Information and Communication Technology and Interactive Communication

As explained previously (see Subsection 1.1.1 Informed Consent) the consensus among research bioethics commentators is that voluntariness (assuming competence), disclosure (assuming full understanding) and decision (accepting or refusing) characterise informed consent (Meisel and Roth, 1981; Beauchamp and Childress, 2002). Disclosure, for example, was argued to be an unrealistic expectation; and the paradox is that if it is not fulfilled a question would be raised about the legitimacy of informed consent (Manson and O'Neill, 2007). The main disclosure assumption is that an explicit amount of information should be disclosed to participants, which includes all the relative information about the research, the

106 choice, the alternatives, the risks with their likelihood and any information that might affect the final decision in a way that is comprehensible to the participant. The list of details is growing to the extent it would be impossible to comprehend the whole amount (e.g. a 30 page consent document and/or information sheet) (Manson and O'Neill, 2007). Due to the complex nature of MGE research where information is very sophisticated the disclosure would be even more difficult.

4.3.1 Informed consent and the assumption of vulnerability

The other challenge to the way in which informed consent is gained, is the assumption of voluntariness. I will take voluntariness in the same way intended by the Saudi NCBE regulation as being free to act without exploitation or coercion (NCBE, 2010). Beauchamp & Childress (2009) argued that coercion requires a genuine actual threat of force to ‘displace a person’s self-directed course of action’

(Beauchamp and Childress, 2009, p133). The problem is that both physician and patient/participant come to the consent interview with a set of norms and values that drive specific assumptions about the relationship between them (Corrigan, 2003).

Therefore, it is problematic if a person genuinely thought that upsetting her physician by saying ‘no’ would threaten her treatment privileges or might cost her access to that physician.

An informed consent is intended to prevent overt coercion (Corrigan, 2003), but covert coercion also needs to be taken into account. For example, in the Saudi context as I explained (see Subsection 1.2.4 Patient Vulnerability) patients are under the influence of two strong forces. The first is their feeling towards their physicians as their healer who should be trusted without question. Second, the fact that MGE

107 research is running in most sophisticated hospitals where only those who have the support of a Crown Prince can be treated (see Subsection 4.1.1 Autonomy-Based Bioethics). One can argue that this is especially the case because there were no clear unified Saudi research ethics guidelines before 2010 to address the risk of coercion among Saudi patients. This means that physicians were acting according to the environment of trust rather than a dictated specific imported ways of understanding coercion.

4.3.2 Informed consent and the value of trust

This environment of trust is not alien to the Saudi cultural context explained in subsection 1.2 The Saudi Arabian Context. The reality of the tribal culture is built on trust. The tribe members come to trust a specific person in the tribe, either one of their elders or the most religious tribal member. This person is trusted to protect the interests of his people under the tribal cultural laws. This culture is even reflected in the Saudi political system. The Saudi monarchy is mainly a tribal monarchy. In this system the king represents the family wise person, the elder who make decisions on behalf of the tribes that agreed to obey him. Based on this, it can be said that the value of trust is deeply rooted in the Saudi culture. Therefore, it is not strange for Saudis to try and find an authoritative figure in health-related services to trust and obey.

This, however, should not mean that Saudis must trust their physicians to the extent that they will donate blood for MGE research even when this is something they do not want to do. Consent must be crucial; the problem is that a signed document is all that is needed to extract patient blood for MGE research.

108 4.3.3 Informed consent in Saudi hospitals

Saudi hospitals used to use their own local hospitals’ regulations to regulate research and, specifically, informed consent long before the Saudi National Committee announced its new regulations in 2010. One of the central goals of the national committee was to provide unified regulations for all the hospitals and research centres that legally bind every researcher who uses human participants. In numerous cases, informed consent in Saudi Arabia is no different than many other places that reduced the informed consent process to the technicality of a signed informed consent document on official paper (Abolfotouh and Adlan, 2011; Adlan, 2013).

Another point that might affect the consent process, as understood by Western policy-makers, is that there is a clash between the regulations (i.e. expecting Saudi patient to choose based on explicit informed consent) and the Saudi culture (where a patient trusts his physician to uphold his best interests I have already published the results of a quantitative cross section survey that suggests that patients are dependent on their physicians and fear upsetting them (Abolfotouh and Adlan, 2011). It was a survey of 162 patients designed to assess the quality of informed consent for invasive procedures at a tertiary hospital in Riyadh, Saudi Arabia. The majority of the patients (87.7%) who agreed to sign the informed consent form thought that they were fairly well informed, despite 66.5% reporting that they were told that signing the form was simply routine paperwork. We doubted the claim that patients were informed, they might think that they were informed because they were told that the signature on the informed consent form is just paperwork (Abolfotouh and Adlan, 2011). In addition,

109 approximately 35% of them thought that the information given as part of the process of gaining consent was insufficiently explained to them. Another interesting finding was that the mean score of the overall experience and satisfaction is almost 54 ± 17.88, which reflects lack of satisfaction. Sixty-six percent of the surveyed sample reported that they were told that the informed consent is just paperwork. This could mean either that the Saudi doctors are breaking the law or it could support my overarching argument that autonomy-based bioethics framework need to be reviewed to regulate bioethics in Saudi Arabia. Among these survey participants it seems that patient-physician relationship was more regarded than the right of patient to decide individually because the overall quality of informed consent is better when the doctor is the one who is taking consent as oppose to any other member of the research team (Abolfotouh and Adlan, 2011) which reflects the importance of patient-physician relations.

Another cross-sectional survey of 528 persons attending Saudi outpatient clinics at a tertiary care hospital investigated patients' attitudes towards the idea of using their medical files in retrospective research without their consent and using their surplus tissue in research (Al-Qadire et al., 2010). They reported that patients are more likely to accept researchers using data from their medical records (MR) than non-patient (companions) who attended the same hospital. Most importantly, they found that Saudis perceived MR differently to surplus tissue-based research, which is strong indication, that blood, even surplus blood, ought to be treated differently than MR.

110 It is also important to note that Al-Qadire’s (2010) findings in term of people who wish to be consented contradicts the work I published in 2011. They reported that only 38% and 37% of their sample would accept use of MR and Tissue-based Research (TR) respectively without consent. It is important to bear in mind that the sample population is different but more important than the population difference is that both are cross sectional studies using surveys. The main limitation of cross sectional studies is that they only provides specific information about a specific time in a specific context described by the researchers which means it is not generalizable (Sugarman et al., 2001). Another way of looking at it is that in our 2011 published work we found a positive correlation between the overall satisfaction and quality of the informed consent when physicians are the ones who gain consent. The 2010 study did not specify the consenting context (for example who asked the patients to consent).