Memorandum 9
Submission from the Wellcome Trust
INTRODUCTION
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.
BALANCING BENEFITS
AND RISKS
OF RESEARCH
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.
RESPONSIBILITIES
OF RESEARCH
INSTITUTIONS
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.
RESPONSIBILITIES
OF REGULATORS
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
EUROPEAN COMMISSION—GREEN PAPER ON
BIO-PREPAREDNESS JOINT RESPONSE BY RESEARCH COUNCILS UK AND THE
WELLCOME TRUST (SEPTEMBER 2007)
INTRODUCTION
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: www.rcuk.ac.uk.
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: www.wellcome.ac.uk.
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.
GENERAL COMMENTS
ON THE
GREEN PAPER
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.
RESPONSES TO
CONSULTATION QUESTIONS
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
REFERENCES
1 For more information on the European Biosafety
Association (EBSA), see: www.ebsaweb.eu
2 The Statement of Journal Editors and Authors
Group on Scientific Publishing and Security (February 2003) may
be accessed at: www.asm.org/Policy/index.asp?bid=20507
3 Further information on the EBSA'a International
Laboratory Biorisk Management Standard project can be found at:
www.ebsaweb.eu/EBSA+Activities/Laboratory+Standard.html
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: www.royalsoc.ac.uk/document.asp?id=2830
5 The UK Chief Scientific Adviser's Universal
Ethical Code for Scientists can be accessed at: www.berr.gov.uk/science/science-and-society/public_engagement/code/page28029.html
6 The InterAcademy Panel Statement on Biosecurity
(published December 2005) can be accessed at: www.royalsoc.ac.uk/document.asp?id=3948
7 The report of the Foresight project on the
detection and identification of infectious diseases was launched
in April 2006 and is available at:
www.foresight.gov.uk/Previous_Projects/Detection_and_Identification_of_Infectious_Diseases/
Annex B
MANAGING RISKS
OF MISUSE
ASSOCIATED WITH
GRANT FUNDING
ACTIVITIES
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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