As I argued in the first two chapters, the principal overarching assumption of the analysed international guidelines is the individualistic notion of informed consent. The broad overview suggests that this concept originates from the liberal political and moral philosophy that flourished after World War II in North America and Europe. The idea that an action could be ethical only if the concerned person was informed and agreed to conducting it freely and without coercion or inappropriate influence. Gillon (2003) for example rated autonomy as the most critical of the four principles or what he termed ‘the first among equals’. On the other hand Manson &
99 O’Neill (2007) argued that autonomy is an extremely vague concept and that it is used inconsistently in the literature to promote highly contested views.
The term ‘autonomy-based bioethics’ reflects notions of respect for personal autonomy and respect of the person in the clinical and research contexts by accentuating freedom of choice and self-determination (Azétsop and Rennie, 2010).
Despite the differences among them, the numerous definitions of autonomy tend to include an emphasis on agency (i.e. the personal capacity to act intentionally) and liberty (i.e. the ability to take decision free from influences) (Gillon, 2003; Manson and O'Neill, 2007; Beauchamp and Childress, 2001; Azétsop and Rennie, 2010). The Nuremberg Code, which is among the most highly regarded international biomedical ethics guidelines and one of the principal references that have crystallised the new Saudi bioethics guidelines, is one of those documents leaning towards autonomy-based bioethics autonomy-based on the criteria agency and liberty (see Subsection 2.2.2:
Consent).
Individualism is pivotal to the autonomy-based model of bioethics as it is mainly orienting its attention to obtaining the informed consent of ‘individual research participants’ with less attention given to what is best for the community where the research will be conducted (Azétsop and Rennie, 2010).
To summarise the agreement on the autonomy-based bioethics model, it seems that it is built on two principal assumptions: 1) the liberal commitment to decision-making: in the Western societal context, this makes sense because liberal values are prized within that society. They even constitute the principal theory of international relations, which assumes that the election of leaders is an individualistic act that is
100 independent from the state’s direct influence and based on free choice through the operation of democracy; 2) Agency: the ability of an agent to make decisions free from external influence.
In Chapters Two and Three, I argued that the Saudi regulations and the international selected research ethics guidelines were oriented toward promoting individualistic notions such as promoting informed consent. Accordingly, and based on autonomy based bioethics, the Saudi guidelines and the international ones are mainly autonomy oriented guidelines. I will further, in this section, assess the suitability of such an approach to the Saudi context.
Autonomy-based bioethics would not be the best framework to regulate MGE research in general because the participant is not an individual in the sense that his/her genetic material is shared with his/her kin, (Widdows, 2009) nor considering the genetically homogenous nature of the Saudi population specifically (See Subsection 1.2.5.3 Stigmatisation). The Saudi NCBE regulations made it clear that the national committee’s main job is to insure that informed consent was properly given. Informed consent is pivotal to the autonomy-based bioethics model, and is problematic because the individualistic decision of the research participant has ramifications for the information of other individuals who chose not to participate or do not want to know the results of MGE ‘tests’.
Another challenge that ought not to be neglected is the level of education of the average Saudi. The autonomy-based bioethics model seems to shift the responsibility for decisions to the patient in the clinical setting and to participants in the research setting. Such responsibility requires a full awareness of the ramifications of any
101 decisions. One of the requirements of informed consent is to provide full information to the consenting person to enable an informed decision to be made by them based upon what they want to do. The Saudi guidelines devote many articles and sub-articles to describing the content of the consent document as a means of educating the patient. There are many challenges in this approach (i.e. expecting the form to be the ultimate tool of disclosure) like the assumption that patient will read carefully, a document that is neutrally written, with a level of disclosure that does not omit any information, and contains all the facts s/he needs to have, and most importantly do all of this in a small window of time. To start with, Manson and O’Neill (2007) argued that it is impossible to provide such a document (i.e. neutral, explicatively disclosing and with no omissions). However for the sake of argument I will assume that someone could provide such a document or process. Even so it requires a certain level of education to absorb that information, weigh it against his/her own interests, family interests, and tribe’s interests in the case of MGE research in Saudi Arabia, and then decide. The nature of the Saudi political cultural climate does not support such assumption. As I explained in Chapter One, Saudis tend to accept the physician’s decisions with no objections (Al-Jumah and Abolfotouh, 2011; Jamjoom et al., 2011; Adlan, 2013).
Saudi patient vulnerability (see Subsection 1.2.5.5 Patient Vulnerability), suggests that they will not decide free of a physician’s influence which was discussed earlier. The autonomy–based bioethics model gives more weight to the informed consent practice, therefore any challenge to the informed consent would also challenge the autonomy-based model, and this is certainly the case in Saudi
102 Arabia. The hospitals that have the capacity to recruit for MGE research are the highly specialist hospitals (See Subsection 1.2.3 Health-related Services in Saudi Arabia). Those hospital are not part of the free Saudi MOH services, they are usually the most expensive services in Saudi Arabia. However, Saudis can ask for the support of a Royal Prince Order to wave the health cost charges according to strict eligibility criteria; this means that the bills will be transferred to the Crown Prince to pay (Adlan, 2013). Giving the impression that a very expensive service is going to be given for free would create a sense of gratitude that might impinge on the patients’
ability to say no. The long waiting lists even inside these specialist hospitals places patients under stress because they are on waiting lists for months or, in some cases years, before their follow-up visits.
In addition to all of those features, Saudis, like most people in the Eastern world, are oriented to thinking about decision-making within the context of and benefit to the extended family, not just what is wanted by or is best for any one individual (Tan-Alora and Lumitao, 2001; Barr, 2002). This is a point taken up by some Western commentators who argue that health ought to be perceived in a more general way than just as the right of several individuals to decide (Ter Meulen et al., 2007). In Western ethics, on the other hand, there is nothing to stop an individual regarding his/her interests as being inseparable from those of his/her family or community. But individuals are not presumed to be subjugated to the interests of the family as a whole. However, according to Dunstan (1994) individualistic autonomy presupposes the right to decide what to do based on one’s own preferences about what matters in one’s life without interference by others. This view is dominant in
103 Western liberal bioethics literature (Stirrat and Gill, 2005). Dunstan (1994) contrasts this with non-Western cultures, where ethical norms do not require having the right to choose as individuals. Most decisions are not made with a sole focus on the individual themselves; rather, they concern how decisions would affect not only one’s spouse and children but also one’s parents, siblings, and, in some cases, one’s wider family. The core difference, I therefore argue, is in how the policymakers see the patient, not the grounds on which the individual’s decision is taken. The policymaker regards the patient/participant as an individual who has the right to decide individually according to his own beliefs even if the decision would infringe on others’ interests. Alternatively, someone might say that the policy-maker ought to look at the participant as part of a community, tribe, or family that could be harmed by that individual’s decision. MGE research in Saudi Arabia is regulated based on the autonomy-based bioethics where an informed consent document records the consent of participants as individuals rather than as part of bigger families, or even tribes.
In the Saudi context individualism might not be the most appreciated value;
family however is considered to be extremely valuable for Saudis, and it lies between the levels of individuals and governments. The marriage between two people, for example is about family decision-making, it is the union between two families or, in some cases, two tribes, not just two individuals. Thus, the approval for the marriage should originate from a circle of people that is larger than the two persons who wish to get married. Such practices provide a cultural safety net, if something goes wrong.
For example, if someone has children, the whole extended family is morally
104 responsible for taking care of them in the event that their parents are unable to do so.
In the extreme case, people take the value of family to mean that when a father dies, it would be the duty of his brother to marry his widow and raise his children. In such a culturally rich environment (i.e. where even marriage decisions are taken by the entire family and brothers feel obliged to raise their nephews and nieces) promoting an individualistic autonomy-based can be regarded as untenable (Alsuwaigh, 1989).
Despite these complex cultural forces, the current Saudi guidelines suggest that consent should be gained from individuals. The concern is that in Saudi Arabia, MGE research is still in its early stages (Adlan, 2013; Abolfotouh & Adlan, 2011), although because of massive investments, MGE research is advancing rapidly. The common practice, however, seems to be international collaborations, which help researchers to advance their knowledge and publish in higher impact journals. That in turn depends on research with global impact thereby encouraging further international collaborations (Alwattan, 2015).
Notwithstanding the cultural norms of family decision-making there is the additional issue that MGE research may have an impact on whole families rather than individuals. For instance, according to Saudi policies, collecting blood from a few members of a family who have individually consented is sufficient to conduct family-based genetic research. Depending on the type of investigation, a research team can obtain information about a whole family, including those family members who did not consent. This is a general issue raised in genetic research, not only MGE research in Saudi Arabia (Hallowell et al., 2003; Forrest et al 2003). However, what makes such texts in Saudi Arabia more controversial is that the genetic information
105 from one family can give substantially reliable information about the whole tribe because of the genetically homogenous tribes in Saudi Arabia that was described earlier (See Subsection 1.3 Challenges of MGE research in Saudi Arabia).
One of the principal objections to the current Saudi guidelines is that individualism seems to undermine the value of groups, family and/or community.
This encourages the idea that when a critical medical decision must be made, health providers look for people to decide what is best for them individually, which, in some cases, comes into conflicts with the potential good of families or communities (Wolpe, 1998, Lindemann, 1995, Bowman and Hui, 2000, Glass and Rud, 2012, Etzioni, 2011). Despite all the challenges described in this subsection, autonomy-based bioethics is a main characteristic of the Saudi NCBE regulations. It seems to adopt the idea that signing the individual informed consent form is the main tool to protecting a participant’s interests.