Transcript Ethics for the Laboratory Physician

Ethics for the Laboratory
Physician
Web Teleconference Feb 21 2012
JF Magee
Laboratory Medicine/Pediatrics IWK
objectives
 to provide practical examples of how ethical issues may
impact the practice of present day laboratory medicine
 to provide an brief overview of
 ethics and the growth of bioethics
 professional conduct
 laboratory medicine specific issues
 autopsy practice
 utilization of biological materials
 medical error
 questions of bioethics
 ‘spin’ and rules
 critical appraisal
conflict of interest
no conflicts to declare
definitions
morals
 derived from the Latin word moralitas ‘custom or habit’
 principles, standards or habits with respect to right or wrong in conduct
 conformity with generally accepted standard
ethics
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derived from the Greek word ethikos ‘pertaining to custom and habit’
a generic term for various ways of understanding and examining moral life
a system or code of morals of a particular person, group, religion or profession etc.
conformity with an elaborated or ideal code of a particular profession
terms may be used interchangeably
Johnstone MJ. 1999 Bioethics-a nursing perspective 3rd ed
profession
 an occupation requiring advanced training
 self-policing
 professional: worthy of the high standards of that profession
ethics-a history

society
 benevolence, sincerity, kindliness
[Confucius]
 concept of personhood [Akan Cultures,
Africa]
 religions
 truth and competence
[Christianity]
 good character [Islam]
 personal virtue [Judaism]
 social security [Hinduism]
 philosophers
 duty based ethics [Kant]
 utilitarianism-compare good
and bad outcomes [Stuart Mills]
 social contract to provide for fair
process of distribution
 legal systems
 theories from all of the above have
become entrenched in the more recent
field of bioethics

medicine
 ‘the work of healing…in all cultures has
been wrapped in moral and religious
meanings’
 Hippocrates
 do no harm
 Ayurvedic medicine
 strive with all being to heal the
sick
 Islam (Oath of the Muslim Doctor)
 strive to heal
 Thomas Percival
 medical ethics 1803
 Florence Nightingale
 epidemiologist-1854
 American Medical Association
 adapted Percival’s text 1847
bioethics-a history
 1753 : Lind (HMS
Salisbury):
 concluded that the
‘intervention’ group
were more likely to be
disease free
 1798 : Jenner (cowpox
vaccine)
 his own child and
other young children in
the neighborhood
 1897: Saranelli (yellow
fever) :
 to prove this claim he
had injected 5 persons
with the isolate
 US Surgeon General
commissioned Walter Reed to
identify the cause of yellow
fever
 self experiment on
members of the ‘Yellow
Fever Board’
 only adults would be
enrolled
 written contract
 payment of $100 if willing
to be exposed
 further $100 if developed
illness.
bioethics-a history
 23 Nazi doctors and beaurocrats were tried by
the Allies for performing ‘illegal’ experiments on
thousands of prisoners
 court documents identified 1750 prisoners
 high altitude [low pressure] experiments
 freezing
 malaria
 mustard gas
 sulphanilaminde
 typhus
 poison
 incendiary bomb
 sterilization
bioethics-a history
 as a result of this the Nuremberg code was
enacted
 viewed as a
‘document that was needed to restrain a
totalitarian regime of unquestionable brutality but
was not applicable to the “rest of us”
 NYT coverage :
less than 12 articles 1945-47, only the Aug 47 guilty
verdict appeared on page 1.
bioethics-a history
 22 studies which he claimed
‘violated basic standards of ethical
research with human beings’
 children deliberately exposed to
hepatitis (Willowbrook, NY)
 rheumatic fever trial : penicillin
withheld from the controls
 live cancer cells injected into 22
human subjects (Jewish Chronic
Disease Hospital, Brooklyn)
 during bronchoscopy, needle
inserted into the left atrium
 conclusions
 ‘informed consent’
 ‘virtuous investigator’
Beecher, HK. Ethics and clinical research, NEJM,
1966;274:1354-60
 Mc Dermott: ‘medicine has given
to society the case for its rights in
the continuation of clinical
investigation’
Annals of In Med,1967;39-42

Eisenberg: ‘the economic and
social costs of disease and death
eminently justified human
experimentation in spite of the
inherent limitations of the informed
consent ideal’
Science, 1977;1105-10
 Lasagna: ‘for the ethical
experienced investigator no laws
are needed and for the
unscrupulous incompetent no laws
will help’
Human Aspects of Biomedical
investigation,1971;109
bioethics-a history
 study initiated in 1932, Macon County, Alabama
 400 males recruited
 not informed of true nature of their condition or of the
study, nor were their partners informed
 no treatment for syphilis (even after 1940 when penicillin
became available)
 study ran until 1972
 74 still alive
 perhaps more than 100 had died directly from advanced
syphilitic lesions
 compensation authorized for survivors in late 70s
 formal apology by President Bill Clinton 1997.
Reverby SM. Ed ‘Tuskegee’s Truths’. Chapel Hill, University of North Carolina,
2000
regulations
 The Declaration of Helsinki : Ethical Principles for
Medical Research involving Human Subjects [1975]
 The Belmont Report : Ethical Principles and Guidelines
for the Protection of Human Subjects of Research [1979]
 The Common Rule; Title 45 (Public Welfare), Code of
Federal Regulations, Part 46 [Protection of Human
Subjects) [1991]
 The Council for International Organization of Medical
Sciences (CIOMS) in collaboration with the World
Health Organization (WHO) [2002]
 The ICH Harmonized Tripartite Guideline for Good
Clinical Practice (ICH-GCP Guideline) [1996]
 Tri Council: Ethical Conduct for Research involving
Humans [1970-94]
georgetown principles
 beneficence
 an ethical principal which requires
 provision of benefits and
 balancing of benefits and harm
NCBHR, Canada
 non-maleficence
 not to inflict evil or harm
 to prevent evil or harm
 to remove evil
 respect for the individual
 individuals be treated as autonomous
 persons with diminished autonomy are entitled to protection
 justice
 equals to be treated equally
 fairness in distribution
 provision of what is deserved
summary
medical research has not always been
conducted in an ethical manner
‘society’ has expectations
medical research be conducted
benefit will accrue from such medical research
research be conducted in an ‘ethical manner’
informed consent is viewed as a ‘self evident moral
obligation’
presently numerous sets of ‘rules’ of ethics now
exist
profession
 an occupation, vocation or career where specialized
knowledge is applied.
 term usually applied to occupations that involve
prolonged academic training and a formal qualification.
 "professional activity involves systematic knowledge
and proficiency.”
 usually regulated by
professional bodies
may set examinations of competence
act as a licensing authority for practitioners
enforce adherence to an ethical code of practice
articulate a commitment to service
medicine
 ‘the work of healing has been
wrapped in moral and religious
meanings’
 Hippocrates
 a commitment to the highest
standards of excellence in the
practice of medicine
 do no harm
 Ayurvedic medicine
 strive with all being to heal the sick.
 Islam (Oath of the Muslim Doctor)
 strive to heal
 treat patient with respect
 a commitment to sustain the
interests and welfare of
patients
 Thomas Percival
 medical ethics 1803
 Florence Nightingale
 epidemiologist-1854
 American Medical Association
 adapted percival’s text 1847
 a commitment to be
responsive to the health needs
of society

ABIM Project Professionalism
CAP
professional duties consistent with current standards
should not associate with other professionals…. who do
not practice in a recognized scientific method
should not direct or supervise a laboratory if he/she
lacks experience or adequate training
should complete their medical consults in a prompt,
accurate and complete form
autopsy practice

organ retention

Bristol inquiry [UK]
 1998 BRI Inquiry (Kennedy)
• public alarm of death rate in children undergoing cardiac surgery 1996
• parents concern over the death of her 11 month old daughter in 1992
• public inquiry into surgical management of children with complex cardiac disorders
• identified a practice of organ retention following autopsy
‘without the realization of parents’
• viewed as standard of care
 Alder Hay referred to as an example
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Alder Hay [UK]
 1999 Royal Liverpool Children’s Inquiry (Redfern)
• public inquiry into practices of the then Professor of Pathology
 inappropriate organ retention
 identified tissue museum
Halifax
 IWK 1995-8
• same anatomic pathologists as Alder Hay
• body parts stored in a warehouse
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Melbourne [Aus]
 2000 Royal Children’s and Royal Women’s Hospitals
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Sydney [Aus]
 2001 Inquiry into matters arising from post-mortem and anatomical examination practices of the institute of Forensic
Medicine
autopsy practice
Khong TY et al J Peds and Child Health 2006
 autopsy rates falling
 1999-2001
 2001-2
 2002-3
71.7%
61.5%
50.5%
 more detailed consent process
 less ‘extensive’ procedures
 ‘it is likely that they have introduced choice as evidenced by the
increase in the number of external examinations in the later years of
this study’
 less likely to submit tissue for research and educational purposes
granted
not granted
 1999-01
 2001-2
 2002-4
220
92
43
26
21
110
autopsy practice
Cartlidge PHT el al. Value and quality of perinatal and infant postmortem exmination:cohort analysis of 400
consecutive deaths BMJ 1996;310:155-158
all perinatal deaths during a calendar year
assessed ‘quality’ on the basis of the
Royal College Guidelines
autopsy rate 53-58%
below standard in 44% of cases
contributory in 17%
autopsy practice
Magee JF Drysdale J, ISPD 2010
 a critical appraisal of data obtained from 92 stillbirth autopsies performed at the IWK
Health Centre
 2004 consent for ‘full’ autopsy examination in 97% of cases.
 2005 consent in for ‘full’ autopsy examination in 73% of cases.
 gross examination of fetus
 performed 100% of cases-SNF in 29% of cases
 microscopic examination of fetal tissue
 performed in 97%-SNF in 16% of cases
 cytogenetic studies
 performed in 50%-SNF in 15% of cases
 radiologic studies
 performed in 92% -SNF in 7% of cases
 detailed CNS examination
 performed in 89%-SNF in 5% of cases
 placental examination
 performed in 98% of cases-SNF 4% of cases.
 average time to produce reports
 preliminary 14 days
 final reports was 90 days (no CNS)
 170 days (CNS).
autopsy practice
ethical considerations of the perinatal autopsy
TY Khong. J Med Ethics 1996
 consent
who is asked?
who asks?
lack of knowledge in those seeking consent in cases of
adult autopsy
Chana J et al J Coll Phy Lon 1990
 what constitutes an autopsy
 what does consent allow for
 who performs the test
 what is an acceptable test
biological materials
ryk ward and the nu’uchalnuth
 ryk ward
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born UK
grew up NZ
BSc [anthropology, biology, genetics) NZ
Phd [human genetic Ann Arbor]
UBC [faculty position in Medical Genetics]
 UBC
 1983 arthritis study-HLA typing
 blood samples from the nu’uchalnuth band
 later moved to Utah/Oxford (professor of biological anthropology)
 kept blood and used them in subsequent studies (migration of aboriginals)
 eventually comes to light [1998/9]
 nu’uchalnuth
 demanded return of samples
 demanded codes of behavior
 IAH http://www.health-sciences.ubc.ca/iah/
 BC Aboriginal Capacity and Research Development Environment [ACADRE]
http://www.health-sciences.ubc.ca/iah/acadre/
biological materials
 collection and storage of human biological materials has
become integral to disease diagnosis and human
research
 nature of materials is wide ranging
 tissue
 solid tumor tissue [-70C]
 paraffin block
 blood samples
 NBS blotters
 plasma/serum samples
 laboratory medical practice requires retention of
diagnostic samples-may be viewed as ‘resource’ by
research community
biological materials
d wendler
 systematic review of individuals views regarding
consent for research with biological materials
2483 articles
31 [views on 33,000 individuals]
90% want to make their own decision
• 80-95%% would donate
• 5-10% would not
6 dealt specifically with residual samples
• in 5/6 studies >90% were willing to donate samples for
research
• in the 6th study 83% were willing to donate
biological materials
d wendler
 6 studies
 2 date from the 90s
 Start D et al BMJ 1996;313:1366-68
 Hamajima N et al J. Journal Can Res 1998;89:341-6
 2 published by same group
 Lack and Womack
• BMJ 2003;327(Aug):262-3
• BMJ 2003;327(Oct):781-2
 ECOG
 Malone T et al. JNCI 2002;94:769-771
• 2 consent forms
 89.4% shorter version
 93.7% explicit version
 92.1% for >65 years
 88.7% fro <65 years
biological materials
1990-2000 randomly selected
1494 donated blood screening for future
research on cardiovascular disorders and
diabetes mellitus
2001-attempted re-contact
1494
1409-1342 of whom responded
• 93% gave consent for future ‘genetic research’ subject to
 IRB approval
 22.3%-to be informed
biological materials
evidence
strong support for biological studies
recommendation
initial consent followed by IRB review
if in doubt seek advice
NSHEN
biological materials
 scenario
 2001
 13 year old female treated at a pediatric institution with a diagnosis
of ARMS (2;13 translocation)
 consent obtained for biological study
 2009
 option for new epigenetic study
 request to use some of the residual tissue
 question
who consented?
pediatrics
 ‘triadic’ experience
 HCW
 parents
 child
 more complex consent process
 assent
US National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research’
 the child’s agreement to participate
 that assent be obtained from those children whom the local institutional
review board [IRB] judged as capable of assenting’
 Canada National Council on Ethics in Human Research
 voluntary agreement
parental views
Fernandez CV, Magee JF Pediatr Blood Cancer 2011
N=54 (10 with deceased children)
tissue sent anywhere in the world [prefer
pediatric aims]-89%
genetic research if it might improve child’s
health-76%
research profits used for childhood cancer
research-73%
child should confirm consent or reaching
majority-98%
NBS
 consent
 screening panel
 storage (newborn screening blotters)
 how long?
• Canada-no uniformity
 Quebec-destroy after 1 year unless abnormal
 NL, PEI 1-5 years
 rest 2-21 years
• Germany
 all samples destroyed after 3 months
• US
 Texas-4.5 million samples to be destroyed within 120
days (Dec 23rd 2009)
 Minnesota-should all samples be destroyed at 10
years
 use for future research?
medical error
to err is human IOM
 error occurs when there is a ‘failure to complete a
planned action as it was intended, or when an incorrect
plan is used in an attempt to achieve a given aim’
 an error may be an act of commission or omission
 medical error is a significant problem
 44-98,000 hospitalized patients die annually in US
 negligence is established only in a court of law
 perfection is not the standard
medical error
 how do mistakes occur?
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most are not through negligence
incomplete knowledge base
error in perception/judgment
lapse in attention [fatigue]
system failure
individual competence
 not possible to quantify the full magnitude of safety challenge
 medication error (wakefield et al, 2001)
 mortality rates in intensive care (sexton, 2003)
 nurse safety practices (zohar, 2007)
 non-optimal practice (mcglynn 2005)
 terminology
 near miss
 adverse event
medical error
Nakleh RE Arch Pathol Lab Med 2008
 error rate in surgical pathology
 1%
 0.26-1.7%
 percentage of errors
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specimen identification
defective specimens
analytic misinterpretation
defective reports
33%
4-10%
25%
33-40%
 interventions
 generic-safety culture
 specific
 factors that could decrease analytic errors rates
•
•
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•
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standardization of all procedures
‘safe’ environment-remove distractions like phones
increased automation
decreased use of inconsistent tools
printing/barcoding versus hand writing
 reports
•
synoptic reporting leads to a 24% increase in ‘complete’ reports
medical error
 do physicians have an ethical duty to disclose
information about medical mistakes to their
patients?
CMA Code of Ethics
disclosure
CMPA
disclosure
hospital policy
IWK-disclosure
hospital accreditation body
US-disclosure
disclosing adverse events
PAMAP Model
 prepare
 apologize/express regret
 manage the clinical problem
 analyze
 prevent further harm/events
apology act of nova scotia 2008
why don’t doctors apologize
John Muir, Dalhousie
 difficult to admit fault
 consequences are substantial
 guilt, shame
 lawyers advice
 not my fault-that of care team/system
why doctors should apologize
 why disclose
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to prevent further harm
patients due information out of respect
maintains trust
acknowledges commitment
shows understanding
reinforces physician integrity
consistent with trend towards transparency
assures patients that they are not at fault
law suit less likely
 non disclosure
 involves deception and is a breach physicians fiduciary responsibility to
patient
 undermines trust in physicians and the medical system
spin
willowbrook
 beecher
 22 studies which he claimed ‘violated basic standards of
ethical research with human beings’
 children deliberately exposed to hepatitis (willowbrook, NY)
 study followed a successful campaign to eradicate measles infections in
the institution
 epidemiologic study of hepatitis
 strain was mild [no deaths 1953-57]
 infections acquired while at institution by patient contact
 initially treated patients with gamma globulin-protected for 39 weeks
 hypothesis-’vaccinate’ children with mild strain under gamma globulin
cover to develop immunity
 no IRB approval
untrue
 no consent
untrue
spin
 Europe 1945-7
 Nuremberg
 23 Nazi doctors and
beaurocrats were tried by the
Allies for performing ‘illegal’
experiments on thousands of
prisoners
 court documents identified
1750 prisoners
 Asia 1933-56
 Japanese Experiments in China
 Shiro Ishii [Unit 731]
 captives called ‘maruta’ [logs]-identified
only by numbers
•
•
•
mainly Chinese
US, ANZACS
3000 deaths [possibly more]
 US granted the researchers
granted immunity in return for data
 USSR
 1949-trial at Khabarovsk
 no western media coverage
 all 12 defendants returned
to Jan by 1956
 China
 trial in 1956
 all defendants returned to
Japan by1964
questions
who
how
evaluate
evidence that bioethics has improved health
outcomes?
not talked about
 Screening
 Prenatal
 Newborn screening
 Molecular genetics
 DTC (Direct to consumer)
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Access
iKT and utilization
QA and patient safety
Conflict of interest
Priority setting and resource allocation
 Cost benefit/utility
 Opportunity cost
 Organizational ethics
resources
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bioethics and professionalism
 ABIM Project Professionalism
 CMA Code of Ethics
 advances in bioethics [vol 10]
• lost virtue-professional character development in medical education
 eds. Kenney N et al Elsevier JAI
 cambridge textbook of bioethics
• Eds. PA Singer, AM Viens
 research
• ethical and regulatory aspects of clinical research-readings and commentary
 eds. Emanuel Ezekiel et al Johns Hopkins University Press
• the oxford textbook of clinical research ethics
 eds Emanuel Ezekiel, Christine Grady Robert Crouch et al.
 nursing ethics
• toward a moral horizon-nursing ethics for leadership and practice. Janet Storch, Patricia Rodney, Rosalie
Starzomski. Pearson Prentice Hall Toronto
 screening
• screening-evidence and practice
 A Raffel, JA Muir Gray OUP
• ethics and newborn genetic screening
 eds Mary Ann Baily, TH Murray
 molecular genetics
• genetics, health care and public policy. Alison Stuart et al. Cambridge Medicine
evidence based decision making
 evidence based healthcare and public health 3rd ed.
• JA Muir Gray Churchill Livingstone
 evidence based health economics-from effectiveness to efficiency in systematic review. Donaldson and Mugford
 using research for effective health promotion. Oliver and Peersman