Ethics in Laboratories

1
Ethics in Laboratories

• Prof Lise Korsten
• Department of Microbiology and
• Plant Pathology
• University of Pretoria
• lise.korsten_at_up.ac.za

2
NSTF Workshop

• Does your organisation do enough to monitor and
  promote ethical practices?
• Although ethical practices are mostly voluntary
• What can government do?

3
NSTF Workshop

• 4 Professional bodies and learned societies can
  enforce ethical practices by sanctions
• 5. To what extent are they playing that role?
• 6. Do we have funding for Ethics studies?

4
Define a Laboratory

• A laboratory is a place where scientific research
  and experiments are conducted http//www.everythin
  gbio.com/glos/definition.php?wordlaboratory
• A place equipped for scientific research,
  experiments or testingeducation.jlab.org/beamsact
  ivity/6thgrade/vocabulary/index.html

5
Define a lab

• a workplace for the conduct of scientific
  research http//www.yourdictionary.com/laboratory
  
• A room, building or institution equipped for
  scientific research, experimentation or analysis
  a place where chemicals, drugs or microbes are
  prepared or manufactured en.wiktionary.org/wiki/
  laboratory

6
It Defines

• The lab space
• The lab environment
• The activity (research)
• But
• What about People, the Human factor in terms of
• qualifications
• training and experience
• competence
• And, the ethical approach to science

7
What type of labs

• Medical labs
• Metrology labs
• Accredited labs
• Government labs
• Forensic labs
• Reference labs
• Research labs
• Academia
• Non academia
• Informal labs
• Labs serving the various industry sectors

8
What type of labs

• Labs serving the various industry sectors
• Agricultural and food sector
• Biological labs
• Animal and animal products
• Plants and plant products
• Fish and fishery products
• Food processing labs etc
• Chemical labs
• Manufacturing sector
• Industrial labs
• Etc, etc, etc

9
What governmental institutions are linked with or
have labs

• DoE
• DST
• NRF
• CSIR
• DWAF
• DoH
• DoA
• PPECB
• ARC
• The dti
• NMRI
• SABS
• SANAS

How much activities is integrated?
Does the one know what the other is doing?
10
Two Important Bodies

• SANAS
• South African National Accreditation System
• NLA
• National Laboratory Association

11
South African National Accreditation System
(SANAS)
Auditor
OECD GLP
ISO / IEC 17025 2005
Accredited Labs

• Calibration laboratories
• Legal metrology
• Medical laboratories
• Blood transfusion services
• Pharmaceutical laboratories
• Testing laboratories
• Veterinary laboratories

12
South African National Accreditation System
(SANAS)
Auditor
OECD GLP
ISO / IEC 17025 2005
Process of accreditation
Accredited Labs
National Laboratory Association (NLA)

• Calibration laboratories
• Legal metrology
• Medical laboratories
• Blood transfusion services
• Pharmaceutical laboratories
• Testing laboratories
• Veterinary laboratories

13
IAF
ILAC
SADCA
Process of International recognition
ISO 17011
OECD

• Accreditation Bodies
• from various countries

South African National Accreditation System
(SANAS)
Cross Frontier Agreement
Mutual Recognition Agreement
Auditor
OECD GLP
ISO 17025
Process of accreditation
Accredited Labs
National Laboratory Association (NLA)
Stakeholder

• Calibration laboratories
• Legal metrology
• Medical laboratories
• Blood transfusion services
• Pharmaceutical laboratories
• Testing laboratories
• Veterinary laboratories

14
Why the need for Accreditation

• Critical role players
• WTO, Codex, IPPC, OIE, WHO, OECD
• Global trade
• WTO SPS/ TBT Agreement

15
IAF
ILAC
ISO 17011
OECD
National Standards SABS
South African National Accreditation System
(SANAS)
The dti

• Accreditation Bodies
• from various countries

SQAM
ISO 17025
SA Quality Institute (SAQI)
OECD GLP
National Metrology Institute of South Africa
(NMISA)
Accredited Labs

• Metrology Laboratories
• Acoustics Vibration Metrology
• DC, Low Frequency Metrology
• Dimensional Metrology
• Force Hardness Metrology
• Gas Metrology
• Humidity Metrology
• Inorganic Plasma Spectrometry Metrology
• Mass Metrology
• Organic Chemistry Metrology
• Photometry Radiometry Metrology
• Radiation Dosimetry Metrology
• Radioactivity Metrology
• Radio Frequency Metrology
• Temperature Metrology
• Time Frequency Metrology
• Torque Metrology

National Laboratory Association (NLA)

• Calibration laboratories
• Legal metrology
• Medical laboratories
• Blood transfusion services
• Pharmaceutical laboratories
• Testing laboratories
• Veterinary laboratories

Process of International recognition
16
ILAC
SADCA
Process of International recognition
ISO 17011
OECD
National Standards SABS
South African National Accreditation System
(SANAS)
SANAS
The dti
Cross Frontier Agreement
SQAM
Auditor
OECD GLP
ISO / IEC 17025 2005
Process of accreditation
SA Quality Institute (SAQI)

• Accredited Labs

National Laboratory Association (NLA)
Stakeholder

• Calibration laboratories
• Legal metrology
• Medical laboratories
• Blood transfusion services
• Pharmaceutical laboratories
• Testing laboratories
• Veterinary laboratories

National Metrology Institute of South Africa
(NMISA)
Non accredited Labs
Government Labs
Reference Labs
Forensic Labs
17
Why the need for Accreditation?

• Two dimensions
• Governments must have a supportive legislative
  framework to ensure compliance to new
  international trade rules or standards
• Requires a SQAM landscape
• Major retailers require compliance to voluntary
  standards.

18
Where does Ethics fit into this picture?

• For accredited labs it is about
• Competency
• Repeatability
• Accuracy
• Consistency
• Compliance

19
Accredited Labs

• ISO/IEC 17025 1999
• Competence of testing and calibration
  laboratories
• Good Laboratory Practices (GLP) non clinical
  safety testing to promote the development of
  quality test data

ISO
GLP
20
Types of Quality Systems

• ISO/IEC 17025 1999
• Competence to carry out tests and or
  calibrations including sampling
• Uses standard methods, non standard methods and
  laboratory methods
• GLP
• Non-clinical safety testing of items
  (pharmaceutical-, pesticide-cosmetic products,
  veterinary drugs, food additives, feed additives,
  industrial chemicals)
• Why? to obtain data on their properties, safety
  with respect to human health and the environment.
  
• Can be done in the field, greenhouse and
  laboratory

ISO
GLP
21
Accredited Laboratories

• Ethics in Accredited Laboratory Systems
• ISO 17025
• 4.1.5 d) The laboratory shall have policies and
  procedures to avoid involvement in any activities
  that would diminish confidence in its competence,
  impartiality, judgment or operational integrity

ISO
22
Accredited Laboratories

• Ethics in Accredited Laboratory Systems
• GLP
• 1.2 e) Do the Study Director ensure that
  procedures specified in the study plan are
  followed and assess and document the impact of
  deviations from the study plan on the quality and
  integrity of the study
• 1.2.2 f) ensure that all raw data generated are
  fully documented and recorded?
• 1.4.3 Do the Study Personnel record raw data
  promptly and accurately and in compliance with
  the Principles of Good Laboratory Practice? Are
  they responsible for the quality of their data?

Responsibility
GLP
23
Accredited Laboratories

• Conflict of interest
• ISO 17025
• 4.1.4 If the laboratory is part of a larger
  organisation, the organisational arrangements
  should be such that departments having conflict
  of interest such as production, commercial
  marketing or financing does not adversely
  influence laboratories compliance

ISO
24
Accredited Laboratories

• Personnel are free from undue commercial pressure
• ISO 17025
• 4.1.5 b) The Laboratory shall have arrangements
  to ensure that its management and personnel are
  free from undue internal and external commercial
  financial and other pressures and influences that
  may adversely affect the quality if their work

ISO
25
Accredited Laboratories

• Requirements (ISO)
• ISO 17025
• Legal requirement for laboratory (ISO no 4.1.1)
• Responsibility (OECD Principles of GLP)/
• Regulatory requirement Compliance monitoring
• DoA The Registrar Act 36 of 1947
• DoH (Medicines Control Council of SA)

26
Accredited Laboratories

• Issues to consider towards addressing ethical
  challenges
• Critical to have contracts / job descriptions /
  internal complaints system
• Also to have clarity/ transparency/ openness/
  reporting structure
• Ensure continual training / mentoring /
  witnessing
• Soft issues commitment/ loyalty/ support/
  happiness
• Consider emotional side IQ EQ

27
Accredited Laboratories

• Effective management systems
• Internal audits
• Document control
• Archive system
• Traceability
• Contracts and Job descriptions
• The human factor
• Adequate number of staff
• Adequate qualifications
• Competent staff
• Monitoring, witnessing, mentoring

28
NSTF Workshop

• 2. Although ethical practices are mostly
  voluntary

29
NSTF Workshop

• 2. Is it voluntary?
• Given the requirement to ensure compliance with
  international standards, rules and norms?
• Given legislative requirements?
• Given retailer pressure

30
NSTF Workshop

• 4 Professional bodies and learned societies can
  enforce ethical practices by sanctions
• 5. To what extent are they playing that role?
• 6. Do we have funding for Ethics studies?

31
The South African Council for Natural Scientific
Professions (SACNASP)

• Natural Scientific Professions Act No 27 of 2003

Concerned with competence of individuals!
32
Primary Function of the SACNASP Council
To protect the public interest in relation to
the work of registered Professional Natural
Scientists, e.g. to safeguard public health and
safety from adverse consequences of natural
science activity.

• Monitor standard of education training of
  natural scientists

33
NSTF Workshop

• 3. What can government do to promote ethical
  practices?

34
The Non accredited side of the story

• Academic institutions
• Research labs
• Bush labs

35
Types of Quality Systems
RL

• The Research Laboratory
• What system regulate quality?
• Peer reviewed publications
• Funding bodies
• Professional status
• What is the concern?
• Requires total integrity in research and
  scholarship
• Requires insurances that the highest scientific
  standing and ethical standard (including honest,
  thoughtful inquiry, rigorous analysis and
  accountability) has been followed

36
The Reality of non accredited labs

• Research pressure Publish or Perish
• Academic pressure Science rating
• Funding pressure Progress reports and a product
  / solution
• Commercial pressure on labs Lack of funding
• Political pressure on labs Appoint
  inexperienced staff not always adequately
  qualified

37
What can Government do?

• The Government has no single data base on the
  number of non- accredited laboratories, their
  activities and functions within South Africa
• NRF data base not covering bush labs or
  industry specific labs
• Industry starting to take some initiative
• Water sector (WRC),
• Food sector (FSI)

38
What can Government do?

• The Government has no single data base on the
  number of non- accredited laboratories, their
  activities and functions within South Africa
• NRF data base not covering bush labs or
  industry specific labs
• Industry starting to take some initiative
• Water sector (WRC),
• Food sector (FSI)

Need a single data base Need to integrate
activities Who to take the initiative? Who has
the mandate?
39
What is Academia doing to address ethics

• Is it a problem?
• Who is doing what?
• What is happening internationally?
• Do we need a national or integrated system?

40
Academic Research Laboratory

• Misconduct can include (University of Ontorio)
• Plagiarism (claim credit for ideas, writing,
  research results or methods) Turntin
• Fabrication/ falsification of research data
• Failure to recognise contributions of others or
  their unpublished material or use of archival
  material in violation of the archive rules
• Stealing manuscripts or grant applications
  during the peer review process

ARL
41
Academic Research Laboratory

• Misconduct can include continue
• Attribute authorship to persons other than those
  who have participated sufficiently in the work
• (to take public responsibility for its
  intellectual content)
• Submission of publication of articles published
  elsewhere
• Intentional diversion of research funds
• Failure to reveal material conflict of interest
• Failure to reveal material financial interest in
  a company that contracts research (personal
  gains)
• Deliberate destruction of ones own research data
  to avoid detection of wrongdoing

ARL
42
The Softer issues
Stop

• Stealing time
• Chatting
• Coffee times.
• Smokers
• Private Phone calls / Emails / SMS
• Pornography websites
• Computer games Solitaire

43
Code of Conduct for Responsible Research Practices

• Shall act with intellectual honesty and
  professionalism
• Shall fulfill the legal obligations
• Shall fulfill the ethical rules of University/
  professional body in the field
• Shall account for income and expenditure related
  to research
• Shall keep comprehensive records of all actions
  in respect to data
• Shall refrain from research misconduct
• Shall not violate the trust placed in them by
  colleagues
• Shall ascribe to international recognised
  discipline-orientated ethical codes, standards
  and rules

44
Code of Conduct for Responsible Research Practices

• Ethics committee or activities (University of
  Pretoria)
• Animal welfare used in experiments
• GMO research, development and release
  registration of facilties
• Social welfare of individual, person, group or
  community used in experimental studies or surveys
• Occupational Hazards (Lab safety)
• Bio-Hazards (i.e. Human pathogens)
• Radio activity Monitoring
• Environmental, plant, biodiversity etc impact
  

45
BioethicsInternational Trends

• ELSA (Ethical, Legal and Social) issues
• Legal protection of biotechnology inventions,
  biodiversity and regulatory frameworks for
  biological research indigenous knowledge
  (patent law)
• Fundamental applied values in biomedicine,
  embryo fetus protection, personal data
  protection, data bases and ethics committee

46
Bioethics continueInternational Trends

• Current most important global sensitive ethical
  issues
• Involve human beings in i.e. clinical trials
• Use of human tissues in i.e. embryonic and fetal
  tissue
• Use of animals in i.e. genetically modified
  animals and non human primates
• Protection of indigenous knowledge/ biodiversity
  legislation addressing bioprospecting

47
Bioethics continue

• Examples of relevant international conventions
  and declarations
• Convention on human rights and biomedicine 1997
• Universal declaration on the human genome and
  human rights UNESCO 1997
• Universal declarations within the United Nations
• Cartagena protocol on biosafety
• Convention on biodiversity

48
Bioethics continue

• Relevant international conventions/declarations
• Charter of fundamental rights of the EU 2000
• European Group on Ethics in Science and new
  Technologies
• European Science Foundation Policy briefings
  i.e.
• Good Scientific Practice in research and
  scholarship
• Use of Animals in Research
• Genetically Modified Plants
• Controlled clinical trials

49
Bioethics continue

• Relevant international conventions/declarations
• EU Directives i.e.
• Protection of personal data
• Protection of workers from risks related to
  exposure to biological agents
• Guidelines for the development of national
  strategies and best practices to ensure
  co-existence of genetically modified crops with
  conventional and organic farming

50
Strive towards Global recognition
Stop

• How do I bring my lab in line with global ELSA
  values?
• Awareness of ELSA
• Instill deeper understanding sense of
  responsibility
• Ethical committee
• Continues Training and reminders
• Re-visit contracts

51
Bioethics continue

• Global recognition for National competency
  include matters of morals or ethics
• Cultural differences tolerances
• Sexism, racism
• Moral fiber of society

52
NSTF Workshop

• What can government do to promote ethical
  practices?
• What system/s?
• Who should take the initiative?
• Who has the mandate?
• DoE/ DST/ NRF

53
NSTF Workshop

• What can government do to promote ethical
  practices?
• What about industry
• go accreditation route
• What about the bush labs?
• Is it a concern?

54
A new dimension in lab ethics

• Is it a concern?
• Well yes
• Why?
• Biosecurity

55
Biosecurity

• A biosecurity guarantee attempts to ensure that
  ecologies sustaining either people or animals are
  maintained.
• This may include natural habitats as well as
  shelter and productive enterprise (especially
  agriculture) and deals with threats such as
  biological warfare or epidemics.

56
Biosecurity

• Challenges include the proliferation of
  biological threats, the difficulty of tracking
  contamination (especially if carried by the
  natural internal processes of an eco-region), and
  numerous political barriers.
• This is related to the more passive concept of
  biosafety.

57
Agents of Concern

• Biological agents deemed a biosecurity concern by
  the US Government
• The US Select Agent List.
• The list is divided between agents that can
  infect only
• humans,
• zoonotic agents (which can infect both humans and
  animals),
• agents that can only infect animals,
• and agents that can infect only plants.

58
Plant PathogensAgents of concern

• USDA Plant Protection and quarantine slected
  agents
• Candidatus Liberobacter africanus
• Ralstonia solanacearum race 3, biovar.

59
Animal AgentsUSDA Select agents

• Research areas i.e.
• African horse sickness virus
• Foot-and-mouth disease virus
• Newcastle disease virus (velogenic)
• Not present
• Avian influenza virus (highly pathogenic)
• Bovine spongiform encephalopathy

What are you working with in your lab?
60
Zoonotic AgentsSELECT AGENTS TOXINS

• Bacillus anthracis
• Botulinum neurotoxin producing species of
  Clostridium
• Brucella spp (B. abortus B. melitensis B. suis)
  
• Burkholderia spp (B. mallei B. pseudomallei
  (formerly Pseudomonas)
• Clostridium perfringens epsilon toxin
• Shiga toxin
• ?Staphylococcal enterotoxins
• Rift Valley fever virus

So how effective are we managing it?
61
Human AgentsSelect agents and toxins

• Cercopithecine herpesvirus 1 (Herpes B Virus)
• Crimean-Congo haemorrhagic fever virus
• Ebola virus
• Marburg virus
• Rickettsia rickettsii
• Tick-borne encephalitis complex (flavi) viruses
• Variola major virus (Smallpox virus)
• Yersinia pestis

How ethical is our staff?
62
Can it really happen?

• Hospital in Dallas, TX, 1996, Diane Thompson was
  a clinical laboratory technician
• Objective Unclear, possibly revenge against
  former boyfriend and cover-up by infecting
  co-workers
• Organism Shigella dysenteriae Type 2, acquired
  from clinical laboratory
• Dissemination Contaminated pastries in the
  office breakroom
• Infected 12 of her coworkers, She was arrested,
  convicted, 20 year sentence

63
Some more cases

• Japan 1964-1966, Dr. M. Suzuki was a physician
  with training in bacteriology
• Objective Revenge due to deep antagonism to what
  he perceived as a prevailing seniority system
• Organisms Shigella dysenteriae and Salmonella
  typhi
• Dissemination Sponge cake, other food sources
• He was later implicated in 200 400 illnesses
  and 4 deaths
• Official investigation started after anonymous
  tip to Ministry of Health and Welfare. He was
  charged, but was not convicted of any deaths

64
In the name of religion

• 1984 Rajneeshee religious cult attacks Dalles,
  Oregon
• Objective Gain control of the Wasco County Court
  by affecting the election
• Organism Salmonella typhimurium, purchased from
  commercial supplier
• Dissemination Restaurant salad bars
• 751 illnesses, Early investigation by CDC
  suggested the event was a naturally occurring
  outbreak. Cult member arrested on unrelated
  charge confessed involvement with the event

65
More recent

• 1990s Aum Shinrikyo in Tokyo, Japan
• Objective Fulfill apocalyptic prophecy
• Organisms
• Bacillus anthracis (Vaccine strain),
• Clostridium botulinum (Environmental isolate,
  Avirulent strain)
• Shinrikyo ordered Clostridium botulinum from a
  pharmaceutical company, a
• and Ebola virus (Attempted to acquire from Zaire
  outbreak under guise of an Humanitarian
  mission)
• Dissemination Aerosolization in Tokyo (B.
  anthracis and Botulinum toxin)
• Leader Asahara was convicted of criminal activity

66
Is it really far off?

• Richard Schmidt, a gastroenterologist in
  Louisiana, convicted of attempted second degree
  murder for infecting nurse Janice Allen with HIV
  by injecting her with blood from an AIDS patient
  1998
• Brian Stewart, a phlebotomist, sentenced to life
  in prison for deliberately infecting his
  11-month-old baby with HIV-infected blood to
  avoid child support payments 1999
• And in SA? Gangs with needles

67
NSTF Workshop

• Does your organisation do enough to monitor and
  promote ethical practices?
• What can government do?

68
What are we doing or not doing?

• The more controlled
• GMO research
• Medical research (MRC)
• The uncontrolled
• Biological control
• Industrial Microbiology
• Biocontrol fermentation systems

69
What is the rest of the World doing?

• European Commission Green Paper on
  Bio-Preparedness (November 2007)
• recommends developing European standards on
  laboratory biosecurity including Physical
  protection, access controls, accountability of
  pathogens, and registration of researchers

70
US Select Agent Regulations

• Facility registration if it possesses one of 81
  Select Agents
• Facility must designate a Responsible Official
• Background checks for individuals with access to
  Select Agents
• Access controls for areas and containers that
  contain Select Agents
• Detailed inventory requirements for Select Agents
  
• Security, safety, and emergency response plans
• Safety and security training
• Regulation of transfers of Select Agents
• Extensive documentation and recordkeeping
• Safety and security inspections

71
What is International bodies doing?

• Organization for Economic Cooperation and
  Development
• published Best Practice Guidelines for
  Biological Resource Centers including a section
  on biosecurity in February 2007

72
Is Africa a special case?

• Kampala Compact (October 2005) and the Nairobi
  Announcement (July 2007)
• Stress importance of implementing laboratory
  biosafety and biosecurity in Africa
• Two important factors
• Lot of EU investment in African lab capacity
  building
• Corruption?
• Political instability?

73
NSTF Workshop

• Does your organisation do enough to monitor and
  promote ethical practices?

74
Let me ask you a few questions

• Are your scales micropipettes etc calibrated?
• Do you have service contracts?
• Do you have a preferred suppliers list?
• Do you have signed contracts with your employees
  / students?
• Have you trained them in ethics?

75
NSTF Workshop

• Do we have funding for Ethics studies?
• Is it a priority?

76
Thank you

• Acknowledgements
• Workshop Organisers
• University of Pretoria
• SANAS
• NLA