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 ETHICAL CONSIDERATIONS IN
INTERNATIONAL NURSING RESEARCH:
A REPORT FROM THE INTERNATIONAL
CENTRE FOR NURSING ETHICS
Working Group for the Study of Ethical Issues in International
Nursing Research*; Chair Douglas P Olsen

Key words: ethics; institutional review board; international nursing research; local
research ethics committee; research

Ethical issues in international nursing research are identified and the perspectives of the
International Centre for Nursing Ethics are offered in an effort to develop an interna-
tional consensus of ethical behaviour in research. First, theoretical issues are reviewed,
then initial conditions for ethical conduct are defined, and protocol design and procedure
considerations are examined. A concerted effort is made to identify and avoid a western
bias. Broad guiding principles for designing and reviewing research are offered:
(1) respect for persons; (2) beneficence; (3) justice; (4) respect for community; and (5) con-
textual caring. A collaborative model of the researcher–participant relationship is sug-
gested and discussed.

Introduction
The International Centre for Nursing Ethics (ICNE) is a world-wide association
of university research and teaching centres that focuses on issues of morality, pro-
fessional ethics, philosophy of care, cultural and religious values, law and

International Centre for Nursing Ethics:

Anne Davis*, International President
Verena Tschudin*, Education Director
Geoffrey Hunt, Research Director
International Council Members: Arie JG van der Arend* (The Netherlands), Theresa Drought*
(USA), Maureen Eby (UK), Ulla Fasting* (Denmark), Chris Gastmans* (Belgium), Helena Leino-
Kilpi* (Finland), Kim Lützén (Sweden), Sayumi Nojima (Japan), Douglas P Olsen* (USA),
Samantha Pang* (China), Leila Shotton (Australia), Janet Storch* (Canada)
Address for correspondence: International Centre for Nursing Ethics, European Institute for
Health and Medical Sciences, University of Surrey, Guildford GU2 7TE, UK. E-mail:
g.hunt@surrey.ac.uk v.tschudin@surrey.ac.uk

Nursing Ethics 2003 10 (2) © 2003 Arnold 10.1191/0969733003ne587oa

 Ethical considerations in international nursing research 123
accountability in the field of nursing and related disciplines. The ICNE promotes
international research, the development of ethics teaching, cross-cultural discus-
sion and understanding, and ethical interprofessional and interagency co-
operation. It runs regular conferences and seminars. This is the first of a series of
articles produced by ICNE’s teams of researchers and working groups.
The goals of this article are to identify ethical issues that nurse researchers and
research ethics review committee members should consider regarding nursing
research extending across national boundaries, and to stimulate discourse. Our
hope is to move towards a broad consensus among nurses of all nations on norms
of ethical conduct in international nursing research. The present discussion
proceeds as follows: (1) specifying the scope of consideration; (2) reviewing
theoretical issues that frame the topic; (3) defining initial conditions for research
to be considered ethical; and (4) examining research protocol design and proce-
dure considerations.

Scope of consideration
Most recent efforts to examine issues in international research ethics in some
developed countries focus on medical research. The executive summary of the US
National Bioethics Advisory Commission’s (NBAC) report, Ethical and policy issues
in international research, specifically states ‘the Commission’s attention was focused
on the conduct of clinical trials . . . in particular those trials such as Phase III drug
studies’ (p. ii).1 In the UK, the Nuffield Council on Bioethics report, The ethics of
clinical research in developing countries, lists the scope of research considered:
clinical trials of new drugs, vaccines and diagnostics, or improved clinical management
strategies . . . basic clinical research studies on the natural history of a disease, the func-
tioning of the body or on behaviour . . . Epidemiological studies may be aimed at iden-
tifying risk factors (p. 3).2
Although not excluding research of primary interest to nurses, these reports are
clearly focused on medical research. A recent more comprehensive report from
the Nuffield Council, The ethics of research related to healthcare in developing coun-
tries, does more to recognize the need to broaden consideration beyond clinical
trials, stating:
In the developing world, research to find new or improved medicines and vaccines is
often given high priority . . . but research to find better ways of delivering existing
products and services to those in need is often equally or more important (p. 5).3
However, this Nuffield report still does not deal specifically with nursing.
This article addresses international nursing research, that is, research where
investigators and participants are from different countries, rather than research
targeting populations by race or ethnicity. Although cultural differences between
researchers and participants are often an essential consideration in international
research, it is not the only consideration. Furthermore, situations where
researchers from one culture study persons from a distinctly different culture
within national boundaries occur frequently in multi-ethnic countries like the USA
and South Africa, or in countries with indigenous populations such as Australia
and Finland. When research is conducted within national boundaries on minority

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124 D Olsen et al.
populations, there is a commonality of law and there may be a greater shared
common sense of norms regarding authority and social goals.
There are many categories within the broad designation of international
research, distinguished by different combinations of researchers and participants
from developed and developing countries, and by varying types of collaborative
arrangement between researchers, sites for recruiting, and origins of sponsorship.
Some types of research that cross national boundaries have a higher potential for
ethical difficulties than others. The two factors that determine the level of ethical
concern are the degree of cultural difference between the involved countries and
the potential for exploitation. Therefore, studies with principle investigators from
a more developed country who are recruiting participants from a less well-devel-
oped country are of greater concern than collaboration between researchers of
similarly developed countries collecting data for purposes of comparison, because
of the greater potential for exploitation.
In the context of international HIV/AIDS research, UNAIDS identified factors
that create conditions that make countries or communities potentially vulnerable
to exploitation. These include:
• the level of the proposed community’s economic capacity;
• limited experience with, or understanding of, scientific research in the country
as a whole;
• limited local infrastructure, personnel and technical capacity for providing
health care and treatment options;
• limited experience and capacity for conducting ethical and scientific review;
• an uncertain ability of individuals in the community to provide informed
consent, for instance, as a result of class, gender and other social patterns.4
Method and data-gathering techniques of particular concern to nurses, such as
interviewing, psychosocial intervention, participant observation, and other
anthropological techniques, may be liable to different types of problems to quan-
titative health care research.5–7 Although qualitative research does not usually
involve the risk of physical harm, it carries a greater risk of social and psycho-
logical harm, particularly from breaches of privacy.8 For example, Upvall and
Hashwani9 reported difficulties with informing participants in developing coun-
tries because in qualitative research the direction the inquiry takes cannot be fully
anticipated in advance. Although it is becoming more accepted, qualitative
research has often received less attention by research review committees because
the medical establishment has traditionally considered this type of research to be
of lesser value. 10 Current ethical and legal guidelines, developed by the western
medical establishment and designed to regulate clinical drug trials, are often a
poor fit with the realities of the qualitative research and methods more frequently
used in nursing.11
In a final note about the scope of consideration, we acknowledge a historically
long view of potential problems. History is filled with examples of events widely
accepted at the time, even enjoying a semblance of local approval, but which, in
retrospect, are seen as exploitive. The most dramatic of these may have been the
slave trade during the eighteenth century. Researchers and reviewers cannot
always be held accountable for the reactions of future generations but must
remain alert for instances when present thinking and evidence are ample to

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 Ethical considerations in international nursing research 125
anticipate problems. In the words of one research participant, ‘I fear your writings
would hurt the feelings of village people if they could read; they will certainly
hurt our great grandchildren who will read . . .’ (p. 3).12

Theoretical issues
A discussion of theoretical issues provides a background for the ethical consid-
eration of specific design and procedure aspects of international nursing research.
In any discussion of ethics with an international scope, an inherent tension exists
between conceptions of ethics as a set of universal principles and ethics as con-
tingent norms relative to culture. The position adopted by researchers and review-
ers along the continuum between relativistic and universal ethics has practical
implications. The degree of credence, acceptance and personal endorsement
accorded to codes of ethics and guidelines intended to apply across national
boundaries depends on an individual’s beliefs regarding the balance between uni-
versalism and relativism or, from a more relativistic perspective, how well the
‘universal’ code of ethics fits with local custom.
Suggestions for approaches to the relativism issue in the international regula-
tion of medical research have ranged from the emphasis on uniform international
standards13 to stressing ethical procedure to negotiate the specific content of pro-
tocols.14 The ICNE adopts the intermediary position that general principles can
be articulated with sufficiently broad international support to offer a framework
for considering the various facets of the research process. Although providing a
useful guide, these principles would also allow sufficient latitude to negotiate
specific research activities when substantive variation in behavioural and ethical
norms exists between the researchers and the local population being recruited.
This is in accordance with Nagel’s idea that ‘[morality involves] occupying a
position far enough outside your own life to reduce the importance of difference
between your self and other people, yet not so far outside that all human values
vanish . . .’ (p. 222). 15
In endorsing the possibility of stating broad principles that can be widely
accepted across national and cultural boundaries, it is essential that we do not
assume that these principles are coincident with western values. Such ‘ethical
imperialism’ in medical research has been widely criticized. 16–18 In relation to
nursing, Davis states:
The use of western philosophical ethics, sifted through the USA’s cultural lens, as a
standard by which all else is compared, contrasted and judged, reflects a type of ethical
influence that may be harmful. This influence combines attitudes and actions that essen-
tially support the idea that all other people and cultures should have and use the same
values and ethics as are found in America (p. 123). 19
The ICNE suggests five broad principles to frame the initial discussion and
development of guidelines for the ethical conduct of international nursing
research: (1) respect for persons; (2) beneficence; (3) justice; (4) respect for com-
munity; and (5) contextual caring. To be useful in an international context, these
principles must be understood in the broadest sense as overarching ideals of
behaviour and not as prescriptive rules. The first three are the touchstones of the

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126 D Olsen et al.

western bioethics tradition 20 and are articulated with respect to research in the
Belmont Report.21 In this report the principle of ‘respect for autonomy’ is a key
feature to the implementation of ‘respect for persons.’ Although the principle of
respect for persons is inclusive enough to garner broad acceptance in the inter-
national community, the emphasis placed on respect for autonomy has been fre-
quently criticized as idiosyncratic to the West and the USA in particular.19,22 Thus
the ICNE follows the Belmont Report in ‘respect for persons’ without the speci-
fication that the chief method of showing respect for competent persons is to
respect their autonomy.
The next two suggested principles, beneficence and justice, are also part of
the standard Western canon.20,23,24 Beneficence, the principle that one should act
for the benefit of others, encompasses both maximizing positive good and mini-
mizing or preventing harm.21 In the context of research ethics, justice means fair
treatment of participants and communities, and the fair distribution of both the
benefits and burdens of research at individual and community levels.25
The fourth principle, respect for community, goes beyond the standard appli-
cation of western bioethics to the research situation requiring consideration of a
wider context than concern for the individual participant. Researchers and
research ethics committees should consider the effects of possible results on a
community’s self-conception, altered perceptions outside the community, changes
to health care delivery methods by implementing results or potential problems
with implementing results, as well as any effects on the entire community arising
from individual participation. This principle recognizes that ‘individualism (the
cornerstone of western nursing) may often be inappropriate where the concept of
individual rights does not exist’ (p. 222). 26 This principle should serve as a guide
for research in all countries and not be taken as a supplemental guide for con-
sidering research protocols only in nonwestern countries. Respect for community
is intended as a corrective to the overly intense focus on individual rights found
in most western guides to research ethics.
Although intrinsic tension can exist between the good of the individual and the
community, it cannot be said that the solution always resides in the priority of
one over the other. Always to value the good of the collective over the individ-
ual can lead to oppression,27 while always to give priority to the individual over
the community can lead to ethical isolation and the overemphasis of rights, as
boundaries, to the detriment of attention to relationships and responsibilities.
The final guiding principle, contextual caring, entreats the researcher to behave
towards each participant as a person within an ethical relationship of caring
concern grounded in the researcher ’s personal values. This differs from benefi-
cence, the abstract principle that one’s behaviour should be guided by the desire
to do good for others.20 In contextual caring one acts in accord with personal
caring concern for the concrete specific other within one’s immediate scope. The
call to caring behaviour is more difficult to prescribe than a beneficence because
it is more closely bound to an individual’s emotional reactions; however, there is
increasing recognition that emotion is inextricably bound to moral good.28,29 The
principle of caring concern encourages the consideration of what good can and
may be done for another to whom one feels responsible beyond the obligatory
dictates of what must and must not be done.30–33

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 Ethical considerations in international nursing research 127

Initial conditions for ethical conduct of international

nursing research
There are three initial conditions for the ethical conduct of international research:
(1) that the local community has an early opportunity and an ongoing mecha-
nism to provide input into the purposes, goals and methods of the research; (2)
that the research design generates knowledge that has the potential to benefit the
community or population providing the participants; and (3) that there is an eth-
ically justifiable reason to target the population from which participants will be
recruited. Although these conditions can be applied broadly to research in general,
they are particularly vital to prevent exploitation in less developed countries.
Although the concept of local input has broad endorsement,34–36 ethical con-
siderations remain regarding the details of how local input should be obtained.
Determining who is appropriate to provide local input regarding cultural norms
and practices (i.e. who speaks for a culture or community) remains an issue. An
example of a potential problem would be using local scientists as co-investigators
who may be influenced by the possibility of enhancing their personal reputations
by working with US or European scientists.2,11,37 In the study commissioned by
the National Bioethics Advisory Committee1 of researchers from the USA and
other countries who have conducted international studies, one of the informants
described a situation where the presence of western researchers conferred signif-
icant status on a local research assistant. In referring to the local person, who
assisted with recruitment, the researcher says: ‘They actually call him master, they
have a high level of respect for the guy’ (p. B-25).38 The point illustrated here is
somewhat different from the NBAC report, where the quote is used to show the
degree of commitment researchers have towards obtaining local input; however,
the statement also speaks to the potential conflicts created when local persons are
working with foreigners who are perceived as powerful. The ability to gain and
wield this status could potentially work to the detriment of a local individual’s
role as community advocate.
The practical aspects of local input are solved to a degree when the local country
requires committee review of research as prescribed by the Helsinki Declaration. 39
In countries that do not have this requirement, researchers should assist in moving
towards establishing the infrastructure.1,3,40 However, when participating in
‘capacity building’, care must be taken not simply to recreate western derived
procedures and ethical standards where they may not be appropriate. The Council
for Organizations for Medical Sciences guidelines 40 stipulate that this is to be
avoided by providing funds to, but not allowing direct involvement by, local
authorities.
Although local committee review, such as that performed by an institutional
review board in the USA or a local research ethics committee in the UK, greatly
helps in assessing a specific protocol’s adherence to local norms, this does not
fully solve the issue of local input regarding what should be researched and with
what method and conceptual framework. Other avenues of local input may also
be appropriate, such as local nurses, community leaders, or advocacy agencies,
who may need to be consulted to appreciate fully the community’s perception of
priorities in health care concerns and the appropriateness of the procedures of
specific protocols.

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128 D Olsen et al.

However, considerations of respect for the community and the sense of unique
local perspective to which the researcher may not be privy must be balanced with
the researcher ’s scientific autonomy and integrity. Part of this balance would be
a consideration of why an outsider conducts this particular research in this par-
ticular locale: is it a matter of technical know-how in performing something for
the local community that they would otherwise do for themselves, or does the
researcher have some unique interest, possibly born from his or her position as
an outsider?
In an effort to build local capacity towards just and effective negotiations with
foreign researchers, one conceptual guide for a method to gain true consensus
between the parties is offered by Habermas’ 41 conditions of discourse:
• All participants in the discourse must have the same chance to speak so that
at all times they may open and perpetuate discourse through address and
reply, question and answer.
• All participants must have the same chance to put forward interpretations,
assertions, recommendations, explanations and justifications.
• Discourse allows only for speakers who have an equal chance to express
views, feelings and wishes, and make them known without omission or decep-
tion.
• All participants have an equal chance to employ regulative acts of speech, such
as to command, to resist, to allow, to forbid and to make and retract promises.
Foreign research efforts would be expected to work towards fulfilling these con-
ditions and for assessing progress by reference to the conditions.
The second condition for carrying out research using a population sample
outside one’s own country is the intention to generate knowledge of direct benefit
to the population from which the sample is drawn. This requirement helps to
prevent exploitation. Specific groups should not be targeted because of conve-
nience, particularly if the convenience is in the form of reduced regulatory
requirements or easy recruitment based on power differentials between the
researcher and the participants. The abuses of the Tuskegee study, in which the
natural progress of syphilis was allowed to continue in African-American men
after treatment was available, were made possible by such a power differential. 42
Local benefit is a well-established standard in guides to research on specific
populations (e.g. US regulations on using prisoners as participants 43) and guide-
lines for the use of international samples.1,3,40 This requirement has a fairly
straightforward application in clinical drug trials but it may require some reflec-
tion in the ethical justification of certain types of nursing research.
An honest declaration of local benefit further requires that any intervention that
may be shown to be successful is affordable and practical in the local milieu.
Although this stipulation is often applied to drug research, much nursing research
involves testing person-to-person interventions, which can also be economically
costly and may need to be implemented or administered by personnel with
training that is largely unavailable in the local community.
In nursing research where the objective is to learn more about cultural attitudes
and customs regarding health, it must be presumed that the intent is for that
knowledge to lead to better local health care. The connection between under-
standing a culture and giving quality nursing care will be direct in many studies;

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 Ethical considerations in international nursing research 129

examples are those by Åstedt-Kurki et al.44 and Konishi and Davis.45 However, in
some cases, the presumption of benefit through cultural understanding may be
inferential.
In meeting the third initial condition for conducting international nursing
research, the justification of targeting participants from another country, the fol-
lowing criteria should be considered: (1) the phenomenon under consideration is
biologically unique to that group or relates to a phenomenon that is biologically
unique to that group (e.g. thalassaemia, sickle cell anaemia); (2) the phenomenon,
although culturally mediated, is widely known to be group specific (e.g. the effect
of local diet or sexual practices); (3) there is an empirically demonstrated ratio-
nale for targeting a specific group (e.g. there is a demonstrated difference in inci-
dence, rate of detection or recovery); (4) extensive normative data exist that do
not include the targeted population – if it is reasonable to believe that the targeted
population may vary from the general population described by the data; or (5)
comparative data between groups would be helpful to mutual understanding or
in designing treatment, service delivery or education (e.g. efforts to understand
differences in ethical concepts cross-culturally).

Design and procedure considerations

The ethical conduct of research requires careful design, including specific atten-
tion to enrolling and maintaining participants, assessing benefit and risk, maxi-
mizing benefit, minimizing risk, and ensuring confidentiality, all in a way that
respects both individuals and the community, and also fosters contextual concern.

Enrolment and maintenance

In the West this would mean a discussion of informed consent; however, for this
document we prefer to frame this topic as the consideration of conditions for
ethical entry into a protocol and continuation of the person’s participation in
research. Informed consent as a formalized documented process is a relatively
new concept, even in those countries where it is established as a norm. Informed
consent, first widely endorsed as a formal condition for the ethical conduct of
research after the Nuremberg Code, was issued in the context of the 1945–1949
war crimes trials. Its first statement of principle is: ‘The voluntary consent of the
human participant is absolutely essential’ (p. 181). 46 However, this did not become
a regulatory requirement for all publicly funded research in the USA until the
1970s.20 Despite its relatively recent codification, the conceptual basis of informed
consent is deeply embedded in a long tradition of the individual as the locus of
decision making originating in fifth century BC Athens.20,47
Although many research situations exist where written and documented
informed consent, as understood in parts of the West, may be the most appro-
priate means for ensuring the ethical enrolment of persons into a study, it is eth-
nocentric to assume that a procedure so closely tied to a particular way of thinking
is acceptable to people from all other traditions.19,48 Because individualism is so
deeply embedded in the western understanding of humanity and ethics, the use
of alternatives to informed consent remains perhaps the most difficult issue for

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130 D Olsen et al.

western people to confront and, thus far, ethical guidelines and literature
considering international research ethics consistently include a strong endorse-
ment of individual informed consent.1,3,49,50
Obtaining proper informed consent, as it is conceived in the West, requires
shared assumptions about the nature of decision making, and at least some degree
of shared understanding of the meaning of the research and the nature of the
risks and benefits involved in the particular study. Reliance on informed consent
is problematic when the assumptions of researchers and participants differ in any
of these areas. Although the therapeutic misconception (a person’s belief that the
researcher is acting for his or her benefit in the manner expected of clinicians) fre-
quently occurs in the USA,51–53 the researchers participating in the NBAC study38
suggested a widespread occurrence of the therapeutic misconception in research
in developing nations. Some of these researcher participants noted that the word
‘research’ did not exist in the native language and was translated as ‘medicine’.38
With growing experience in cross-national research there has been increased
interest in potential alternative strategies, such as the consent of community
leaders.38 In the NBAC study of international researchers, 51% said they enrolled
participants with the consent of community leaders and 19% enrolled them with
the consent of a family member.38 In any arrangement where one person’s delib-
erations determine the inclusion of another person in a study, the possibility
of individual dissent presents a problem. Situations may occur where some
individuals, although acknowledging that either a collective or a paternalistic
decision-making process is their cultural norm, disagree with that norm and
prefer that the usual process should not hold sway over them. Culture is dynamic
and dissent fosters change. Women in many industrialized countries would not
be allowed to vote if dissent against cultural assumptions and accepted proce-
dural norms could not occur. Culture is not a fixed entity and individuals make
their own interpretation of cultural norms and the value of those norms.
Researchers and members of review committees must strike a balance between
overvaluing western ideals in the form of written, individually-signed informed
consent documents, while not supporting oppression in the name of cultural rel-
evancy. The use of a male family member to provide consent for a female
member’s participation because males in that culture are the sanctioned decision
makers presents such a dilemma.

Benefit and risk

In the western tradition, the central purpose of informed consent is to respect and
promote a person’s autonomous decision to assess the balance between the
benefits and risks of participating in a protocol. Thus individual variation is rec-
ognized and allowed within a shared cultural paradigm. However, even within
the context of honouring individual variation in the assessment of benefit and
risk, a great deal of overlap in culture is required. Information disclosure is the
key procedure in informed consent, with the standard used being what a rea-
sonable person would want to know.20 Therefore, the researcher must share
enough assumptions with the potential participant to anticipate what infor-
mation needs to be disclosed for effective informed consent. Therefore, ethical
and practical considerations in protocol design are enhanced by greater

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 Ethical considerations in international nursing research 131

knowledge of local custom and significant local input.

However, a conceptual framework for ethical enrolment into international
research studies needs to go beyond fitting cross-national situations into a western
paradigm through better anticipation of local norms in assessing benefit and risk.
Awareness of the potential for a fundamental disconnection in the values people
use to weigh the risk–benefit balance must be acknowledged and maintained. We
therefore suggest that there should be emphasis on informed consent at the entry
into a protocol as the decision point for individuals to balance the risks and
benefits, and more emphasis on the maintenance of an ongoing relationship. Even
in those countries where people share initial assumptions, there is an increased
recognition that an individual’s risk–benefit assessment fluctuates, leading to
more emphasis on informed consent as a process rather than as a one-time inter-
action.54

Confidentiality
Control over the way one is viewed by others is a fundamental mechanism of
personal identity that sets the foundation for social relations. 55,56 Thus, the assur-
ance and maintenance of confidentiality in research serves both ethical and prac-
tical functions. Researchers respect participants by granting them control over
personal information and protecting them when they are vulnerable from unwar-
ranted revelations. This demonstrates researchers’ respect for both the participant
and the community. Confidentiality is also of practical concern because
researchers often seek information that participants would prefer to keep private
from the community at large; thus they will not reveal such information unless
the promise of confidentiality is credible. In this way researchers have a respon-
sibility not only to the individuals in a specific protocol but also to the culture,
community and future researchers for maintaining the credibility of assurances
of confidentiality.57
The embarrassment and shame that individuals experience when others
observe behaviours or personal characteristics that are considered to be aberrant
or undesirable lead them to seek privacy.58,59 Privacy also allows persons some
opportunity to express characteristics and desires that they do not wish revealed
to others. An inability to maintain some secrecy about aspects of the self can result
in a profound loss of identity.57 Despite variations in the content of what is con-
sidered as private, all cultures maintain and value this concept.60
The international research situation is problematic because norms in the assess-
ment of what embarrasses or shames vary considerably among cultures.58
Research ethics guidelines written from the western perspective deal with confi-
dentiality mostly in terms information and record keeping, generally echoing the
way in which medical records are handled. Western guidelines are also prob-
lematic because some cultures rely more on oral communication and tradition
than on written record keeping. Therefore, international researchers need to attend
to the broader concept of privacy, which encompasses confidentiality of informa-
tion as well as privacy of person. Such attention is particularly significant in
anthropological or other research that describes people, their behaviours or their
social environment.
In international research, researchers are inevitably outsiders who are

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132 D Olsen et al.

intending to reveal information about the local community to a large foreign

audience. To respect the community, researchers must attend to its privacy as a
whole to maintain the community’s control over its presentation to the world.
Nursing researchers must be especially vigilant of privacy needs because of their
focus on the psychosocial aspects of care.

Alternative models of the research relationship

With the increasing globalization of health care research, now is the time to re-
examine the heavily western influenced bioethical literature that tends to focus
on either individual informed consent or substitute procedures that are justified
in the ethical terms of informed consent. An ethical model emphasizing the rela-
tionship between researchers and participants may be more congruent to the inter-
national situation where many researchers find that the cultural gap ensures that
participants cannot be truly ‘informed’ in the same manner as a person who shares
the researchers’ basic assumptions.38
One effect of the emphasis on informed consent is that it fosters a ‘willing
object’ approach to the researcher–participant relationship; that is, the sense that,
as long as the person knows what he or she is getting into and agrees, then enrol-
ment is ethical. A collaborative model of the researcher–participant relationship,
first offered by Katz61 as early as 1973, is an alternative conception of researchers’
relationship with participants that offers more flexibility with greater account-
ability. This model was more recently endorsed by a 1998 Canadian Tri-Council
Policy Statement: ‘Such collaboration entails an active involvement by research
subjects, and ensures both that their interests are central to the project or study,
and that they will not be treated simply as objects’ (p. i.7)62 (see Table 1). A shift
to a collaborative model for assessing ethics in the conduct of research receives
empirical support from a study by Verheggen et al.63 in which it was shown that
participants place more weight on verbal discussion of the protocol and any prior
relationship with the clinician conducting the study than on the written informed
consent. The effective implementation of a collaborative model of research
ethics would draw on Moody’s64 concept of negotiated consent, which placed
emphasis on the concrete process of communication in the natural context that
may involve family, social network, local institutions or any other party relevant
to the potential participant.
The collaborative model is more realistic in international and cross-cultural
settings than trying to adapt the western contractual approach. The distinction
between the participant as a willing object in contrast to a collaborator is blurred
in situations where researchers and participants share norms and cultural assump-
tions, because the researcher can safely assume that the participant would not
agree to take part without endorsing the research goals. This supposition is not
warranted when participants’ fundamental conceptions of benefit, risk, research
and the nature of decisions vary from those of the researcher.
Three aspects of shifting emphasis in research ethics from an individual-
orientated basis to a more relational approach include: (1) assessment of
participant investment in the goals of the research; (2) less stress on the partici-
pants’ entry into protocols and more on their ability to exit after enrolment; and
(3) more weight on ensuring that the protocol includes an ongoing process of

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 Ethical considerations in international nursing research 133

Table 1 Comparison of approaches to the researcher–participant relationship

‘Willing object’ approach Collaborative approach

Nature of relationship Participants agree to allow Participants collaborate

themselves to be used by with researcher towards
the researcher the goal of the protocol
Source of harm The protocol itself Problems in the
relationship
Point at which Point of entry Attention to maintaining
ethical participation ethical relationship
is assured throughout duration of
protocol
Chief technique for Informed consent Attention to informed and
respecting participants willing participation
throughout
Examples of specific The experimental Coercion
harms targeted by the intervention causing Deception
model direct harm Participant’s feeling
Uninformed participation that treatment was less
Inappropriate risk or than what was deserved.
burden
Type of benefit Therapeutic effect of Altruistic or personal
emphasized intervention interest in advancing
knowledge

working in collaboration with willing participants.

Research as a collaborative relationship incorporates the principle suggested by
Jonas to move beyond informed consent and identify participants who are them-
selves, for whatever reason, invested in the goals of the research.65 Annas and
Grodin’s suggestion ‘that researchers should presume that valid consent cannot
be obtained from impoverished populations in the absence of a realistic plan to
deliver the intervention to the population’ (p. 563) 66 follows this principle,
although somewhat paternalistically, assuming that researchers can decide what
is best for the community. The assessment of participant investment includes the
typical informed consent requirement of telling participants the purpose of the
research, and would also encompass being knowledgeable of their values, espe-
cially when cultural norms and values differ between them and the researchers.
This moves the research enterprise towards an expectation of contextual concern
in relationship rather than a contractual connection.
Collaboration also means a sustained relationship with ongoing clarification of
research goals and the expectations of both the researcher and the participant, as
well as an ongoing assessment of the participants’ continued endorsement of
the goals and methods and their willingness to meet expectations. Emphasis on

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134 D Olsen et al.

participant investment should lead to increased importance of procedures to allow

participants to end their co-operation, rather than focusing on enrolment. In this
way, techniques that honour cultural norms of leadership or familial decision
making could be used if they were balanced with the possibility of individual
dissent.
In summary, the conceptual basis of western bioethics, with its individualistic
emphasis on informed consent, may be too narrow to ensure an ethical basis for
the recruitment, enrolment and continued participation, risk–benefit analysis, and
respect for the privacy of participants in international research. The basis for
ethical participation in such research is broadened, not by discarding informed
consent, but by expanding the foundation of research ethics to the research rela-
tionship as a collaboration between participant and researcher, and then asking
under what conditions that relationship is ethical. In cases where researchers and
participants share cultural assumptions, typical informed consent procedures will
often ensure an ethical basis for the relationship, but, where assumptions vary,
the broader relational view provides a more flexible conceptual framework for
devising techniques to ensure ethical participation. This goes beyond tinkering
with typical western-style informed consent to provide a more workable and
ethical approach.

Conclusion
In general we advocate a flexibility of approach, an emphasis on the ethical
conduct of researchers, as driven by researchers’ responsibilities to the partici-
pants within a collaborative relationship, an attention to detail that demonstrates
respect for the local community (such as accurate translation and knowledge of
the local situation) through researchers’ own efforts and the judicious reliance on
local input. The goals of the ICNE here, as elsewhere, are twofold: to demonstrate
the possibility of a dialogue moving towards an ethical framework that is inclu-
sive enough to achieve widespread consensus; and to further that pursuit through
inclusion of the widest possible range of ethical paradigms from the international
community.

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