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| Journal of the New Zealand Medical Association,
06-August-2004, Vol 117 No 1199
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Maori responsiveness in health and medical research: key
issues for researchers (part 1)
Andrew Sporle, Jonathan Koea
In 1998, the Health Research Council of New Zealand (HRC)
published the Guidelines for researchers on
health research involving Maori.1 These
Guidelines were produced by the Maori Health Committee of the HRC to assist
health researchers intending to undertake research that involved Maori as
participants, or was on a topic relevant to Maori health.
The HRC guidelines were not binding on researchers but were
more than ‘points to consider’ as they were to be used in the
consideration of applications for HRC funding in future years. The 1998 revision
of the ‘National application form for
ethical approval’ incorporated the principles contained within the
HRC guidelines. As a result, all applicants from all research fields were
required to indicate if they had read the guidelines and to specify what
consultation with Maori had been undertaken in developing the research. The
current HRC research proposal application form requires the host institution to
ensure that consultation with Maori has occurred.
Anecdotal reports and the authors’ personal
experiences indicate that this requirement for all researchers has led to
confusion among researchers and ethics committees as to what constitutes
appropriate and meaningful consultation with Maori. This is confirmed by a study
on researchers’ views of the functioning of ethics committee in New
Zealand.2 There is also anecdotal evidence that
the requirement for consultation by researchers is placing demands on Maori
communities or organisations with limited resources and their own, more
pressing, matters to attend to.
This paper attempts to clarify the issues regarding
consultation with Maori in the development of biomedical and clinical research.
Our experience (in assisting health researchers improve the Maori responsiveness
of their intended projects) has highlighted that there are nine key areas that
researchers can readily address in their proposals.
These issues are outlined in this paper, together with
possible strategies to manage them. The paper concludes with a review of the
first year of functioning of the Maori Research Review Committee of the Auckland
District Health Board—an initial institutional committee formed to address
these issues. A second paper3 will review the
historical development of the Maori responsiveness requirement for health
research funding to demonstrate that this process follows similar requirements
of the rest of the health sector, and will outline an institutionally based
model to assist researchers in meeting the obligations related to Maori
responsiveness.
Common issues of Maori responsiveness in research applicationsIn their roles (within
research-funding bodies, universities, and healthcare providers) the authors
have provided advice to biomedical, clinical, and public health researchers on
ways of improving the Maori responsiveness of their intended research projects.
Over the last 5 years, nine issues have predominated in such
discussions with researchers. All of these issues are readily addressed, as
outlined below.
UtilityWhenever possible, health research
on a health issue relevant to Maori should have clear benefits for Maori health.
Such benefits need to be clearly articulated, and the research process must be
designed to realise those benefits.
Research undertaken in New Zealand can often overlook its
relevance for Maori health, and this may significantly undervalue the research
project. The first step is for the researcher to recognise the relative impact
of the health issue being researched upon different population
groups—including Maori. This should include an assessment of likely future
relevance given the marked changes in New Zealand’s population over the
next 50 years.
For public health and clinical research, this assessment of
relative impact on population groups is usually straightforward (as the burden
of most health issues falls disproportionately upon Maori). Occasionally, the
ethnic specific burden of a health issue may not be known, but addressing this
gap in knowledge can then be an additional research outcome.
For example, the initial planning of an investigation into
possible causes of abdominal aortic aneurysm in New Zealand had not included
consideration of ethnicity. However, a detailed examination (of ethnic specific
incidence and mortality) highlighted a previously unknown higher mortality and
earlier incidence of aortic aneurysm in Maori.4
This was a key research finding, as it was the first time such elevated rates
have been described outside a population of non-European descent, and the
results are now being used to inform further research into potential modifiable
causes of aneurysm for Maori.
The second step is to ensure that the benefits of the
research reflect the relative impact of the health issue. A vital part of this
process is the identification of, and consultation with, potential end-users of
the research results. Both HRC and the Foundation for Research, Science and
Technology (FRST) applications require researchers to indicate the relevance of
their project, the relationship with endusers and the strategy for the
dissemination of results.
Addressing Maori responsiveness requires a similar process,
but made Maori-specific. Where a research team has a focus on a specific issue,
the consultation with Maori or non-Maori endusers is likely to involve an
ongoing reciprocal relationship that may shape the research focus, design, and
methods—or the dissemination strategy across the team’s research
portfolio. Suitable Maori end-users may be any combination of Maori staff or
sections within mainstream organisations working with Maori on the health issue,
or Maori-specific health or other community organisations.
One strategy is to include a specific focus on Maori within
the project. This may involve undertaking ethnic-specific analyses, or ensuring
there are sufficient Maori participants to enable Maori specific analyses. Some
projects include a distinct Maori segment, involving Maori specific research
processes and Maori staff.
With clinical studies, the combination of small participant
numbers and sampling strategy can preclude a distinct ethnic analysis,
especially when the research is exploratory in nature. In such instances, the
researcher should specify in their application the anticipated proportion of the
sample that will be Maori (based on previous clinical activities) and determine
whether this enables a statistically valid ethnic specific analysis. If not,
then the option of an ethnic over-sampling should be explored, and the decision
regarding its practicability justified within the application.
Where ethnic-specific analyses are not possible, then the
research and dissemination process can be designed to enable the research to
form the basis of later work that is more directly relevant to Maori
health.
Some researchers have chosen to exclude Maori as subjects
from studies due to investigator-perceived difficulties in consultation,
recruitment, or analysis. This is an effective means to ensuring that the
Crown-funded research has an unknown applicability to Maori. Of note, the United
States’ National Institutes of Health (NIH) insists that women and
minorities be included in all NIH biomedical and behavioural research involving
human participants—to ensure that the results are applicable to all
population groups. Furthermore, where there is prior evidence of differential
clinical or public health importance of the health issue, then both ‘the
primary question(s) to be addressed by the proposed ... trial and the design of
that trial must specifically accommodate this.’5
Subgroup analyses are required where the evidence of
differential impact is equivocal and strongly encouraged, even when there is no
prior evidence of differential impact. Exceptions are possible, but only when
‘a clear and compelling rationale and justification establishes to the
satisfaction of the relevant Institute/Center Director that inclusion is
inappropriate.’5 New Zealand’s
research and health policies would suggest a similar requirement could be made
for Crown-funded research in this country.
For biomedical research, the benefits for Maori health may
not be so readily identifiable—as the research is concerned with more
fundamental biological processes, many steps removed from application in a
health setting. However, there may still be ways the research could contribute
to Maori health development—these need to be explored and practicable
options (if any) outlined in the research proposal.
In such instances, the research process may be able to
provide workforce development opportunities via studentships or scholarships
that can assist in addressing the low levels of Maori participation in
biomedical research. Another option is for biomedical researchers to focus on an
issue of high Maori health relevance.
In 1964, a paper was published that described a Maori family
in which members had died of diffuse gastric
carcinoma.6 However, this Maori family did not
benefit from this research in terms of improved surveillance or treatment.
Nearly 30 years later, a joint venture between the family and biomedical
researchers at Otago University resulted in definition of an inherited genetic
defect in cell adhesion proteins integral to the development of diffuse gastric
cancer.7 This partnership led to an innovative
research process that has resulted in major publications, development of local
community health services, further research projects and the establishment of
improved surveillance and treatment protocols for family members.
The Royal Society of New Zealand has recently published a
report outlining good practice guidelines for working with Maori in scientific
research.8
Defining and identifying MaoriUndertaking ethnic specific analyses
can be a useful way of highlighting differences in morbidity and mortality
between population groups as well as highlighting differences in effectiveness
of services or other interventions. All of these analyses can be useful in
informing improvements in health policies and practices for Maori. To make this
possible, research projects need to use standardised definitions and processes
for determining the ethnic identity of participants.
The use of non-standardised definitions and processes makes
the results non-comparable with other studies (or even official data), and
introduces bias that reduces the usefulness of the results in informing
improvements in Maori health. Although this problem has plagued official health
statistics in the past,9 it does not need to
affect current or future research.
The solution is to use the content, delivery, and counting
methods of ethnicity questions contained in the most recent New Zealand Census.
The use of the standard Census question ensures that the results are comparable
with the Census data (that forms the baseline population data for the
determination of incidence or prevalence rates).
As ethnicity is a self-defined concept, and the Census is
(usually) self-completed, researchers should get participants to answer the
question (if possible). The researcher then needs to use the standard means of
aggregating the results (especially multi-ethnic responses) into ethnic
categories.10
Finally, it is also important for authors to describe the methods used when
writing up the project.
In 2001, Thomas11 reviewed
research reports, which made comparisons between Maori and non-Maori samples
from 1980 to 1996. Only 19% reported any information on the criteria used for
categorising ethnicity, and only three papers mentioned how people of dual or
multiple ethnicity were defined. As with other research methods, outlining
ethnicity criteria and their application in publications is essential for the
audience to assess the validity and applicability of the research
results.
Informed consentObtaining informed consent for
involvement as a participant in a research process usually involves the consent
of the individual concerned, or (in certain circumstances) proxy consent from
parents, family, guardians, or persons with power of attorney.
However, for Maori, a more collective approach to consent
may be required depending on the nature of the research processes involved. This
is especially true when the research process involves traditional Maori
knowledge or processes that challenge Maori values or tikanga.
For Maori, traditional knowledge is entrusted to
individuals. As such, it is not universally available despite it remaining the
property of the collective and cannot be shared with the consent of the
collective stakeholders. With the exception of genealogical information and
traditional therapies, most mainstream health research will not involve such
information. When traditional knowledge or potential breaches of tikanga (Maori
lore and protocol) are involved in research processes, then individual consent
is insufficient. For traditional knowledge, the consent of the collective
(whanau [family], hapu [subtribe], or iwi [tribe]) is required.
Where issues of tikanga are involved, then the HRC
guidelines require that the mana whenua (people with authority) of the region
(such as the local iwi) need to be consulted, and the results of the
consultation documented in the application. In addition, it is prudent for
researchers to provide opportunity (including the necessary time) during the
consent process for potential Maori participants to discuss their involvement
with whanau.
ConfidentialityParticipation in research usually
involves confidentiality of participant identity. Maintaining this
confidentiality can be difficult for Maori, especially with smaller or regional
studies. The combination of extensive Maori social networks and (possibly) small
numbers of eligible Maori participants requires researchers to minimise the
inclusion of identifiable information in any research reports or
publications—to avoid the unintentional identification or
mis-identification of an individual, community, or organisation.
Conversely, Maori participants may ask that their research
information is made available beyond themselves (in line with collective
accountability, or to ensure wider benefit from the research process for their
communities). The research application should specifically indicate if either of
these situations could apply to the intended project, and (if so) they should
include a strategy to address the issue.
Handling and disposal of tissueMaori view all tissue and body
fluids as taonga (to be treated as a treasure). However, body fluids and tissues
are also regarded as tapu (and therefore need to be treated with caution) rather
than noa (neutral). This distinction is important, since biological specimens
must be treated with great care and kept away from food and cooking
utensils.
The process of consent to the taking of tissue and body
fluids (as part of a research protocol) amounts to entrusting the researcher
with this taonga. Consent for tissue or body fluid collection is not given
lightly, and consequently all tissues should be handled with respect. Many
universities and hospitals already have protocols for the sampling, storage, and
disposal of tissue from Maori. These can include Maori supervision of the
process, and rituals for the cleansing of the storage site or samples.
Where samples are required, it is important that the
researcher seek and follow the advice of the local Maori advisory or management
team and document this in their application.
It is expected that where tissues and body fluids will be
transported (particularly outside of New Zealand), there will be evidence of
specific processes in place to ensure that samples are used only for the
purposes for which consent has been provided and then disposed of in a suitable
manner. The application form should outline what protocols are being followed
for handling human tissue and what, if any, specific processes are being
followed for any Maori specimens.
Genetic informationThe use of genetic material from
Maori, as well as from indigenous flora and fauna, is highly contentious and
there is a general reluctance amongst Maori to be involved in genetic research.
Many of these contentious issues have been discussed by Baird et
al,12 or are outlined in the submissions to the
Royal Commission on Genetic Modification.13
However, several Maori-specific genetic projects have
proceeded, including at least two researcher-initiated projects. In all cases,
extensive consultation was required with whanau, hapu, and iwi. Involving Maori
in mainstream projects is less straightforward. Possible strategies include
excluding Maori from such a study or not collecting ethnicity data, making Maori
samples non-identifiable. Again, researchers should familiarise themselves with
the issues, then follow local protocols in determining how to address this issue
and refer to these in their applications.
Intellectual propertyIntellectual property issues are an
important consideration for researchers, particularly those involved in the
development of patentable knowledge or new services.
If a research project involves a unique contribution from
Maori organisations or individuals, then that contribution needs to be given due
recognition in the research process. Important issues for Maori are retaining
control over things that are viewed as being owned by them, and the prevention
of exploitation.14 Researchers must remember
that ownership of Maori knowledge is often collective, and that intellectual
property rights need to be negotiated with organisations or kin groups (whanau,
hapu, or iwi) rather than individuals.15
Previous mechanisms to acknowledge intellectual property within the research
process have included authorship (primary and joint) on publications as well as
joint ownership of intellectual property.
In the case of Guilford et
al7
the intellectual property relating to discovery of the e-cadherin gene in
gastric cancer is jointly owned by both whanau and the institution hosting the
research. This is clearly defined in a contract between the researchers’
host institution and the whanau trust.
If this issue is relevant to an application, then the
applicant should either include a description of how any intellectual property
would be managed, or outline the process that will resolve how the issue will be
managed.
KohaIt may be appropriate to provide
koha (a gift) to participants in recognition of the contribution that
participants make to the research process. The recent Operational Standard for
Ethics Committees 16 allows for reimbursement
for participation, including any costs incurred by the participant. Such
reimbursement needs to be reasonable, and indicated in advance to potential
participants.
Financial incentives to participate can negate the basis of
informed consent as well as create a source of bias in recruiting a research
sample, and should therefore be discouraged.
However, it may be
appropriate to provide participants with a small gift in recognition of their
time and contribution. Often this will be in the form of a letter or certificate
of thanks/acknowledgement. Other possible examples are petrol or book vouchers,
or gifts of food. One way to ensure that a koha is not regarded as an inducement
is not to signal it in advance to participants.
In projects where reimbursement or koha may be provided,
researchers should include (within their applications) a description of any
reimbursement and or koha, clearly outlining the amount or form of the koha and
whether potential participants are advised in advance.
Involvement of regional Maori health servicesMost biomedical centres in New
Zealand have now established Maori health services within the District Health
Boards (DHB), which work to assist Maori undergoing medical
treatment—either by advocacy, or by more practical assistance such as
accommodation and transport.
In the case of clinical research, discussion of the intended
research protocol with the regional Maori Health services is one important
avenue of consultation. In addition, Maori Health services are often able to
assist with patient recruitment, interaction between researchers and primary
healthcare providers, and dissemination of results.
Any such involvement should always be negotiated during the
development of a research proposal—to ensure the Maori health service
staff workload is not compromised, and to ensure any required costs are built
into the research budget.
Inclusion of a regional Maori Health Services’ contact
phone number on patient information sheets for clinical research protocols also
allows Maori Health Services to assist researchers in supporting Maori patients
and their whanau through the research process.
The Maori Research Review Committee of the Auckland District Health BoardAt the Auckland District Health
Board (ADHB), a Maori Research Review Committee has been developed. The
Committee meets once a month to review Treaty of Waitangi and tikanga aspects of
all research to be carried out within Auckland District Health Board
institutions.
The Committee was formed by Maori working within the ADHB in
response to issues that have been outlined in this paper. Prior to its
formation, most research proposals were being directed informally toward Maori
working in the organisation for review—this was an unsatisfactory
arrangement for both researchers and Maori.
All research applications are now directed through the
District Health Board Research and Development Office, and are reviewed by the
Maori Research Review Committee. This committee includes a Maori clinician, a
Maori nurse, a representative from the Research Development Office (who provides
secretarial and administrative support), representatives from the local ethics
committee, and mana whenua.
All research is assessed in terms of adherence to the
guidelines prepared by the Committee to assist researchers. Research that deals
with difficult or contentious areas will be directed to a group of Maori
kaumatua/leaders (the kaunihera) who regularly advise the ADHB on all aspects of
their work.
The Committee does not rewrite the Treaty components of a
submission but simply indicates whether the research meets the institutional
guidelines in this area or points out deficiencies and makes suggestions
regarding improvement. Furthermore, the Committee strives to be constructive and
to help researchers develop research proposals that are relevant to Maori, and
to answer questions that are important to all New Zealanders.
Summary of the first 12 months of the ADHB Maori Research Review CommitteeDuring its first 12 months, the ADHB
Maori Research Review Committee convened 13 times and reviewed 128 separate
research proposals, thus emphasising the significant amount of work involved in
this process. The significant issues highlighted in the Committees’
reviews are presented in Table 1 (in 6-month blocks).
Table 1. Summary of the review outcomes for 128
proposals assessed by the Auckland District Health Board Maori Research Review
Committee during its first year. (For most proposals, changes were recommended
in more than one area.)
The principle areas highlighted by the Committee pertain to
a lack of written documentation of consultation with the proposal, a lack of
detail on patient consent tissue handling and disposal, and the inclusion of
contact details for regional Maori health services.
The planned use of questionnaires developed outside New
Zealand to examine psychological and other parameters in Maori, and the use of
complex technical language in patient information sheets were also significant
issues.
Table 2. Summary of the review outcomes for 128 proposals
assessed by the Auckland District Health Board Maori Research Review Committee
(stratified by the first and second 6 months of the Committees
functioning)
Table 2 presents (in 6-month blocks) summary statistics for
approved research projects, or where changes were recommended. It indicates an
increasing proportion of research applications approved without change in the
second 6 months of the Committees’ tenure (due to clarification of the
goals and requirements of consultation).
Author information:
Andrew Sporle, Lecturer/Research Fellow; Jonathan Koea, Hepatobiliary Surgeon;
Department of Surgery, Auckland Hospital, Auckland
Correspondence:
Jonathan Koea, Clinical Associate Professor, Clinical Advisor Maori
Health, Department of Surgery, Auckland Hospital, Private Bag 92024, Auckland.
Fax: (09) 375 4334; email: jonathank@adhb.govt.nz
References.
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