2.5 Ethical issues in international biomedical research
2.5.4 Vulnerability
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voluntariness of research participants found that black respondents perceived consent to be less voluntary than did white or Indian respondents. Another recent South African study assessing voluntariness in HIV clinical trials found high levels of perceived voluntariness with the majority of participants reporting an absence of controlling influences from other people. The authors reported that there was a significant association between lower perceived voluntariness and feeling of having no choice but to participate (Mamotte & Wassenaar, 2016).
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groups, the entire community or country can be vulnerable to exploitation particularly in international clinical research funded by wealthier countries and conducted with human participants in developing countries.
RECs are required to ensure that investigators justify the recruitment of vulnerable populations and to ensure that there are additional measures in place to safeguard the rights, safety and wellbeing of vulnerable populations from coercion or undue influence (Horn et al., 2014). The National Bioethics Advisory Commission (NBAC, 2001) proposed a framework involving six specific characteristics that might create vulnerability of an individual research participant, i.e., (i) cognitive or communicative vulnerability: cognitive incapacity may cause participants not to be able to sufficiently understand information, deliberate and make informed decisions, (ii) institutional vulnerability: people in dependent relationships with authority figures, e.g., students and prisoners may be exploited for convenience, hence negating or undermining their voluntary consent, (iii) deferential vulnerability: cultural or societal norms such as in the case of women whose cultural norm is to defer to the husband for decisions regarding participation in research may be vulnerable to exploitation , (iv) medical vulnerability: an individual suffering from a serious health condition for which there is no satisfactory standard treatment may have the perception that research is the only hope to which may negate the voluntariness of their participation in research , (v) economic vulnerability: conditions of poverty may cause less privileged participants to enrol in research when such research appears to offer benefits that are much needed and only available to the participant through research participation and (vi) social vulnerability: some societal groups or individuals may be viewed as less valuable by others such that researchers may unfairly treat them e.g., by giving them inadequate information during the
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informed consent process or by recruiting them into a study with a risk/benefit ratio that would not be acceptable to more privileged people (DuBois, 2006).
Kipnis (2001) offers a taxonomy delineating six types of vulnerability, i.e., cognitive (ability to understand and make decisions), juridic (being under a dependent relationship with a person with legal authority), deferential (customary obedience to medial or other authority), medical (having an illness without treatment), allocational (poverty educational deprivation) infrastructural (limitations of the research setting to carry out proposed research), and social vulnerability (belonging to a disadvantaged group). He argues that these six types of vulnerability may limit the ability to provide informed consent. However, while accepting the usefulness of the taxonomy, Levine et al. (2004) criticize it for two reasons. First the taxonomy makes an
assumption that everyone who fits in any of these categories is vulnerable. Second, the taxonomy implies that everyone capable of autonomous consent is not vulnerable (Levine et al., 2004).
Ballantyne and Rogers (2007) argue that vulnerability exists as a spectrum rather than a simple (present or absent) dichotomy. They propose a conceptual framework outlining two types of vulnerability, i.e., extrinsic and intrinsic vulnerability. In their view, extrinsic vulnerability is caused by external situations, e.g., low socio-economic status or education, while intrinsic vulnerability is as a result of internal characteristics of individuals themselves, e.g., medical illnesses, mental disabilities and extremes of age (for example in children and some elderly). The authors recommended that RECs should distinguish between intrinsic and extrinsic
vulnerabilities, as these may require different mechanisms to protect the rights, dignity and safety of potential research participants (Ballantyne & Rogers, 2007).
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Luna (2009) argues that vulnerability should not be a label assigned to certain subpopulations, but rather proposes a conceptual framework of "layers of vulnerability" (p. 128). In other words, Luna suggests that the notion of vulnerability is highly contextual and that RECs can only determine if participants are vulnerable by considering the contextual details of the proposed research (Luna, 2009). Dhai (2015) proposes a Vulnerability Assessment Scale to assist RECs and researchers identify research participants with vulnerabilities and develop focused
safeguards for their protections. According to her scale, the REC would need to ask the
following eight questions, i.e., “1) Has the essential minimum standard afforded all participants in light of universal vulnerability been met? 2) Has the baseline for respecting human dignity been met? 3) Will any participant be used in the research as a means to an ends she/he may not endorse? 4) Will all the research participants in this study be able to safeguard their own needs and interests? 5) If no, is there an increased likelihood of any of them being identifiably wronged as a result of their participation in the study? 6) Is there an increased likelihood of any participant being identifiably wronged to a greater degree than other participants? 7) Have the identifiable wrongs been recognised? and 8) Have special safeguards been developed to protect those participants in need of such safeguards?” (p. 221).