Discussion Groups » Consent. » Cultural issues in obtaining informed consent

Binh Nguyen Thi Cam, an Oxford University Public Health DPHil student has just posted a blog on the Ethox website about cultural issues in obtaining informed consent. The post can be viewed here: http://www.ethox.org.uk/ethox-blog but has also been pasted below.

It's a fascinating read and has me thinking about how 'tailored' informed consent approaches should be to the particular community in which they are being implemented.

Please do read and comment on this post.
Dina Rippon

The post has been reprinted (with the author's permission) below:

Cultural issues in obtaining informed consent: what do they mean for the standard of practice?

Nguyen Thi Cam Binh, The Ethox Centre

11th June 2013

Morality differs in every society, and is a convenient term for socially approved habits.

Ruth Benedict, Patterns of culture (1934)

The requirement to obtain consent has become central to the ethical conduct of research involving human subjects. Various descriptions of the process and nature of informed consent can be found in the published national and international regulations and guidelines pertaining to research ethics. However, the requirement of obtaining consent is based on the fundamental ethical principle of respecting for patient autonomy[1]. Following from this principle, three components must be met: disclosure, capacity and voluntariness[2].

As clinical research has become more global, bringing with it a requirement to obtain consent in different places where many disparate values are held, the obtaining of valid consent increasingly poses unique challenges. Discussions in the literature are mainly concerned with what processes and documentation are deemed appropriate in various cultures and social contexts[3-5] . Some are convinced that consenting should adhere to internationally agreed-upon ethical standards of voluntary informed consent for research, even in the face of cultural diversity[4] while opponents claim that "[i]t is ‘ethical imperialism’ at its worst to assume that the informed consent requirement, which does indeed serve one (only one) moral principle in the Western setting, is in itself such a universal ethical standard"[6] and argues that "the investigator might better stick to the research, and accept the local assessment as to adequate protection of individual rights"[6].

In a paper on the ethical and regulatory challenges arising in a randomized control trial of adjuvant treatment for breast cancer in Vietnam[7], Love and Fost (1997) describe difficulties in applying ‘Western notions of informed consent’ in the Vietnamese medical context. They report that the investigator "found himself uncertain about the application of American standards of informed consent in the Vietnamese setting". After consultation with experts on Vietnam and Vietnamese culture, he concluded that, “American standards would not be acceptable to Vietnamese physicians, political leaders in Vietnam, or the vast majority of Vietnamese patients”, because “[Vietnamese] patients expect and look to their physicians to tell them the appropriate treatment. It is unacceptable for a physician to openly express uncertainty with regard to what is the best treatment”. In the light of this, the researcher came to the view that participants in the clinical trial should not receive any information that would convey the treating doctor's uncertainty - specifically, information about alternative therapies and the use of randomization to determine the subject's proposed treatment. Interestingly, similar challenges have also been reported in other countries like Japan and India where paternalism is dominant in doctor-patient relationship[8].

Other recent issues in relation to the obtaining of consent in research in Viet Nam include the following: (i) the avoidance of using the word “research” by study doctors when imparting information to research participants because of a view that Vietnamese patients, when hearing the word “research”, usually think about research with bad meaning that they would be treated as a kind of ‘Guinea pig’ for experiments, and as such, they would not participate in research; (ii) issues relating to the enumeration of benefits that could be gained from participating in research on the grounds that participating in research requires time and effort, and if it does not bring any benefits, patients would not want to take part; and, (iii) requests, by study doctors and local institutional review boards (IRBs) to reduce blood volumes taken for research on the grounds that patients are often afraid of getting blood drawn as, to them, blood is a treasured source of existential support, and thus, losing blood especially during an episode of illness would let them weaken[9].

As a Vietnamese person and through doing empirical research on Vietnamese medical research setting, I know that these issues do arise in Viet Nam, but even so, they do not, in my view, provide adequate justification for the proposed modifications to the obtaining of consent to research - such as using other words like ‘programme’ or ‘survey’ in replacement of ‘research’, emphasizing benefits, or reducing blood volumes only for the mere fact that it would help to recruit patients easier and faster. It is true that with the long established paternalistic style, many Vietnamese patients expect and look to their physicians to tell them the appropriate treatment. However, it seems wrong to conclude from this that “it is unacceptable for a physician to openly express uncertainty with regard to what is the best treatment”. Patients may put a high expectation on doctors to give them the best advice and treatment, but it does not follow from this that they would not be able to understand and accept a doctor’s truthful explanation about the existence of uncertainty in medicine and the need to conduct research to develop effective treatments for a better life and future for the patient him of herself and other people. Would they not feel more disappointed by the doctor who, while knowing about the uncertainty, still decides to withhold information about this, appears to be certain about everything, but finally fails to provide adequate care? Or, from the doctor’s point of view, after a long while carrying lots of responsibilities and expectations, doctors would find themselves in a position where they would find it unacceptable to confess things they haven’t learnt or known about, and doing this would make them lose their face. I think the paternalism expected of Vietnamese doctors here can sometimes make it difficult for study doctors to explain uncertainty and discuss it openly with research participants, but this cannot be inferred as something unacceptable or even wrong. In my view, doctors and researchers should use the exact word “research” to explain honestly to research participants what we are doing and how we are doing research though this may take up quite a lot of time at the beginning. Otherwise, prejudices on research and the knowledge of people about medicine in general cannot be improved, leading to bad impacts on individuals and society as a whole. The fact that many people may currently think research is bad, or value direct benefits gained from research more than other things, or think that taking blood when they are sick would cause harm to them, is just a form of belief, and is not inherently ‘cultural’ on any definition[10]. And, for the better, belief can be changed after time with the provision of experience, evidence and reasons. In fact, today when the educational level of people is higher than it has ever been and when they are more aware of their rights to healthcare, patients and research participants in Viet Nam are entitled to know more about their medical status, the research, available treatments and other side effects, and expect medical staff to give more time for consultation and discussion[9]. Even though we may hold different beliefs on what would make a good health system, the values of truth telling, respecting for persons are still appreciated and shared in common by countries with different cultures.

So what should researchers do when confronted with issues relevant to culture and customs? I think those examples mentioned above suggest us to be open to other beliefs and cultural patterns which may seem to be irrational or contrary to our individuals so that we can have an understanding of values and other factors shared by members of societies, but also to be open and honest about the limitation of health care practice and about the nature of research practice. This departure will help us to figure out good approaches for the matter at hand in the way that may bring benefits to the targeted population while upholding good values and beliefs for a moral progress of the society.


1. Norman, G.V., Informed Consent: Respecting Patient Autonomy. 2011: p. 36-46.

2. Etchells, E., et al., Bioethics for clinicians: 1. Consent. Canadian Medical Association Journal 1996(155): p. 177-180.

3. Lindegger, G. and S. Bull. Ensuring valid consent in a developing country context. 2002 [cited 2013 18 April].

4. Ethical and Policy Issues in International Research : Clinical Trials in Developing Countries. 2001, National Bioethics Advisory Commission: Bethesda.

5. Silverman, H., Enhancing research ethics capacity : implications for protection of research subjects , avoiding exploitation and achieving global health *. Middle East Fertility Society Journal, 2005. 10: p. 105-109.

6. Newton, L.H., Ethical imperialism and informed consent. IRB, 1990. 12(3): p. 10-1.

7. Love, R.R. and N.C. Fost, Ethical and regulatory challenges in a randomized control trial of adjuvant treatment for breast cancer in Vietnam University of Wisconsin Medical School , Madison , WI 53706 . ( Dr . Fost is currently the DeCamp Visiting Professor of Bioethics at Princeton University .) Supported in part by NIH. Pediatrics.

8. Cultural Issues in Informed Consent. 2009, Pfizer. p. 1-6.

9. Nguyen, B.T., Research ethics in rapidly evolving epidemics: an international perspective. 2013.

10. Center for Advanced Research on Language Acquisition, Regents of the University of Minesota. What is culture. 2013 [cited 2013 18 April]; Available from: http://www.carla.umn.edu/culture/definitions.htm


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