Select Committee on Innovation, Universities, Science and Skills Written Evidence

Memorandum 9

Submission from the Wellcome Trust


  1.  The Wellcome Trust is grateful for the opportunity to respond to the Innovation, Universities and Skills Committee's inquiry on biosecurity in UK research laboratories.

  2.  The Wellcome Trust is the largest charity in the UK. It funds innovative biomedical research, in the UK and internationally, spending around £600 million each year to support the brightest scientists with the best ideas. The Wellcome Trust supports public debate about biomedical research and its impact on health and wellbeing.

  3.  Through our grant funding schemes, the Wellcome Trust supports a broad portfolio of research in immunology and infectious diseases of humans and animals—providing research and career support for outstanding scientists in both the UK and in developing countries. We also support the development of key resources for the research community— for example, we have funded the Health Protection Agency's National Collection of Pathogenic Viruses since its establishment in 1999.

  4.  In addition, we fund the Wellcome Trust Sanger Institute in Hinxton, Cambridgeshire—one of the world's leading genomics research centres. The Sanger Institute has sequenced the genomes of many pathogenic organisms of medical significance—including the causative agents of tuberculosis, malaria, typhoid fever and plague. It has a number of major ongoing research programmes that aim to further understanding of the genetic basis of pathogenicity, interactions with host immune systems, and anti-microbial drug resistance in a range of human and animal pathogens.

  5.  This response reflects the joint views of the Wellcome Trust and the Sanger Institute, and was informed by limited additional consultation with members of our research community.


  6.  We recognise that it is absolutely vital that research involving hazardous pathogens and toxins is conducted in appropriately equipped and adequately resourced facilities, with robust safety and security procedures in place that minimise risks of harm to laboratory workers, the wider public, and the environment.

  7.  It must be emphasised, however, that research involving these agents will be absolutely crucial to combat the threat of both existing and newly-emerging infectious diseases. The UK has considerable research strength in this area, and it is vital that the resources and conditions are in place to enable responsibly conducted research to flourish. It is important therefore that the regulatory framework achieves a suitable balance—providing appropriate safeguards whilst not unduly restricting this essential research.

  8.  All research institutions funded by the Wellcome Trust are required, as a condition of grant funding, to comply with the requirements of all relevant regulatory authorities in taking forward the funded research. The Sanger Institute has appropriate processes in place to ensure that it complies with requirements of all regulatory authorities in relation to its work involving pathogenic organisms and materials derived from them. These processes are reviewed regularly.


  9.  We accept that it is primarily the responsibility of research institutions that work with hazardous biological agents to ensure that this research is conducted safely, and that all associated risks are mitigated in line with regulatory provisions and guidelines in this area. It is crucial that institutions ensure that their staff members are fully aware of all relevant regulatory requirements to address all risks of harm associated with their research. In addition, researchers, students and technicians working with hazardous agents must receive tailored training before they begin this work and refreshers at regular intervals thereafter, including updates on regulatory developments.

  10.  The role of dedicated Biological Safety Officers (BSOs) in institutions is vital in this regard. Their responsibilities ought to include actively tracking regulatory developments, advising their institution's senior management team on their implications, and liaising with regulatory authorities on an ongoing basis. In addition, they need to take the lead in raising awareness of regulatory requirements among staff and in ensuring the delivery of effective training provisions.

  11.  At the Sanger Institute, for example, a dedicated BSO operates within the Health & Safety Team. The Institute supports fully the vital importance of this role in helping to ensure that regulatory compliance and best practice in managing biological safety in research are achieved. A key contribution has been the development of a regime of training for researchers operating in Containment Level 2 and Containment Level 3 facilities, both ab initio and refresher to maintain competences.

  12.  In order to ensure best practice across the sector, it would be valuable to develop a common understanding of what the role of the BSO should involve. This would include defining professional competence requirements and providing common, independently accredited training modules addressing biosecurity issues within a dedicated syllabus of general biological safety training, which institutions could apply in a flexible manner to their circumstances.

  13.  To help achieve this, there might be scope to formalise the roles and responsibilities of dedicated institutional BSOs within the context of existing regulatory instruments—particularly the Control of Substances Hazardous to Health Regulations (COSHH) and the Genetically Modified Organisms (Contained Use) Regulations. We suggest that this could be considered in implementing the recommendations of the Callaghan review, as part of a new single regulatory framework for work on human and animal pathogens.

  14.  We are aware that there are concerns relating to sustainability of research on hazardous biological agents - both in terms of the provision of adequate funding for research facilities equipped to undertake work on these agents, and also in terms of the retention of technical expertise in research institutions. It is vital that the Government ensures that sufficient long-term funding is provided to key national institutions. This must enable them to maintain, and upgrade as required, the facilities required to conduct vital research involving hazardous agents in a secure environment, and to retain core technical staff. It is also important that institutions themselves develop appropriate succession planning arrangements to ensure retention of skills within their staff.


  15.  Whilst the primary responsibility for ensuring safety and security must rest with institutions, we believe that relevant regulatory agencies also have an obligation to ensure that they coordinate effectively in developing and implementing regulatory processes. In particular, they should seek to minimise duplication and overlap as far as is possible. Regulators should also ensure that they communicate requirements effectively through provision of accessible and practical guidance for research institutions, and through regular engagement activities with designated points of contact therein.

  16.  We would note that there is a considerable amount of existing regulation relating to biosecurity. The overall picture is quite complex, with several different Government departments and agencies responsible for different elements of the overall framework. These include the Health and Safety Executive, the Home Office (through the Anti-Terrorism Crime and Security Act 2001); BERR (through Export Control regulations); the Foreign and Commonwealth Office (via the Academic Technology Approval Scheme); the Department of Health and Defra.

  17.  It is our view that these existing regulatory instruments provide a highly rigorous framework to protect biosecurity of research conducted in UK laboratories. We would suggest that any gaps, deficiencies or inconsistencies should be addressed through the further development or enhanced implementation of these existing tools, rather than through the development of new regulations—which we feel could unnecessarily raise the existing regulatory burden on the research community. We would, however, welcome any improvement and simplification of the existing framework consistent with the principles of the Hampton review.

  18.  To this end, we welcome the recommendations of the recent Callaghan review to create a single regulatory framework to govern work with human and animal pathogens, the implementation of which should streamline and enhance existing processes. It will be important that there is adequate consultation with the research community as this process moves forward. We urge regulators, particularly those identified in paragraph 16 above, to seek further opportunities both to coordinate their procedures and to undertake joint communication activities which clarify how different elements of the regulatory framework fit together.

  19.  For instance, a single focal point of contact between a research institution and the cohort of regulators would be helpful. This function could sit within the Health and Safety Executive, and could operate regionally so that it acts as a conduit between research institutions and the relevant authorities responsible for regulatory oversight in that location. At the local level, such a system would help to build integrated arrangements between institutions and the various regulators. Strategically, at the national level, it could assist the various regulators to have a clearer picture of, and to develop enhanced responses to, biosecurity risks.

  20.  Finally, we would like to draw the Committee's attention to the recent European Commission Green Paper on Biopreparedness, which was published in July 2007. Whilst broadly supportive of parts of this document, we were concerned that some of the options under consideration might seek to duplicate or replace existing national processes at UK level and increase the regulatory burden on researchers. Research Councils UK and the Wellcome Trust submitted a joint response to this consultation in which we outlined these concerns. This response is appended as Annex A.

January 2008

Annex A



  Research Councils UK and the Wellcome Trust are pleased to have the chance to respond to the European Commission on the policy options set out in its Green Paper on Bio-preparedness.

  1.  Research Councils UK (RCUK) is a strategic partnership that champions the research supported by the seven UK Research Councils. The Research Councils are independent non-departmental public bodies, funded by the UK Government's Science Budget through the Department for Innovation, Universities and Skills. They are incorporated by Royal Charter and together manage a research budget of over £2.8 billion (

4 billion) a year. Through RCUK, the Research Councils work together to champion the research, training and innovation they support. See:

  2.  The Wellcome Trust is the largest charity in the UK. It funds innovative biomedical research, in the UK and internationally, spending around £500 million (

715 million) each year to support the brightest scientists with the best ideas. The Wellcome Trust supports public debate about biomedical research and its impact on health and wellbeing. See:

  3.  Over the last few years, our organisations have contributed actively to policy discussions at UK and international level aimed at addressing risks that life sciences research could be misused for terrorist purposes. In September 2005, the Biotechnology and Biological Sciences Research Council (BBSRC), the Medical Research Council (MRC) and the Wellcome Trust published a joint policy statement on managing risks of misuse associated with grant funding activities. This statement identifies a series of agreed actions that the three organisations have implemented to raise awareness and to help ensure that any risks of misuse associated with research proposals are considered at the grant application stage. The full statement is appended as Annex B.

  4.  The Research Councils and the Wellcome Trust support a broad portfolio of research aimed at enhancing our understanding of infectious diseases in humans and animals, and at developing improved approaches for their control. In particular:

    —    the BBSRC sponsors the Institute for Animal Health (IAH), which provides world reference laboratories for the United Nations Food and Agriculture Organisation on foot-and-mouth disease, rinderpest and peste des petits ruminants, and a regional reference laboratory service to the World Organisation for Animal Health for several other diseases—including bluetongue and Marek's disease;

    —    the MRC funds and sponsors work on human pathogens—for instance, the MRC's National Institute for Medical Research (NIMR) conducts research on influenza and through the World Health Organization (WHO), characterises newly emergent influenza viruses from across the world. It helped to detect the avian H5N1 and H9N2 strains that caused human outbreaks in 1997, 1999 and from 2003 to the present day; and

    —    the Wellcome Trust funds basic and clinical research in the fields of infection and immunity, pathogen and host genetics, and tropical medicine—both in the UK and internationally. It supports the Wellcome Trust Sanger Institute, a world-leading genomics research centre, which has sequenced the genomes of many key human and animal pathogens—including the agents that cause tuberculosis, typhoid and plague.

  5.  Our response begins with some general comments on the Green Paper. We then provide our views in response to the specific questions highlighted in the consultation document. We have restricted our comments to those questions which fall within our remit as research funders.


  6.  RCUK and the Wellcome Trust are supportive of the stated aim of the Green Paper to stimulate debate within and between EU member states on how to reduce biological risks. We also agree with the statement in the Green Paper that whilst the risk of bioterrorist attacks has been statistically low, the consequences of any such incidents could be devastating. Public concern regarding the risk of such attacks is also significant. We recognise, therefore, that it is crucial that appropriate mechanisms exist at national and international levels to address risks that biological research could be misused for terrorist or other harmful purposes.

  7.  It is equally important to recognise, however, that research involving hazardous biological agents will be essential to address the diseases that these agents cause and to enhance our ability to respond to bioterrorist threats. Indeed, such research should be seen as an integral component of overall "bio-preparedness" efforts. It is vital, therefore, that responsibly-conducted research of this type is not unduly restricted.

  8.  We would also emphasise that international collaboration, mobility of scientists across borders and open exchange of research results through peer-reviewed publication are essential to the international research endeavour and scientific progress. We would be extremely concerned by the addition of any new regulatory measures which might unnecessarily limit these processes.

  9.  We agree fully with the statement in the Green Paper that the measures taken should be proportionate in terms of the threat they seek to minimise and to respond to. We support the view that approaches such as awareness-raising and supportive financial programmes should be used in the first instance rather than new legislation. We also agree that if additional measures are considered appropriate, they should build on existing regulatory processes and use existing structures and expert groups wherever possible.

  10.  Further to this point, we consider that the UK already has a regulatory framework in place to ensure that biological research involving hazardous agents is conducted safely and securely. Whilst any scope to further strengthen these existing instruments should be explored in a manner proportionate to the threat faced, we do not think there is a need for any additional formal regulatory mechanisms in the UK at this stage.

  11.  Within this existing regulatory framework, we do, however, support the need for the scientific community to strengthen mechanisms of self-regulation to ensure that risks that research could be misused for harmful purposes are considered and addressed in an appropriate manner. It is important to acknowledge that issues of "dual-use" may arise both in cases where research directly involves the use of hazardous agents and in cases where it does not. Our organisations believe that processes based on responsible self-regulation by the scientific community will ultimately provide the most sensitive and effective way of addressing these issues.

  12.  We recognise that awareness-raising is crucial in underpinning effective self-regulation and we strongly support the Green Paper in promoting dialogue on European-level actions that could enhance awareness-raising efforts across EU member states.

  13.  Finally, we also support the Green Paper in promoting discussion on how public and animal health surveillance and response mechanisms can be strengthened and coordinated more effectively across member states in order to enhance our ability to respond to disease threats, whether these are naturally occurring or the result of a terrorist attack. However, these issues fall outside our remits as research funders, and we will therefore leave detailed comment on the role of different national and EU-level bodies to organisations more closely involved in this area.


Q1  Is a comprehensive approach to European biological risk reduction and preparedness required?

Q2  How could the EU bridge the perceived gap between non-proliferation and international cooperation in a dual-use field such as biology?

  14.  We consider that the response to biological risk reduction needs to be coordinated globally. We are unsure how some of the proposals set out in the Green Paper would fit within existing international processes—such as the Biological and Toxin Weapons Convention and the work of the WHO and Organisation for Economic Co-operation and Development (OECD). It is also unclear how some of the proposals would relate to ongoing European activities—such as the work of the European Biosafety Association (EBSA).1 We would emphasise that it is essential that the need for any further European-level activities is considered based on a clear analysis of previous and ongoing work, and in the context of a wider global framework.

  15.  We agree, however, that there could be significant benefit in the development of EU-level actions to promote cooperation and communication between member states—particularly in terms of sharing regulatory good practice and in developing training and awareness-raising activities. This could also facilitate coordinated European input into global-level discussions. It is essential, however, that any activities avoid the unnecessary creation of additional regulatory burden, where existing national processes are already fit-for-purpose.

Q5  Would peer evaluation methods be useful in addressing existing shortcomings across Europe?

  16.  We consider that the assessment of biosafety and biosecurity issues associated with individual research institutions and research programmes should be regulated at national level by member states. We agree, however, that there could be value in European-level processes, involving appropriate expert "peers", that periodically review overarching national regulatory frameworks and share best practice amongst member states. This would be provided such systems could be implemented without adding to the regulatory burden for states where existing processes are sufficiently robust.

Q6  What role should be played by the private sector in a public-private partnership?

  17.  We agree strongly that the private sector has a key role to play in discussions on reduction of biorisks. In particular, there will be considerable benefits in promoting dialogue and information sharing between public and private sector research organisations regarding best practice on biosafety and biosecurity concerns. There are already effective models for promoting networking between public and private sector on these issues—including the European Biosafety Association.

Q7  Should an EBN (European Bio-Network) be created in order to support the implementation of the results of this consultation?

  18.  The case for establishing the proposed "European Bio-Network" should be explored in light of existing advisory structures and ongoing work at national, European and global level. Clearly, the role and make-up of any such body would depend on the nature of the actions required at EU-level, which we expect will be informed by the outcomes of the present consultation. If plans to establish an EBN do proceed, it will be crucial that it seeks to draw on the experiences of other similar bodies—such as the US National Science Advisory Board on Biosecurity and the WHO Scientific Working Group on Life Science Research and Global Health Security.

Q9  Should awareness among stakeholders be increased about possible risks related to biological research and commercial activities and about the rules they have to comply with? If so, how?

Q10  Do you experience difficulties in following new adjustments of rules and restrictions? If so, which ones?

  19.  We agree that existing regulatory frameworks in this area are complex. We support the need for improved awareness-raising both on risks associated with biological research and on regulatory requirements, and agree that there could be an important role for EU-level actions to assist member states in strengthening activities at national level.

  20.  In the research institutes and units operated by the UK Research Councils, dedicated Biological Safety Officers (BSOs) have a responsibility for tracking regulatory developments; advising their senior management on their implementation; and raising awareness of these requirements more broadly within their institutions. We suggest that there might be scope to establish a common understanding at European level for the role of BSOs in research institutions and for EU-level work to support member states in training these individuals.

  21.  Since 1998, the MRC has, in collaboration with the University of Sussex, provided its own course to train BSOs to a common standard of competence. In addition to training BSOs at MRC Units, this course has been provided to a wide range of delegates from universities and private sector research institutions in the UK and from overseas. As far as we are aware, this is one of few training courses of this type and might provide a useful model to assist in the identification of common training requirements. We would be happy to provide further information on this course if this would be helpful.

Q11  Should common minimum bio-standards and the exchange of best practices be developed at the EU level?

  22.  We believe that the EU could play an important role in promoting the exchange of regulatory good practice in biosafety and biosecurity between member states. However, it is crucial that any such work uses existing frameworks and does not add unnecessarily to the regulatory burden in member states (such as the UK) with fit-for-purpose existing systems. It is also vital that all member states are encouraged to adhere to best practice rather than simply to minimal standards, and that individual states have the freedom to "gold plate" any EU requirements as they judge appropriate.

Q12  Would you be interested in developing rules for national certification and registering of facilities and researchers which could facilitate European and international exchange of samples and expertise?

  23.  We expect that responsibility for the development of any such rules in the UK would fall to the UK Government and relevant regulatory authorities. The Research Councils and the Wellcome Trust would be happy to feed into these discussions and input scientific expertise as required. If a system could be developed which could facilitate the exchange of samples and expertise at EU and international level without adding unduly to the existing regulatory burden in the UK, then we would of course be supportive of this.

Q13  What should be included in national registers—agents, facilities, activities—ensuring that there are no loopholes and that the security and oversight requirements avoid damaging health, safety, research or industrial activities?

  24.  We would note that such registers are already in place in the UK as the result of existing regulatory requirements.

Q14  Should a limited number of bio-researchers possess security clearance? If so, on what basis would you identify them?

  25.  We agree that appropriate levels of security screening for researchers working with potentially hazardous agents should be undertaken. However, we do not feel that the number of researchers possessing "clearance" to conduct such research should be "limited" to any arbitrary number (which might be one interpretation of the question). We also strongly disagree with the suggestion that access to "sensitive" research results should be limited to researchers with such clearance—this threatens the principle of open communication in science and could be detrimental to the research enterprise (please refer to our response to Q22 below).

  26.  We welcome the statement in the Green Paper regarding the importance of international exchange of scientific personnel to the research enterprise, and the need to ensure that, whilst appropriate security checks are undertaken, these do not unduly restrict the ability of talented scientists and students from overseas to work in laboratories in EU member states.

Q15  Should a specific and limited number of laboratories, health institutions, production establishments, pharmaceutical and food-processing plants be accredited on the basis of compliance with minimum security standards?

  27.  We consider that the UK already has a system in place which ensures that only laboratories with appropriate safety and security standards can conduct work on specified hazardous agents. Hence an "accreditation" process essentially already exists at the national level. As noted in our response to Q11, there could be benefit in work to share regulatory best practice at EU-level, but we would emphasise once again that where existing national systems are fit for purpose they should not be duplicated nor replaced by new processes.

  28.  Whilst we agree that only those laboratories meeting required standards should be licensed at national level to conduct work involving hazardous agents (and that in reality only a small number of specified laboratories will be equipped to work with the most dangerous organisms), we would again question why an accreditation system would be restricted to a "specific and limited" arbitrary number of laboratories.

Q17  Should there be EU funding for joint training and awareness raising?

  29.  We agree that the EU should provide funding for training and awareness-raising activities for those member states that require this support.

Q18  Should EU-level lists of biological agents of special security concern be developed jointly by the Member States and the Commission?

Q19  If you believe that each Member State should have its own pathogen lists, do you agree that interaction with other Member States on this topic could be beneficial for your organisation?

  30.  We agree that a single list of biological agents of special security concern which was developed and coordinated effectively at international level would be very helpful if this could be achieved. Ideally, we feel such a list should be maintained at a global, rather than a European, level (for example, via the World Health Organization).

  31.  Either way, we believe that member states should have the freedom to add additional agents to any such list as they feel appropriate at national level. We agree that mechanisms to facilitate dialogue between member states on this issue should be encouraged.

Q21  Should public and private funding for research on bio-substances be made conditional on the compliance of bio-standards?

  32.  Yes, we agree fully that research funders should make their funding conditional on compliance with national biosafety and biosecurity regulations. Institutions funded by the UK Research Councils and the Wellcome Trust are already required, as a specific condition of grant funding, to comply with the requirements of all relevant regulatory authorities in taking forward their funded research.

  33.  Our organisations also have additional processes in place to ensure that the research we fund complies with the highest ethical, as well as scientific, standards. In particular, the Research Councils and the Wellcome Trust have ethical advisory procedures through which we can obtain expert advice on research proposals that raise concerns that would not be addressed through standard licensing or local ethical review processes. In addition, our organisations actively promote best practice in the conduct of our funded research. We provide guidelines on good research practice, which set out minimal standards with which we expect researchers and institutions in receipt of our funding to comply, and have explicit policies on research misconduct.

  34.  As highlighted above, the BBSRC, the MRC and the Wellcome Trust also have a common approach in place to help ensure that possible risks of research misuse associated with research proposals are considered by both grant applicants and reviewers (see the policy statement at Annex B). We have introduced a standard question on application forms and ask both our expert referees and our Funding Committees to consider any risks of misuse associated with the proposals they review. We hope that our policy provides a useful model for other funding agencies, and we would be more than happy to provide further information on this as required.

  35.  Whilst we accept that funding agencies have an important role in addressing risks of research misuse, we are slightly concerned by some of the language in the Green Paper—particularly the suggestion that research grants should be assessed on the "ability of the given applicant to comply with bio-standards, as well as possible future security guidelines". We believe that this type of assessment is the role of the relevant national regulatory authorities and employers, and not funding agencies. It is also unclear how either funding bodies or the majority of scientists who peer review our grant applications could be in a position to judge the nature of "possible future security guidelines".

  36.  It is also important to emphasise that it is not the role of funding agencies to monitor compliance with biostandards once a research grant has been awarded. This is the responsibility of research institutions in receipt of the funding, with oversight by relevant national regulatory authorities. We agree, however, that funding bodies should have appropriate sanctions in place for researchers or institutions where breaches of accepted regulatory practice have been proved.

Q22  Do you agree that a publication procedure should be applied where sensitive biological dual-use research should be published in two versions: a public version with no publishing restrictions (without sensitive content); and a restricted version containing the sensitive parts of the research with access only for relevant bio-stakeholders?

  37.  No, we believe that the results of research, incorporating the full content of peer reviewed scientific publications, should be available in the public domain, unless there is a specific reason why they should be withheld in an individual case (such circumstances being very exceptional).

  38.  We would therefore be extremely concerned by the introduction of any system which imposed limits to the principle of open communication in science. We believe that the dissemination of research results through publication in peer reviewed journals should be subject to voluntary self-regulation by the scientific community, and not formal regulation by governments or the EU. It is important to acknowledge that the scientific publishing community has been proactive in recognising and promoting discussion on this issue—for example, through the "Statement of Journal Editors and Authors Group on Scientific Publishing and Security", which was published in February 2003.2

  39.  In terms of the specific process proposed in the Green Paper, we believe that it would be infeasible to define "sensitive" research in any meaningful way that would enable the identification of the small subset of publications that might be of concern. We would also question how such a system would identify "relevant bio-stakeholders" or control how they assessed and disseminated information contained in research papers. Furthermore, it would surely be impossible to regulate scientific publication—which is an international activity—at European level. In short, we feel such a system would be at best unworkable, and could potentially seriously hinder the scientific enterprise.

Q23  Could the EBN assist in the development of bio-security and bio-safety guidelines for publicly funded research?

  40.  Any such activity would need to be carefully coordinated with other relevant organisations, and avoid duplicating other work. For example, the European Biosafety Association is already engaged in a process to develop international standards for the laboratory management of biorisks,3 which we understand to be covering similar ground to the guidance envisaged by the Green Paper.

Q24  Should mandatory academic courses on bio-standards and best practices become part of the university curriculum in the field relevant to life sciences?

  41.  The Research Councils and the Wellcome Trust do not fund undergraduate education. At post-graduate level, we would support in principle the inclusion of standard content in courses which informed students of relevant regulatory requirements in this area and encouraged them to think about the wider implications of their research. We believe there could be value in the development of EU-level actions to assist member states in introducing such training at national level, as a component of wider awareness-raising activities. We suggest that this could best be incorporated through the development of modules that could be incorporated into existing courses, rather than through the development of new dedicated courses.

  42.  We would emphasise that scientists, technicians and students working in high risk areas should receive relevant tailored training from their research institutions on formal regulatory requirements and best practice before initiating such work. Appropriate refreshers (which include updates on any new regulatory requirements) should also be provided to such staff at regular intervals. As noted above, we believe dedicated institutional Biological Safety Officers would have a key role to play in provision of this training.

  43.  It is important that training requirements are introduced in a flexible way that does not disadvantage visiting scientists from overseas or researchers who move into biological science disciplines later in their careers. For example, it may be possible to build any new training into standard health and safety induction programmes in institutions.

Q25  Should researchers in life sciences be obliged to adopt a professional code of conduct?

Q26  Should the above-mentioned professional code of conduct be developed at EU level? If so, by whom?

  44.  We believe that codes of conduct have an important role in awareness-raising and encouraging responsible self-regulation within the scientific community, and their development and dissemination by appropriate national and international bodies should be encouraged. We consider, however, that codes of conduct do not provide the appropriate tool through which to enforce compliance with biosecurity standards, and feel, therefore, that a mandatory code that was enforced top-down at EU-level would not be appropriate. As has been highlighted in previous discussions of this topic, the extent to which biological researchers form a single, defined "profession" is open to debate, and so an overarching professional code might not be applicable in this area.4

  45.  We agree that there could be a role for EU-level activities to assist member states in developing codes of conduct, as part of their awareness-raising efforts, and promoting their adoption at institutional level. The Research Councils and the Wellcome Trust are supportive of the UK Chief Scientific Adviser's Universal Ethical Code for Scientists,5 which we suggest represents an excellent model. It is also important to acknowledge that there is existing international work on which member states and other organisations could draw in developing suitable codes—such as the InterAcademy Panel Statement on Biosecurity.6

Q30  Should the EU look into the possibility of developing a capacity for test detection tools on live and dangerous substances?

  46.  Yes, we agree that the EU should investigate this possibility. The EU might find the UK Government's Foresight initiative work on Detection and Identification of Infectious Diseases helpful in informing its work in this area.7


1  For more information on the European Biosafety Association (EBSA), see:

2  The Statement of Journal Editors and Authors Group on Scientific Publishing and Security (February 2003) may be accessed at:

3  Further information on the EBSA'a International Laboratory Biorisk Management Standard project can be found at:

4  See, for example, the report of the joint Royal Society-Wellcome Trust workshop Do no harm: reducing the potential for the misuse of life science research in October 2004, available at:

5  The UK Chief Scientific Adviser's Universal Ethical Code for Scientists can be accessed at:

6  The InterAcademy Panel Statement on Biosecurity (published December 2005) can be accessed at:

7  The report of the Foresight project on the detection and identification of infectious diseases was launched in April 2006 and is available at:

Annex B


A joint Biotechnology and Biological Sciences Research Council (BBSRC), Medical Research Council (MRC) and Wellcome Trust policy statement

  The BBSRC, the MRC and the Wellcome Trust have each issued position statements on bioterrorism and biomedical research. These cover issues such as: balancing benefit and risk; funding decisions; dissemination of research; international collaboration and training; and promoting research best practice and ensuring public trust. The position statements are available on the organisations' websites.

  The position statements propose that a system based upon self-governance by the scientific community will ultimately provide the most effective means of managing risks of misuse. We suggest that the community should take active steps to further develop mechanisms of self-governance, and that through doing so the community can ensure that responsibly conducted research is not unnecessarily obstructed.

  The BBSRC, the MRC and the Wellcome Trust already have rigorous processes in place for ensuring that the research we support is of the highest scientific quality and conforms to all relevant ethical and regulatory requirements. In light of concerns over research misuse, we have been working in partnership to examine how these existing procedures could be strengthened to help ensure that risks of misuse associated with research projects are identified and assessed at the grant application stage, where it is possible to do so.

  We have consulted members of funding and advisory committees across the three organisations, on the basis of a discussion document. The outcome of this has led the BBSRC, the MRC and the Wellcome Trust to agree changes to our policy statements, guidance and procedures in four areas:

    —    introduction of a question on application forms asking applicants to consider risks of misuse associated with their proposal;

    —    explicit mention of risks of misuse in guidance to referees as an issue to consider;

    —    development of clear guidance for funding committees on this issue and the process for assessing cases where concerns have been raised; and

    —    modification of organisational guidelines on good practice in research to include specific reference to risks of misuse.

  The misuse of research for terrorist purposes may be only one of a number of possible ways in which the outcomes of research could conceivably result in harm. Therefore, these changes refer to all kinds of research misuse.

  These changes have been introduced to heighten awareness, and as a means of identifying possible risks of misuse at an early stage. Ultimately what matters most is people's motives. The changes we are implementing to our processes will not be sufficient on their own to prevent misuse by somebody with that primary intent. Other processes within the research environment are therefore also important; these include effective research governance at the local (institutional) level, appropriate levels of caution in making appointments, and compliance with existing health and safety regulations.

September 2005

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