sou · GXB355 · 2009-06-10 00:00:00 — An external evaluator may also ask how well the possibilities of collaboration within the campus between laboratories working within the field of HIV vaccine development have been used. Perhaps a special insti- tute collecting all groups under a single umbrella working on HIV should be considered. The department of Virology is also employed in molecular epi- demiological studies of hepatitis C in the Baltic countries and NW . Another project is studying the genetic diversity of hepati- tis viruses globally. The relevance of these studies to the work of SMI is low-to-moderate although their impact in the target coun- tries may be quite significant. Finally, the department is involved with a couple of EU-wide projects that have an impact on the work of SMI. Rotavirus strain surveillance monitors adoption of rotavirus vaccination into natio- nal childhood vaccination schemes and another trying to find new sites for antiviral drugs using enteroviruses as models. Their rele- vance to the mission of SMI is moderate-to-questionable. Based on the information that has been obtained from SMI and the comparison with the other Nordic institutes, a SWOT-analysis is presented for the research in SMI: 1.High quality and broad basis for research in microbiology. Close collaboration with KI ensures this also in the future. 2.A well functioning national surveillance system (SmiNet) provides data for epidemiological research. 3.Stable and solid basic funding from the and safeguards a platform from which further research funding can be sought. 4.International contacts (EU, ECDC, WHO) provide good frame for important international contributions. 5.Good usage of EU-wide networks enables fruitful sharing of know-how and resources with other countries. 6.Established collaborative links with developing countries help tackling of diseases and problems that are not very prevalent in but pose a threat globally. 7.Established links with some of the Eastern European countries help a regional collaboration to tackle communicable disease problems. 8.The possibility to recruit doctoral and postdoctoral students is currently very good. 9.Laboratory facilities are very good and the possibility to im- prove the situation even further in collaboration with KI is an asset. In particular, the animal facilities with P-3 level working areas and the P-4 level safety laboratory gives the SMI opportu- nities to do research that most similar national institutes in Europe do not have. 1.Infectious disease epidemiology has been weakened by the loss of key personnel. 2.Not much research is oriented towards planning and implementa- tion of interventions (outside vaccination studies). 3.Utilization and development of methods for the use and linking of various registers. (Examples of usage: Disease burden linked with immigration, day care, occupational risks, hospitalisation in other countries, , long term outcomes of infectious diseases). 4.Lack of day-to-day contact with microbiological diagnostic work. This may compromise the ability of SMI to respond to new emerging threats and to provide proper guidelines for microbiological laboratories in the country. 5.The role of SMI in collecting and organising microbiological sample collections with national coverage is not clear. 6.There seems to be no organised system for involving national stakeholders outside SMI, such as , smittskydds- läkarna, food safety authorities and the hospitals, in defining the research agenda of SMI. 7.There seems to be no organised system for merging data on individual cases in SmiNet with typing data on the causative microbes from the reference laboratories. 8.Newer methods for genetic typing and sequencing provide a large amount of biological data. There is a lack of a parallel development in bioinformatics to fully utilise the data. 9.Competitiveness of recruitment of researchers. Current activi- ties are good compared to any other similar institute, but the trend of losing competitiveness to other fields of medicine is Perhaps a long-term career development could be an added bonus. 10.Guidelines for the conduct of research work that would meet the specific requirements that are derived from the role of SMI as a central governmental research institute are missing. SMI should have quite strict and open rules that define conditions for declaring conflict of interests and other important ethical issues. 1.Various registers in the country are reliable and often updated without significant delay. This can be a valuable source of in- formation and new ideas for research. New registers, such as a register for vaccinations and a register for health-care associated infections, may provide a wealth of new research opportunities. 2.Proximity with KI provides opportunities to further expand collaboration and sharing of technical resources. 3.Proximity with KI provides opportunities to further expand collaboration and sharing of intellectual resources both in research projects as well as in emerging situations where only limited expertise may be available in SMI. 4.Recruitment of external money for research projects in SMI has been quite successful. Supporting this will enable SMI to take new initiatives in research and expand the current projects. 5.New arrangements with at KI will allow SMI to expand its activities to include new aspects of planning and implementing public health interventions. 6.Establishment of STRAMA has provided a good potential to combat the threat due to emerging antibiotic resistance. 7.Proximity with ECDC provides opportunities to expand net- works among similar national institutes in Europe. 1.Lack of coordination between various stakeholders in infectious disease control in . The roles of , SMI and should be kept clear and overlapping activities avoi- ded, so that SMI keeps its central role in research. 2.Restriction in the use or availability of external funding. If the availability of external funding is restricted, it will seriously af- fect the attractiveness of SMI for high quality researchers and by doing that, seriously threat the future of the institute as a high quality research center. This is particularly relevant now as ECDC is competing for the same people. 3.Loss of long-term strategy for research work. The contents and orientation of research work in SMI is depending not only on the goals set by the general director and the ministry, it is also linked with the scientific interests of strong researchers, who, in order to reach their own goals need to develop a strong research team and sufficient time to establish it into the international sci- entific community. Only then significant external funding may become accessible. The lack of involvement and influence of other stakeholders (, smittskyddsläkarna etc) on the research agenda of SMI may result in less support for SMIs role in research. In order to put those interests together, a long- term research strategy built on input from all relevant stake- holders is very important. 4.A major problem in the future may be a limited possibility to recruit doctors, notably specialists in microbiology, as research leaders in relevant departments. doctors may be very strong research leaders but may not have sufficient training and understanding of complicated epidemiological and clinical problems in communicable diseases. A long-term stra- tegy for recruitment and career planning for talented doctors for such positions is important. The following general conclusions can be drawn as a response to the questions presented in the terms of reference to our group: An evaluation and categorization of the research work that is conducted in SMI with special emphasis on its relevance to the infection control of today. Are there differences between research financed by external money vs. the institute money? If so, what are the consequences? As a research institute SMI is of considerable size with more than 350 regular employees and numerous scientist and stu- dents (75 doctoral students) on short term basis. In addition, the laboratory facilities are modern and well equipped. SMI is closely linked with () with shared professorships, core facilities doctoral training programmes and numerous com- mon research groups and projects. It is fair to conclude that the SMI-KI campus is one of the big centers for research in the field of infection control even internationally. A comparison with other Nordic institutes is given in chapter 3. The research portfolio includes activities from very basic mole- cular biology to interventions at population level. In many fields the research is scientifically of very high quality, in some areas close to the leading edge in the world. Examples include HIV vac- cine research and research on tuberculosis, helicobacter and pneu- mococci. Basic research in immunology and cell biology pave way for new scientific discoveries that may greatly enhance our ability for successful interventions in various infections. Research supporting modern laboratory diagnostics is well developed and molecular diagnostics has been implemented among others for pertussis, HIV and gastrointestinalviruses. The researchers have access to P-3 level animal facilities and P-4 level containment labo- ratory widening the possibilities for critical studies in emerging threats like sars virus infections or drug-resistant tubercu- losis. The research covers all relevant fields of bacteriology, viro- logy, parasitology and mycology and provides good basis for SMI acting as a national reference center giving support and advise to other actors in the field. Surveillance of communicable diseases is a key area of respon- sibility for SMI. It could have more activity and resources linked to interventions such as behavioural sciences. A considerable part of the research activities are financed from external, competed funds. Some are big international financiers such as Union, and , AREAS just to name a few. Winning such grants may be taken as an indicator for the high quality of research in SMI. The research supported by them is directed to fields that are important for the role and image of SMI and are very relevant. Some research funds are earmarked by other criteria than research area such as funds to support research in some of the neighbouring countries (, Estonia, Belorussia). Vaccine research is often strongly supported by commercial sources but such funding is necessary today due to the high total costs of many vaccine studies. We have not observed any undue bias in the research focus due to the demands by exter- nal . How does the quality of research in SMI compared to corresponding research internationally? A study based to a couple of countries is asked for. Also an evaluation of the laboratory capacity and its role in supporting the relevant research is asked for. As indicated above, the quality and quantity of research conducted in SMI meets highest international standards. Compared to insti- tutes responsible for infectious disease control in the neighbouring countries SMI easily matches them in almost all areas. (See chapter 3 and 9, SMI related research in the other Nordic countries). The laboratory capacity in SMI is excellent for research work. A number of core facilities are available and the laboratories are well equipped. Sharing resources with KI helps to find even the most sophisticated applications that may be needed. SMI does not conduct laboratory tests at primary diagnostic level. Yet, it is supposed to guide and support diagnostic laborato- ries in the country and to participate in the External Quality Assessment (EQA). We may ask to what extent lack of direct contact with clinical diagnostic microbiological laboratory work may impair SMIs ability to meet with this demand, or should there be rearrangements, for instance joint activities between SMI and microbiological laboratory of the hospital of . Question 3: How is the research in SMI focused compared to infection control related research in other countries. Does it give support to the work and actions of other actors in the field in ? Are there obvious gaps? What is the importance and im- pact of EU collaboration and demands from complying with IHR? The research in SMI has a strong basis in basic academic research. Such a basis is necessary for proper response to new challenges, be they from research field, from changing environment or from practical issues such as indentifying and characterisation of new emerging biological threats. Research orientation is to some extent dictated by strong indi- vidual scientists who can create large and successful research groups around them. Such groups may not always be very flexible what comes to the contents of the research work but they have great value in terms of recruitment of new and able researcher and acquisition of external research money. SMI has an extensive and excellent corporation with countries in in the area of especially AIDS/HIV, tuberculosis and malaria and to a much lesser degree with Latin and , , , , , and other Asian countries and . Except for influenza and SARS it might not be so easy to justify such wide collaboration from the point of view of the tasks of SMI, since the big malaria, tuberculosis and HIV are co- vered by collaboration with . Collaboration with EU-wide networks and WHO projects have helped SMI to stay in the front line of research and applications. Collaboration with ECDC will introduce new tasks and responsi- bilities and will most probably also create new collaborations with laboratories in the SMI campus. Already now some of the laborato- ries are regarded as international reference laboratories. Certain areas may need strengthening: Epidemiological research would greatly benefit if fields outside strictly biological could be involved, such as behavioural and perhaps social sciences. The new arrangements referred above may open a possibility to this. SMI is supposed to play a key role in identifying risks that re- quire specific actions according to IHR. It has broad scientific ba- sis and good laboratory capacity, including the P3 and P4 facilities, which helps it and to respond in appropriate way that is useful not only for but to the whole world. 1.SMI is strong in microbiological research. This strength should be supported and maintained. It serves at least three important functions: (In emergency situations) it provides the expert views and information that is needed for proper and prompt response. (Conflicting views given by different authorities would de- stroy the public trust) b.It has the potential to contribute to significant public health improvements such as HIV-vaccine, more effective tuberculosis-control etc. c.It has a central role in the recruitment and training of new experts. 2.SMI has extensive network of international scientific collabora- tion. It has role in functions (for instance the reference laboratory for tuberculosis), in EU-wide collabo- ration (for instance hub-function for EU-wide networks) and collaboration in developing countries (for instance HIV-vaccine related projects). This collaboration has been very successful and serves the functions of SMI very well. It is also an impor- tant source for external research funding. 3.In spite of the high level of microbiological research, SMI does not have direct contacts with clinical diagnostic work in micro- biological laboratories. This may affect its ability to contribute to setting the standards for diagnostic work, collect proper sample banks or play a role in the training of people who are re- sponsible for the diagnostic work. 4.Research that would be directly linked with public health inter- ventions is not very prominent in the institute. It has no resour- ces for behavioural studies (will probably help), infectious disease modelling is not a strong area and the use of various health-related registries is patchy. 5.Epidemiological research as a discipline is not as well developed as the microbiological fields. 6.There is a rapidly growing need for bioinformatics resources due to implementation of new techniques. 7.Since several groups and departments share research objectives and use similar methodologies, further development of i.e. core facilities could improve the overall scientific coherence of SMI. 8.The role of SMI in the network of actors in the control of infec- tious diseases (Smittskydd) is not quite clearly expressed in the legal framework. A system of national reference laboratories is necessary and SMI could and should be able to host most of this need and link the microbiological typing information and the surveillance system (SmiNet) information. However, there does not seem to be a clear mandate given to SMI in this field. 1.SMI should continue as a main actor in infectious disease con- trol research in . Some research areas are very close to basic academic research even if they have clear relevance to pub- lic health related to infectious diseases and infection control. In many cases there are close links with EU-wide research collabo- ration and in certain areas SMI is the leading partner in Europe. If certain fields of research are considered to expand too much beyond SMIs capacity, a possibility to be considered is to create a special European research and reference center that would join the resources from KI, SMI and possibly ECDC. This would also bring more coherence to the strong areas where many groups in different departments are . Feasible areas would include HIV vaccine research, perhaps tuberculosis and changing patterns of infectious disease due to environ- mental (climate) changes. Some of the current WHO reference centres could act as models (i.e. 2.SMI should explore a possibility to make special arrangements for instance with Microbiology Laboratory to create closer links with basic microbiological laboratory diagnostics. This could facilitate training, development of methodology, harmonisation of quality assessment and collec- tion of national sample depositories. 3.Research linked with public health interventions should be expanded, including modelling, disease burden studies, impact evaluations, communications are areas of importance for suc- cess. A step to liaise with at KI may fa- cilitate this process. 4.Infectious disease epidemiology know-how should be expanded. The area will need a strategic plan with clear objectives and vi- sions about the contents. Setting a short-term strategy group to define medium-term objectives for the tasks of the department of epidemiology should be considered. has, like the other Nordic countries, unique registries that could be utilised in epidemiological work in a very productive way. SSI in has a strong scientific profile in this field and a possibility to expand collaboration should be explored. New registers, such as for vaccination and health-care-associated infections, may be considered. 5.The current biostatistics core facility should be expanded with expertise in bioinformatics and mathematical modelling. 6.SMI should facilitate organising a system of national reference laboratories in the country. 7.A plan for long term career development for doctors who spend some of their training time in SMI should be consi- dered. 8.SMI should explore ways of involving national stakeholders, such as , smittskyddsläkarna, the hospitals in- fectious disease control units, and the food safety authority, in the development of a research strategy and prioritisation of research projects. This will help to create support for SMIs role as a central research institute. 9.SMI should explore possibilities to benefit from its proximity to ECDC. ECDC will for the foreseeable future depend on net- working the national research capacities. SMIs laboratory faci- lities, strong research base and field epidemiology resources puts SMI at and advantage as a partner for ECDC. Attachment 1: Terms of reference for the evaluation: (S 2008:06) behöver få stöd i sin bedöm- ning av den forskning som bedrivs av (). Det är främst följande frågeställningar utredningen önskar få bedömda: 1.En bedömning och kategorisering av forskningen som bedrivs på efterfrågas där särskilt forskningens relevans för aktuell smittskyddsproblematik belyses. Finns skillnader i innehåll och inriktning för forskning som finansieras med externa medel jämförd med övrig forskning? Hur yttrar sig dessa skillnader i så fall? 2.Vilken kvalitet håller forskningsverksamheten på sedd i ljuset av internationell forskning inom motsva- rande fält? En studie baserad på några jämförbara länder efter- frågas. Härvid önskas också en bedömning av SMIs laboratorie- kapacitet och dess roll i att stödja forskningens inriktning och resultat. 3.Hur bedöms inriktningen på forskningen inom jämförd med andra länders smittskyddsforskning? Uppfattas inriktningen som ändamålsenlig för att stödja smitt- skyddsområdet i på nationell/regional/lokal nivå jäm- förd med andra, jämförbara länder? Finns det angelägna områ- den som behöver uppmärksammas ytterligare? Det vore värde- fullt om analysen också tar i beaktande de ökande krav som ställs på ett effektivt smittskydd genom EU-samarbetet och implementeringen av IHR. , M.D., at present State Epidemiologist and Department Director at , at , . He a member of the at , as well as editor of the journal of . , M.D., Dr. Med.Sci., at present professor of Microbiology and chairman of at , i.e. , M.D., Ph.D. and professor emeritus in virology at the former . He has a background in epidemiology as well as in virology. is the editor of the evaluation report to the Inquiry on Communicable Disease Control. Följande frågor önskar utredningen svar på: Vilka omvärldsförändringar bedömer SMI har betydelse för hur myn- dighetsansvaret för smittskyddet bör utformas ? Vilka av dessa är de viktigaste ? Vilken eller vilka av dessa åtgärder skulle kunna falla helt inom SMI:s ansvarsområde givet nuvarande ansvarsfördelning? Vilken eller vilka åtgärder skulle kräva samverkan med andra myndigheter såväl på nationell, regional som lokal nivå? Hur kommer den ökande internationaliseringen av smittskydds- arbetet att påverka SMI:s verksamhet ? Hur bedöms den redan ha påverkat SMI, dels i fråga om myndighetens egen verk- samhet, dels när det gäller institutets samverkan med och gränsytor gentemot andra aktörer? Vilka förändringar i inriktning av verksamheten i SMI har större omvärldsförändringar redan lett till ? I utredningens direktiv (s. 17) används begreppen respektive satta i ett utvecklingsperspektiv. Dessa begrepp är inte entydiga och kan tolkas på olika sätt. Vad och vilka verksamheter lägger SMI in i begreppet expert- myndighet? Vilka är de intressenter som behöver ha tillgång till den expertis som myndigheten tillhandhåller genom uppgiften som Hur ser kontaktvägarna ut mellan myndig- heten och dessa intressenter? Hur svarar myndigheten upp mot rollen som så som myndigheten definierar begreppet? Vad lägger SMI på motsvarande sätt in i begreppet Kunskaps- centrum? Hur bedömer myndigheten att SMI fyller denna roll och vidare hur ser gränssnitten ut gentemot andra myn- digheter som även de har till uppgift att vara , t.ex. FHI? Finns det – som anges i – några nya kompetensområden som skulle behöva uppmärksammas och vilka specialkompetenser skulle i så fall krävas för dessa nya områden? I nu gällande instruktion för SMI (SFS 2007:1215) beskrivs ett antal konkreta och specificerade uppdrag som myndigheten ska utföra. behöver – utöver den beskrivning som ges i regleringsbrev och årsredovisning och som bygger på tidigare verk- samhetsstruktur – även få fram en bild av hur SMI:s samlade upp- drag kan beskrivas som bygger på instruktionens uppgiftsbeskrivning.