Dr Caitríona McLeish & Dr Paul NightingaleSussex Day 16th March 2005

The impact of dual use The impact of dual use controls on UK science:controls on UK science:

results from a pilot results from a pilot studystudy

Background to the pilot projectBackground to the pilot project

Basic question: Have attempts to secure life sciences against misuse affected its practice in the UK?

Anecdotal evidence from the USA and Germany that governing dual use has impacted on practice of science

Reclassification of scientific knowledge

Redirection of science

Spread of technical capabilities

Global affects of biosecurity controls

What is happening in the UK?

Highlights: legal barriers against misuseHighlights: legal barriers against misuse

2001 Anti Terrorism Crime and Security Act

Part 7 and part 14

Schedule 5 pathogens and toxins

19 viruses, 5 rickettsiae, 13 bacteria, 11 toxinsInclude genetic material or GMO containing a sequence

Notify if keeping or using these pathogens

Notify who has access to these pathogens

Disposal requirements for these pathogens

Highlights: other legal barriers against misuseHighlights: other legal barriers against misuse

1974 Biological Weapons Act

Ratifies the 1972 Biological Weapons Convention

Criminal offence to develop produce stockpile acquire or retain any biological agent or toxin of a type and in a quantity that has no justification for prophylactic, protective or other peaceful purposes

Any weapon, equipment or means of delivery designed to use biological agents or toxins for hostile purposes or in armed conflict

Amended by Anti Terrorism Crime and Security Act 2001

Criminal offence to transfer or make arrangements to transfer

Applies to acts done outside the UK but only if they are done by a UK person

Highlights: other legal barriers against misuse Highlights: other legal barriers against misuse (continued)(continued)

2000 Terrorism Act

Providing or receiving instruction or training in the making or use of chemical, biological or nuclear weapons

Inviting another person to receive such training, inside or outside the UK

Inciting another person to commit an act of terrorism wholly or partly outside the UK where the act includes … poisoning

Reference to Sections 23 and 24 of the Offences against the Person Act 1861 (administering poison, and administering poison so as to endanger life)

1. How institutions operate under biosafety and biosecurity regimes

2. Have the new biosecurity requirements impacted on current R&D programmes?

Are their concerns about future impacts?

3. What is the perception of current interaction between scientific practitioners and the government designers of these regulations?

Could this interaction be improved?

Pilot project objectivesPilot project objectives

Project methodsProject methods

Needed to create a community

Scientists, funders of science, biosafety personnel and biosecurity officials

Practioners connected to listed pathogens and toxins

The sample was constructed using standard bibliometric methods

plus triangulation with other datasets

Core sample of 100 Use of a control group not associated with listed pathogens Total sample size was 128

Project methods (continued)Project methods (continued)

Questionnaire

Needed to effectively communicate across barriers Sections of questionnaire: background information, impact on

administrative costs and benefits, institutional costs and benefits and perceptions

Validated over a six month period

Interviews

27 in-depth interviews

Exploration of questionnaire responses and test general trends

The project achieved a 53% response rate (68 usable responses)

Profile of the sampleProfile of the sample

All practising scientists in the sample worked with listed agents

71% with pathogens, 76% with toxins 91% with the genetic material

71% overall responsibility for research projects

68% day-to-day managers of laboratories

53% actively engaged in research

56% previously interaction with officials

Majority of total respondents located in university/teaching institutions (68%)

Government labs (9%) and commercial R&D facilities (6%)

Typical institution size: 11 and 100 active researchers

91% hazard group 2, 74% hazard group 3

79% under conditions of containment

General findingsGeneral findings

Results suggest introduction in the UK has not had the same negative impact as has been reported in the US and Germany

Success of implementation related to

1. Pre-existing security and biosafety measures

2. A responsive approach to regulation by the implementing body

3. Flexible and socially responsible reaction by the scientific community

Future implementation could be more difficult

How did the sample get its information?How did the sample get its information?

0

10

20

30

40

50

60

70

80

90

Receipt oftargeted HSE

material

Proactivescanning of

H&S literature

Receipt oftargeted

informationfrom other

governmentagencies

Personalscanning of

wider sources

Receipt oftargetedDEFRAmaterial

Informationfrom other

bodies

Other

‘‘Biosecurity’ procedures in place prior to 2001Biosecurity’ procedures in place prior to 2001

0

10

20

30

40

50

60

70

80

90

100

Containment Access byshort-termworkers

Acquisition Disposal Access byoccasional

visitors

Offsitetransfers

Onsitetransfers

Proposals topublish

Changes to operational procedures since 2001Changes to operational procedures since 2001

0

10

20

30

40

50

60

70

80

Increasedattention tobiosafetymeasures

Morerigorous

(safety) riskassessment

Improvedrecording andregulation ofpossession

Increasedrequirementsfor material

safety

More attentionto ethicalreviews

Review ofpersonnel

with currentaccess

Increasedsecurityauditing

requirements

Increasedtraining

requirements

Increasedscreening for

proposedaccess

Suitability ofdata for

publication

Major complications or setbacks experienced since 2001Major complications or setbacks experienced since 2001

0

5

10

15

20

25

30

35

40

45

No majorcomplicationsor setbacks

Diff iculty inobtaining

pathogens ortoxins

Increasedmandatorybiosafety

requirements

Increasedmandatorybiosecurity

requirements

Changes tow aste disposalrequirements

Increasedmandatory

licencerequirements

Other Diff iculty inobtainingpieces ofequipment

Who ought to have responsibility for protecting Who ought to have responsibility for protecting the life sciences against misuse?the life sciences against misuse?

0

10

20

30

40

50

60

70

80

Theinstitutions

themselves

The scientificcommunity at

large

Governmentofficialsprimarily

involved withhealth or

safety

Bodies thatfund research

Othergovernment

officialsprimarily

involved insecurity

Governmentofficialsprimarily

involved inexport

controls

Scientificjournals

The Police Industrialorganisations

Which biosecurity policies are worth considering?Which biosecurity policies are worth considering?

0

10

20

30

40

50

60

70

Increasedsecurity

checks oncurrent

personnel

Increasedscreening of

newpersonnel

Procedures toauthorise and

control of f -site transfers

Increasedmaterialcontrol

Scrutiny byfundingbodies

Scrutiny byscientif icjournals

More rigorous(safety) riskassessmentof proposed

w ork

More rigorousethical reviewof proposed

w ork

Codes ofconduct

Denyingaccess to

nationals f romcountries of

concern

Analysis

Important to recognise these are pilot study results

Results are indicative rather than conclusive

Results suggest that the sample believes implementation of new biosecurity controls in the UK has been conducted very successfully

79% regarded the current balance as satisfactory

Possibility that research was performed too early

The lack of substantial disruption is an important finding

Suggests science and security do not necessarily have to be in conflict with one another

Analysis (continued)

Three factors that have contributed to the successful implementation (thus far) of UK biosecurity controls:

1. Pre-existing biosafety measures which ensured a degree of biosecurity prior to ATCSA

2. A responsive approach to regulation by the implementing body

3. A flexible and socially responsible reaction to the new controls by the UK scientific community

Factors influencing successful implementation 1: Factors influencing successful implementation 1: biosafety and biosecuritybiosafety and biosecurity

Recurring theme in this project

Implementation of UK biosecurity measures has drawn heavily on the biosafety model

‘Flexible system’ has since created procedures to deal with a range of security issues

Concentrated on tightening existing practices rather than introducing radically new requirements

Some of the procedural changes might as easily have occurred as a result of the periodic reviews of biosafety as specifically in response to biosecurity legislation

Factors influencing successful implementation 2: Factors influencing successful implementation 2: the implementation processthe implementation process

Effective implementation is challenging

Implementing body has come close to producing a textbook example of successful change management

Exploited pre-existing links and channels of communication

Biosafety as avenues into the scientific research community

Non-confrontational approach

Has to some extent been responsive to the organisational culture of the scientific community

However, only 21% of the sample supported the police taking the role of protecting the life sciences

Current low support may increase once direct communication begins

Factors influencing successful implementationFactors influencing successful implementation 3: 3: the response of the scientific communitythe response of the scientific community

Proactive response of this sample of the scientific community

Recognised that scientific research does not exist within a moral or social vacuum

Recognised the need to be responsive to public concerns

General awareness about current issues relating to misuse was quite low

Much higher level of awareness about how a scientist might unknowingly contribute

Believed awareness could improve if there was an opportunity for increased interaction with designers of biosecurity policies

Factors influencing successful implementationFactors influencing successful implementation 3: 3: the response of the scientific community (continued)the response of the scientific community (continued)

Many in the sample repeatedly expressed their desire to be better guardians of their science

Requires a better understanding

Their desire to have more active engagement unlikely to be a result of any perceived direct benefit

Stems from revulsion towards the possibility of their legitimate science being misused

Concerns about the impact of inappropriate regulations

Risk management and the scientific communityRisk management and the scientific community

Project findings suggest a major change in how the scientific community conceives of risk and attempts to manage it

Social legitimacy of scientific knowledge is increasingly dependent on scientists engaging with wider society

Consistency of project responses suggests a subpopulation of the scientific community that

Recognises the risks of misuse of scientific knowledge

Recognises the importance of perceptions of that risk

Recognises their role in responding to those perceptions

Policy issue: provide them with the time and resources they need to effectively engage in policy making

Final reflectionsFinal reflections

Thus far implementation of UK biosecurity controls seems to have been performed with limited negative impact on the scientific community

Less disruptive in the UK than has been reported for the US and German scientific communities

Necessary to regularly review the impact of dual use controls on UK science

This project has developed and validated a methodology to identify relevant members of the scientific community and obtain such information

Final reflections (continued)Final reflections (continued)

Biosecurity policies need a two-stage implementation process

First stage is securing adherence with minimal costs

Second stage is culture change within the scientific community

Second stage may require a change in to the type of interaction currently undertaken to take into consideration

Cultural norms

Work practices

An appreciation of these norms and practices will

Reduce potential resistance to new or extended biosecurity legislation

May encourage full and effective participation in UK efforts to reduce the threat from biological weapons

QuestionsQuestions