office (03) 9820 3006 or 920 3008
fax (03) 9820 3007

Step 8 - Ethics

Ethics

Cultural competence in:

Cultural competence in research ethics

Fundamentals

Socio-cultural context

Belinda Seto ( 2001) at the US National Institutes of Health has reviewed the issues in minority recruitment and involvement in health research.[3] She notes that the nineteenth century saw a spate of articles on medical ethics in France, England and the United States. She recapitulates the modern history, with the World Medical Association adopting the Nuremberg Code (1947) in 1948, followed by the Helsinki Declaration. modern research ethics are themselves born of a response to atrocities inflicted by researchers on an ethnic group in the ‘interests’ of medical science. [seto2001]

 Christakis (Christakis 1992) in an important review of the cultural context and cross-cultural variation in the ethics for clinical research, points out that ethical relativism is itself not value-free. He posits whether, instead, an empirically based approach based on examining systems of medical ethics cross-culturally might identify universal principles. Christakis, based on his examination of Asian systems of medical ethics, believes it is unlikely to derive common principles. Medical ethics might, on one perspective, be viewed as ‘local knowledge’.

In an important review for the HTA in the UK, Ashcroft et al. ( 1997) offer a review of international English-language literature from a British social-justice perspective that is primarily concerned with the contribution that cultural difference, as one of a range of variables (most notably gender and socio-economic status), makes to health inequalities.

People’s understanding of ‘risk’ depends on their cultural background (Eiser 1998). Very little research has been conducted into whether cultural or religious objections exist regarding the fundamentals of research theory and practice (e.g. in the case of clinical trials - randomization, placebo, trial continuation even after effects start to emerge) (Ashcroft, Chadwick, Clark, Edwards, Frith, & Hutton 1997). However, there is evidence that understandings about the ‘knowability’ of risks involved in research may be fundamentally different in some cultures (Parker and Barrett, 2003).

Cultural meaning of protection versus common good

Again, in the case of informed consent, Ashcroft et al. ( 1997) distinguish between the ‘practical’ problem of establishing that consent has been sufficiently informed to be worthy of the name and an ‘ethical’ problem that relates to concern for the participant’s protection, regardless of whether he or she consents or not. To illustrate the difference between these problems, Ashcroft et al. offer an example of an intrinsically unethical trial which should never have been offered to participants in the first place, but to which people might still happily sign up with a good understanding of the procedures involved. A complication of the ethical problem is that it assumes a paternalistic role on the part of research ethics committees and researchers by which they are given authority to decide what ‘any reasonable person would (or should) refuse’ (p. 32) – highly problematic in the context of linguistic, conceptual and behavioural differences across cultures. 

The threshold based on mutual understanding – how to adjust for cultural differences

The World Health Organization is among a number of international organizations giving attention to participation in research by indigenous and other minority groups in resource poor settings. Sims & Kuhnlein ( 2004) set out the issues in their report on indigenous peoples & participatory health research planning & management. The principles emerging from that work apply to multicultural research in Australia. One example of the threshold of mutual understanding is found in the context of informed consent: “Consent is truly informed when the person understands (a) the purpose and nature of the study, (b) what participation in the study requires him or her to do and to risk, and (c) what benefits are intended to result from the study” (Council for International Organizations of Medical Sciences 1991).

Cultural construction of the agreement to participate in research

Individual versus collective decision-making by potential research subjects

One perspective on the cultural construction of the agreement to participate in research is reviewed by Ashcroft et al. ( 1997). He critiques the view of consent as a culturally neutral reflection of a Kantian philosophical tradition that idealizes the free and autonomous individual subject above all else. Ashcroft et al. are particularly interested in the protective role of consent, and the extent to which there is agreement across cultures as to who needs to be involved in the consent procedure to ensure this has been satisfactorily achieved. In the UK, as in Australia, the consent of several classes of individuals is assumed to be insufficient for these purposes and must be accompanied or (in some cases) replaced by proxy consent from one in authority. Given the cultural dependency of concepts such as childhood or mental impairment, the question of which individuals should be deemed capable of fulfilling a self protective role when consenting seems open to various interpretation.

Research and health interventions

Informed consent requires that the physician communicates about the intervention so that the patient reaches their own conclusion regarding their preferred options (Levine 1986). However actual cross-cultural practice may not reflect the ideals of disclosure (Jecker, Carrese, & Pearlman 1995) and truth-telling (Brusamolino & Surbone 1997;Capone 1993;Krakauer, Crenner, & Fox 2002), patient autonomy (Blackhall et al. 1995) and informed consent (Macklin 1998;Mitchell 1998b;Muller & Desmond 1992).

Western bioethics principles, such as autonomy, are viewed as universally binding (Gallagher 1998;Jennings 1994), but in many cultural settings the idea of autonomy in decision-making may not make sense (Fan & He 1997;Ip et al. 1998;Takahashi 1990) and local culturally sensitive values should not be sacrificed to western ‘universal’ values (Konishi 1998;Liu et al. 1999;Mitchell 1998a;Pfefferbaum, Levenson, & van Eys 1982;Zockler 1989).

Whoever signs, what is the consideration – for the signer, or their community?

Parker and Barrett ( 2003) identify the relative merits of autonomous versus heteronomous consent. There is diversity in cultures that place emphasis on the role of family in making collective decisions about best courses of action for the individuals therein. E.g. recruiting Iban people from Borneo to take part in research who attached little significance to the immediate risks posed to the individuals involved (and still less in written consent) but were greatly concerned by what they saw as the unpredictable danger to the group as a whole.

The cultural durability of participation in research

Barrett and Parker ( 2003) in their review of rites of consent in negotiating research participation in diverse cultures, propose, firstly, that the consenting process continues throughout the life of any research project, long after the signature has been secured, and secondly, that both group and individual dimensions of consent, and the sequence in which these dimensions are addressed, should be carefully considered in all cases where consent is sought.