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| Journal of the New Zealand Medical Association,
25-February-2005, Vol 118 No 1210
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Informing consent in New Zealand research: researchers’
conflict of interest and patient vulnerability
Martin Tolich, Kate Mary Baldwin
Recent debates about informed consent in the
New Zealand Medical Journal
(NZMJ)1–3 focused on a narrow reading of
the nature of informed consent. Their combined discussion was limited to the
dynamics of informed consent within doctor and patient relationships. The Health
and Disability Commissioner Ron Paterson2
quotes the Medical Practitioners Disciplinary Tribunal’s latest ruling
that makes it clear informed consent is achievable and that the rationale for
informed consent is to protect patient’s, not doctors.
Paterson’s comments follow arguments put forward by
Frank Frizelle who outlines a defensive risk management rationale for securing
the patient’s informed consent. Paterson states that the reason informed
consent matters (and is not an over-emphasis of the patient’s autonomy),
is, as explained by the Tribunal, an essential component to maintaining trust; a
vital element in the doctor-patient
relationship.2 Furthermore, he dispels other
common myths such as the obligation of the doctor to ensure the patient
understands the information; when he
states: Doctors are required to facilitate
understanding, but cannot be expected to guarantee patient understanding, and
the law makes no such requirement.
Gillett3 endorses this approach in his
paper titled At last some common
sense.
Promoted by a recent complaint about his practice,
Frizelle1 defends informed consent but argues
that legislation of what should be a medical act has increased to such an extent
that it is almost impossible to fulfil the requirements of informed consent. He
cautions doctors to be realistic about the information they give to patients,
and warns that even though retrospectively one may wish they had told the
patient more about a particular complication, there is increasing evidence that
the patient or family will not remember the information.
McKeague and Windsor4 (see
also Williams, French, et al;5
Snowdon6) support this claim with their study
on elective surgical patients—finding that a significant number of
elective surgical patients were either dissatisfied with the information
provided to them or had no memory of the consent process. Furthermore, McKeague
and Windsor recommend that consent givers should understand that the information
is neither supported by case law nor a requirement of the Operational Standard
for Ethics Committees.7
The Commissioner2 clarifies
the legal requirement as follows:
Although it is a requirement that a patient
is given the information as detailed in the first point above, the Commissioner,
Paterson2 states,
‘...it does not follow that in giving my
consent to proceed, I truly understand the information provided.’
Situating a discussion of the nature of informed consent
solely within doctor and patient discourse is problematic when unconnected to
research-based informed consent or the web of ethical principles that underlie
informed consent.
We ‘problematise’ the NZMJ debate by making
three suggestions for informing consent
in New Zealand, as follows:
Two sub-principles
concern us: first, the self-regulated option for researchers to declare their
conflict of interest when researching their patients; second, the definition of
who warrants vulnerable research subject status is too narrow; it is limited to
certain statuses (such as children, elderly, or terminally ill) when
vulnerability may be more pervasive.
To this vulnerable persons list we can add the term
‘vulnerable times’8 suggesting that
all persons can be vulnerable when faced with the possibility of losing their
bowel, breast, limb, or facing their imminent demise. Therefore, in failing to
effectively address these two principles of conflict of interest and
temporal/contextual vulnerability, the Operational Code undermines
patient/subject’s informed consent.
The authors’ intention here is to revise these
sub-principles. Our goal is to provide sufficient conditions to enable research
subjects to truly make an informed
consent to participate, thereby ensuring that health research in New Zealand is
of a robust ethical standard. Therefore, we end this paper demonstrating how the
revision of Section 26 of the Operational Code7
advances this goal.
‘Informed’ consentBeauchamp and
Childress9 provide a more stringent rationale
for informed consent than offered in the recent NZMJ debates. Beauchamp and
Childress’s justification for informed consent is that it respects the
patient’s right to autonomous choice; they define an informed consent to
be:
‘An informed consent in the
first sense occurs if and only if a patient or subject, with substantial
understanding and in substantial absence of control by others intentionally
authorises a professional to do some thing’
According to this definition, sufficient information is
given to the patient to enable them to evaluate the treatment. For the patient
to have a substantial understanding, they need information on factors that
concern (or are important to) them.9 What is
insignificant to the practitioner or most reasonable people may be the deciding
factor to a patient. Indeed, the only way a clinician will know of the
information needs of the patient is by a ‘mutual exchange of
information.’9
For the patient to be able to freely consent, they must have
information that is relevant to the treatment and in the context of the
patient’s cultural and personal beliefs. Buchanan and Brock (in
Wilkinson10) go further, stating it is an
important mechanism to protect the patient’s well-being—as the
patient is most likely to be best able to determine what makes their life good.
The partnership model of healthcare encourages clinicians to
recognise the unique knowledge and perspective patients have on their treatment
and care and to involve them in the decision-making. When time allows, the
consent process takes place over time as the patient’s knowledge builds
through ongoing information sharing between patient and
clinician.11
The goal of healthcare, the betterment of the particular
patient, directs the relationship and principles of health care providers and is
described by various models: the agency model12
whereby the professional carries out the wishes of the patient, and the contract
model13 whereby the patient’s
expectations of the clinician and the clinician’s expectations of the
patient are clearly defined by the contract.
Both agency and contract models are based on an egalitarian
sense of power between the parties. Fiduciary
relationships12 however, are unequal;
professional codes of practice recognise the inequalities of power between both
parties and thus require the professional to act in the patient/client’s
best interest. This is a primary expectation of the medical profession and is
reflected in the acceptance by patients, society, the law, and the clinicians.
Thus if a patient is incompetent and the situation is urgent then the clinicians
should provide treatment that is (in the clinician’s considered opinion)
in the patient’s best interests.
The moral authority of doctors to make decisions is reliant
on the doctor being trustworthy. Kohen14 (1994)
identifies seven conditions a professional must meet to be considered
trustworthy. These conditions are that the professional must have the
client’s interests at heart and exhibit an open-ended willingness to act.
This willingness must be sustained for as long as it takes to either render help
or determine that nothing further can be done for the client. The professional
must be competent and be able to demand from the client the degree of
accountability and discipline necessary for the treatment to proceed. The
professional is bound to monitor their own behaviour and they must have freedom
to serve each individual client’s well-being with discretion.
The irony of this list of obligations is that if they worked
in practice, written informed consent for the patient would not be necessary.
Moreover, would this set of obligations change when the professional is a
researcher or if the individual subject’s risks and benefits are measured
as an aggregate public good?
The primary guiding principle of health research,
established by the Declaration of Helsinki15
stated:
Concern for the interests of the
subject must always prevail over the interests of science and society.
The spirit of this declaration directs researchers to
acknowledge the inherent risks of the researcher /subject relationship; the
conflicting goals of personal health care and health research forces the
researcher not only to develop strategies that protect the subject from these
risks but that their patient’s interests prevail.
New Zealand has its own Helsinki document. The Cartwright
Commission Inquiry into Allegations Concerning
the Treatment of Cervical Cancer at National Women’s Hospital and into
Other
Matters16
exposed a breakdown in the trustworthiness of the doctor/researcher in
terms of the absence of informed consent confounded by unstated boundaries
between treatment and research, and a failure to recognise the conflict of
interest inherent in the role of clinician/researcher. Eight women died taking
part in a research project conducted by Associate Professor Green. Most notable
in this research project was the fact that these women took part in an
experiment for which they knew nothing
about.18
Research practice has changed in the post Cartwright era. No
longer are researchers trusted to know what is in the patient’s best
interests and to act accordingly. Instead, an ethics committee (comprising of a
balance of academics and laypeople) now approves all human-subject research. The
new emphasis is on informed consent; providing the patient with sufficient
information about the research to decide their participation; and recasting the
fluidity in the doctor, researcher, and patient relationship. However, informed
consent does not rely solely on information.
We now demonstrate that informed consent is not sufficiently
robust and is undermined when a patient’s vulnerability is not
acknowledged, and/or when conflicts of interest between the clinician (as
researcher) and the patient are not recognised and disclosed, as
follows.
‘Informing’ consentThe
Operational Standard for Ethics
Committees, most recently published in 2002, guides the work of the
ethics committees and promotes the highest standard of ethical behaviour among
researchers and healthcare providers. However there are glaring omissions in the
code. Specifically, there is no requirement in the Operational Code for a
researcher (researching their own patients) to acknowledge and justify to any
ethics committee that a conflict of interest exists. Although research
committees are able to request clarification on any matter, the reality is that
it is not only researchers that fail to recognise the risks of conflicting
interests. Ethics committees follow closely the Operational Code and weaknesses
in the code results in weak examination in that particular aspect.
Failure to recognise the inherent conflict of interest is
the fundamental problem and can be located within the Cartwright Commission
findings. Professor Green’s fundamental ethical issue is usually taken to
be informed consent. He failed to inform his patients of the research and gain
their consent. A more fundamental error was his failure to differentiate between
the patients’ individual needs and his research requirements and a failure
to recognise his conflict of interest.
But for some unknown reason, this essential ethical
condition was neither part of the Commission’s final report nor has it
become part of the Operational Code. Conflict of interest is mentioned in
passing in the Health Ethics national application form in question
3.3.3.
Is there any special relationship
between the participants and the researchers? (e.g. doctor/patient,
student/teacher)
There is no follow-up to question 3.3.3 in the application
form. At a minimum, a researcher should be required to recognise their conflict
of interest and describe how they plan to minimise and monitor the conflict of
interest. In the guide to researchers for question 3.3.3, the instructions do
not mention conflict of interest but are limited to information about
researchers providing copies of notices and/or
advertisements for participants. Thus the ethics committee’s
attention is directed to a very narrow view of conflict of interest.
The only reference to ‘conflict of interest’ in
the Operational Code is in Section 26, but again it does not explicitly mention
doctor and patient conflicts of interest. Section 26 reads:
Respect for persons requires that
greater protection be provided to those persons with diminished autonomy (such
persons may include children, inmates, persons in dependent relationships,
persons with an intellectual disability, and unconscious patients) to ensure
that they are not subjected to abuse, exploitation or discrimination. Often,
additional protection is provided to persons with diminished autonomy by
requiring the input/advice of third-person representatives. Other classes of
research participants that are sometimes considered to be more vulnerable
include terminally ill patients, aged persons, and students and employees of the
researcher.
There are two significant omissions in Section 26. First, a
conflict of interest is established in two specific power relationships between
students and their teachers and between employers and their staff. No power
relationship is seen to exist between a doctor as researcher and their patients.
An irony does exist however in the Question 3.3.3 above. There the
doctor/patient relationship is clearly identified as being a conflict of
interest. It would seem the national application form researchers fill out is
not sufficiently connected to its Operational Code.
The second omission involves the limited reading for the
protection of vulnerable persons. Section 26 fails to capture the everyday lived
experience of normal patients coming to terms with what ails them during routine
crisis of the human condition when learning for the first time they are to
undergo surgery to lose a bowel, breast, or limb—or when they are in acute
pain or in life threatening situations.
Under Section 26, these persons are not considered
vulnerable. Yet we assert these persons are vulnerable by adding the notion of
vulnerable times to the category of vulnerable persons. A patient learning that
a bowel or a breast is to be removed may heighten their sense of vulnerability,
albeit temporarily. We suggest that such vulnerable times weaken the
person’s capacity to give an informed consent and particular boundaries
should be placed around such situations.
Section 26—revisedRespect for persons requires that
greater protection be provided to those persons with
diminished autonomy
when gaining informed consent. Diminished autonomy status is afforded to three
categories of persons and/or relationships:
Category 1 involving compromised
persons is virtually how it reads in the existing Operational Code. A notable
omission from this list of compromised persons is Aged Persons who are no longer
identified as in need of special protections (if ever they required any special
protections). In Categories 2 and 3 above, our focus has been on re-informing
informed consent by having researchers recognise the breadth of conflicts of
interests and the contexts of patient vulnerability.
As members of regional ethics committees, the authors
suggest that recognising and addressing conflict of interests in research is one
way of beginning to shore up the inherent weaknesses of informed consent in
research settings. Clinician/researchers, therefore, should be very specific in
their research design on how they will counter the inherent conflict of
interest. A second way is to re-contextualise the conditions under which a
person can be classified (albeit temporarily) as a vulnerable person. Rewriting
Section 26 of the Operational Code for Ethics Committees is a start to
re-informing consent in New Zealand research.
Author information:
Martin Tolich, Senior Lecturer in Sociology, Department of Anthropology,
University of Otago, Dunedin (and a past member of the Manawatu-Whanganui
Regional Health Ethics Committee. He currently Chairs the Multi-region Ethics
Committee); Kate Mary Baldwin, Executive Director of Nursing – Primary
Care, Otago District Health Board, Dunedin (and a past member of the Waikato
Regional Health Ethics Committee).
Correspondence: Dr
Martin Tolich, Sociology, University of Otago PO Box 56, Dunedin. Fax: (03) 479
9095; email: martin.tolich@stonebow.otago.ac.nz
References:
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