NZ Journal of Physiotherapy November 2008, Vol.

36 (3) 138
Scholarly Paper
Ethical review of physiotherapy research
Lynley Anderson, DipPhysio, MHealSc, PhD
Neil Pickering, BA(Hons), MA, PhD
Senior Lecturers, Bioethics Centre, Medical and Surgical Sciences, Dunedin School of Medicine
ABSTRACT
Recent writing on physiotherapy research has raised awareness of the need
for ethical review of research, and of basic ethical norms such as consent and
confdentiality. This paper aims to raise awareness further by considering the
underlying values within research ethics, and focusing on the realities of the research
context for the physiotherapist. In this article, we discuss a number of ethical issues for
physiotherapists conducting research. Compliance with ethical standards expected
of all health care professionals involved in research including the requirement to
submit research for independent ethical scrutiny can usefully be supplemented
by examination of the ethical reasons for these standards, and also refection upon
the reality of conducting physiotherapy research, often in the midst of clinical
practice. This article seeks to explore these issues. Anderson L, Pickering N (2008):
Ethical review of physiotherapy research. New Zealand Journal of Physiotherapy
36(3): 138-143.
Key Words: Research ethics, ethical principles for medical research, institutional
review boards, bioethics
INTRODUCTION
In this article, we discuss a number of ethical
issues for physiotherapists conducting research.
Compliance with ethical standards expected of
all health care professionals involved in research
including the requirement to submit research
for independent ethical scrutiny can usefully be
supplemented by examination of the ethical reasons
for these standards, and also reection upon the
reality of conducting physiotherapy research, often
in the midst of clinical practice. This article seeks
to explore these issues.
Discussion of the ethics of research focussed
explicitly on physiotherapists is timely. Currently
in physiotherapy, as in other professional health
activities, there are demands for more research on
the one hand, and for greater ethical awareness and
compliance on the other. In a recent article, Henley
and Frank (2006) recognise the drive for more
and better evidence of the effectiveness of clinical
practice, and the current pressure for compliance
with ethical standards being led by publishers of
journals. They recommended that Physical therapy
journals should standardize ethical protections and
make documentation of compliance a prerequisite
of publication (Henley and Frank 2006: p.499).
The insistence that research should have been
conducted in an ethical manner before it can be
published gives researchers a strong reason for
ensuring that their research does comply with
standard ethical protections for as Henley and
Frank describe, it is a powerful mechanism for
encouraging ethical research (p.504). They suggest
that published research comply with three such
protections, these are: seeking research ethics
committee approval prior to carrying out research;
getting informed consent from participants, and
keeping information gathered about participants
condential (Henley and Frank 2006).
Physiotherapists not explicitly involved in
research may consider a discussion about research
ethics is irrelevant to them. However many
physiotherapy treatments have evolved greatly from
their original form and/or have been applied to
new patient (and perhaps more vulnerable) groups
in which this treatment has not previously been
used. Questions must be asked about whether
such treatment should proceed without supporting
research that is able to assess the appropriateness
of such treatment. This article is designed for
physiotherapists engaged in research and those
involved in the creation of innovative therapies.
Research ethics committee approval:
The importance of independent
ethical review
We know from history that research participants
have not always fared well and concern for their
welfare has, at times, been lacking (Beecher 1966,
Paul 1988). There has been recognition world-
wide in the light of this history that safeguards
are required to ensure that the welfare of research
participants is protected (Evans and Evans
1996). Central among these safeguards is that
the proposed research should be reviewed by an
independent ethics committee (World Medical
Association 2000, Nuremberg Code 1946-49). The
establishment of independent ethics committees in
New Zealand (NZ) was in direct response to events
at National Womens Hospital where research into
the natural course of carcinoma in situ of the cervix
was carried out from 1966 until 1987 (Cartwright
1988). The research was brought to the attention
of the public by two journalists (Coney and Bunkle
1986), leading to a government-appointed inquiry
chaired by Judge Silvia Cartwright. The Inquiry
found that a research trial had been undertaken
in which many women did not know that they were
NZ Journal of Physiotherapy November 2008, Vol. 36 (3) 139
participants in research and that some women had
died due to a failure to supply standard treatment
(Cartwright 1988).
The primary researcher had taken his research
to a hospital ethics committee (Paul 1988), but
this committee had failed to recognise the potential
harms and other ethical issues the research raised.
Part of the explanation for this might be that it
was not sufciently independent or empowered to
question and reject research. The committee was
made up of many of the researchers peers, and was
supportive of the concept of professional freedom
for clinicians (Paul 1988). As such, it lacked the
objectivity required to identify the aws in Greens
research and also the perspective required to
protect the study participants (Paul 1988).
The current system of ethical review in New
Zealand is to a major degree the child of this
experience (Nie & Anderson 2003). Where health-
related research on patients is concerned, there
are currently 6 regional committees (3 on the North
Island and 3 on the South Island) and a multi-
region committee (which reviews research going on
simultaneously in more than one region) charged
with the task of ethical review of research. These
committees have a membership appointed by the
Ministry of Health. Some human research that
which does not involve patients for example may
be reviewed by committees established within
tertiary educational institutions (universities and
polytechnics). Their membership is a mixture of
community and institutional appointments.
Ethics committees are guided by a number of
recognised and widely accepted ethical standards
(for an account of these, see next section) and by
the system of accreditation by the Health Research
Council (HRC) Ethics Committee. The HRC Ethics
Committee accredits ethical review committees on
the basis of the Operational Standard (Ministry
of Health, 2006). To achieve accreditation,
committees must, for example, have the appropriate
mix of community (e.g. non-health professional,
or non-institutional) and expert representation
to make effective ethical judgements. They also
must have sufcient Maori representation, and an
acceptable gender balance. Their processes and
principles must be consistent with thorough and
efcient review; e.g. they need to guarantee that
each protocol receives sufcient consideration, and
that mechanisms are in place to inform researchers
of the committees decisions. All of the Ministry of
Health (regional and multi-centre) committees are
currently accredited, as are a number of the major
institutional committees.
In New Zealand, the ethical review system has
two other elements: rstly Maori consultation is
regarded as an important element of much research
(Sporle and Koea 2004). This consultation is in
addition to the review carried out by the committees,
including their Maori members. Secondly, as far as
health research goes, there is also what is called a
locality assessment which is, at least, a declaration
signed by the relevant local health institutions that
the research is practical in the locality and site
planned (e.g. that the researcher has time to do the
research, or that the local hospital has the facilities
to enable to research to take place).
However, important though it is to get independent
ethical review, approval of a research proposal by
a research ethics committee should not be viewed
by physiotherapists as the end of their ethical
obligations nor a substitute for their own ethical
awareness. Attention to ethical concerns should be
a primary concern of all researchers throughout the
time period of the research, and researchers must
be alert to these.
Values informing ethical review
As was mentioned in the previous section, there
are some widely accepted ethical principles which
are understood to apply to research. In addition,
there are a number of guidelines which express
these values, which have been promulgated over the
years by different organisations and committees:
some of these will be mentioned briey below after
the consideration of the values themselves.
A well accepted framework of such values is that
of Beauchamp and Childress (2001). Among the
values they list which are most obviously applicable
to research are: respect for autonomy; benecence;
and non-malecence.
Autonomy refers to the idea that each individual
should be in control of their own destiny and their
own person (Beauchamp and Childress 2001,
57). Respecting this value, in the general context,
means protecting people from those things, such as
coercion and manipulation, which might threaten
to undermine this control, and ensuring people are
empowered to exercise this control, for example by
making sure they have relevant information. In
the research context in New Zealand, autonomy
is realised most obviously in the right to informed
consent the right to decide upon the basis of
good information whether or not to participate in
research (Health & Disability Commissioner 1996).
It may also be realised in respect of condentiality
of health information, since control over oneself
may be perceived to extend to control over certain
information about oneself (Ministry of Health
1994).
Benecence refers to the aim to make things
better for people in general. In the health research
context this relates to the fundamental moral
justication for health research, which is to ensure
the development of effective and safe treatments for
human ills, including of course physical treatments.
Non-malecence refers to the avoidance of doing
harm, and is often seen as rooted in the Hippocratic
tradition (Campbell et al 2005). In the health
research context, it is often argued that there
needs to be some balancing of benecence and
non-malecence: for the term research implies
trying something out that has not been tried out
previously, which implies that the potential to do
NZ Journal of Physiotherapy November 2008, Vol. 36 (3) 140
good or harm is not yet understood. So, the people
on whom the treatment is being tried out are, to
some extent, guinea pigs albeit in most cases
informed and consenting guinea pigs who take
on the risk of harm on behalf of and for the benet
of a wider group.
Amongst the guidelines which reflect these
values, and apply to research and researchers in
a general way, are those of the Health Research
Council of New Zealand (e.g. Guidelines for Health
Research With Children, HRC 2007; Guidelines
for Researchers on Health Research Involving
Maori, HRC 2008) and of the National Ethics
Advisory Committee (NEAC) which has developed
guidelines on conducting observational studies,
audits, and related activities (NEAC, Dec. 2006)
and is developing a parallel set of guidelines for
intervention studies and innovative practice (NEAC,
Work Programme). There are also international
guidelines which apply in New Zealand, for example
the World Medical Association Declaration of
Helsinki (WMA, 2000).
The values of autonomy, benecence and non-
malecence, and their general applicability to health
research (including physiotherapy research), are
well established. But in any actual circumstance
in which physiotherapy research is conducted,
all kinds of more or less hidden ethical dangers
lurk. These may undermine the application of
the accepted bioethical values. The aim of the
remaining sections of this paper is to bring some
of these hidden dangers to light.
Autonomy: Some hidden dangers to
informed consent
As stated earlier, obtaining the consent of
a person to participate in research is plainly
important. It may not be a requirement in all
cases, as we discuss below. Consent, where it is
required, as in the vast majority of cases, functions
as a protection for participants, ensuring that they
are not subject to any experimental or innovative
treatment or other intervention which they do
not want. Typically, in fulfilment of consent,
potential participants must be adequately informed
about what is proposed. This means writing an
information sheet for participants which is clear,
fully states the purpose of the research, any
attendant risks, costs and compensations, as well
as what the data to be collected are to be used for.
Other information may include how data are to be
stored, and for how long. Furthermore, participants
are generally assured that they can withdraw their
consent at any point in the research, without the
need to give any reason, and without any penalty
or come back.
What if consent cant be obtained?
Physiotherapists will from time to time want to
carry out research on people who are not competent
to consent. Where there is a choice, research should
always be carried out in groups that are competent
to consent. But this might restrict the ability of
physiotherapists to develop properly evidenced
therapies for some groups of clients, for example
for those with severe brain injury associated with
increased muscle tone, where the clients inability to
consent and special physical needs may be related.
One possible way forward in a case like this is to
ask would this person, when competent, have been
willing to take part in research. A clients family
may be a good source of information for answering
this question. A highly detailed application to an
ethics committee would be necessary and advice
should be sought on proper practice.
While it is the case that there are some people
who are incompetent to consent, care needs to be
taken not to assume this. For example disabled
people may be thought to be unable to give consent
when in fact many may be perfectly competent. It
may just mean that they need more time and more
effort put in to explaining the research rather than
just assuming that they lack the competence to
consent. A rule of thumb in this area is that there
should be a presumption of competence in all cases.
Incompetence must be proved, never assumed.
Consent and relationships between
physiotherapists and participants
A hidden danger in seeking someones consent to
take part in research lies in the surrounding context
of physiotherapy practice and the relationship
the physiotherapist has with participants. The
context and the relationship have the potential
to threaten autonomy even when other aspects of
obtaining consent are in place (Tolich and Baldwin
2005). Many practicing physiotherapists, like other
practicing health professionals, appear to have a
readymade pool of potential participants in their
own clients. This is not to say that recruitment
is limited to this pool. But in many cases the
physiotherapists own client base will be easy to
contact, easier to introduce the subject of possible
research participation to, and may well be easier to
recruit since they may place a good deal of trust in
the physiotherapist, and believe that the research
must be worthwhile being part of just because he
or she is conducting it.
But sel ect i on of part i ci pant s f r om a
physiotherapists own client base should sound
ethical alarm bells. One question might be how
easy individuals in this client pool would nd it to
say no? How far is their capacity to formulate and
express doubts about the research and/or their
participation in it undermined by their existing
relationship with the physiotherapist? For example,
a physiotherapist helping with rehabilitation during
long-term care after an accident or illness may enter
a long-term and intense relationship with a patient,
through frequent, lengthy sessions. Moreover, the
role of the physiotherapist in trying to return the
patient to optimal function may mean that he/she
has a particularly important actual and symbolic
role in the patients life. These factors, in a situation
NZ Journal of Physiotherapy November 2008, Vol. 36 (3) 141
where the physiotherapist makes a request of the
patient, may undermine the patients ability to
make a considered and independent decision.
An ethically problematic context such as this
is not, however, necessarily a red-light to doing
research. One possible way around this problem is
for the physiotherapist to ask someone else to take
on the role of obtaining consent to participate where
the potential participants are clients. Where this
is not possible, the physiotherapist might advise
clients to think very carefully about whether they
really want to participate, suggest they consult
with family members before deciding, and make
certain that they are aware that participation is by
no means expected of them, and that if they say
no their care will not in any way be affected. Just
allowing time for the decision (Ill see how you feel
about it again next week) may help the client reect
upon things in a truly independent way.
There are some populations whose ability
to refuse consent to take part in research (or
judgement) may be undermined by wider social
attitudes and their reliance on others. This group
may include prisoners, elderly people in long
stay care and children. For example an elderly
person in long term care may feel unable to refuse
to participate if he/she believes the care will be
affected by a refusal. Particular care needs to be
taken with these groups that information is given
appropriately and full opportunity given to refuse
consent without any detrimental effect on care
provision or treatment.
Condentiality: Promise and practice
Confidentiality is a protection for research
participants in that it restricts access to knowledge
gained about them as part of or simply during
the research. The
p a r t i c i p a nt i s
usual l y assured
t hat onl y t hose
actually collecting
data will get to know
who the data came
from, that the data
will be kept hidden away from others, and that
there wont be any way for a third party (such as
a statistician or the reader of a journal) to be able
to connect the data with an individual participant.
These guarantees of condentiality usually extend
for the whole period of research and beyond. This
can be understood to include the period of data
collection and analysis, presentation and nal
storage (Ethics committees may demand a storage
period of raw data of a number of years.) Where
these safeguards of confidentiality cannot be
offered, the participants should at least be told, so
they can decide whether or not they are happy with
whatever level of condentiality can be offered.
Confidentiality is generally regarded as an
important right for research participants, but it
may be argued that some physiotherapy research
is unlikely to threaten it. For example, quantitative
physiotherapy research often involves objective
measurements of variables, and efforts to generalise
from the sample in the research to its wider
population, according to statistical norms. This
might include, for example, measuring the range
of motion of a particular joint. This data would
most often be useless for identication purposes on
its own: if someone who was not intended to see
it did, theyd be none the wiser about the person
from whom it came, and because it is unlikely to
be sensitive material, most participants would be
less concerned about it being kept condential.
However, this doesnt negate the need for care:
data sets may contain or be easily linked to names
and other personal details if they are not effectively
anonymised or if the personal details of participants
and the data are kept in too close a proximity to one
another in the same le or folder for example. And
it shouldnt be assumed that data the researcher
considers altogether non-sensitive is non-sensitive
from all the participants points of view.
Moreover, physiotherapists may well carry out
qualitative research. In qualitative research,
identifying details may well be an integral part of
the data for example, names, places, dates in a
taped interview narrative. Anyone who happens to
have access to this data may be able to identify the
participant or others in the narrative. Those who
have such access may include people other than the
researcher for example a person who transcribes
the interview. Condentiality may also be breached
through dissemination of results. Although
information such as name, age and location will
be expected to be removed prior to publication,
there is always potential for participants to be
recognised through other identifying information.
This is a particular
concern in a small
country such as
New Zealand where
including data in
a published article
about a participant
such as a diagnosis,
t he number of
children, and that the participant lives in a small
town may be sufcient to result in identication
of a participant. This problem may be avoided by
changing personal and other details.
In responding to concerns about condentiality
and privacy, researchers generally make certain
promises. Typically promises about condentiality
include guarantees to keep data gathered for
research purposes in a locked ling cabinet in
a locked cupboard or ofce, or on a password-
protected computer. However, these promises may
presuppose ideal conditions, rather than the reality
of practice. One can easily imagine circumstances
in which a busy physiotherapist comes into his/her
ofce, putting things down momentarily on a desk,
only to be called away to take a phone call or see
innovative extensions of normal
treatments require careful monitoring
not only retrospectively, but
prospectively
NZ Journal of Physiotherapy November 2008, Vol. 36 (3) 142
a client who is in a hurry. Anyone who happens
to enter the ofce may see the things dumped on
the desk, including photos of someone known
to him/her, and suddenly good intentions about
condentiality fall down.
These realities of practice arent unique to
physi ot herapi st s: however, t hey remi nd
physiotherapy researchers that condentiality in
practice is achieved only with constant vigilance;
that it involves many practicalities, and that the
real contexts in which people exist often need
to be carefully monitored to full the promise of
condentiality.
Non-malecence and benecence:
Ensuring the well-being of participants
As stated earlier, there is a need to consider
the harms and benefits that might eventuate
from research. As far as doing harm goes, it may
be considered that physiotherapy is unlikely
to be ethically troubling. It is fairly clear what
sorts of harms may arise from taking substances
into the body in the form of drugs or from new
surgical techniques: both are in their different
ways physically quite invasive. But it might be
argued that physiotherapy is not anywhere near
so physically invasive, and doesnt have the toxic
potential of the drug or the serious injury potential
of the scalpel. This is potentially a problematic
attitude, and there are at least three strong reasons
for taking the potential for harms eventuating from
physiotherapeutic interventions being researched
very seriously.
The rst reason is that some physiotherapy
interventions do contain serious potential for
physical harm. Electrotherapy modalities,
acupuncture spinal manipulation and even some
forms of mobilization can all result in undesirable
outcomes. Therefore we need to consider any
potential for physical harm when involving patients
in research even on well accepted procedures.
The second reason is that potential for harm
may result from the adoption of new treatments,
or the adaptation of old treatments on populations
in which such treatments have not previously been
used. In 1998, the Journal of Pediatrics published an
article written by Harding, Miles, Becroft, Allen and
Knight. The article concluded that encephaloclastic
porencephaly a characteristic form of brain
damage, sometimes with fatal or severely disabling
outcomes might be a previously unrecognized
complication of chest physiotherapy in vulnerable
extremely preterm infants. The article centred on
a series of cases in Auckland. The outcomes in
Auckland were reminiscent of those in an earlier
article, written by Cross et al (1992), which reported
on a case series in Birmingham, in the UK. In both
cases, the physiotherapy that was being given was an
established treatment; however it had not been tried
before on very premature babies. It was extended
to their care presumably because it seemed to have
advantages in other age groups, but in retrospect
physiotherapy emerged as a possible cause of
serious, sometimes mortal, outcomes.
The Birmingham and Auckland case series
alert us to a number of important things about
physiotherapy research. First, that research
needs to be done innovative extensions of
normal treatments require careful monitoring and
checking not only retrospectively, but prospectively.
Second, that innovative physiotherapy is potentially
extremely harmful. This may be particularly the
case where the patient group which it is thought
might benefit from the physiotherapy is itself
physically vulnerable.
The third reason is because other sorts of harm
can arise from the non-physical research carried
out by physiotherapists, which might be perceived
as very low-risk methods such as interviewing. For
example, the recollection of emotionally difcult
experiences in the course of an interview can cause
harm in participants. It is important that this
possibility is identied. Recognising the possibility
of such emotional and/or psychological harm is the
rst step to putting in place safeguards to prevent
such harm. If physiotherapy researchers themselves
do not recognise the potential for this form of harm,
they may not recognise that ethical review of their
study is required through an ethics committee.
Further responsibilities to participants
There are times during research when a
researcher may come across information that has
signicant implications for the health or wellbeing
of the participant. For example, a physiotherapist
may carry out research on elderly people, and while
screening participants for research into falls may
nd out a participant has very high blood pressure.
A question arises about what physiotherapists
should do with this kind of information. Should
they report this concern, or keep such ndings
condential? If the participant is not a patient of
the physiotherapist, the physiotherapist may feel
that he or she has no obligation to respond at all.
However a duty of care to participants may indeed
extend further than the described limits of the
research. To some extent these concerns should
have been predicted prior to commencement of the
study and appropriate steps put in place of which
the participant is made aware as a part of the
consent process. Such steps might include
A further example is when undertaking research
on dependent people, a researcher may be told
during an interview or simply in passing that a
participant is suffering abuse at the hands of a
caregiver. In this example, a researcher may be
unsure about exactly how to respond. They might
be fearful that they may make the situation worse
if they respond inappropriately. There is also a
possibility that such information is not true and in
passing it on, the physiotherapist risks impugning
the name of the caregiver. A physiotherapist may
need to access other health care services in order
to respond in a sensitive manner. Appropriate
NZ Journal of Physiotherapy November 2008, Vol. 36 (3) 143
mechanisms for responding to such possibilities
should be provided when submitting an application
for ethical committee approval.
CONCLUSION
Our primary aim has been to emphasise
three things with respect to ethical conduct of
physiotherapy research. First, that independent
ethical review of research is vital, but that it is
not a substitute for the researchers own ethical
sensitivity and awareness. Second, that the ethical
ideas which underlie the traditional foci of research
ethics (for example the idea of autonomy which
underlies informed consent and condentiality)
need to be supplemented by taking into account
the implications of other ethical ideas, such as the
avoidance of harm and doing good. And third, that
ethical conduct of physiotherapy research requires
a focus on the realities of the research context, and
on the details of what can happen, on the part of
the researcher.
Key Points
Where possible, physiotherapy treatment should
be based on research conducted under the
widely accepted values of bioethics
In practical situations there are many hidden
threats to the effective application of these
values
Physiotherapists in New Zealand are expected
to seek independent ethical review of any
proposed research
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