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Ethics
notes
November 2014
The ethics of placebo use in vaccine trials
By Dr Nikki Turner
Director of the Immunisation Advisory
Centre at the University of Auckland
Dr Nikki Turner
Superficially, Primum Non
Nocere seems to be a simple
principle. However, when
applied to the ethics of placebo
use in vaccine trials, it is not so
straightforward.
Vaccines are delivered in every
country in the world via national
vaccination programmes, mostly to
large population groups of healthy
children. For reasons of safety,
community acceptability, and resource
management it is important to know
the vaccine profile as accurately as
possible before widespread usage.
Vaccines that have been in use for
many years were less likely to have
undergone large randomised trials,
which are the gold standard today. This
means that for some products, such
as the inactivated trivalent influenza
vaccines, there is little data comparing
the biological agent with a placebo.
For the introduction of any new
vaccine the standard requirement is
a randomised controlled trial, ideally
using an inert placebo (usually saline)
delivered to a control group.
trial designs include the use of an
alternative vaccine that provides
protection against an unrelated
infection in the control group, or
add-on vaccine approaches which
offer some gain to the control arm
participants. This has to be weighed
up against the risk of a different
vaccine in the control group creating
immunological action that may bias
the outcome.
Is it acceptable to give an inert
substance to the control group in
a vaccine randomised controlled
trial (RCT)? Guideline 11 of The
International Ethical Guidelines for
Biomedical Research [1], states that it
is acceptable to use a placebo with a
control group if the use of a placebo
would not add ‘any risk of serious or
irreversible harm’.
However, the international world of
vaccine availability is currently very
inequitable: excellent new vaccines
such as conjugate pneumococcal and
rotavirus vaccines are well used in
wealthier countries but much less
so in more resource-poor countries
who carry a much greater burden of
the disease in their populations. The
major barrier to vaccine introduction
is funding and the high costs of the
more recently licensed vaccines.
Newer vaccines are continually being
developed that are cheaper, therefore
offering options to countries unable
to purchase existing vaccines. Should
an existing vaccine be used as a
comparator every time a country
or area wishes to trial a different
vaccine that may be a more viable
option? This may be the gold standard
approach but such studies would be
more resource intensive than using
placebos. Because disease is likely to
be prevented in both treatment groups
the trial may need to be very large to
be adequately powered. This approach
may often delay the introduction of
effective vaccines.
RCTs clearly have an important role
to play in establishing baseline data
for a new vaccine and therefore the
use of a placebo is generally seen as
acceptable, recognising there are small
risks, including the use of unnecessary
injections, pain/distress, and family
inconvenience. In the case of a new
vaccine with the potential to reduce
significant morbidity and mortality and
with no existing effective intervention,
the small risk is generally acceptable,
so long as harm is minimised with
appropriate informed consent and
quality control measures in place in
a well-run clinical trial. Many trials
also incorporate other aspects of
prevention for the control group,
such as education and promotion, as
seen in HIV vaccine trials [2]. Other
(Continued on page 2)
HRC Ethics Notes November 2014
(Continued from page 1)
Another challenge is that vaccines with
established efficacy in one population
may not be as effective in different
populations: the epidemiology,
demographics, host response, and
environmental effects may differ
altering the vaccine performance.
Therefore, further trials may be
needed to assess the relevance of the
established licensed vaccine.
An example given by Brian Greenwood
in a commentary article for The Lancet
is that of malaria vaccines [3]. There is
now a licensed anti-malaria vaccine
(RTS,S/AS01) that is of mediocre
effectiveness at about 30 per cent [4].
Will future malaria vaccines need to
be compared head to head with this
one, or is it ethical to continue with
placebo-controlled RCTs?
With all these challenges there is
significant variability across national
ethics committees as to what is seen as
acceptable.
In January 2013 the World Health
Organization convened a group to
provide recommendations on the
ethical issues associated with vaccine
trials [5]. This expert panel concluded
that, where the epidemiology of an
infection is expected to be substantially
different from the communities where
the pivotal trial that led to licensure
was undertaken, then placebo
controlled trials can be justified.
They considered five situations where it
was justified to use placebo-controlled
trials instead of a comparator. The
first is where the licensed vaccine is
not expected to be introduced in the
foreseeable future due to resource
constraints. An example was using a
novel protein-based pneumococcal
vaccine in Bangladesh [6] where
pneumococcal conjugate vaccines
are not used due to cost. The next
four situations were around scientific
constraints; the need to establish
efficacy and safety in different settings;
variability with local epidemiological
and demographic data making the
existing licensed vaccines scientifically
inappropriate as a comparator, such as
2
Source: Shutterstock
seen with rotavirus disease; uncertainty
around the public health significance
of the vaccine introduction; and local
population acceptability about the
licensed vaccine, such as concerns with
vaccines containing porcine gelatine or
other ingredients.
The greatest ethical dilemma today
with vaccines is the inequitable
availability to those communities
who stand to benefit the most. If
requirements are too stringent or
too resource heavy then needed
vaccines may not become available
to the populations that would
benefit the most. However, this does
not automatically give the right of
clinical trials to potentially cause
harm to individuals through the use
of placebos in control groups when
a valid comparator vaccine or other
study design offering benefit to the
control group is readily available.
There remains a difficult balance
between protecting individual research
participants from unjustifiable risks
versus the potential for significant
reductions in morbidity and mortality
across large populations. Where at
all possible it is preferable to use an
existing vaccine as a comparator.
However there are situations where
placebos may be ethically acceptable,
even with the existence of an
efficacious vaccine. Ethical acceptance
Health Research Council of New Zealand
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of a trial must include the ability for
the vaccine to be made available to
the population on completion of the
trial if it is proven to be efficacious. If a
placebo-controlled trial is the chosen
design, the risks in using a placebo
need to be ‘minimal, preventable or
reversible’ [5].
1. Council for International Organizations of Medical, S.,
International ethical guidelines for biomedical research
involving human subjects. Bulletin of Medical Ethics,
2002 (182): p. 17.
2. rgp, H.I.V.V.S.G., Placebo-controlled phase 3 trial of a
recombinant glycoprotein 120 vaccine to prevent HIV-1
infection. Journal of Infectious Diseases, 2005. 191 (5):
p. 654–665.
3. Greenwood, B., The use of a placebo in vaccine trials. The
Lancet, 2014. 383(9935): p. 2101–2102.
4. Rts, S., et al., A phase 3 trial of RTS, S/AS01 malaria
vaccine in African infants. The New England Journal of
Medicine, 2012. 367 (24): p. 2284-95.
5. Rid, A., et al., Placebo use in vaccine trials:
Recommendations of a WHO expert panel. Vaccine,
2014.
6. Wu, K., et al., Mucosal and systemic immunization with a
novel attenuated pneumococcal vaccine candidate confer
serotype independent protection against Streptococcus
pneumoniae in mice. Vaccine, 2014.
HRC Ethics Notes November 2014
Consent and the legality of research
Research involving human individuals requires their informed consent to participate. However, vulnerable groups, such
as children, intensive-care patients, and people with an intellectual disability may not be able to provide such consent.
Should they be excluded from participating in research? Is it legal to include someone who lacks the competence to
consent in the study? In recent months there has been discussions and media interest about the consent and legality of
research involving incompetent participants. In this issue of Ethics Notes we have included two commentary pieces about
this matter, one from Bruce Northey, General Counsel at the Auckland District Health Board (ADHB), and another from
Colin McArthur, Clinical Advisor for Research at the ADHB.
Health and Disability Ethics Committees
and the law
meets established ethical standards
that aim to protect participants.
These ethical standards are set
out in guidelines authored by
the National Ethics Advisory
Committee (NEAC),
By Bruce Northey
General Counsel, Auckland District
Health Board
Bruce Northey
Health and Disability Ethics
Committees (HDECs) are
created and resourced to
confirm on behalf of the
public that a study meets
generally accepted ethical
standards. This is clearly set
out in the Standard Operating
Procedures for HDECs (SOP)1:
What HDECs do
8. HDECs check that proposed
health and disability research
Despite this unequivocal statement,
Ministry of Health Legal advised
all Health and Disability Ethics
Committees (HDEC), via a letter dated
7 April 2014, that “Investigators must
satisfy the committee that the proposed
research is lawful before a committee
approves an application”. Following
that letter, the Ministry of Health
reissued in August 2014 the SOP,
without consultation with stakeholders,
redrafting the section headed “What
HDECs do not do” to include a new
responsibility that HDECs must do (?!)
(the new obligation is underlined):
HDECs do not provide legal
advice.
15. Researchers and sponsors are
responsible for ensuring that their
health and disability research is
conducted lawfully. HDECs need
to be satisfied that any research
approved by the Committee is
consistent with New Zealand law.
An HDEC may not approve an
application that is inconsistent
with New Zealand law, even if
that application is consistent with
ethical guidelines.
16.The New Zealand Bill of Rights
Act 1990 (NZBORA) applies to
acts done by HDECs. Approval
by an HDEC of research that
breaches the NZBORA may result
in the approval being found to be
unlawful if judicially reviewed by
the courts.
18. Where an HDEC suspects that a
research proposal is not lawful, it
should advise the applicant of its
concerns, and may suggest that they
seek formal legal advice. However,
HDECs are not themselves
responsible for providing such
legal advice. HDECs may seek
independent legal advice if they
are unclear as to the lawfulness of
proposed research.
Rather unhelpfully, the Ministry
of Health has not provided any
guidelines or interpretation of relevant
New Zealand law for HDECs when
contemplating this new obligation,
thus raising the spectre that each
HDEC will apply both a different
approach and a different interpretation
of the relevant law.
How might HDECs approach the
issue of lawfulness of research when
it is generally accepted, including by
lawyers, that ethics and law are as
similar as oil and water?
(Continued on page 4)
Health Research Council of New Zealand
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HRC Ethics Notes November 2014
(Continued from page 3)
The first issue is that HDECs are
constituted to have the expertise to
address the ethics of an application,
not the lawfulness. Should HDECs
then simply add to their membership
an individual who might have the
expertise to review the complexities
of New Zealand law as it applies to
clinical research (a very rare breed
of lawyer)? I suggest not, as such a
member in meeting this obligation
would be giving legal advice. All the
law and related rules relating to the
provision of legal advice2 would thus
need to be applied as if this member
was taking instructions from the
HDEC as a client. Also, in taking that
advice and accepting or declining an
application citing the HDEC’s opinion
as to compliance with the law, would
the HDEC not implicitly be providing
legal advice to the applicant, contrary
to law and SOP?
There is the option noted in clause 18
of seeking independent legal advice.
However an opinion is exactly that.
It is not a determinative statement
of the law and why should an HDEC
incur that cost when HDECs are “not
themselves responsible for providing
… legal advice”? That cost would also
need to be funded. I would suggest that
the ministry is not wishing to impose a
new cost, and delay, into the approval
process.
So, how might HDECs reach a
common approach to these changes
to the SOP? One option would be
to universally apply the guidance in
clause 18: “Where an HDEC suspects
that a research proposal is not lawful,
it should advise the applicant of its
concerns, and may suggest that they
seek formal legal advice.” For an HDEC
to give advice of a concern to an
applicant would not delay or increase
the cost of the HDEC process.
The answer I suggest lies with the
jurisdiction of the Health and
Disability Commissioner (HDC) and
Human Rights Commissioner. The
ministry in the SOP notes that the two
significant features of New Zealand law
applying to the research are the New
Zealand Bill of Rights Act and the Code
of Health and Disability Consumers’
Rights (Code).
HDECs might therefore collectively
seek guidance from both the HDC
and Human Rights Commissioner on
the law as it applies to research. This
guidance could then be promulgated
to all stakeholders, with the HDECs
advising that all applicants should
be cognisant of this guidance when
meeting an applicant’s obligation to
ensure a study is lawful. I would suggest
that HDECs would, by this approach,
meet any obligation they may have
under the SOP or otherwise to make a
determination as to the lawfulness of
research. They might also raise concerns
with an applicant when reviewing and
responding to a proposal.
Meanwhile, researchers should
continue to integrate the current
approach to obtaining consent to
research from consumers, including in
respect to those who lack competence,
which has been in effect and advised
to HDECs for more than a decade.
HDEC approval should continue
to be provided, both parties being
comforted by the fact that neither the
Human Rights Commissioner nor the
HDC have ever received a complaint
or issued any advice that the approach
taken by researchers is non-compliant
with the Bill of Rights or the Code.
1. Standard Operating Procedures for Health and Disability
Ethics Committees, Ministry of Health, August 2014.
2. Section 21 Lawyers and Conveyancers Act 2006
Only a person who holds a current practising certificate as a
barrister or as a barrister and solicitor may provide advice in
relation to any legal or equitable rights or obligations for any
other person
Law, ethics, and research in critical illness
By Dr Colin McArthur
Clinical Advisor for Research, Auckland District Health Board
Chair, Australia and New Zealand Intensive Care Society Clinical Trials Group
“Drugs tested on critically ill coma patients” ran the front-page headline. “Thousands of critically
ill or unconscious patients have been enrolled without their consent…” The implication was that this
was a convenient study population who could not object to trials of experimental therapies which
offered little or no benefit to the individual, but might be good for ‘Big Pharma’. Great for selling
newspapers, perhaps, but the truth was rather different.
Since 2001 over 7000 patients in New
Zealand intensive care units have been
enrolled into interventional studies.
Due to the nature of their illness or
the effects of treatment, most of the
4
participants were unable to consent for
themselves at the time of enrolment.
Following the principles outlined
by the National Ethics Advisory
Committee1, New Zealand’s research
Health Research Council of New Zealand
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ethics committees approved these
studies with deferred consent.
Consistent with international ethical
guidelines such as the Declaration
of Helsinki2 and those of the World
HRC Ethics Notes November 2014
Health Organization3, in very specific
circumstances it is ethical to enrol
participants into clinical trials without
their prior consent. These include
the requirements that the study
cannot reasonably be conducted in
a population that can consent, that
any additional risk conferred by
participation is balanced by potential
benefit to the individual and/or to the
patient group to which the individual
belongs, and that the consent of a
substitute decision-maker is gained.
However, under current New Zealand
law (and in contrast to many other
jurisdictions), in most cases noone can legally consent to research
involving an incompetent adult.
Therefore, as an ethically equivalent
alternative, prior ‘assent’ (agreement)
is sought from family/whānau
member(s) in a manner equivalent to
consent.
Dr Colin McArthur
In the subgroup of emergency care
research involving participants who
cannot consent, the study question may
involve a time-critical intervention
precluding prior discussion with
family members. If there is no other
way of addressing the question, then
ethics committees may approve such
studies only if they are satisfied that
there is no additional risk compared to
usual care or that a minimal increase
in risk is balanced by a significant
potential individual or group benefit.
In all cases family assent to continued
participation must be sought as
soon as reasonably practical after
enrolment, and the deferred consent
from participants for any future study
procedures and use of data is sought if/
when participants regain competence.
What then of the thousands of
patients? A review of studies
approved by New Zealand research
ethics committees between 2001
and 2014, with a provision for some
or all participants to be included
when they were unable to consent,
found 40 examples of which 32 were
investigator-initiated. Seven were
observational studies but included
measurements or assessments
beyond those required for clinical
care. Of these, five were able to gain
prior agreement for the additional
assessments from the patient or their
family and the other two required
time-critical laboratory samples for
which delayed consent for subsequent
analysis and use of data was obtained.
In the 33 interventional studies,
participants were randomly
allocated to one of two different
treatment options. Twenty-one were
“comparative effectiveness” studies of
two approaches to treatment that were
within the range of standard acceptable
practice, and therefore were treatments
that patients would be given randomly
by individual clinician choice outside
of the study. These offered no greater
risk than usual treatment, and account
for over 97 per cent of patients enrolled
without their prior consent. In all
these studies, the participant’s family
and the patient if/when competent
were approached for assent or consent
(or provided with information and
the option to opt-out) to ongoing
participation as soon as reasonably
practical.
The other 12 interventional studies
included a treatment not currently in
clinical practice, and where some or
all of the participants were expected
to be incompetent. In eight of these
studies, prospective prior assent was
obtained from the patient’s family or
consent from the patient if they were
competent. If initial participation
had been agreed by the participant’s
family, then delayed consent to
ongoing participation was obtained
from patients if/when they became
competent.
The final four studies, including a
non-standard treatment arm where
delayed assent to ongoing participation
was sought from families (and later
consent to continue in the study from
surviving competent patients), were
all studies of emergency treatment
for brain injury causing coma. None
involved pharmaceutical products. For
all these studies, the ethics committees
considered that there was little or
no additional risk to participants
compared to standard care, that
there was evidence that the study
intervention was potentially beneficial,
and that there was no other way of
appropriately assessing the treatment
with prior assent from families or
consent from participants.
Is this an acceptable approach? We
have good evidence from some of
the more major studies that delayed
consent in these circumstances is
supported by patients and families.
The overall proportion of families or
patients who declined delayed consent
after they or their relative had been
enrolled in an interventional study
comparing two approaches to standard
care was as follows: SAFE (albumin vs
saline resuscitation fluid) 0.8 per cent;
NICE-SUGAR (blood glucose control
target) 2.0 per cent; RENAL (high vs
low dose renal replacement therapy)
2.6 per cent; CHEST (hydroxyethyl
starch vs saline resuscitation fluid) 3.6
per cent. This shows that over 95 per
cent of families and participants do
not decline delayed consent, which is
strong support for the approach taken
by researchers and ethics committees
in New Zealand over the past 15 years.
Although the ethical position is
reasonably clear, the same cannot
be said for the legality of research
involving participants who are unable
to consent. The Code of Rights section
7(4) allows for legal surrogates
(Continued on page 6)
Health Research Council of New Zealand
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HRC Ethics Notes November 2014
(Continued from page 5)
consent”. But is a structured research
protocol with ethics committee
approval “experimentation”?
Fundamentally, there is a clash of
paradigms: the law has as a priority
protection of individuals, whereas
ethics is the balancing of competing
principles of respect, justice,
beneficence, and non-maleficence
where risk to an individual can be
weighed against benefit to others.
Source: Shutterstock
such as parents, welfare guardians,
and holders of enduring powers of
attorney to consent vicariously for
medical procedures, but their enabling
legislation prevents consent to most
forms of research. If there is no-one
with legal authority to consent, then
medical treatment, including research,
may proceed taking into account the
views of the patient (if known) and
those with an interest in their welfare,
but only if it is in the patient’s “best
interest”. Although treatment within
comparative effectiveness studies
is probably as much in the patient’s
best interest as usual random clinical
practice, the interpretation of this
requirement with regard to research
interventions, for which (by definition)
there must be clinical equipoise,
remains a source of much debate.
More confusion comes from the Bill of
Rights Act, which asserts the right “not
to be subjected to medical or scientific
experimentation without that person’s
Yes, drugs have been tested on critically
ill coma patients. But if medicine is
going to continue to improve treatment
for critically ill or otherwise vulnerable
patients, societies need to have
consistent ethical and legal frameworks
that carefully balance respect for
individual autonomy against societal
benefit, and ensure that future patients
are not deprived of the benefits
of research, but at the same time
current patients are protected against
unreasonable risk.
1. National Ethics Advisory Committee. 2012. Ethical
Guidelines for Intervention Studies: Revised edition.
Wellington: Ministry of Health
2. World Medical Association. 2013. World Medical
Association Declaration of Helsinki: Ethical principles
for medical research involving human subjects. FerneyVoltaire: World Medical Association
3. Council for International Organizations of Medical
Sciences. 2002. International Ethical Guidelines for
Biomedical Research Involving Human Subjects. Geneva:
World Health Organization
Research misconduct
By Dr Greg Pringle
“...his meteoric rise in the ... scientific establishment had left behind a trail of ruined careers
and shredded egos, and he was equally loathed and admired by his colleagues... It had not gone
unnoticed in certain circles that much of his success had come from the shameless stealing of other
people’s research and the ruthless undermining and intellectual carpet-bombing of anyone he
perceived as a rival.”
So wrote Quinn Berentson in his
recent book ‘Moa: The Life and Death
of New Zealand’s Legendary Bird’
(Craig Potton Publishing, 2013),
referring to a renowned UK anatomist
Professor Richard Owen on his career
6
to 1839. Such behaviour would still
be immoral today, and the ‘stealing
of other people’s research’ is surely
misconduct. But has anything changed
since 1839, considering the global
research community has expanded by
Health Research Council of New Zealand
Te Kaunihera Rangahau Hauora o Aotearoa
several orders of magnitude? Evidence
would suggest that it has not.
Drivers of behaviour
For those with lofty career aspirations,
it is not surprising that there are
HRC Ethics Notes November 2014
personal incentives to maximise one’s
publication record in a competitive
environment with a bias towards the
weight of publication. The Performance
Based Research Fund has undoubtedly
increased the pressure for publication
across a range of academic positions
in New Zealand universities. This
is tied directly to a major funding
mechanism and is thus of interest to
the researcher’s institution. There is no
evidence to date that this has resulted
in a lowering of publication ethics in
New Zealand.
There are also personal incentives for
publishing first in some of the more
fast-moving disciplines, and this may
lead to quality issues, self-plagiarism,
‘salami’ publishing (splitting one paper
into several to increase the count) and
duplication.
Grades of irresponsible practice
At the extreme, there are many
examples overseas of health researchers
fabricating and falsifying data, and
of plagiarism (collectively labelled
‘FFP’). These acts are deliberate –
there is an intent to deceive. The
world record for this would have to
be recent revelations of a Japanese
anaesthesiologist fabricating data for
172 papers (Akst, 20121). These and
other examples often require the public
retraction of the offending articles
(http://retractionwatch.wordpress.
com) and through their journals, of
which there were over 500 in 2013.
We would be naive to think that
irresponsible research practices are
totally absent in New Zealand. Not all
retractions are the result of misconduct
or bad science – a recent retraction
involving New Zealand researchers
was due to the subsequent discovery
of equipment effects, and was rightly
retracted quickly and in the correct
manner2, leaving reputations intact and
a professional service to the research
community.
Of lesser evil are questionable research
practices (QRPs), which while not
1. http://www.the-scientist.com/?articles.view/articleNo/32312/
title/Anesthesiologist-Fabricates-172-Papers/
2. http://onlinelibrary.wiley.com/doi/10.1111/jnc.12241/full
deliberate, are ‘sloppy’ behaviours
and may be claimed to be more
prevalent3. Deleting the data outlier
from analysis, inappropriate authorship
(inclusion or exclusion), insufficient
acknowledgement, lack of citation (or
improper citation), inadequate research
design, and biased or inappropriate
conclusions from the data fall into
this category. In the relatively small
research community we have in New
Zealand, conflicts of interest in peer
review are almost unavoidable, with
differences of academic opinion at
times irresolvable and potentially
damaging for the applicant. True
confidentiality (of concepts and
commercial end-points) is also hard to
achieve in a community such as ours.
End-users of reported research also
have obligations. The researcher’s
moral rights need to be respected –
acknowledging their contribution
correctly and appropriately, ensuring
the integrity of the work (without
alteration, distortion or mutilation),
respecting any request for anonymity,
and the avoidance of false attribution.
These requirements are easily manifest
in the research contract between the
research provider and the sponsor.
Clauses that mandate the need for
researcher vetting of sponsor report
alterations or communications based
on the research, naming the researchers
and their organisations, work hand-inhand with the researcher’s obligations
to acknowledge the contributions of
the sponsor or funder of the research.
Surveys of the incidence of FFP have
revealed rates of up to 2 per cent for
FFP and 72 per cent for QRPs4,5,6.
Rates have been increasing markedly
in recent years, due in part to the
3. John, L.K., Loewenstein, G. & Prelec, D. (2012).
Measuring the prevalence of questionable research
practices with incentives for truth telling. Psychological
Science 23(5), 524-532.
4. Tavare, A. (2012). Scientific misconduct is worryingly
prevalent in the UK, shows BMJ survey. BMJ Group.
http://www.bmj.com/content/344/bmj.e377
5. Butler, D (2010). Journals step up plagiarism policing.
Scientific American, July 5. http://www.scientificamerican.
com/article.cfm?id=journals-police-plagiarism
6. Fanelli, D. (2009). How many scientists fabricate and
falsify research? A systematic review and meta-analysis of
survey data. PLoS ONE, May 29. http://www.plosone.org/
article/info%3Adoi%2F10.1371%2Fjournal.pone.0005738
exposure research misconduct is
having internationally, systems
being put in place within the science
community, and an increased ability to
detect such behaviour.
Exposure, review, sanctions and
consequences
Retractions can be made years after the
original publication. The concern here
is for the research of others who have
relied on the original (mis)information,
and possible consequences for followon research, clinical practice or
commercial activity. The retraction of a
paper by an Australian-headquartered
company late last year resulted in a
fall in their share price from 95c to
60c. More spectacular examples have
resulted in the collapse of companies
founded on bad science, at the expense
of investors.
A common theme in cases of proven
misconduct is that close colleagues
were often aware of questionable
practices. Their willingness or ability
to challenge false findings may
be diminished by internal power
relationships, dogma or the pressure
to publish, and perhaps by a quiescent
authority within the institution. A
public challenge is enough to bring
the misconduct to light, such as
happened in the National Women’s
cervical cancer work of the 1960s
when colleagues were exasperated
enough to publish a challenge to Dr
Green’s findings in 1984. As a result
of similar incidents, protection of
the whistleblower is enshrined in
some overseas guidelines but must be
exercised with caution, as there is the
opportunity for malicious or frivolous
challenges7.
Such practices could draw disciplinary
action through employment provisions
in the researcher’s institution. Ethics
committees may be an initial port of
call for investigations of ethicallyapproved research, but they should
not necessarily be the arbiters of
irresponsible behaviour or misconduct
(Continued on page 8)
7. http://ori.hhs.gov/complainant
Health Research Council of New Zealand
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HRC Ethics Notes November 2014
Ethics Summer Studentships
Four students were awarded HRC Ethics Summer Studentships in 2013/2014. The purpose of the
studentship is to enable a student to train with a research team during the summer break and have
the opportunity to explore ethical issues that face New Zealand. Here we feature brief reports of the
students’ projects.
and consumers. It considered the ways
in which each of these areas represents
a potential risk to the cornerstone
principles of autonomy, beneficence,
non-maleficence and justice. The
research detailed how providers
who may be fully meeting their legal
obligations to consumers under New
Zealand law, may still fall short of
satisfying important ethical obligations
incumbent on them as professionals
under their respective code of ethics.
Colleen Bain, AUT University
Supervisor – Professor Louise Longdin
Ethics implications arising from
the delivery of New Zealand
health services via mobile device
applications
Many health providers are now
turning to mobile device technology
to deliver health services through
the use of smartphone applications,
known as mHealth. The functionality
spectrum of mHealth services ranges
from low-level appointment reminders
and reference resources for searching
symptoms, to registered medical
devices allowing, for example, realtime monitoring of an embedded
device. This research identified and
analysed key issues raised by mHealth
that differed from those encountered
in traditional delivery models, focusing
on concerns about privacy and
information security as well as specific
problems thrown up by the remote
interaction existing between providers
Charlotte Stockwell, the University
of Auckland
phronesis (practical wisdom), lie at the
core of what New Zealand students
need to learn, both in regards to sex,
and life in general. This study tried to
demonstrate that flourishing can best
be promoted by reducing the numbers
of unwanted pregnancies. To achieve
this, the study suggested providing
comprehensive sex education to
students, starting before they reach
13 years of age, and by making
contraception as readily available as
possible.
Bonnie White, University of Otago
Supervisor – Professor Rosalind
Hursthouse
Supervisors – Professor Jennie Connor
and Dr Simon Walker
Abortion, virtue ethics and the role of
the state
Freedom as responsibility:
Rethinking the ethics of alcohol
policy in New Zealand
Virtue ethics is a theory of normative
ethics which tries to look at the bigger
picture of a person’s life as a whole,
rather than only at individual actions.
It encourages us to view ethical issues
in context. Political issues such as
abortion need to be viewed both
in the wider socio-political context
(education and health care in general,
for example), and in the context(s)
of the great variety of individual
circumstance. It stresses the need for
individual eudaimonia (flourishing,
living well, or “the good life”), as
well as emphasising the role of the
state in enabling and promoting the
flourishing of its people. The researcher
argued that at its very core, virtue
ethics provides an excellent basis for
comprehensive sex education; virtues
such as responsibility, love, kindness,
justice, and honesty, tied together by
Health Research Council of New Zealand
Te Kaunihera Rangahau Hauora o Aotearoa
Alcoholic drinks have an established
place in most societies (Law
Commission Report 114, 2010) and
are often consumed in dangerously
large amounts (Rehm et al., 1999 and
2003). Given the responsibility of the
state to promote the overall health of
society, there is a need to review the
current national policies related to
alcohol consumption. The researcher
considered the ethical basis of reforms
that were proposed in a 2010 Law
Commission report (Law Commission
Report 114, 2010), and responded to
the claim that such policies constitute
an unjustified restriction of autonomy.
The researcher argued that policies
that effectively enable safe alcohol
consumption enhance autonomy by
allowing rationalised decision-making
and promoting self-determination.
HRC Ethics Notes November 2014
Laura Crawford, Massey University
Supervisors – Associate Professor Fiona
Alpass and Dr Andy Towers
Data linkage, ethical considerations
and the HART data linkage project
Data linkage involves pairing data from
two sets of records which are assumed
to belong to a single individual or
entity (Bohensky et al., 2010). This
makes use of available public records
and is increasingly becoming the
gold standard of health research
internationally. The Health and
Ageing Research Team (HART) data
linkage project aims to link existing
HART longitudinal research data with
health records held by the Ministry
of Health (MoH). HART longitudinal
research comprises psychological,
economic, and social data from five
waves of survey responses from middle
aged and older New Zealanders.
The successful linkage will increase
generalizability and validity of HART
studies, as well as dramatically increase
the scope of potential research projects.
The main data linkage includes a
number of MoH health data sets.
The secondary mortality data linkage
focuses on the MoH mortality
database. As with all data linkage,
these linkages are accompanied by a
variety of ethical issues which may be
more complex than in other research.
Consent is an important issue,
especially in data linkage involving
large samples where it may be difficult
for researchers to obtain consent. The
HART linkage also includes elderly and
Māori samples, which bring further
consent considerations. Privacy and
confidentiality risks are increased in
data linkage, where data migration can
lead to re-identification of data. These
issues need to be carefully considered
as the data linkage process requires
data to be available to a wider range
of people. This report firstly describes
the HART data linkage study and its
progress. Secondly, it discusses related
ethical issues in detail considering
alternative views and potential
solutions. The considerable benefits of
data linkage research are explored in
light of ethical considerations.
Health Research Council Ethics
Committee membership
The HRC Ethics Committee (HRC EC) welcomes
Professor Lesley McCowan, ONZM, MBChB,
FRANZCOG, MD, CMFM as a new member of the
committee. Professor McCowan replaces Professor
Sue Stott who finished her term with the HRC EC in
December 2013. The HRC EC would like to thank
Professor Stott for her valuable contribution over the
past six years.
Professor Lesley McCowan is head of the Academic Department
of Obstetrics and Gynaecology at the University of Auckland. She
Professor Lesley McCowan
is a sub-specialist in maternal-fetal medicine at National Women’s
Health, and her main clinical interests are in managing high-risk
pregnancies, especially those with fetal growth restriction and pre-eclampsia. She has chaired the perinatal mortality
review process at National Women’s for many years and was a founding member of the national Perinatal and
Maternal Mortality Review Committee, which reviews deaths of babies and mothers nationally.
Health Research Council of New Zealand
Te Kaunihera Rangahau Hauora o Aotearoa
HRC Ethics Notes November 2014
(Continued from page 7)
– this is best left to an institution’s
discipline procedures and/or that of
a relevant professional body. There is
little in law to provide sanctions or
remedies to research misconduct.
Within an institution, mechanisms
for detection, and fair and transparent
review of allegations, should be in
place, along with overt sanctions for
proven cases. One could also argue
for some degree of independence of
review (such as those in Europe8 and
the USA9) from that of institutional
management, where conflicts of
intent, power imbalances and
working relationships (favouritism or
otherwise) may cloud independent
review. One should also be cognisant
of the variation in the approach to
research integrity across different
jurisdictions, and thus where these
expectations may collide in an
international sector such as ours.
8. E.g. http://www.ukrio.org/, http://en.fi.dk/, http://www.
etikkom.no
9. http://ori.hhs.gov/
Similarly, ‘naming and shaming’ isn’t in
the ethos of the New Zealand research
community. The process of review of
an allegation should be very discrete, as
premature disclosure may be sufficient
to cause irreversible reputation damage
to an innocent person. In overseas
jurisdictions, guilty parties have been
excluded from the ability to apply
for research grants, have had close
supervision imposed, or been excluded
from acting in any advisory capacity
for such processes. The greatest damage
though is to the researcher’s reputation,
as well as that of the laboratory and
institution, and is thus a serious
limitation to career progression.
Prevention is better than cure
Awareness and education are
precursors for good research practice.
This must begin during undergraduate
and postgraduate researcher education,
and extend across the ‘value chain’ of
early career researcher induction to a
new research environment, funding
agencies, journals and professional
bodies.
Upcoming meeting dates
HRC Data Monitoring Core Committee (HRC DMCC)
21 and 22 April 2015
20 and 21 October 2015
HRC Ethics Committee (HRC EC)
18 February 2015
13 May 2015
19 August 2015
11 November 2015
Please note: Any submissions to the HRC EC need to be
sent to Lana Lon, at [email protected] three weeks
before the meeting.
In Australia, the need for a research
integrity governance framework is tied
to the university’s key funding agencies
(ARC and NHMRC), effectively
‘forcing’ compliance and behaviour.
This compliance has come at a cost
of both the need for infrastructure
(Research Integrity Officers) and
in-kind time input (all staff). New
Zealand would benefit from the softer
approach of awareness and education.
Regulation is not a preferred option at
this point, but educational resources
and training opportunities are largely
missing. The Royal Society of New
Zealand does publish a code of
conduct, but it is enforceable only
for its members and does not cover
the full range of research conduct in
sufficient detail. Such codes of conduct
refer to unethical behaviour, but as
we all know, there are behaviours that
would be considered unprofessional
but not unethical – such as the example
mentioned at the start of this article.
In the continuum of professional
behaviour, it would be impossible to
regulate this cleanly.
About Ethics Notes
Ethics Notes is not a refereed journal and does not publish
full length articles. The opinions expressed are those of the
writers, and do not necessarily represent the views of the HRC.
Ethics Notes can be read on the HRC website: www.hrc.govt.nz.
Contributions are welcome. All articles in Ethics Notes may be
reprinted, provided the source is acknowledged.
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ISSN 1171-4263 (Print) ISSN 1171-4220 (Online)
Health Research Council of New Zealand
Te Kaunihera Rangahau Hauora o Aotearoa