testing – and not the test labs themselves



it should not only include retesting but also exchanging 3R information and Turned down projects


There should be a regime to ensure that data obtained from authorised testing centres are recognized across the EU.

66




This assessment is based only on data for retesting of pharmaceutical products, which is only one specialised part of regulatory testing on animals where repeat testing is done intentionally. In other areas, such as chemicals testing, a database would be more effective in preventing duplication and is necessary to ensure that read across and grouping of substances can take place, to minimise testing. The need for data sharing, by means of databases, was a recommendation of a 2005 study ‘Regulatory Animal Testing: A Survey of the Factors Influencing the Use of Animal Testing to Meet Regulatory Requirements’ by Marie-Jeanne Schiffelers et al. of Utrecht University (See website: www.bio.uu.nl/scienceshop). Such a database or databases would certainly have a positive impact on animal welfare.




It is unclear where this figure has come from. We do not agree with the statement that ‘retesting is a legal requirement for general medical products for human and veterinary use’. Harmonisation of testing requirements under ICH and OECD mean that this should not happen. We do not accept that there is a general requirement for retesting of medical products. Duplication of animal tests is a problem at both the basic, applied and regulatory research level (see 2001 White paper on REACH, APC Review of the cost: benefit assessment of the use of animals in research 2003, Bridges, J. 2000 Chemistry and Industry 20 Nov). All forms and sources of duplication should be tackled. To fail to tackle regulatory testing goes against the ethos of the existing legislation and the 3Rs.

67





PETA Europe Ltd.


Worldwide both 1.3 No – Any requirements to carry out repeat testing due to lack of harmonization of information requirements must be tackled through Mutual Recognition Agreements, and the revised directive should identify this as a priority for action. Duplication of studies carried out within the EU should be prevented in part through a central authorization system for regulatory tests, where regulators are made aware of which substances are being tested or have already been tested before granting an authorization. Systems similar to this are in place in Germany, and will be introduced through REACH. Application of the 3Rs requires that duplicate testing is eliminated, so the cost of establishing the system should be embraced as an expression of the commitment made by the EU to animal welfare.

68





As we have outlined in our report “Keep animals out of REACH”, we would expect some positive impact following the introduction of a EU database. Reference: Keep animals out of REACH (2005) ADI report http://www.navs.org.uk/downloads/reachbriefing.pdf




both Please refer to statements by ECEAE and PETA

69

Question IX.1.4.

Question text:

Statistics:




Comments received:





IX.1.4a.

Ethical concerns – basic research: An EU database would assist in the ethical evaluation of projects (outside regulatory testing), because during ethical review competent persons could more easily double check the project information on an EU-wide basis, taking into account results of previous experiments. Do you support the preliminary findings? Yes/No/ No opinion

70



Local; National yes No, too much dependent on informatio submitted




at 1.4 No No welfare effect of central database, sufficient assessable scientific databases exist.






Hannu Komulainen


National; European

Is relevant The whole concept about avoiding replication is wrong. The results should be replicated by another study to be true. If there is only one result, it is not posiible to know , how "right" it is. This will be the main problem for example in toxicity testing in REACH.

71




No No welfare effect of central database, sufficient assessable scientific databases exist.





Proof of reproducibility of results and including control groups is imperative in science. However, this is not a duplication of experiments or projects. This can exluded in a well organized scientific community




Yes, guess so ... I just don´t think this is a reality, and not even a "good thought".





72




XXX See 1.11



Worldwide there are others No welfare effect of central database, sufficient assessable scientific databases exist.




The EU contributes a decreasing share of scientific results globally. More results are being generated in US and increasingly in Asian countries, eg Japan and China. I cannot see how such a data base would be able to compete with existing tools. It is doubtful that during ethical review competent persons could more easily double check the project information. The researcher him/herself has usually the deepest insight in competing results. The potential impact of such a separate data base is grossly overestimated.





This would increase the administrative load considerably to the applicants but would not have any positive impact, since negative results from other groups, unless performed adequately, described in detail, and published in peer-reviewed journals, can not be the basis for planning further experiments.

73



National yes, competitive in the field of small animal research

In case in science a duplicate experiment is performed it has often also benefits since it provides evidence concerning other environmental and local factors that we are unaware of.In our experience some interventions in cardiovascular research that were performed in mice in the USA, could not be repeated here in Europe (NL and Germany), for reasons that are still not understood. Many factors were excluded and retested and small deviations in genetic background may lead to very different phenotypes. If it is not allowed anymore to duplicate another study, as an additional control, science is not going to benefit from this, in contrast.




this is totally unreasonable. I would be horrified to hear that I was unable to do an experiment because someone in an unknown laboratory somewhere/anywhere in Europe has done a similar experiment and was unable to get a positive result. This is not good scientific practice. I would certainly restrain from doing experiments that have been done in good labs that appear to be similar to my own, or answer the questions that I would have liked to address. In addition to publishing manuscripts, we apply for grant money to fund our work. If we propose experiments that have been done or those that have been addressed well and have been published, then we are not funded for these projects. This is yet another level in which our experimental work is evaluated, criticized and, so to speak, authorized.




The establishment and updating of such a database would be an enormous task and we doubt whether it can be more up to date as the searchable scientific literature is or just a doubling of information.



Local representative A central data base is a bureaucratic monster without welfare effect on animals. Nowadays all relevant information can be retrieved from scientific databases

74



Local yes No, because such a database can only work if it really contains all information from all institutions / companies of all Member States and if it is always immediately updated. The experience with the statistical reporting (it takes years until all Member States can submit the data and even France is one year behind) clearly demonstrate that this is not feasible. A database with old or / and incomplete data makes situation worse! Furthermore, ethical evaluation has to take the projects and results on an international level into account.



National no No welfare effect of central database, sufficient assessable scientific databases exist.



Regional; National

yes see 1.11




This is impractical and if the experiements are not undertaken identically the information may be meaningless



National yes No welfare effect of central database, sufficient assessable scientific databases exist.





see 1.1 above

Bayer HealthCare



1.4 Such a database can only be useful if contains all information in real time. Feasibility of actual data is doubtful.

75



No as above in 1.2




Such a database can only be useful if contains all information in real time. Feasibility is extremely doubtful.



National yes See comments point A, keeping the database up-to-date will be very time-consuming, it is questionably if this aim could be achieved.





See introductory comment. The time taken to get the data into a database and the work load needed would lead to data being redundant long before it is available in the base.



Worldwide Yes The feasibility of getting comprehensive and up to date information into a database to make it truly useful is extremely doubtful

76




It should be not possible to complete the database in real time



Worldwide Yes Duplication of experiments is not considered a major problem, since most researchers work in specialized fields. For ethical review, harm-benefit assessment is more critical and in this respect, the database will be of little value for a different experiment with a different test compound



National; Worldwide

yes The practical management of such a database would be very complex, resource consuming… if manageable!




It should be not possible to complete the database in real time




This preliminary finding is not supported by the arguments cited above as scientists would be conducting individual studies within the context of programmes of work already authorised. The proposal would bring no new information to scientists than that presented a scientific conferences and through the publication of peer-reviewed manuscripts. The proposal would only work by constricting the number of authorised facilities and this will suffocate innovation. Various EU sponsored programmes already aim to bring scientists across the EU into dialogue and collaboration.



Worldwide pharmaceutical To be really efficient, such a database need to be frequently updated. Feasibility is absolutely doubtful.



Worldwide Yes There are many variations of individual experiments and, consequently, it will be extremely difficult for a central administrator to determine which are duplications.

77




This would not be practical at all due to the impossibility of having a real time database.




real time access ?



Worldwide yes Such a database can only be useful if contains all information in real time. Feasibility is extremely doubtful.



National Yes This would require that all information was available and continuously updated. This is extremely doubtful.



Worldwide Representative See above comments.



Worldwide yes This would not be practical at all due the impossibility of having a real time database.



Worldwide yes Such a database can only be useful if contains all information in real time. Feasibility is extremely doubtful.

78







Such a database can only be useful if contains all information in real time. Feasibility is extremely doubtful.



National representative Such a database can only be useful if contains all information in real time. Feasibility of actual data is doubtful.




The feasibility of getting comprehensive and up to date information into a database to make it truly useful is extremely doubtful.



see 1.2.

79


Public authority National Yes Knowledge bases are already used for the purpose. And they are not restricted to Europe only.

Francois Lachapelle INSERM

Public authority National BEA du CNRS, de l'INRA, du CEA

this would require a high level of scientific competence of the members of Ethical comitee







yes Such information is largely available in published papers. The probablility of a databse being able to deliver sufficient information to assist in this evaluation is very slim. It seem likely that to extract relevant information form the database would be difficult. Many apparently duplicated experiments in fact are not. Duplication can occur outside EU and this database will not assit in preventing this.


Public authority National Yes Absolutely wrong. You leave the present project.


Public authority Local; Regional no see comment on 1.2

80



Yes Sounds really cumbersome.






Unlikley that database could give sufficient inforamtion for scientisits to judge if work is relevant etc.




Doubt of welfare effect due to a central database. Sufficient scientific databases exist.


Public authority National representative No welfare effect of central database, sufficient assessable scientific databases exist.

81




See 1.11 - Justification


Other European No No, because such a database can only work if it really contains all information from all institutions / companies of all Member States and if it is always immediately updated. The experience with the statistical reporting (it takes years until all Member States can submit the data and even France is one year behind) clearly demonstrate that this is not feasible. A database with old or / and incomplete data makes situation worse! Furthermore, ethical evaluation has to take the projects and results on an international level into account.

Cris Iles-Wright Other Not applicable Not applicable Animal experiments of this type are done for purely legal reasons and are routinely approved.




see 1.11.



Highly negative impact (--)! Each project has to be evaluated on its own merit. Considering the presence of a similar project in the ethical evaluation as “duplication” bears the risk of misjudgement and refusal of the given project.

82




Other National Yes A database would only be useful if it contained all the information in real time. It is highly unlikely that this would be feasible.


Other Not applicable not applicable I doubt that such a database is always up to date and current at all times.





Other European yes Such a database would only be useful if it contained all the information in real time; this is highly unfeasible.




No further comment

83



National; European

Yes No, because such a database can only work if it really contains all information from all institutions / companies of all Member States and if it is always immediately updated. The experience with the statistical reporting (it takes years until all Member States can submit the data and even France is one year behind) clearly demonstrate that this is not feasible. A database with old or / and incomplete data makes situation worse! Furthermore, ethical evaluation has to take the projects and results on an international level into account.




Recent UK history of the development of major national databases has shown that they are very expensive, fraught with technical problems and rarely fit for purpose.




There are significant logistical problems with providing a current database.






Worldwide - -

84



National yes It is not in the scope of the ethical evaluation.



Worldwide yes No welfare effect by central database, sufficient accessible scientific databases exist.


Breeder of animals

Worldwide Representative Because there exists no general regulation to evaluate scientific results regarding the ethical aspects.


Regional; National


Such information is largely available in published papers. The probability of a databse being able to deliver sufficient information to assist in this evaluation is very slim. It seem likely that to extract relevant information form the database would be difficult. Many apparently duplicated experiments in fact are not. Duplication can occur outside EU and this database will not assist in preventing this


National; European


First, it will not be possible to assimilate and publish on the database all research data in a timely manner to be useful. Second, the premature dissemination of data will be a threat to intellectual property. Third, previous results are considered in the peer review process prior to research being funded or conducted. Fourth, the proposal also seems to focus on project authorisation rather than experimental authorisation.


Regional; Worldwide


85



Yes see below


Local representative It is not in the scope of the ethical evaluation.



Yes, we are representarive for the field

It is not in the scope of the ethical evaluation.

86

Question IX.1.5.

Question text:

Statistics:




Comments received:





IX.1.5a.


Local Yes Knowledge bases are already used for the purpose. And they are not restricted to Europe only.

Ethical concerns – regulatory testing: 0 An EU database will have no positive impact on the improvement of ethical evaluation of projects in regulatory retesting, because these tests are required by national legislation. Do you support the preliminary findings? Yes/No/ No opinion

87



Local; National; European; Worldwide

representative of a research university

Nevertheless they may still be capable of refinement and standard tests should be challenged




This underlines the importance of authorities to also make full use of such a database and acknowledge testing results performed in other countries.



National; Worldwide

there are other relevant organisation in the region

An EU database certanley will improve the nationla level of ethical evaluation of projects



European Yes As mentioned in 1.4, regulatory retesting will immensly recheck the necessity of the set project nad save the scientist to waste time, material and animal life.



Worldwide No This should be addressed. If we are talking about harmonising all these areas with regard to animal use, similar effort should be made where legislation forces duplicate testing.






implementing of 3Rs within prescribed methods is beneficiary and possible

88


There should be a regime to ensure that data obtained from authorised testing centres are recognized across the EU.



National Yes because such a database can only work if it really contains all information from all institutions / companies of all Member States and if it is always immediately updated. The experience with the statistical reporting (it takes years until all Member States can submit the data and even France is one year behind) clearly demonstrate that this is not feasible. A database with old or / and incomplete data makes situation worse!




It is crucial to the ethical evaluation of projects, even in regulatory testing, to ensure that the proposed testing is not duplicating tests already carried out and that the testing requirement cannot be waived on the basis of making use of existing data from other sources. A database or databases, preferably associated with the appropriate regulatory authorities, would be necessary for obtaining information to allow such assessments during ethical evaluation. The need for data sharing, by means of databases, was a recommendation of a 2005 study ‘Regulatory Animal Testing: A Survey of the Factors Influencing the Use of Animal Testing to Meet Regulatory Requirements’ by Marie-Jeanne Schiffelers et al. of Utrecht University (See website: www.bio.uu.nl/scienceshop).




To state that the impacts will be neutral because you are excluding one aspect (which should not be excluded) of duplication is incorrect and suggests that the full implications of this proposal have not been properly assessed. An EU database would avoid duplication and enable read-across and grouping of substances.

PETA Europe Ltd.


Worldwide both Regulatory testing, even where tests are required by national legislation, should be subject to ethical evaluation based on the proposed purpose of the substance being tested and the existence of similar substances or data already held on that substance.

89





As we have outlined in our report “Keep animals out of REACH”, we would expect some positive impact following the introduction of a EU database. Reference: Keep animals out of REACH (2005) ADI report http://www.navs.org.uk/downloads/reachbriefing.pdf




both This EU database could have a positive impact as it would make read-across and grouping of substances possible, and possibly lead to more data sharing between countries.

90

Question IX.1.6.

Question text:

Statistics:




Comments received:





IX.1.6a.

Regulatory compliance: An EU database would have low positive impacts on national inspections, due to better availability of comparative information, especially regarding control on group authorisation of projects in regulatory testing. Do you support the preliminary findings? Yes/No/ No opinion

91







Local; National yes see above





might have a high impact in some MSs

92




see 1.4



Local yes see top 1.4



Local organisation is representative

this question was not in the questionnaire when I printed it out

Bayer HealthCare



1.6 This information would be confidential anyway. Also, it is very rare for two companies to work on the same molecule.



This is unlikely unless this database provided extremely rich context.

93




This information would be confidential anyway. Also, it is very rare for two companies to work on the same molecule



National yes There are made too great demands on authority, they cannot check the differences between all experiments to distinguish between duplication of experiments or not, especially some information is confidential.





Much of the information would be confidential and there wouldbe constant challenged to intellectual property. It is also highly unlikely that any two companies would be working on the same molecule and thus there would be inherent differences in the data.




Problem of confidentiality and time required to do this comparison




Problem of confidentiality and time required to do this comparison



Worldwide pharmaceutical Much better than a database would be mutual recognition of sets of studies that were already done.

94




This information would be confidential.



Worldwide yes This information would be confidential anyway. Also, it is very rare for two companies to work on the same molecule.



National Yes It is very rare for two companies to work on the same compound.



Worldwide Representative It is almost unrealistic that different Companies work on exactly the same molecule.



Worldwide yes This information would be confidential.

95






Worldwide The bquestionaire will be completed for the German sites. Other site head in other countries will reply individually

As companies are very much specialized nowadays, double testing on the same molecule is very unlikely, we would even say can not happen.




This information would be confidential anyway. Also, it is very rare for two companies to work on the same molecule.



Worldwide yes ----

96



National representative This information would be confidential anyway. Also, it is very rare for two companies to work on the same molecule.



yes It is VERY unlikely that the level of detail available on a database will be sufficient to inform the inspection process. It could show where similar work is going on in order that similar standards could be applied to similar projects and inspectors could find colleagues with whom to discuss complex matters, but good communication systems between inspectors could serve this purpose at much lower resource implication.






see 1.11



its effect is underrated


We need the database and more inspections.

97


Other European No see top 1.4



Probably no impact. This is mere speculation on the outcome of non existent, hardly realizable mechanisms.




Other National Yes This information would be confidential. It is also very unlikely that two companies would be working on the same molecule.

98


Other Not applicable not applicable Confidential information. Also, it is very rare that two companies work on the same target molecule.





Other European yes This information would be confidential. Furthermore, it would be extremely unlikely that two companies would be working on the same molecule.



National Yes see top 1.4




We believe that a database would only have a positive effect on national inspections if consultation of the database were mandatory as part of the authorisation and ethical evaluation process. If group authorisations are allowed, provision of the results obtained from consultation of the database for each substance tested should be made a condition of the authorisation, and audited by the authorities.

99







National; European

Yes No, because such a database can only work if it really contains all information from all institutions / companies of all Member States and if it is always immediately updated. The experience with the statistical reporting (it takes years until all Member States can submit the data and even France is one year behind) clearly demonstrate that this is not feasible. A database with old or / and incomplete data makes situation worse! Furthermore, ethical evaluation has to take the projects and results on an international level into account.



Worldwide - -

100


Breeder of animals

Worldwide Representative see 1.4


Regional; National


It is VERY unlikely that the level of detail available on a database will be sufficient to inform the inspection process. It could show where similar work is going on in order that similar standards could be applied to similar projects and inspectors could find colleagues with whom to discuss complex matters, but good communication systems between inspectors could serve this purpose at much lower resource implication


National; European


Data will likely be confidential.


Regional; Worldwide




Yes see below

101

Question IX.1.7.

Question text:

Statistics:




Comments received:





IX.1.7a.



National jes -

Administrative burden: The establishment of an EU database would create a high administrative burden at establishment level due to the need for timely reporting of up-to-date information. Do you support the preliminary findings? Yes/No/ No opinion

102




Our organisation is representative within the field of cancer research but we have many collaborations with other like organisations.

We would not welcome additional administrative burdens on top of what we already have to achieve in terms of administration and documentation load.




This would be confidential information



administrative burden might be overrated one doesn't have to include every single detail but with a kind of bulletin board system




Clearly there would be some administration necessary at an establishment level but this should not be high. All projects require evaluation and reporting of results, and provided the nature of the information and the way it is presented is well defined, then submission to a database should require little extra effort. A good evaluation and reporting system will be of benefit in the long term.

103




The negative impacts on this have been overestimated and should be reduced to – Establishments already have to complete a license application and will have to submit figures and severity levels retrospectively (see Ethical Review). Reporting of results is a minor burden on establishments since it is already required for reports to funding bodies and/or publication submissions, regardless of outcome. There will be limited administrative burden on establishments to collate this information in the correct form for submission to the EU database.

PETA Europe Ltd.


Worldwide both Regulatory testing, even where tests are required by national legislation, should be subject to ethical evaluation based on the proposed purpose of the substance being tested and the existence of similar substances or data already held on that substance.

PROFESSOR RD COMBES - FRAME


Worldwide THERE ARE OTHERS

No evidence is provided for this assertion and I do not believe there would be a high burden.



National; European


Thats part of the work not a burden.

104





Due to the large potential of an EU database to significantly reduce duplication of animal experiments, the administrative burden seems to have been widely overestimated, since avoiding duplication would lead to a notable decrease in administrative burden. Such a database should improve effectiveness and efficiency at establishment level which would offset any additional administrative burden.




both The negative aspects have been overstated.


National Not sure Administration could be cut if the database was like a non-peer reviewed journal, where experiments could be fully cited and could contribute to author’s publications. It is frustrating for (academic) researchers to carry out unpublishable experiments, so they would probably be quite motivated to contribute in timely fashion to the database. The requirements could be for a brief summary of the procedure, sample size, control groups, etc – something the authors could almost cut and paste from their grant proposals, with the addition of the negative result. Google scholar might make it wonderfully searchable. Even an incomplete database would be a great help.

105

Question IX.1.8.

Question text:

Statistics:




Comments received:





IX.1.8a.

Cost to establishments: Although 60% of establishments already have internal statistical registration that goes beyond the legal requirements, the additional cost to feed information into such a database would be high, because establishments would be forced to collate it, write it up in an orderly fashion, and provide on-time information. Do you support the preliminary findings? Yes/No/ No opinion

106



National jes -



Worldwide Representative Additional costs to feed information into such a database could be low, is personal is motivated and determined. Importance of training and education of personal.








yes Yes the information collected at present is not useful to prevent duplication. This would entail a whole new set of information which it seems difficult to see what format much of the useful data could be presented in other than free text. This would not be amenable to database entry.



might be overrated

107




Clearly there would be some additional costs at an establishment level but these should not be high. All projects require evaluation and reporting of results, and provided the nature of the information and the way it is presented is well defined, then submission to a database should require little extra resources. A good evaluation and reporting system will be cost-effective in the long term.




This cost has been overestimated and also duplicates the cost described in 1.7. See response to 1.7.

PETA Europe Ltd.


Worldwide both the information is already available and systems introduced at EU level will support facilities by providing uniform requirements thereby reducing the burden on individual facilities. This will also assist in ensuring market harmonisation.



National; European


So the 40% has to organise things better

108





Due to the large potential of an EU database to significantly reduce duplication of animal experiments, the cost to establishments seems to have been widely overestimated, since avoiding duplication would lead to a notable decrease in costs. Access to results published in the database by other establishments would add to the saving, since fewer experiments would need to be carried out. The data requirements are unlikely to exceed existing reporting requirements within the institution.




both please refer to statements by ECEAE and PETA

109

Question IX.1.9.

Question text:

Statistics:




Comments received:





IX.1.9a.

Administrative costs for Member States: The establishment and maintenance of an EU database would create high, partly temporary, administrative costs for most Member States, as only 25% of all Member states currently have an automated system of data collection. Do you support the preliminary findings? Yes/No/ No opinion

110








The primary cost of an EU database would be to the EU government institutions, commission etc, itself: see 1.10

111



The costs will be ongoing due to maintenance of the automated system.



The case has not been made that there is a significant amount of unnecessary duplication. Whist the UK strongly encourages and promotes data sharing, the proposed database would be prohibitively expensive and difficult to establish and maintain if it was ever to be seriously considered as a means of finding sufficient high-quality, comprehensive, accurate and up to date information to be of practical use. The above proposition is wrong to assume that anyone currently has either the infrastructure or information required to make this happen.



it should be like traces: an EU based system with EU as guardian

112




Level of costs depends on how efficiently the system is set up. All Member States should set up a system for data collection for the efficient administration of project licencing. There is no reason why compatibility with the needs of a central database should entail high additional costs.





The costs of such a system should not be prohibitive.

113

Question IX.1.10.

Question text:

Statistics:




Comments received:





IX.1.10a.

Resource requirements at an EU-level: An EU wide database would create high additional administrative burden at EU-level due to the costs involved in establishing, managing and coordinating the system internationally and the need to organise effective data collection (right information in right format) on a regular basis to meet deadlines. Do you support the preliminary findings? Yes/No/ No opinion

114



Worldwide Representative Advantages are too much.








The costs of an EU database would, it could be expected, have to be borne primarily by EU institutions, e.g Commission. It would be unreasonable for the EU to impose a central EU database and then also the cost.



European Yes Defiend argument s true but again, if this would be the main mentality and the right one for the development of scientific society, very sure we would not have any of our crucial online databases, like Pubmed or ScienceDirect whose benefit is out of discussion.


The welfare benefits and the rationalisation of data would outweigh the administrative burden.

115




A system to collect data and avoid duplication will be cost-effective in the long term. Level of costs also depends on how efficiently the system is set up.




The cost at this level has been overestimated. It would only be a low to moderate administrative burden, since for example, substance related databases already exist. Establishments already have to complete a license application and will have to submit figures and severity levels retrospectively (see Ethical Review). Incorporating this information and results into a database is the only additional burden. Electronic reporting and formatting of information with keywords, etc., further can reduce administrative burden. Harmonisation of this collation of information in the form a of a database will satisfy improvements to statistical reporting, ethical review, public transparency in addition to duplication of animal tests. Positive impacts can therefore be added but negative aspects should not. It is suggested that the authorisation fee for licenses incorporates these costs.

PETA Europe Ltd.


Worldwide both The administrative burden is over estimated and there is no account taken of the fact that the majority of the cost is in setting up the new system but the benefits over time include economic benefits due to standardized reporting and administrative procedures being introduced. The animal welfare benefits are high, and so the additional cost should be embraced as an expression of the commitment to animal welfare made by the EU.

116





The additional administrative burden should be low.





117

Question IX.1.11.

Question text:Justification (open text box)

Statistics:(no numbers registered as this was not a closed question)

Comments received:





IX.1.11. Justification

C. Norman Scholfield



yes High cost Cannot be sure that the current experiments are well conducted Good research ideas can be stolen by other workers, particularly those outside the EU

118




The statements on potential benefits cannot be supported as they are based on an assumption that a significant amount of duplication, outside of that required by national/international regulations, takes place. There is no evidence to support this; to the contrary, the experience of the UK Home Office is that there is minimal duplication of animal studies.

Hannu Komulainen


National; European

Is relevant The database very likely would not be any solution and would be very expensive vs. the benefits.

Prof Alan Palmer


Worldwide Yes Clearly to be of use, the database will need to contain sufficient detail to assess whether any proposed study is indeed a duplication. However, too much information would make the whole thing unwieldy and therefore reduce its utility. The obvious data that would be of most use would be outcome measures. However, these are sometimes rather protracted in becoming available and any delay in entry into the database would provide ample opportunity for duplication. The only real way of avoiding duplication is rapid entry into the database in which case it would have to rather promissory without guarantees that the research would be successful or the results definitive.





Duplication, however, can and should be avoided in primary safety testing (e.G. REACH).

119


Local Yes 1.6. They can use the very same world-wide knowledge bases already existing.




XXX We cannot see how these suggestions could be workable. First, the work to get all data into a consistent searchable format would be enormous. Second, to be useful, the results would need to identify the research group, which, as indicated elsewhere, is not feasible on security grounds. [It is not realistic to imagine that a database available to all scientists across the EU would not soon become publicly available]. Third, issues of IP protection would obstruct the objective. Fourth, the central support needed would be considerable and ongoing to maintain the database.





But it would still be worth the gain. One might have to make some allowance for experiments of replication to confirm an existing result, from duplication that simply carries out the same experiment unwittingly through e.g. not doing a thorough review of the literature. In the field of regulatory toxicity testing it seems more clear cut, but in those instances efforts should be made to ensure that the first time it is carried out it is done correctly so that retesting is not needed. That means coordination of regulatory bodies to avoid different protocols between countries for the same objectives. 1.4 I agree but It might also provide some practical guidance on the incorporation of ethical criteria and approaches to animal based research and good practices (NB This should link in with current proposals in DG ENV RES for FP7).




Database for basic research does not make sense; good planning of basic research experiments is done at the level of the scientist through checking the literature, this can not be exercised by a database due to the large diversity of topics and the individual interpretation of results required for these purposes.

120




Results need to be replicated. Reliability and reproducibility are crucial for medical ethics and quality. Research has to deal with species and strain differences. In this respect public opinion is often misled. Legislation should not contribute to such misunderstanding. The EU contributes a decreasing share of scientific results globally. More results are generated in US and increasingly in Asian countries. Results from pharmaceutical industry would hardly contribute to decrease animal numbers since companies typically work on patentable compounds. Other mechanism to limit replication of experiments are by far more efficient in academia and in industry: eg, simple replicatiom causes costs and reproduction of existing data is hardly publishable. An EU data bank covering only a minor share of relevant information in a problematic way would hardly contribute to animal welfare but rather enhance the bureaucratic burden and decrease in scientific competitiveness of the EU.





Overall, the value of an EU wide database would be low, or even adversely impeding research progress and costs would be inappropriately high



National yes, competitive in the field of small animal research

This database will only cost money and is a waste of time. Many things can now be found at internet and scientists have discussion platforms to exchange also things that do not work. Writing negative publications is not going to work because details at each lab make sometimes the outcome of studies very different

121




Yes While unnecessary duplication should be avoided by all means, the new directive must not harm the principle of replication which is essential to science and calls for an independent confirmation of a novel finding. Information on experiments is already widely available through databases such as Pubmed. However, some facility for publication of negative findings would be useful so that these can be accessible through the peer-reviewed literature.



European Yes Overall the establishment of database of project authorisations and scientific results, available to inspectors and scientists for exchange of information about problems and for promoting best-practice is a sensible and helpful proposal. The administrative burden will not be high but the potential benefits should be worthwhile.




ridiculous amount of wasted time and money without any impact at any level.




Yes Very difficult to co-ordinate especially with funding bodies and different techniques. It’s more important to standardise data/tests so data is comparable.




Yes Careful thought will need to be given to how scientific results are captured. The right balance should be struck between sufficient details to make the scientific record useful, while avoiding the provision of excessive information.




Yes The key to capturing scientific results is to appreciate the limited public knowledge of science and also the extended period before the outcome of work is appreciated.

122



National; Worldwide

yes, major UK research organisation for aquatic organisms and environment

We agree with the principle but the detailed implementation relies upon too many factors to anticipate the outcome. In particular, the database must have quality assurance on all data entered and will be useful only when the vast majority of studies are entered. It could become a "badge of identity", so that results from any study not in the database would not be accepted for publication, because the study "did not exist". In the longer term, the database would create leverage to amend national laws as suggested, so there may be an argument for starting the database to highlight duplication before trying to eliminate it. Nevertheless, such a project must be seen as a substantial and permanent function, and funded on that basis, not as a pilot.








Regional; National

yes I work with genetically modified mice in basic research. Studies with such mice are hardly ever duplicated, because there are so many variables (genetic background, targeting strategy, transgenic line etc), that no 2 studies are the same. In addition, certain overlaps between similar studies is often desirable to ascertain and reproduce findings. Such studies take several years. Nobody will abandon the study half way into the project, when they find out in the database that others have done a similar study. Rather, before even applying for a grant including such a study, researchers will try to get all information possible through the channels of the scientific community, whether such a study is on the way or not in another laboratory. These channels will be much more up to date than a database which no researcher will submit to in any detail before their study is published.

123




This will not work because not all experiments are the same, one may get some benefits in harmonisation of industrial testing, but they won't want to share data.



Local Yes The bureaucracy required for the establishment of such a database in my country or even the communication of data required from my country to EU headquarters would be extremely high. Lack of specialised personnel in the public sector is a major handicap.

Bayer HealthCare



See reference: http://www.efpia.org/5_conf/qualitybioresearch300904.pdf.



There appear to be two assumptions here: 1. Duplicate regulatory testing is a ‘lost cause’; it should not be and the Commission can be influential 2.That it will be possible and beneficial to create a useful repository of all results of animal experiments. At present posters and publications synthesise available significant knowledge; this proposal appear to say the all primary data needs posting in a database, whatever the significance, if animals were used. This discussion may be useful: http://www.nuffieldbioethics.org/go/browseablepublications/ethicsofresearchanimals/report_432.html




Reference document: EFPIA public preliminary impact assessment, July 2003

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This would be a major undertaking requiring significant administrative input and support. Industry would come up against intellectual property issues. Data input would create significant work loads and the data could be redundant long before it is accessible.



Worldwide Yes The competiveness of EU Pharma industry will go down markedly due to increased cycle times. In addition, such a database will be very difficult to update due to the need for confidentiality and for IP reasons. You cannot get a patent on data, which are in public domain!




Lots of difficulties to answer in real time. Confidentiality and accuracy of data may be compromised in this kind of data base and leading to important risks of serious consequences on public health and patient safety.



Worldwide Yes A EU wide database would create high additional administrative burden, the impact of this database is highly questionable – especially as most of the data from animal experiments will be published in scientific journals and available via databases anyway



National; Worldwide

yes See the EFPIA document on public preliminary impact assessment (July 2003)




no comment



Worldwide yes 1.4 Heavy doubts about the quality of the database

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Overall this proposal is of great concern as it is entirely inconsistent with the innovation that comes through a variety of competitors working on similar high risk projects. Also many aspects appear to neglect the essential nature of intellectual property being inherent in paradigms of drug discovery.



Worldwide No Duplicate testing for regulatory purposes is not a large issue in overall animal use, and should be addressed from the angle of the regulations requiring conduct of the tests. Publication of information to assist others in design and conduct of studies should be encouraged, even whe the results are negative in relation to the original purpose. Journals should be encouraged to do so.



Worldwide pharmaceutical see reference document: EFPIA public preliminary impact assessment, July 2003




A central database would result in an enormous amount of work to input information and it would be difficult if not impossible to keep the information current in real time. . The massive resource impact would be out of proportion with any benefit gained. More benefit can be gained from ICH and mutual recognition agreements.




see EFPIA public preliminary impact assessment - July 2003



Worldwide yes Reference document: EFPIA public preliminary impact assessment, July 2003

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there are multiple independent Contract Research Organisations in UK and EU

No comments



National Yes It is being assumed that there is a problem with duplication of testing. This is not the case. There is limited retesting (batch release for e.g. polio testing. ICH and mutual recognition agreements would be more useful than any data base.



Worldwide yes A central database would result in an enormous amount of work to input information. The massive resource impact would be out of proportion with any benefit gained. More benefit can be gained from ICH and mutual recognition agreements.



Worldwide The bquestionaire will be completed for the German sites. Other site head in other countries will reply individually

A database can only be as good as the data input. The feasibility that this leads to a current, at any time updated information status of the content is very low taking the complex EU world into account.




Reference document: EFPIA public preliminary impact assessment, July 2003

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National representative http://www.efpia.org/5_conf/qualitybioresearch300904.pdf



Such a database would be onerous and possibly too simplistic to be cost-effective on any large scale. Would an EU database be an optimally reliable source of information when so much research is conducted outside the EU? Care must also be taken to avoid the cost of intellectual property theft, and commercial confidentiality must also be catered for as such factors may lead to research going outside the EU.



I have strong doubts about the feasability of such a data-base: • Keeping the data-base up-to-date. This will require substantial administrative support and expenses • Almost unlimited number of variables in an animal experiment which will make it very difficult to decide whether the proposed study indeed is a duplication • Who will decide about possible duplication? Only (expensive) experts will be able to decide about that

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Federal Public Service - Public Health (div. animal welfare & CITES)

Public authority National Yes, representative.

EU regulatory legislation (medication, biocides, pesticides) all with their respective review processes must provide in setting up necessary databases with results of animal tests per molecule (active substance). Letters of access and/or coordination by EU inspectors between applicants (sharing registration costs) must interfere in the process of duplication of animal tests.

UK Medical Research Council

Public authority Local; Regional; National; European; Worldwide

The MRC is the UK's leading publicly funded biomedical research organisation

We have supported the proposal in principle. However, careful thought needs to be given to the balance between costs and benefits of such a development, and to the risk e.g. of inadvertent public disclosure of sensitive personal information. Benefits will only be realised if the database is sufficiently complete and up-to-date. This may be a challenge to achieve and may then require unrealistic resourcing. Furthermore, the right balance will need to be struck between providing enough detail to make the scientific record useful, while avoiding excessive information. If the ‘results’ to be collected are the scientific outcomes, there will be a significant delay before reporting during which time research could be inadvertently duplicated. If the ‘results’ summarise the intentions of the project, this can be done immediately after authorisation (and funding) of a project facilitating the objective of avoiding duplication.



yes The information collected at present is not useful to prevent duplication. This would entail a whole new set of information which it seems difficult to see what format much of the useful data could be presented in other than free text. This would not be amenable to database entry. this would be an administrative cost to all member states at currently collected statistical information will NOT assist in this matter. It would be almost impossible to keep this up to date. Duplication may occur between granting authorisation and publication of results.




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Negative results are not generally published in peer reviewed publications and could not be identified for listing on a database. This would make the database incomplete. Also details in the database would probably be insufficient to make a judgement on the exact studies conducted to determine if work is being repeated. Science operates globally and establishment of a EU database would miss a substantial quantity of information. Overall the principle is good but it would not be possible to achieve stated results and would have huge resource implications.


Public authority Local; Regional This is the only representative organisation for the Federal Government of Styria.

An EU wide database would have a high positive impact on animal welfare. We need to have information on negative results.


There should be a statutory obligation to avoid any duplication. To suggest that it would be too complex to introduce such legislation represents a lack of compassion and a disregard for the suffering of fellow sentient beings. A regime that permits duplication is an affront to the Universal Declaration of Animal Rights (proclaimed in Paris on 15 October 1978 at the UNESCO headquarters, and made public in 1990).




We cannot see how these suggestions could be workable. First, recent UK history of the development of major national databases has shown that they are very expensive, fraught with technical problems and rarely fit for purpose. Second, the results would need to identify the research group, which is not acceptable for security reasons. Third, issues of IP protection would obstruct the objective, as if competitors in a particular research field are doing similar research they are not going to release information to the other side An objective and evidence-based cost-benefit analysis would need to be undertaken before these proposal should be taken forward.

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The mentioned database open to all scientists of Europe will in fact be a public database which will cause severe problems with a minority of potentially violent animal rights activists. Avoidance of duplication may be possible in regulatory testing. However, in basic research proof of reproducibility provided by other groups is a necessity to ensure a critical approach! Databases introduced for scientific reasons already exist and are used in the evaluation of projects by authorities too (see Chapter XII).

The Association for the Study of Animal Behaviour

Other Worldwide yes There is a danger that in striving to be seen to be reducing duplication, undue confidence will be placed in existing experimental results. Replication and subtle variation in experimental methodology to retest outcomes is an essential part of fundamental research and must not be jeopardized


Other National Yes It is our view that an EU wide database would create significant economic costs for the European Commission.


Other Not applicable Yes The majority of results in research institutions is published in regular journals and can be assessed in databases such as Pubmed. Forcing the research institutions to provide these data in another manner also in a central EU database will lead to a severe burden. However, reporting of negative findings, that will not be published, within eg one year of finishing the project, to a central database might be useful.



National Yes General: Proof of reproducibility is imperative in natural science

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The assessment is severely hampered by lack of a clear definition of the scope and nature of the proposed database. For this reason, all assessments of potential costs are highly suspect. Re 1.2, benefits would also accrue from improving completeness of literature reviews and warning of ongoing projects before the results are published. Duplication does not just occur because of lack of publication of negative results. Researchers may not search the literature properly and/or information may be poorly accessible or in different languages.




In order to be fully useful the database should be mandatory and include all project applications. Since these are required for authorisation anyway, the burden to put them onto a searchable database is relatively low. Only truly ‘commercially sensitive’ information should be omitted. In addition, there is considerable merit in requiring companies (subject to commercial confidentiality considerations) to publish proposed test plans for a limited period, as happens under the US High Production Volume Program. This enables other companies (and NGOs) to alert the testing company and regulator where the data has already been generated, as well as giving them the opportunity of contending that there may be a better way of generating any required data applying the 3Rs. Such a database has also the potential to provide a mechanism for data sharing and compensation to the test result provider, as is occurring with REACH.

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The statements on potential benefits cannot be supported as they are based on an assumption that a significant amount of duplication, outside of that required by national/international regulations, takes place. There is no evidence to support this; to the contrary, the experience of the UK Home Office is that there is minimal duplication of animal studies.

Nuffield Council on Bioethics


National; Worldwide

There any other relevant organisations

The Council questions the assessment of the overall preliminary impacts as neutral. It is possible that the potential long-term benefits gained from establishing a centralised EU-wide database, in terms of reducing the number of animals used in experiments in the EU, would outweigh the costs in terms of resource requirements. Paras 15.16, 15.17, 15.68-15.70 and 15.84-87 describe the Council’s views on duplication, data sharing and the harmonisation of international guidelines, in Nuffield Council on Bioethics (2005) The ethics of research involving animals (London: Nuffield Council on Bioethics) Available at: http://www.nuffieldbioethics.org/go/ourwork/animalresearch/publication_178.html

PETA Europe Ltd.


Worldwide both The administrative burden is over estimated and there is no account taken of the fact that the majority of the cost is in setting up the new system but the benefits over time include economic benefits due to standardized reporting and administrative procedures being introduced. The animal welfare benefits are high, and so the additional cost should be embraced as an expression of the commitment to animal welfare made by the EU.

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PROFESSOR RD COMBES - FRAME


Worldwide THERE ARE OTHERS

The main problem with databases is finding ways to establish and maintain them and how to encourage their use. Several ongoing initiatives at EU level to develop databases of animal experiments should be encouraged. Databases on alternative methods exist e.g. FRAME, ALTEX, INVITTOX (ECVAM), and the need for strategic planning before conducting research work, to ascertain whether all or some of the planned research objectives could be achieved without using animals, should be emphasised.





Duplication has been found to occur frequently, and a recent study supported by the UK National Health Service concluded that animal studies are often carried out even after clinical trials on humans have been conducted. The study concluded that publication bias was a frequent problem (i.e. not equal publication rate for positive and negative results). The authors of the study suggest several steps to improve the validity and usefulness of results from animal models, among them “Prospective registration of animal experiments would enable researchers conducting reviews of animal studies to confront the problem of publication bias” (Roberts et al. 2006). References: Roberts, I et al. 2006. Testing treatments on animals: relevance to humans. NHS report for project RM04/JH18/IR.




The ability to verify results by repeating experiments lies at the heart of the scientific method. It should be accepted that non-regulatory duplication is most likely to occur in rapidly-moving, high-profile and high-value fields of research, where the rapid pace motivates against up-to-date central information and where some duplication is scientifically desirable as a check on over-enthusiastic claims of major advances.





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National Represents all Finnish pharmacologists

Difficult to imagine how this database could be constructed to be useful and not unwieldy. It could well be a useful resource if it were designed properly.



National The Danish Society of Pharmacology and Toxicology represents Danish pharmacologists and toxicologists.

Replication of experiments is an essential part of the scientfic process. Substantial information about previous experiments is already available in databases such as PubMed. However, due to publication bias some negative data may not be accessible.



Worldwide - -



Worldwide Representative Information on experiments is already widely available through databases such as Pubmed. However, some facility for publication of negative findings would be useful so that ese can be accessible through the peer-reviewed literature.



Worldwide yes But restrictions are absolutely necessary due to Activist issues, legal property rights and confidentiality reasons. This tool would be very helpful, but will increase costs and working time as well.

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Breeder of animals

Worldwide We are representative for the field and constitute about 50 percent of the activity

No justification required.

Biotechnology and Biological Sciences Research Council

National Representative BBSRC supports the principle but the following issues should be considered by the Commission: i) security (although access would be restricted to the inspectorate and scientists public access may be possible under freedom of information legislation); ii) compliance (low compliance would render the database useless); iii) detail of information captured and iv) when during a project the information is captured. In the analysis, the Commission has recognised the high cost that might be associated with this proposal.


Regional; National


supplementary information for 1.8: the information collected at present is not useful to prevent duplication. This would entail a whole new set of information which it seems difficult to see what format much of the useful data could be presented in other than free text. This would not be amenable to database entry. Supplementary information for 1.9: this would be an administrative cost to all member states at currently collected statistical information will NOT assist in this matter. Supplementary information for 1.10: It would be almost impossible to keep this up to date. Duplication may occur between granting authorisation and publication of results.


Regional; Worldwide

also others While unnecessary duplication should be avoided by all means, the new directive must not harm the principle of replication which is essential to science and calls for an independent confirmation of a novel finding. However, some means to publish negative findings should be supported, but at an international, not just EU-wide level. With regard to reducing the number of animals, efforts to avoid duplication of tests for regulatory purposes would certainly be more effective.

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Yes An EU database is unlikely to prevent duplicate testing, especially these duplicate testings due to the fact that negative results are not published. One should also consider that different research groups will perform seemingly similar experiments with slight differences, or may have different creative thoughts about the meaning of their negative data. Thus, denial of approval of seemingly similar experiments may impede progress in basic science.


National There are other relevant organisations

The capture of scientific results should be carefully thought out and the right balance struck between sufficient detail to make scientific record useful, while avoiding the provision of excessive information. If the “results” to be collected are the scientific outcomes, there will be a significant delay before reporting during which time research could be inadvertently duplicated. If the “results” summarise the intentions of the project, this can be done immediately after authorisation (and funding) of a project facilitating the objective of avoiding duplication.

Documents

Excel Sheet semifinal duplication rev1 - European Commission · duplication may be possible in regulatory testing. However, in basic research proof of reproducibility provided by