Research article

Informed consent practices of

Chinese nurse researchers

Nursing Ethics
17(2) 179187
The Author(s) 2010
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10.1177/0969733009355545
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Douglas P Olsen
Veterans Health Administration, Washington, USA

Honghong Wang
Central South University, Changsha, China

Samantha Pang
Hong Kong Polytechnic University, Hong Kong, China

Abstract
Nursing research in China is at an early stage of development and little is known about the practices of
Chinese nurse researchers. This interview study carried out at a university in central China explores the
informed consent practices of Chinese nurse researchers and the cultural considerations of using a
western technique. Nine semistructured interviews were conducted in English with assistance and
simultaneous translation from a Chinese nurse with research experience. The interviews were analyzed
by one western and two Chinese researchers and major themes were identified. All participants
endorsed informed consent as ethically required. Differences were noted between some of the
informed consent practices typically recommended in the USA and those identified in this study, such as:
recruitment using local and government officials, recruiting directly from medical records without special
permission, family consultation in consent and consent control, and not revealing randomization to
intervention groups receiving different treatments.
Keywords
China, informed consent, interview methodology, research ethics

Introduction
Informed and voluntary consent given by participants in biomedical research is a mainstay of western
research ethics. Nursing research in China is in an early stage of development and Chinese nurse researchers
often model their methods on those of their western peers, including the techniques used to ensure the ethical
conduct of research. Indeed, many Chinese nurse researchers partner with western and Asian colleagues from
more experienced academic programs, such as those in Hong Kong. This interview study explored two
related aspects of nursing research in China: the practices of Chinese nurse researchers in obtaining informed
consent, and Chinese nurse researchers opinions about using a western technique in China.
The potential for the abuse of human rights in biomedical research was dramatically brought to the
worlds attention by the revelation of experiments performed in Nazi Germany. In response to this the
Nuremberg Code was developed. The codes first statement is: The voluntary consent of the human subject

Corresponding author: Douglas P Olsen, National Center for Ethics in Health Care, Veterans Health Administration 10E, 810
Vermont Ave. NW, Washington, DC 20420, USA.
Email: douglas.olsen@va.gov

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is absolutely essential.1 After establishment of the Nuremberg Code, western research ethics continued to
develop with a strong emphasis on informed consent, with this requirement being highlighted further and
elaborated. Two of the best known documents used to guide ethical review of research provide examples.
The Declaration of Helsinki2 states: In any research on human beings, each potential subject must be
adequately informed ...; and The Belmont Report,3 on which US regulations are based, declares that Respect
for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what
shall or shall not happen to them.
Obtaining informed consent for research is relatively new, even in the West, beginning as an unenforced
requirement in 1949 with the Nuremberg report and being enshrined in US regulations in 1974. However, the
concept of personhood as individually possessed and ultimately isolated, which creates the compelling moral
argument for informed consent, is a paradigmatic assumption of the western tradition.46 The US regulations
relating to ethical conduct of research, and western ethical deliberation in general, take the individual as the
unit of concern. A common theme in cultural studies of Chinese society is that Chinese people exist through,
and are defined by, their hierarchical relationships with others. How one should behave depends on which
role one is assuming at a particular moment in life. In contrast to the western notion of respect for the person
as an autonomous individual, respect should be paid to a person according to the dynamic social roles encompassed in role relationships.7,8 Social roles in China are chiefly defined by familial relations. Chan applies
this to informed consent by describing a familial model in which medical decisions are not considered simply
from an individuals perspective but as embedded in a web of familial relationships with far-reaching
effects.9 Although a Confucian understanding of personhood encompasses the western concepts of free will
and rationality, which provide strong support for informed consent techniques, Confucian concepts of
personhood are balanced with a strong relational perspective or horizontal dimension with specific responsibilities to others.10
The world in general, including China, agrees that informed consent for research is ethically required.2,11
Obtaining informed consent from individuals prior to participating in research clearly prevents the most
egregious abuses, such as those of the Nazi doctors and the Tuskegee syphilis study. The question addressed
in this study is not whether informed consent is ethically appropriate in the face of cultural differences, but
how culture influences researchers application and understanding of informed consent.

Method
Semistructured interviews were conducted with a convenience sample of nine nurse researchers at a large
Chinese university. The participants were asked about their research, informed consent practices and beliefs
about informed consent. The interviews were conducted in English by a non-Chinese, English-speaking
nurse researcher and a Chinese, English and Chinese-speaking nurse researcher. Thus the interviews were
mostly in English, but with some discussion with the Chinese researcher when participants had difficulty
with expressing their thoughts in English, or needed a concept translated for their understanding. The interviews were recorded and transcribed into both Chinese and English. The English portions of the interviews
were translated into Chinese and the Chinese parts translated into English so that two versions were
produced: an all-English transcript and an all-Chinese transcript. The interviews were examined by three
researchers and major themes were identified and agreed on by email discussion. The English speaking
investigator examined the English transcripts and the two Chinese investigators examined both English and
Chinese versions. Conventional content analysis was used for the identification and analysis of themes, as
described by Hsieh and Shannon.12
This research was approved by the Human Subjects Research Review Committee at Yale University
School of Nursing and by the Vice President of Central South University, Changsha, China (the customary
approval in China).

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181

Table 1. Participants demographic characteristics

Characteristic
Age (years)
Average
Range
Highest degree
PhD
Masters
Bachelors
Years clinical experience
Average
Range
Years academic experience
Average
Range
Formal ethics education
Yes
No
Research ethics education
Yes
No

No. (range)
33
(2545)
1
5
3
10.9
(1.527)
5.3
(217)
8
1
4
5

Results
Demographics
One of the nine nurse researchers had a PhD, three had Bachelors degrees and the remaining five were at
Masters level, four in nursing and one in public health. All the Bachelors researchers were graduate students
at the time of the interviews. The nursing Masters in China teaches students to be researchers, unlike in the
USA where it is focused on clinical expertise. Thus, a Masters prepared nurse in China is considered to be a
qualified researcher. The interviewees had a variety of roles: two had administrative positions in clinical
institutions, one was a staff nurse, two had faculty positions and the remaining four were graduate students.
All but one had some formal ethics education (e.g. a college class in health care ethics), but only four had any
formal education in research ethics. None of the reported ethics education was from western sources, such as
a visiting lecturer from the USA or the UK. The average age of the interviewees was 33 years and they had an
average of 11 years in practice. Table 1 presents the participants demographic characteristics.
The stated participants research interests were: mental health, communication, orphans, pain control,
education, depression in elderly people, critical thinking, HIV/AIDS and cognitive function. Their clinical
specialties (if any) were: emergency, oncology, community, education, gerontology and AIDS.

Method
Four of the nine interviewees reported undertaking intervention studies, three of which used control and
experimental groups. Five of the studies used interview and survey methods, one in preparation for an intervention study. Five of the studies discussed related to the evaluation of clinical programs or psychosocial
interventions offered in the community. These nurse researchers were looking into a variety of clinical problems, including early detection of breast cancer, cognitive function in elderly people, nursing education
methods, pain relief during chemotherapy, and problems of HIV/AIDS, including medication adherence,

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nurse patient relationships and stigma. The participants research was being conducted in both urban and
rural settings.

Recruitment
The nurse researchers used a variety of recruitment methods. Some were similar to their US counterparts and
included public advertising, identifying their potential participants through clinicians or medical records, and
recruiting nurses from public lists. In one study, drug abusers are identified in medical records and then
contacted directly by the researcher on that basis. One recruitment method that is not common in US studies,
but was used by three of our researchers, was to identify and contact potential participants via local community or government leaders, such as people who were equivalent to a mayor.

Informed consent
Formal, that is, documented, informed consent was obtained by seven of the nurse researchers interviewed.
Of these, four obtained written informed consent and three obtained this orally. The remaining two described
the informed consent as informal and as permission respectively. One researcher working with elderly
people carries out tests for cognitive capacity and excludes those deemed unable to give informed consent
because they lack competence.
The interviewees reported informing participants about many of the elements typically considered appropriate in US informed consents, including the purpose of the research, risks, benefits, specific expectations,
the ability to drop out at any point and that information would remain confidential. One interviewee reported
using oral consent because she prefers not to reveal too much about the research as her participants are drug
addicts and may ask for too much money.
In three of the intervention studies, the interviewees reported that the participants were not told that there
were two groups receiving different treatments (i.e. intervention and control groups). The usual treatment
was administered to the control groups in all three studies. In addition, there were two versions of the
informed consent process, one for control participants and one for those in the intervention group. Thus,
explanation about the randomization did not appear to be an issue in the informed consent process of these
Chinese nurse researchers because they did not reveal to participants that they were being randomized into
different groups with different treatments.
The interviewees were asked about family participation in the informed consent process for two reasons.
First, since Chinese culture puts greater emphasis on family consultation in decision making than typical
western cultures,13 we wanted to investigate if the potential participants identified by the researchers relied
on their family members when agreeing to participate in research. The interviewees were also asked about
family participation because Chinese theories of ethics give weight to family relationships as an inherent
feature of moral consideration14 to a degree not found in western theory. We therefore reasoned that these
researchers might implicitly or explicitly foster family consultation. The researchers who were using survey
and interview methods reported that participants family members were not consulted. However, two interviewees, whose research involves the more personally intense issues of dementia and chemotherapy,
reported that family members were consulted and integral to the decision to participate, as these quotes
illustrate:
Question: Do the patients ever consult their family before they take part in the research?
Answer: Yes. First they tell their family, relatives, get the permission.
In my research, many family members influence the decision of elderly patients [participants]. I think, in China,
[being a] family member is very important role in decisions about other members of the family.

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Five of the nine interviewees indicated that frequently their participants did not distinguish between
research and therapeutic activities, as the following quotes demonstrate:
No, They dont see the difference between research and treatment.
Question: Why do you think they participate in your research?
Answer: Because breast cancer is most terrible.

When asked about participants understanding of treatment versus research:

... they dont know very clearly ... They do not care that you do research or do other things. They care that the
treatment will give them some benefits ...
They think this is to help them ... they think this helps them to increase their knowledge.
They [student participants] just thought it was an activity which can help their study abilities and professional
abilities.

In one interview it seemed that the nurse researcher also saw the research activity primarily as a way to
benefit the participants.
Because the things in the program are a benefit for their mental health. Because I hold service activities. I just
want to arrange a team for elderly people in the community, so they can communicate freely. I also hold some
activities for the elderly people, such as they can watch a play, and they can perform. I just want them to be happy.

The interviewees differed regarding the fit of informed consent and Chinese culture. One interviewee was
quite clear, stating: It [informed consent] is not very consistent with Chinese culture. Another was equally
adamant in opposition: I think this suits Chinas culture ... some people treat it very seriously. One interviewee distinguished the level of need for informed consent by the type of participant in relation to Chinese
culture:
Because I am Chinese. I dont think it is very important for students [to give informed consent when they are
subjects of research] ... Maybe foreigners think it is very important ... Maybe it is more important for patients.

In discussing the rationale for obtaining informed consent these nurse researchers cited human rights and
the participants dignity. It is interesting to note that, when asked about the purpose of obtaining informed
consent, the same interviewee who stated that informed consent was not consistent with Chinese culture also
said, I want them to understand the research and I want their support. Another stated, I think humans have
the right to receive some treatment or reject some treatment, possibly indicating confusion between research
and treatment. Another interviewee said her reason for obtaining informed consent was that the publisher and
the university required it.

Discussion
Differences were noted between some informed consent practices typically recommended in US research
ethics and those reported by the Chinese participants, such as: recruitment using local and government officials, direct recruitment from medical records without special permission, family consultation in consent, and
consent to control and intervention groups separately, without revealing randomization into two groups
receiving different treatment. There are two critical caveats to this statement. First, despite years of intense

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regulatory scrutiny, and required training for researchers and institutional review board members on the ethical conduct of research, there is not enough consistency in US practice to say definitely that Chinese practices
differ from those of US nurses, only that Chinese practices differ somewhat from what is considered usual
practice in the USA. A US comparison sample would be required to show that Chinese and US nurses practices actually differ. Second, different in this case should not be taken to mean wrong or deficient. The practices in which western and eastern nurse researchers differ may reflect variation in ethical paradigms in
eastern and western ethics.
In the West, ethical guidance for recruitment practices is careful to minimize any coercive influence created by a power differential between potential research participants and any person carrying out or supporting
recruitment. Researchers are warned against recruiting in a situation of unequal power because potential
participants will be vulnerable to coercion.15 Similarly, the Canadian Tri-Council16 notes that: Care should
be exercised in developing relationships between researchers and authorities, so as not to compromise either
the free and informed consent or the privacy and confidentiality of subjects (art. 2.2).
However, it is also widely recommended that communities should be involved in research in the form of
developing protocols as well as monitoring recruitment and data-gathering processes.17 Community consent,
that is, where the permission of community leaders is sought for the conduct of research, has been suggested
for research involving distinct communities.18 However Weijer and Emanuel18 stipulate: Ultimately, no
person can be enrolled in research without his or her individual consent. Properly understood, community
consent is an additional protection; a study may not proceed without informed consent from both the community and the individual research subject.
Thus a tension exists between appropriate community involvement and coercion created by endorsement
of community leaders. The precise balance between involvement and coercion will be highly dependent on
local and cultural considerations. Further research in the Chinese context should explore this area.
Recruitment directly from medical records means that the potential participants provider must reveal
patients names and enough information about them to establish the meeting of inclusion criteria. This is not
generally done in the USA because it is considered a breach of confidentiality on the part of the provider
unless certain criteria stipulated in US regulations are met; that is, the research is not practical without the
waiver and the information revealed presents a minimal risk.19 Although the information revealed to allow
such recruitment is often benign, it is notable that one of the interviewees used this method to identify HIV
positive drug abusers.
Family participation in consent was discussed in these interviews. Consistent with expectations regarding
Chinese culture, family consultations were encouraged and performed when participation in the research
involved substantive treatment issues, personal involvement or risk. However, it is not known how this compares with western practice. The interviewees were deliberately and overtly questioned in this regard because
the family is an area often identified as varying between eastern and western cultural outlooks. It is not at all
unlikely that US research participants consult their families before agreeing to taking part in research with
substantive involvement. It may be that there is no difference in family involvement between eastern and
western participants, or that there is a difference in the level of involvement or the degree of seriousness
of the research before invoking family consultation.
In the USA it is widely considered ethical to inform potential participants in intervention studies and clinical trials (i.e. any study in which participants are divided into groups) that the treatment will be different in
each group and how assignment to groups is made, for example, by randomization.20 Underscoring the ethical need for full disclosure of group assignment, Levine states: In the negotiations for informed consent for
participation in a RCT [randomized controlled trial] nearly all the traditions and motivations of the physician
or nurse must be suspended.21
Comparison of the experimental intervention with either no treatment or usual treatment is considered
essential for determining best treatments.22 The ethical justification for providing various treatments with

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185

likely differences in efficacy is that it is not known for certain which is truly best, the term for this condition is
equipoise.23 A collaborative understanding of the researcherparticipant relationship allows participants to
choose to assist researchers in determining the best treatment option, possibly by receiving the lesser
option.24,25 Olsen states: Thus, subjects in a collaborative relationship are respected by equipoise, entering
a clinical trial aware of the implications of randomization ... but agreeing to submit in order to determine the
interventions efficacy ...25
Therapeutic misconception is narrowly defined as when participants mistakenly believe that group assignment in clinical trials is based on their therapeutic needs, and more broadly understood as participants believing that the object of any research is their personal benefit and not the need to generate generalizable data.26
Both types of misconception were apparent in these interviews. This is not considered a difference between
eastern and western research because therapeutic misconception remains a controversial and difficult issue in
the literature of western research ethics. Although attempts have been made to decrease therapeutic misconception in the West,27 it would be impossible to determine from these data if the problem occurs to a greater
or lesser degree in China.
One potential problem is a disconnection between informed consent as a western technique being used in
China because Chinese researchers perceive it as ethically essential but as pointless paperwork. The results
were not clear in this regard, with some interviewees stating their clear endorsement of informed consent as
essential to human rights, but at least one dismissing it as foreign. It is much too early to label either view as
an ethical problem. Although a western perspective would view a dismissive attitude towards informed consent as an invitation to causing ethical problems, or even abuses, a more culturally adept understanding could
demonstrate that the valuing of participant personhood is not threatened in the Chinese context by such attitudes towards informed consent as a western technique.

Limitations
Although this study began by describing some informed consent practices of Chinese nurse researchers, this
is only a very preliminary beginning and should not be understood as a full characterization of Chinese
nursing research. Generalizability can be limited by several factors. All the interviewees were from one university and thus their practices may be different from those found in other clinical academic institutions. In
addition, language was a significant barrier in several ways, including the interviews and translation of the
transcripts.
The study raised, but did not answer, several issues that should in future be addressed in more depth and
subjected to targeted research, including the nature of family involvement in consent, how research design
influences variations in practice, and how Chinese researchers understand therapeutic misconception.

Conclusion
Throughout our research process, each participant nurse researcher interviewed expressed a high degree of
commitment to the ethical conduct of research in general, and to informed consent in particular. Each difference and theme noted could help both western and eastern nurse researchers to look at what it means
to protect and value those who agree to be our research participants. It is our view that the differences noted
add richness to the discourse.
Acknowledgements
The authors would like to acknowledge the Yale University School of Nursing and the Yale-China
Association for supporting this research.

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Conflict of interest statement

The authors declare that there is no conflict of interest.
Disclaimer
The views expressed here by Dr Olsen are his alone and should not be construed as representing those of the
National Center for Ethics in Health Care, or the US Veterans Health Administration.
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