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R E S E A R C H A R T I C L E Open Access
Seeking consent for research with
indigenous communities: a systematic
review
Emily F. M. Fitzpatrick
1,2,3*
, Alexandra L. C. Martiniuk
3,4,5
, Heather D’Antoine
6
, June Oscar
7,8
, Maureen Carter
9
and Elizabeth J. Elliott
1,2,3,4
Abstract
Background: When conducting research with Indigenous populations consent should be sought from both
individual participants and the local community. We aimed to search and summarise the literature about methods
for seeking consent for research with Indigenous populations.
Methods: A systematic literature search was conducted for articles that describe or evaluate the process of seeking
informed consent for research with Indigenous participants. Guidelines for ethical research and for seeking consent
with Indigenous people are also included in our review.
Results: Of 1447 articles found 1391 were excluded (duplicates, irrelevant, not in English); 56 were relevant and
included. Articles were categorised into original research that evaluated the consent process (n= 5) or publications
detailing the process of seeking consent (n= 13) and guidelines for ethical research (n= 38). Guidelines were
categorised into international (n= 8); national (n= 20) and state/regional/local guidelines (n= 10). In five studies
based in Australia, Canada and The United States of America the consent process with Indigenous people was
objectively evaluated. In 13 other studies interpreters, voice recording, videos, pictures, flipcharts and “plain
language”forms were used to assist in seeking consent but these processes were not evaluated. Some Indigenous
organisations provide examples of community-designed resources for seeking consent and describe methods of
community engagement, but none are evaluated. International, national and local ethical guidelines stress the
importance of upholding Indigenous values but fail to specify methods for engaging communities or obtaining
individual consent. In the ‘Grey literature’concerns about the consent process are identified but no solutions are offered.
Conclusion: Consultation with Indigenous communities is needed to determine how consent should be sought from
the community and the individual, and how to evaluate this process.
Keywords: Ethics, Informed consent, Research, Indigenous, Aboriginal, Oceanic ancestry group
Background
There are an estimated 370 million Indigenous peoples
residing in approximately 90 countries [1]. They are
among the most marginalised of peoples, which has a
substantial impact on their quality of life and health [2].
Many research studies have been conducted in Indigen-
ous communities, however non-Indigenous researchers
have not always addressed community priorities, nor
collaborated in research with Indigenous people [3, 4].
Rather, researchers have often been perceived as doing
research on,notwith Indigenous people, with little re-
gard to local cultural protocols and languages and
without seeking consent from communities [3–6].
When approaching individual participants for consent
to participate in research, researchers often don’tcom-
municate in ways that can easily be understood [3–6].
Recent international guidelines for researchers work-
ing with Indigenous communities stress the need for a
more culturally sensitive and collaborative approach
* Correspondence: emilyfitzp@gmail.com
1
Discipline of Paediatrics and Child Health, Sydney Medical School, University
of Sydney, Sydney, Australia
2
The Sydney Children’s Hospital Network (Westmead), 4 Governor Phillip
Place, West Pennant Hills, Sydney, NSW 2125, Australia
Full list of author information is available at the end of the article
© 2016 The Author(s). Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Fitzpatrick et al. BMC Medical Ethics (2016) 17:65
DOI 10.1186/s12910-016-0139-8
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
[7–14]. By working along-side Indigenous researchers
and in continuous consultation with cultural advisors, some
non-Indigenous researchers working with Indigenous com-
munities are striving to be more ethically sound and cultur-
ally conscious, however, the inequality persists [4, 15]. It
should be noted that due to the diversity of the world’s
Indigenous peoples [1], the United Nations has not adopted
an official definition of ‘Indigenous’[2] and in specific re-
gionstheremaybeapreferenceforothertermsforex-
ample ‘Native Hawaiian’or ‘Aboriginal’. In this paper we
use the term ‘Indigenous’when referring to these popu-
lations in the general sense and when reporting spe-
cify in publications will use the name referred to there.
In this review we include publications that describe
specific guidelines for working with Indigenous popula-
tions, which may not capture research in low to middle
income settings where the majority of the population is
considered to be Indigenous. This review also excludes
reports that are not published in English.
The history of consent itself is interesting. One of the
earliest proclamations for the right to consent in human
experimentation was made in 1891 by the Prussian
Minister of the Interior with regard to Koch’s so-called
‘remedy’of tuberculin injections for the treatment of
tuberculosis in prisoners [16]. Guidelines specified that
‘the remedy must in no case be used against the patient’s
will’[16]. An early record of an official consent form
dates back to 1900, when research was conducted on to
control the transmission of yellow fever from Cuba [17].
This was developed in response to popular resistance,
published in Cuban newspapers, to Spanish immigrants
being used as “Guinea Pigs”[17]. In 1927 Claude
Bernard proclaimed that potentially harmful experi-
ments should not be conducted on men ‘even though
the results might be highly advantageous to science, i.e.
to the health of others’[18]. The Nuremberg Code was
formulated in 1949 to protect against experimentation
such as that conducted without consent on prisoners of
World War II [19]. The term ‘informed consent’as used
today, was coined in 1957 during the landmark case of
Salgo versus Leland Stanford etc. Bd Trustees [20] in the
United States after a doctor failed to inform a patient of
the potential risk of paralysis following a novel surgical
procedure. The World Medical Association worked on
setting up protecting the rights of research participants
and developed the first edition of the Declaration of
Helsinki published in 1964 [13]. Unethical research pro-
jects were relatively common. For instance, in 1966, Bee-
cher’s landmark publication on ethical irregularities cited
at least 22 unethical medical research projects [21].
Other research conducted in the United States that en-
rolled impoverished African Americans with syphilis
from 1932 until 1972 failed to treat participants with
penicillin, long after it was known to be a highly effective
treatment [22]. Even recently, the way in which the
Human Genome Diversity Project has been conducted
has been questioned in places such as Australia, with
concerns that there was a lack of respect for the cultural
values of Indigenous people [23].
Time is rarely invested to ensure that vulnerable popu-
lations understand the information provided to them
about a research study [24]. Minogue (1996) claims that
modern research can be so complicated that even a fully
competent individual is unable to give informed consent
(as cited by [25]). Beyond consent, the issue of owner-
ship of research findings requires consideration. With
advances in biotechnology there are implications with
regard to intellectual property rights, where companies
are trying to patent genetic material of research partici-
pants for their commercial value [26]. The World
Intellectual Property Organisation’s(WIPO)Grand
Council of the Crees [27], endorsed the United Nations
Declaration for the Rights of Indigenous Peoples
(UNDRIP) [9], highlighting the importance of protect-
ing the genetic resources, traditional knowledge and
traditional cultural expressions of Indigenous people.
Many countries supported these values but it was not
until 2007 that colonised countries such as the USA,
Australia, New Zealand (NZ) and Canada formally en-
dorsed this policy, indicating that Indigenous people of
these countries have been particularly vulnerable to
denial of their human rights, including when it comes
to participating in research and intellectual property.
In countries where ethical recruitment of participants
for research requires consent forms and participant in-
formation statements to be written in “plain English”,
many potential participants without English as their
first language require an interpreter [28]. The inter-
preter faces the challenge of both explaining research
jargon across a language barrier, and translating the
cultural and scientific significance of the research [28].
English is often the second, third or fourth language for
Indigenous people, especially in remote communities
[5]. This makes it difficult for Indigenous participants
to fully comprehend the “foreseeable risks”to which
they are consenting [28]. Yet, even with these known
challenges, Indigenous participants’understanding of
and preference for the consent process has rarely been
investigated [5, 29, 30].
Our aim was to conduct a systematic review of peer-
review and grey literature to identify studies and guide-
lines that describe specific methods used for seeking
consent for research with Indigenous communities and
potential individual participants. We also aimed to in-
clude studies that described and evaluated the process of
seeking consent and its impact on promoting under-
standing of research, considering individual participant
preferences and cultural beliefs.
Fitzpatrick et al. BMC Medical Ethics (2016) 17:65 Page 2 of 18
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Methods
This systematic review was conducted and is reported in
accordance with the PRISMA Guidelines [31, 32] (Fig. 1).
With the support of Librarians of The University of
Sydney Medical School, a search for publications was
conducted using Medical Subject Headings (MeSH)
such as ‘Informed Consent’,‘Research’and ‘Oceanic
Ancestry Group’; and key words such as ‘Indigenous’
and ‘Aboriginal’(and derivatives) which were combined
in various ways depending on the functionality of the
search engine (see Additional file 1). These were en-
tered into medical literature databases: Medical Literature
Analysis and Retrieval System Online (Medline); Scopus;
Web of Science; Educational Resources Information
Centre (ERIC); the Cumulative Index for Nursing and
Allied Health Literature (CINAHL); Excerpta Medical
Database (EMBASE); and Informit Indigenous Collection
(IIC). In addition, we searched for resources including
international ethical guidelines that describe the process
of seeking consent for research with Indigenous popu-
lations. Due to the large diversity of Indigenous people
around the world [1], and the lack of a single clear de-
finition for an Indigenous population [2], we limited
the search for research guidelines to international, na-
tional and local guidelines for colonised countries that
held guidelines specifically for Indigenous populations
and published in English. International guidelines that
were included were sourced from websites of organi-
sations such as the United Nations Declaration on the
Rights of Indigenous Peoples (UNDRIP); World Health
Organisation (WHO); World Medical Association
(WMA); and the Council for International Organisa-
tions of Medical Science (CIOMS). National guidelines
were identified through searching websites such as: The
Lowitja Institute; the Australian Indigenous Aboriginal
and Torres Strait Islander Studies (AIATSIS); and the
Fig. 1 Selection Process for Publications Modified from the PRISMA 2009 Flow Diagram [32]
Fitzpatrick et al. BMC Medical Ethics (2016) 17:65 Page 3 of 18
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Australian Aboriginal Health Info-net; the National
Health and Medical Research Council (NHMRC) of
Australia; the Health Research Council (HRC) NZ; the
Canadian Institutes of Health Research (CIHR); and the
National Institutes of Health (NIH), USA. In addition,
we identified a number of guidelines that were state
based, regional or locally created and which had a par-
ticular focus on seeking consent for research with Indi-
genous peoples. This search was conducted for the
most recent and relevant publications from 1979 until
November 2015. Articles that described in detail or
evaluated the process of seeking informed consent for
research specifically with Indigenous participants world-
wide and published in English were eligible for inclusion.
Articles were categorised into original research in which
the process for seeking consent was evaluated; or which
described in detail the process of seeking consent; or
guidelines for ethical research (Fig. 1).
Results
A total of 1447 articles was found. Of these, 1391 were
excluded after abstract or full text review because they
were duplicate publications; not published in English;
not readily available; or did not evaluate or describe in
sufficient detail the consent process for research with In-
digenous people. There were 56 relevant research publi-
cations, 5 of which evaluated preference for method of
delivery of information or understanding of information
provided when seeking consent for research with Indi-
genous people (Table 1). We identified 13 publications
that described methods for seeking consent (see Additional
file 2). In addition, there were 38 guidelines for seeking
consent for research with Indigenous people. These
were categorised into international (see Additional file 3);
national (see Additional file 4) and regional guidelines (see
Additional file 5). We developed a checklist evaluating
these guidelines (Table 2).
Original research evaluating the consent process
A total of five published research projects was identified
which evaluated the preference for method of delivery of
information or understanding of information when seek-
ing consent for participation in research with Indigenous
populations in Australia, USA, and Canada [33–37]. They
emphasised the need for involvement of local Indigenous
people in seeking consent, establishing good relationships
between researchers and potential participants, cultural
competence, and clear communication using plain lan-
guage with visual cues (Table 1).
Of these five, only one study evaluated both prefe-
rences for method of delivery of information and under-
standing of information presented when seeking consent
for research with an Indigenous population [33] (Table 1).
This was a pilot study, set in Alice Springs in the Northern
Territory, Australia, which was designed to evaluate
mothers’understanding of an unlicensed pneumococcal
vaccine trial proposed for their children [33]. Twenty non-
Aboriginal mothers and 20 mothers who identified as
Aboriginal were recruited to the study. Eleven of the
Aboriginal women did not speak English as their first lan-
guage. Non-Aboriginal mothers had the project informa-
tion explained to them by a nurse and were provided with
‘standard consent materials’in the form of an information
booklet containing only English text with time was
allowed for questions. This process was evaluated by the
non-Aboriginal mothers through a questionnaire. Aborigi-
nal mothers had information presented to them by re-
search team members –two of either a doctor, a nurse or
a health worker who also identified as Aboriginal. The
presentation was in plain English using a flip chart con-
taining text and computer graphics. A 12-page booklet
containing black and white diagrams and text was also
provided [33]. Aboriginal mothers were then interviewed
about the consent process with an Aboriginal health
worker, supervised by the principle investigator. Responses
were analysed by two researchers (their ethnicity was
not specified) who rated their impression of the partici-
pants’level of understanding of the consent informa-
tion. Preference for consent materials and mode of
delivery was also evaluated. It was concluded that a
one-off presentation was inadequate to ensure informed
consent from all participants.
Aboriginal participants preferred to receive research
information from a doctor working together with an
Aboriginal health worker using a flipchart rather than
the information booklet [33].
Articles describing the consent process in detail
We identified 13 articles from Australia, NZ, Paraguay,
Canada, Malawi, Peru and the USA. These research
publications describe a variety of methods used to aid
communication during the consent process (Additional
file 2) [4, 29, 30, 38–47]. Methods described include:
using pictorial aids in a flip chart, presented with a
local Aboriginal researcher to seek consent for re-
search [30, 38, 45]. Some studies specify that an inter-
preter presents the research information in local
Indigenous languages [29, 30, 38–41, 47] and some of
these methods resulted in a high participation rates
with 81–95 % [38, 42, 48], while others despite these
efforts participation rates varied from 42–65 % [29, 44].
Authors who identify as Indigenous describe a more
naturalistic approach to research, through an Indigen-
ous research paradigm, embracing cultural protocol
through practices such as storytelling [4, 41, 42]. Re-
searchers only seek oral consent, for fear of creating a
power imbalance between themselves and the Indige-
nous community when seeking written consent [43].
Fitzpatrick et al. BMC Medical Ethics (2016) 17:65 Page 4 of 18
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Community collaboration and consent is essential in
order to prevent researchers who are not local to a
community from making assumptions about how re-
search and the process for seeking consent should be
conducted [4, 30, 38–42, 45–48].
Guidelines for research with Indigenous communities
International and national research guidelines have been
produced by a number of government, health and re-
search organisations. A total of 38 current guidelines
that describe in detail methods for seeking consent for
Table 1 Original Research Evaluating the Consent Process with Indigenous Populations
Citation (location) Study Title Study Description Key Findings
Russell et al. 2005
(Alice Springs, NT,
Australia) [33]
A pilot study of informed
consent materials for
Aboriginal participants in
clinical trials
Information about an unlicensed vaccine
trial for children was provided to 20
mothers who identified as Aboriginal and
20 non-Aboriginal mothers using verbal,
written and visual materials. Preference
and understanding was evaluated through
a questionnaire.
▪A single presentation to all participants
was unlikely to enable informed consent;
▪Participants identifying as Aboriginal
preferred a flip chart with visual content
presented by a doctor with an Aboriginal
researcher present
Bull 2010 (Labrador,
Canada) [34]
Research with Aboriginal
Peoples: Authentic
relationships as a precursor
to ethical research
A researcher who identifies as Aboriginal
and local to the community of Labrador
interviewed 15 community leaders (11
leaders who identified as Inuit, Innu, or
Inuit-Metis and 4 non-Aboriginal leaders
nominated by the community) to
investigate why authentic research
relationships are important and how
they are achieved with people who
identify as Aboriginal.
To seek consent, the researcher must:
▪Establish a reciprocal relationship with
the community, involving them in the
research process and interpretation of results
▪Ensure the community understands the
risks as well as the benefits of participating
▪Respect cultural protocol
▪Ensure the research is relevant to the
community
For this research project:
▪Seek “collective consent”from communities
▪Provide the option of oral or written
consent for individual participants
▪The individual consent process was not
evaluated
McCabe et al. 2005
(Navajo Nation:
Arizona, New Mexico
& Utah, USA) [35]
The informed consent process
in a cross-cultural setting: Is
the process achieving the
intended result?
The consent process for a diabetes
education project with people of the
Navajo Nation was analysed. Standardised
consent forms in English were transcribed
into a phonetic version of Navajo using
the English alphabet. This was back
translated to English and compared to
the original English by a Navajo language
expert. A second version was then tested
with the Navajo Nation Medical
Terminology Standardisation Committee.
333 Navajo people who do not use the
written word were then asked to sign
these forms by 4 Medical Interpreters
who reflect on this process.
▪Concerns were raised about this process
by both participants and interpreters
▪The consent process was contradictory;
repetitive; untrustworthy; lengthy and
discouraged participation
Researchers conclude that consent forms should:
▪Avoid legal and scientific jargon;
▪Avoid repetition and wording that creates
mistrust
▪Have a logical flow of information when
translated into complex languages
Researchers should also:
▪Ensure those seeking consent are culturally
competent
▪Avoid reliance on telephone communication
▪Have community input into the consent forms
▪Use graphics to illustrate concepts and assist
understanding
Fong, M. 2004
(Hawai’i, USA) [36]
Native Hawaiian preferences
for informed consent and
disclosure of results from
research
A survey was conducted with 429
Hawaiian participants (327 of whom
were Native). The survey enquired
whether participants would want to
be asked for consent for the reuse
of stored biological samples.
▪Of native Hawaiian participants 77.9 % said
they would want to be asked for consent for
the reuse of biological samples if samples were
identifiable compared to only 35–37 % if
samples were anonymised
Fong postulates that findings may be due to:
▪Mistrust of research due to past discrimination
▪Cultural beliefs, one which includes forbidding
desecration of the placenta of the deceased
Baydala et al. 2013
(Alexis Nakota Sioux
Nation, Alberta,
Canada) [37]
“Making a Place of Respect”:
Lessons learned in carrying
out consent protocol with
first nations elders
Research team members from the Alexis
Nakota Sioux Nation and from the
University of Alberta held 2 focus groups
of 6 participants to reflect on a substance
abuse prevention program for the youth
of the Alexis Nakota Sioux Nation.
▪Asking community Elders to sign a standard
research consent form was considered
insulting if they had already accepted a
ceremonious offering of tobacco
▪In response, researchers developed a new
protocol to keep track of oral consent. This
was approved by the ethics board, ensuring
trust and respect of the community and
integrity in research
Fitzpatrick et al. BMC Medical Ethics (2016) 17:65 Page 5 of 18
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Table 2 Evaluation of Current Guidelines for Seeking Consent for Research with Indigenous Populations
CBD
2002
[7]
UN
2005
[8]
UNDRIP
2007 [9]
UN
2009
[10]
WHO
2009
[11]
UN
2013
[12]
WMA
DOH
2013
[13]
WIPO
2015
[14]
NHMRC
2003
[49]
NHMRC
2005
[50]
CRC
TS
2006
[51]
NHMRC
2007
[52]
CRIAH2008
[53]
CSIRO
2009
[54]
NHMRC
2010
[55]
NHMRC
2010
[56]
Lowitja
2011
[5]
AIATSIS
2012
[57]
NHMRC
2015
[58]
Guideline characteristics
Indigenous research
guildeline
(versus General)
✓✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Notes that Indigenous
people are a distinct
group
✓✓✓ ✓✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Embodies respect for
Indigenous culture
✓✓✓ ✓✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Recommends Indigenous
consultation in protocol
development
✓✓ ✓✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Indigenous members on
research ethics\advisory
board
✓✓✓✓✓✓✓
Research team includes
local Indigenous
community members
✓✓✓✓ ✓✓✓✓✓✓✓✓
Reciprocity & benefit
sharing with Indigenous
community
✓✓ ✓ ✓✓✓✓✓✓✓ ✓✓ ✓✓✓
Identification of
ownership of data
✓✓ ✓✓ ✓✓✓✓✓✓ ✓✓
Research is identified as
valued by the
Indigenous community
✓ ✓✓ ✓ ✓✓✓ ✓ ✓✓✓✓✓
Risks to the Indigenous
community as a
collective are explained
✓✓ ✓✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
An ethics committee has
approved the project
✓✓✓✓✓✓✓✓✓ ✓✓✓✓
Declare funding source to
Indigenous communities
✓✓✓✓✓ ✓✓✓✓
Recommendations regarding the consent process
Indigenous community
consent required
✓✓ ✓✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Indigenous individual
consent is required
✓✓ ✓✓ ✓✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Free, prior and informed
consent is sought
✓✓✓ ✓✓ ✓✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Fitzpatrick et al. BMC Medical Ethics (2016) 17:65 Page 6 of 18
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Table 2 Evaluation of Current Guidelines for Seeking Consent for Research with Indigenous Populations (Continued)
Waiver of consent may
occur with ethics
committee approval
✓✓ ✓✓
Signed consent is sought
for individuals
✓✓✓✓✓✓✓✓ ✓✓✓✓
Oral consent is possible
for individuals
✓✓ ✓ ✓ ✓
Full disclosure of risks
and benefits of research
provided
✓✓ ✓✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Plain language
explaination of research
provided in writing
✓ ✓✓ ✓✓✓ ✓✓✓✓
Access to an interpreter
is provided
✓✓ ✓✓
Information provided in
particpants language of
preference
✓✓ ✓✓
Suggests the use of
appropriate visual aides
for seeking consent
✓✓
Local Indigenous advice
on consent materials
provided
✓
Research information is
provided on a number
occasions
✓✓ ✓ ✓ ✓ ✓ ✓
Adequate time is
provided to review
research information
✓✓ ✓✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Opportunity is provided
to address participant
questions
✓✓✓ ✓✓ ✓✓
Ensure consent is truly
informed
✓✓ ✓ ✓ ✓
Option to opt out or
decline consent must be
provided
✓✓ ✓✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Consent required for
protocol changes
✓✓✓✓✓✓
Confidentiality is discussed
while seeking consent
✓✓ ✓✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Consent is sought to
identify individuals if
relevant
✓✓✓✓✓
Fitzpatrick et al. BMC Medical Ethics (2016) 17:65 Page 7 of 18
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Table 2 Evaluation of Current Guidelines for Seeking Consent for Research with Indigenous Populations (Continued)
Continued consent
required throughout
project
✓ ✓✓ ✓✓ ✓✓✓✓✓
Consent for reuse of data ✓✓✓✓✓ ✓✓✓
Tiered consent be
obtained for future
research
✓✓ ✓ ✓✓
Broad consent be
obtained for future
research
✓✓ ✓ ✓
Consent for dissemination
of research
✓ ✓ ✓✓✓✓✓✓ ✓ ✓✓✓✓
Feedback of research
results to the
communities
✓✓ ✓ ✓ ✓✓✓✓✓ ✓✓✓✓✓✓
Fitzpatrick et al. BMC Medical Ethics (2016) 17:65 Page 8 of 18
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Table 2 Evaluation of Current Guidelines for Seeking Consent for Research with Indigenous Populations (Continued)
NZ
Ministry
of Health
2006 [59]
PWG
2010
[60]
HRC
NZ
2010
[61]
NEAC
2012
[62]
NEAC
2012
[63]
AAND
2010
[64]
CIHR
2014
[65]
The
Belmont
Report USA
1979 [66]
TEC
2014
[67]
DK&CRC
2005
[68]
DK&CRC
2009
[69]
KLC
2011
[70]
KLC IP
& TKP
2011
[71]
AH&MRC
2013 [72]
Ninti
One
2015
[73]
UoVic
2003
[74]
Nuu-
Chah-
Nulth
2008
[75]
SNC
2014
[76]
Portland
Area IHS
IRB 2002
[77]
Guideline characteristics
Indigenous research
guildeline
(versus General)
✓✓ ✓ ✓✓ ✓ ✓✓ ✓ ✓ ✓ ✓ ✓✓
Notes that Indigenous
people are a distinct
group
✓ ✓ ✓ ✓ ✓ ✓ ✓✓ ✓ ✓✓ ✓ ✓ ✓ ✓ ✓✓
Embodies respect for
Indigenous culture
✓ ✓✓ ✓ ✓ ✓ ✓ ✓✓ ✓ ✓✓ ✓ ✓ ✓ ✓ ✓✓
Recommends Indigenous
consultation in protocol
development
✓ ✓✓ ✓ ✓ ✓ ✓ ✓✓ ✓ ✓✓ ✓ ✓ ✓ ✓ ✓✓
Indigenous members on
research ethics\advisory
board
✓ ✓✓✓✓ ✓ ✓✓ ✓ ✓✓ ✓ ✓✓✓ ✓
Research team includes
local Indigenous
community members
✓ ✓✓ ✓ ✓ ✓ ✓✓ ✓ ✓✓ ✓ ✓ ✓ ✓ ✓✓
Reciprocity & benefit
sharing with Indigenous
community
✓ ✓✓ ✓ ✓ ✓ ✓✓ ✓ ✓✓ ✓ ✓ ✓ ✓ ✓✓
Identification of
ownership of data
✓✓✓ ✓ ✓✓✓✓✓ ✓✓✓
Research is identified as
valued by the
Indigenous community
✓✓✓✓✓ ✓ ✓✓ ✓✓ ✓ ✓ ✓ ✓✓
Risks to the Indigenous
community as a
collective are explained
✓✓✓✓✓ ✓ ✓✓✓✓ ✓
An ethics committee has
approved the project
✓ ✓✓✓✓ ✓✓ ✓✓ ✓✓ ✓ ✓✓✓ ✓✓
Declare funding source to
Indigenous communities
✓✓ ✓ ✓ ✓ ✓✓
Recommendations regarding the consent process
Indigenous community
consent required
✓ ✓✓✓✓ ✓ ✓✓ ✓ ✓✓ ✓ ✓✓✓ ✓
Indigenous individual
consent is required
✓ ✓✓ ✓ ✓ ✓✓ ✓ ✓✓ ✓ ✓ ✓ ✓ ✓✓
Free, prior and informed
consent is sought
✓✓✓ ✓ ✓ ✓ ✓✓ ✓ ✓ ✓
Fitzpatrick et al. BMC Medical Ethics (2016) 17:65 Page 9 of 18
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
Table 2 Evaluation of Current Guidelines for Seeking Consent for Research with Indigenous Populations (Continued)
Waiver of consent may
occur with ethics
committee approval
✓✓✓✓✓ ✓✓
Signed consent is sought
for individuals
✓✓✓✓✓ ✓✓ ✓ ✓✓ ✓✓
Oral consent is possible
for individuals
✓✓✓✓✓ ✓✓ ✓✓
Full disclosure of risks
and benefits of research
provided
✓✓✓✓✓ ✓✓ ✓ ✓✓✓ ✓✓
Plain language
explaination of research
provided in writing
✓✓✓✓✓ ✓✓ ✓✓✓✓✓✓ ✓
Access to an interpreter
is provided
✓✓ ✓ ✓✓✓✓✓ ✓
Information provided in
particpants language of
preference
✓✓✓✓✓ ✓
Suggests the use of
appropriate visual aides
for seeking consent
✓✓
Local Indigenous advice
on consent materials
provided
✓✓✓✓✓
Research information is
provided on a number
occasions
✓✓✓✓✓ ✓ ✓ ✓
Adequate time is
provided to review
research information
✓✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
Opportunity is provided
to address participant
questions
✓✓✓✓✓ ✓✓ ✓ ✓
Ensure consent is truly
informed
✓✓ ✓ ✓ ✓ ✓ ✓
Option to opt out or
decline consent must be
provided
✓ ✓✓ ✓ ✓ ✓ ✓✓ ✓ ✓ ✓✓ ✓ ✓ ✓ ✓ ✓✓
Consent required for
protocol changes
✓✓ ✓ ✓ ✓ ✓ ✓ ✓
Confidentiality is discussed
while seeking consent
✓✓✓✓✓ ✓✓ ✓✓✓✓✓✓✓✓ ✓✓
Consent is sought to
identify individuals if
relevant
✓ ✓✓ ✓ ✓✓ ✓ ✓ ✓ ✓ ✓✓
Fitzpatrick et al. BMC Medical Ethics (2016) 17:65 Page 10 of 18
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
Table 2 Evaluation of Current Guidelines for Seeking Consent for Research with Indigenous Populations (Continued)
Continued consent
required throughout
project
✓✓ ✓ ✓ ✓ ✓ ✓✓ ✓ ✓ ✓
Consent for reuse of data ✓✓ ✓ ✓ ✓✓ ✓ ✓ ✓ ✓
Tiered consent be
obtained for future
research
✓✓
Broad consent be
obtained for future
research
Consent for dissemination
of research
✓✓✓✓✓ ✓ ✓✓✓✓✓✓✓ ✓✓
Feedback of research
results to the
communities
✓✓ ✓ ✓ ✓ ✔ ✓✓ ✓ ✓ ✓ ✓ ✓✓
Fitzpatrick et al. BMC Medical Ethics (2016) 17:65 Page 11 of 18
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research with Indigenous populations is included
(Additional files 3, 4 and 5). These are categorised as
international (n= 8), (Additional file 3) [7–14]; na-
tional (n= 20) (Additional file 4) [5, 49–67]; and state,
regional or local guidelines (n= 10) (Additional file 5)
[68–77]. International guidelines were sourced from
the United Nations (UN); World Health Organisation
(WHO); World Medical Association (WMA) and the
Council for International Organisations of Medical
Science (CIOMS). National guidelines were sourced
from Australia; NZ; Canada; and the USA. These
guidelines espouse broad principles of research with
Indigenous people including reciprocity, respect, equality,
responsibility, survival and protection and spirit and integ-
rity [49]. Many mention the need for both community
and individual consent for research. Most advise re-
searchers to seek free prior and informed consent from
any potential research participant. Consent is to be volun-
tary, sought ‘free’of coercion; with prior notification, with
sufficient time for consideration and consultation. Con-
sent is to be ‘informed’with participants being made
aware of both the benefits and risks of the project and
their right to decline consent or to withdraw at any time.
Details of the research must be explained to potential
participants in plain language. Guidelines highlight Indi-
genous populations as vulnerable research participants
and the potential for power imbalance. Few guidelines
highlight the need for researchers to accommodate an oral
tradition or cultural values. Most guidelines fail to recom-
mend that researchers interpret study information into
the participant’s first language. Few provide practical
advice for seeking consent.
Specific advice is provided in individual guidelines. For
example, in order to uphold the right to self-determination
for Indigenous people [15] the NHMRC Values and Ethics
Guidelines recommend that an Indigenous research project
should be developed and initiated with community mem-
bers, for community members and with the help of non-
Indigenous research bodies only if required. This assumes
that when working in a collaborative way, differences in
culture and values may be resolved as Indigenous people
help conduct the research. However, some authors caution
that some individuals consulted by researchers planning a
study may not necessarily be appropriate to give commu-
nity consent if they are not well connected or respected by
the local community and truly able to advocate for local
needs [78]. Cultural awareness is key when seeking con-
sent in Indigenous communities, and certain members of
the community may be required to oversee proceedings.
For example, when considering a project on vulvar cancer
in women who identified as Indigenous Australians, the
one female member of the local research council was
absent [47]. As the subject of research was considered to
be “secret women’s business”in the community’s culture,
the committee felt it was not their place to approve the
project [47].
When seeking approval for a project from the
Western Australian Aboriginal Health Information
Ethics Committee, researchers are required to explain
exactly how they aim to uphold the six main values
published in the NHRMC Values and Ethics Guide-
line [5, 49, 50, 58, 78]. A Values and Ethics Statement
produced by the NHMRC describes in detail the
values determined to be important to Australian Indi-
genous culture, namely: reciprocity; respect; equality;
responsibility; survival and protection and above all
states that the project be conducted in the right spirit
and with integrity [5, 49, 50, 58, 79]. This protocol is
helpful, however it does not specify how the process
of seeking consent for research could reflect these
values and leaves the interpretation up to the re-
searcher. The NHMRC has recently revised their
2007 statement on ethical conduct in human research
[58]. This specifies that researchers should engage
and seek the support of a community when initiating
a research project; acknowledge the distinctive lan-
guage and culture of individual communities; involve
Indigenous people in upholding these values in an
equal partnership and with respect; and consider any
local language and cultural protocols determined by
the Indigenous communities involved in the research
[58]. The new guideline recommends that researchers
refer to the National Health and Medical Research
Council Values and Ethics Guidelines, Australia [49].
The latest edition of the Australian Institute of Abori-
ginal and Torres Strait Islander Studies guidelines [57]
include a section (Principle 6) that highlights the im-
portance of consultation, negotiation and seeking free,
prior, informed consent for research whether with Indi-
genous or non-Indigenous peoples. It outlines the prepa-
rations one should make prior to approaching an
Indigenous community to seek their involvement in re-
search and advise researchers to seek protocols from the
local community. The AIATSIS guidelines [57] empha-
sise that it is important to seek permission from a com-
munity as a group as well as from individuals and to
provide a plain English statement. They specify that re-
searchers should identify the appropriate individuals
with whom to consult initially, and should involve the
Traditional Owners who speak for the Country. They
emphasise that free prior, informed, consent should
then be sought from all participants. The AIATSIS
guidelines do not address the issue that not all Indigen-
ous peoples use the written word, nor do they discuss
circumstances in which English is an individual’ssec-
ond or third language [57].
The Lowitja Institute (Australia) has published a book
providing practical guidelines for research in Indigenous
Fitzpatrick et al. BMC Medical Ethics (2016) 17:65 Page 12 of 18
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
health [5]. The Indigenous authors describe culturally
safe approaches to conducting research with Indigenous
peoples. They emphasise that when seeking consent for
research community leaders should first be approached
for permission, and that the community should be con-
sulted as a whole before researchers approach individual
participants. Continual engagement with the community
and its leaders and collaboration with Indigenous re-
searchers throughout the project is highly recommended.
This empowers people who identify as Indigenous, enab-
ling the study to be culturally informed and increasing
acceptance amongst the community. The guidelines
are culturally sensitive, clear and applicable to research
in Australia [5].
State, regional and local guidelines (n= 10) included in
this review discuss similar values to those included in
national and international guidelines [68–77]. These
guidelines were difficult to source and it is likely that
some are missed, including online guidelines and guide-
lines embedded in ethics protocols of universities and
other community organisations.
Evaluation of current guidelines for seeking consent for
research with indigenous populations
In our search we found 4 review articles of guidelines
for ethical research with Indigenous populations [80–83].
In some reviews, the attributes of each guideline are critic-
ally analysed and tabulated against a checklist of desirable
qualities. These reviews are valuable in identifying guide-
lines although many are out-dated and not directly rele-
vant to our review. Based on these reviews, we developed
a checklist to assist in evaluating the quality of the 38
guidelines included in our review (Table 2).
Many of these guidelines assessed included general
statements such as ‘the research ethics committee shall
endeavour to protect the integrity of our Indigenous
Knowledge, our culture and the members of the Six Na-
tions from harm or abuse’Six Nations Council [76].
However, guidelines do not specify how to achieve this.
It did not meet criteria to be included under the check-
list requirement in Table 2 for researchers to ensure
‘Risks to the Indigenous community as a collective are
explained’. Guidelines do not always specifically translate
research values into practice.
In regards to consent for re-use of data, some guide-
lines were vague, suggesting that broad consent be ob-
tained for ‘future research’[13, 49, 56, 58]. This may
leave the future use of data open to the interpretation by
the researchers, which historically, may not always
have been done in an ethical way. In one such study
with the Havasupi tribes in the USA, blood samples
were collected for diabetes research in 1990 and these
samples have been re-used over subsequent years with-
out the community’s knowledge [84–89]. Scientists
were using the tribe’s genetic material to examine links
to schizophrenia as well as conducting other studies
which the tribes felt questioned their sovereignty [84–89].
The remaining samples were later repatriated in a cere-
mony [88, 89]. Helgesson [90] argues that it was not the
fact that broad consent was sought from the Indigenous
community that caused the upset, but that the Havasupai
tribe did not realise the implications of broad consent.
That is, the research process, was not adequately
communicated in the first place. It is essential to es-
tablish ethics committees with Indigenous members
to monitor and approve future medical research pro-
jects because there is little protection in national and
international law about genetic sampling protecting
Australian Indigenous people [91, 92].
Most of the guidelines provide a general background
of the principles important to uphold when conducting
research with Indigenous populations, but practical
specifications for engaging an Indigenous community
or communicating with individual participants in order
to seek free, prior, informed consent, are better gar-
nered from individual research studies as described in
Tables 1 and 2 [4, 29, 30, 33–48].
Discussion
We found few publications that describe specific com-
munication methods for seeking informed consent for
Indigenous research and even fewer that evaluate partic-
ipants’understanding or preferences for the process
[4,5,7–14, 29, 30, 33–77]. This may be explained by
publication bias or simply reflect lack of attention to the
consent process in these vulnerable populations [82, 93].
As mentioned previously there are over 90 countries with
Indigenous populations [1], however this review is lim-
ited to reports published in English and might also ex-
clude research from countries in which the majority of
the population may considered to be Indigenous, but
have not necessarily specified that they are working with
an ‘Indigenous’population.
The only original research study evaluating the con-
sent process, Russell et al [33] had a very small study
sample, with only twenty mothers who identified as
Aboriginal. Researchers identified the need for multiple
presentations of information, including by local Aborigi-
nal people, and use of visual aids to enhance partici-
pants’understanding of the proposed research. The role
participants played within the Aboriginal community
and the specific communities where the participants
lived were not described, but it is unlikely that this is a
representative sample of Aboriginal people living in
Central Australia and hence the results may not be
generalizable. Bull [34] did not evaluate understanding
or preferences regarding the consent process by the
community or individuals, but through discussions with
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community leaders concluded that researchers must es-
tablish a reciprocal relationship with the community, en-
sure that research is relevant to that community, respect
cultural protocols and involve Aboriginal people in the
conduct and reporting of the research. McCabe [35] de-
scribes a research approach that was badly received by
the community and provides lessons about what to
avoid, including reliance on telephone communication.
The need for community input into consent forms,
avoidance of scientific jargon, and inclusion of graphics
were recommended to increase understanding [35]. Fong
[36] assumes that Hawaiians’failure to consent to use of
their biological samples for future studies related to cul-
tural beliefs relating to desecration of body parts but did
not substantiate this theory. This illustrates the need for
researchers to thoroughly understand cultural beliefs
and practices. Baydala [37] used a novel consent process
respecting local cultural protocol when seeking consent
with elders of Aboriginal communities of the Alexis
Nakota Sioux Nation, Alberta, Canada, but acknowledged
that this process may be inappropriate among other
First Nations or Inuit communities of Canada.
In articles that describe the consent process in detail,
thosewithhighrecruitmenttypicallyinvolvedlocal
Aboriginal organisations and leaders in the project de-
sign and recruitment [38, 42, 48]. In The Lililwan Pro-
ject, researchers employed local Aboriginal people as
community navigators to disseminate study informa-
tion, assist with recruitment of participants and sup-
port the research team in seeking written consent
from parents and carers [38]. A plain English state-
ment and consent form was read out and interpreted
in their preferred language with the assistance of pic-
torial aides [38]. There was 95 % participation in this
study, while using this method to seek consent [48]. In
NZ there is a term Kaupapa Māori Research, which
encompasses the idea that research with Māori popu-
lations should be driven by Māori researchers [4, 39].
Wilson [42] emphasises the importance of researchers
fostering equitable relationships with the community
they are working with, however some studies we found
do not appear to involve local Indigenous community
members in this way [29, 30, 43]. There is often a
communication gap between Indigenous and Non In-
digenous communities, especially between them and
researchers and health services [94]. Alison Hoy [95]
raised concerns that this may result in Indigenous
people being excluded from crucial projects because of
the perception of exploitation. This may deny Indigen-
ous people the opportunity of helping address major
health disparities and benefiting from the results.
Teams of non-Indigenous researchers often fail to ac-
knowledge their different cultural backgrounds and
philosophies on life compared to Indigenous people
[96]. Indigenous and Non-Indigenous authors com-
pare and discuss how the differences between their
“two worlds”impacts on the quality of research, not-
ing that certain attitudes to research with Indigenous
communities can prevent it from being conducted in a
culturally respectful way [4, 5, 34, 35, 42]. There is a
language of inequality embedded even within today’s
publications, with the idea that Non-Indigenous
people are researchers and Indigenous people are the
researched [4]. It is thus necessary for researchers to
engage a community and foster relationships with
leaders and local organisations [97].
A total of 38 research guidelines were included in
this review, the majority of which define the term
free, prior and informed consent, but few of which
describe how this can be achieved. Some guidelines
do not mention Indigenous communities as a special
group for consideration and simply state that “lan-
guage and cultural”differences must be accounted
for [13, 66]. Others include special sections empha-
sising the vulnerability of Indigenous people with re-
gard to research [10, 12, 14] or remind us of
Indigenous Peoples rights [8, 9, 11].
Some research guidelines note the importance of seek-
ing consent for research initially from a community
leader or council of elders [5, 7, 8, 10–12, 49–51, 53, 54,
56–63, 65, 67–75, 77]. Some determine that only the
community has control over what information may be
publicly released [8]. The concept of community consent
is debated and many questions arise regarding what
comprises a community and who can represent a com-
munity [72, 98]. Tsosie [99] notes that in some commu-
nities a member may hold the duty to keep secret
certain knowledge even from other community members
and that this may prevent provision of consent or dis-
semination of results.
Of the national guidelines (n= 20), NZ appears to offer
the most protection for the rights of Māori, based on
the spirit of the Treaty of Waitangi and Kaupapa Māori
Research [59–63]. Culturally significant language is em-
bedded into the research guideline, which identifies that
it is preferable for Māori researchers to take charge of pro-
jects that are about or may affect Māori people [59–63].
Australia and Canada also have culturally sensitive guide-
lines but it is difficult to translate values espoused into
practice [49–58, 64, 65]. Neither of the USA guidelines
specifically addressed the consent process for research
with Indigenous people [66, 67]. The Tribal Epidemiology
Centres report that research organisations have found it
difficult to work with people who identify as American In-
dian or Alaskan Native due to their mobility, literacy, and
language barriers [67]. Community Based Participatory
Research with locally designed protocols has increased
participation rates [67].
Fitzpatrick et al. BMC Medical Ethics (2016) 17:65 Page 14 of 18
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
Conclusion
Researchers working with Indigenous people must be cul-
turally respectful [92]; cognisant of the law [20, 26, 100];
and conscious of the impact of research on communities
as a whole [101]. Ethical guidelines emphasise the need to
approach Indigenous communities, governing bodies and
leaders for consent prior to approaching individual partici-
pants. Best practice recommends a collaborative approach,
in partnership with local Indigenous people, and research
that addresses community priorities. Communication aids
and involvement of local Indigenous researchers can help
overcome language and cultural barriers when seeking
consent [4, 5, 33–35, 38, 39, 42, 48, 65, 67].
Our literature review identified few original articles
that evaluate preference or understanding of the com-
munication methods used in seeking informed consent
for research with Indigenous populations. To ensure that
future research is of value to Indigenous communities,
there is an urgent need for research to understand how
to best seek consent.
Additional files
Additional file 1: Table S3. Medical Subject Headings and key words
used to search Medline. (XLSX 43 kb)
Additional file 2: Table S4. Research describing the consent process
with Indigenous populations in detail. (XLSM 50 kb)
Additional file 3: Table S5. International guidelines for seeking consent
for research with Indigenous populations. (XLSM 39 kb)
Additional file 4: Table S6. National guidelines on seeking consent for
research with Indigenous populations. (XLSX 40 kb)
Additional file 5: Table S7. State/Regional/Local guidelines on seeking
consent for research with Indigenous populations. (XLSX 35 kb)
Abbreviations
AAND: Aboriginal affairs and northern development; AH&MRC: Aboriginal
health and medical research council; AIATSIS: Australian Indigenous
Aboriginal and Torres Strait Islander Studies; BC: British Columbia;
CBD: Secretariat of the convention of biological diversity; CIHR: Canadian
Institute of Health Research; CINAHL: Cumulative Index for Nursing and
Allied Health Literature; CIOMS: Council for International Organisations of
Medical Science; CLC: Central land council; CRC: Cooperative research centre,
torres strait; CRIAH: Coalition for research to improve aboriginal health;
CSIRO: Commonwealth scientific and industrial research organisation;
DK&CRC: Desert knowledge and cooperative research centre;
EMBASE: Excerpta medical database; ERIC: Educational Resources Information
Centre; HRC: Health research council, New Zealand; HIV: Human
immunodeficiency virus; IIC: Informit Indigenous Collection; IHS IRB: Indian
health service institutional review board; KLC: Kimberley land council; KLC IP
& TKP: Kimberley land council and traditional knowledge policy;
Medline: Medical literature analysis and retrieval system online;
NEAC: National ethics advisory committee; NHMRC: National health and
medical research council; NIH: National institute of health; NSW: New South
Wales; NT: Northern Territory; NZ: New Zealand; PRISMA-P: Preferred
reporting items for systematic review and meta-analysis protocols;
PWG: Pūtaiora writing group; MeSH: Medical subject headings;
REAC: Research access committee; SNC: Six Nations Council; TEC: Tribal
epidemiology centres; TMR: Triple media recording; UN: United Nations;
UNDRIP: United Nations Declaration on the Rights of Indigenous Peoples;
UoVic: University of Victoria; USA: United States of America; Vic: Victoria;
WHO: World Health Organisation; WIPO: World Intellectual Property;
WMA: World Medical Association; WMA DOH: World Medical Association
Declaration of Helsinki; WIPO: World Intellectual Property Organisation
Acknowledgements
I would like to thank Ms Elizabeth Piggott and Mr Andrew Spencer,
Librarians for Sydney University Medical School who ensured my literature
review was to the highest level; Ms Sharon Eadie; Ms Denise Yuille; and Ms
Megan Learmont who assisted greatly with administrative duties; Associate
Professor Nigel Clarke; Associate Professor Nicholas Wood, Sydney University
Medical School Postgraduate Supervisors who have supported the progress
of this review. I would also like to thank my supervisors and fellow chief
investigators Ms June Oscar, Ms Maureen Carter and Ms Heather D’Antoine
for their cultural guidance and expertise; and Associate Professor Alexandra
Martiniuk and Professor Elizabeth Elliott their guidance and expertise.
Funding sources
Professor Elizabeth Elliott who is supported by a National Health and Medical
Research Council Fellowship (No.1021480) and Associate Professor Alexandra
Martiniuk who is supported by National Health and Medical Research
Council Translating Research Into Practice Fellowship (No.1112387).
Availability of data and materials
The datasets supporting the conclusions of this article are included within
the article and its Supplementary files.
Authors’contributions
Dr EF led the study and the writing of the paper. Prof EE initiated and
provided oversight to the study and input in its planning, conduct and
reporting. Ms H D’A and Dr AM contributed to the study and the writing of
the paper. Ms JO and Ms MC invited this study and were the chief cultural
advisors as Aboriginal community leaders of the Fitzroy Valley, The
Kimberley. All authors reviewed and approved the final manuscript.
Competing interests
The authors declare that they have no competing interests.
Consent for publication
All authors consent to the publication of this review article.
Ethics approval and consent to participate
Ethics approval was granted by the University of Sydney Human Research
Ethics Committee (No. 2012/348, reference:14760), the Western Australian
Aboriginal Health Ethics Committee, the Western Australian Country Health
Service Research Ethics Committee (No. 2012:15), and the Kimberley
Aboriginal Health Planning Forum Research Subcommittee (No. 2012–008).
Author details
1
Discipline of Paediatrics and Child Health, Sydney Medical School, University
of Sydney, Sydney, Australia.
2
The Sydney Children’s Hospital Network
(Westmead), 4 Governor Phillip Place, West Pennant Hills, Sydney, NSW 2125,
Australia.
3
Sydney Medical School, University of Sydney, Sydney, Australia.
4
The George Institute for Global Health, Sydney, Australia.
5
Dalla Lana School
of Public Health, University of Toronto, Toronto, Canada.
6
Menzies School of
Health Research, Darwin, Australia.
7
Marninwarntikura Women’s Resource
Centre, Fitzroy Crossing, Australia.
8
Nulungu Research Institute, The University
of Notre Dame, Broome, Australia.
9
Nindilingarri Cultural Health Services,
Fitzroy Crossing, Australia.
Received: 5 April 2016 Accepted: 15 September 2016
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