Changing the method of consent to increase the numbers of cadaveric donors in Saudi Arabia: the autonomy paradox

The article first describes the organ donation system in Saudi Arabia and identifies the high rate of family opposition as one major obstacle to increasing cadaveric organ donation rates in the country. Then, the article presents the three main consent policies: opt-in (explicit consent), opt-out (presumed consent), and mandated choice, advocating for the latter one as the best alternative in the context of Saudi Arabia.

Overall, the article is well written and provides a clear and accessible overview of the consent policy alternatives. One interesting point mentioned in the article is the use of the Tawakkalna app as a means of registration of individual preferences about organ donation. However, the article lacks depth in its analysis and suffers from some mistakes and inaccuracies that need to be addressed.

"Does the paper provide a comprehensive overview of the policy and the context of its implementation in a way which is accessible to a general reader?" 

Only partly. The overview is accessible to a general reader but it is not comprehensive and it lacks depth in its analysis. Also, its main hypothesis is based on insufficient evidence.

For instance, after mentioning that only 33% of approached families authorised in 2019 the retrieval of organs from their loved ones, the article claims that the relatives’ lack of knowledge of the deceased’s wishes as one of the main reasons for the families’ refusal. [By the way, the wording of the sentence beginning "Lack of knowledge of the potential donor…" should be revised.] This second claim is based on Palmer 2012. Although this reference appears to be a good review of the literature, it has not been peer-reviewed. In addition, it is also relatively outdated (meaning that other reviews have been conducted more recently) and the studies reviewed were conducted mostly in English speaking Western countries: the United States, the United Kingdom, Australia, which means that their conclusions may not necessarily be extensible to other cultural contexts such as Saudi Arabia. In other words, although it may be true that lack of knowledge by the family is, in these countries, one of the main reasons for their refusal, there is no guarantee that the same conclusion holds in other countries, especially when these countries (e.g. Saudi Arabia) have a different social organization, religion, and cultural background.

Since the argument of the article is based on the claim that family refusals are mainly caused by the family’s lack of knowledge of the potential donor wishes (which could be addressed, according to the authors, by a mandated choice policy), stronger evidence is needed to support this claim, especially in the context of Saudi Arabia. In other words, authors should provide more updated and compelling evidence that this claim is true—or, at the very least, that it may be true in their country—before proposing a policy to address it. 

There is a rich and vast literature of empirical studies on the factors of family decision-making and willingness/refusal to donate that are contemporary or posterior to Palmer 2012. Here are some peer-reviewed literature reviews I am aware of, including some systematic reviews:

• Kentish-Barnes N, Siminoff LA, Walker W, Urbanski M, Charpentier J, Thuong M, et al. A narrative review of family members’ experience of organ donation request after brain death in the critical care setting. Intensive Care Med 2019;45:331–42.¹
• Miller C, Breakwell R. What factors influence a family’s decision to agree to organ donation? A critical literature review. London Journal of Primary Care 2018;10:103–7.²
• Makmor T, Abdillah N, NurulHuda Ms, Raja Noriza RA, Roza Hazli Z. Family Decision-Making About Organ Donation: A Systematic Review. JUMMEC 2015;18:1–4.³
• Ralph A, Chapman JR, Gillis J, Craig JC, Butow P, Howard K, et al. Family Perspectives on Deceased Organ Donation: Thematic Synthesis of Qualitative Studies. American Journal of Transplantation 2014;14:923–35.⁴
• Walker W, Broderick A, Sque M. Factors Influencing Bereaved Families’ Decisions About Organ Donation: An Integrative Literature Review. West J Nurs Res 2013;35:1339–59.⁵.
• de Groot J, Vernooij-Dassen M, Hoedemaekers C, Hoitsma A, Smeets W, van Leeuwen E. Decision making by relatives about brain death organ donation: an integrative review. Transplantation 2012;93:1196–211.⁶
• Irving MJ, Tong A, Jan S, Cass A, Rose J, Chadban S, et al. Factors that influence the decision to be an organ donor: a systematic review of the qualitative literature. Nephrology Dialysis Transplantation 2012;27:2526–33.⁷

Other relevant reviews and recent articles include:

• Curtis RMK, Manara AR, Madden S, Brown C, Duncalf S, Harvey D, et al. Validation of the factors influencing family consent for organ donation in the UK. Anaesthesia 2021:anae.15485.⁸
• López JS, Soria-Oliver M, Aramayona B, García-Sánchez R, Martínez JM, Martín MJ. An Integrated Psychosocial Model of Relatives’ Decision About Deceased Organ Donation (IMROD): Joining Pieces of the Puzzle. Front Psychol 2018;9.⁹
• López JS, Martínez JM, Soria-Oliver M, Aramayona B, García-Sánchez R, Martín MJ, et al. Bereaved relatives’ decision about deceased organ donation: An integrated psycho-social study conducted in Spain. Social Science & Medicine 2018;205:37–47.¹⁰
• Chandler JA, Connors M, Holland G, Shemie SD. “Effective” Requesting: A Scoping Review of the Literature on Asking Families to Consent to Organ and Tissue Donation. Transplantation 2017;101:S1–16.¹¹
• Shah SK, Kasper K, Miller FG. A narrative review of the empirical evidence on public attitudes on brain death and vital organ transplantation: the need for better data to inform policy. Journal of Medical Ethics; London 2015;41.¹²
• Sharp C, Randhawa G. Altruism, gift giving and reciprocity in organ donation: A review of cultural perspectives and challenges of the concepts. Transplantation Reviews 2014;28:163–8.¹³
• Siminoff LA, Agyemang AA, Traino HM. Consent to organ donation: a review. Progress in Transplantation 2013;23:99–104.¹⁴

After mentioning the lack of evidence as "one of the main reasons for the families’ refusal to consent", the authors write: "To overcome this issue, improvements should be made in documenting potential donors’ consent in organ donation registries." This conclusion does not necessarily follow or only partially. There are several other means to address family refusal rates, on the one hand, and the lack of knowledge issue, on the other. These means include mass media campaigns, targeted educational campaigns, the presence of a Specialist Nurse for Organ Donation (SNOD) as it is done in the UK, extensive training of transplant coordinators for the family interview as it is done in Spain, financial incentives to donation, prioritization programmes as it is done in Israel, etc. Some countries (e.g. Germany) with much lower family refusal rates than Saudi Arabia, do not have an organ donation registry but only an organ donor card. Other countries (e.g. Spain) with very low family refusal rates, do not have any registry at all (except for living wills that are barely used in practice for registering organ donation preferences) nor any official organ donor card. Fostering communication about organ donation among relatives and training the medical staff to conduct the family interview are alternative ways to increase family knowledge without requiring the registration or documentation of individual preferences.

In the next paragraph, the article says: "There are three known methods of consent when registering to become a donor upon death: informed consent (opt-in system), mandated choice and presumed consent (opt-out system)." This wording is confusing. First, the opt-in system is not based on informed consent but only on explicit or expressed consent. Second, although the opt-out system is compatible with a registry of refusals, presumed consent only applies when no registering has taken place. Third, it is important to differentiate the models of individual consent (informed, presumed) and consent policies (opt-in, opt-out, mandated choice) from the means available to individuals to express their consent or refusal to donate. Some countries have registries, others don’t, regardless of their consent policy.

The article then states its main objective: "This paper aims to analyze the different types of consent systems to address the issue of the high rate of family refusal. The study offers some important insights that will aid decision-makers in selecting an alternative that is more likely to reduce the shortage of organs."

This objective presupposes that there is a causal relationship between the consent systems and the rates of family refusal. I would recommend the authors provide references or data to support such an assumption. I ignore whether this is the case or not and whether there is at least a correlation between the two. I am really curious about it. By looking at the Global Observatory on Donation and Transplantation’s Newsletter Transplant 2017, which provides data on family refusal in many countries throughout the world, I fail prima facie to see any trend that may be related to the consent systems in place.

With regard to the article’s proposal of a mandated choice policy, it is true that if registering a preference in favour or against organ donation was mandatory in the country, this would likely increase the registration rates and decrease the families’ lack of knowledge about their loved one’s wishes. As a consequence, the number of family refusals caused by this lack of knowledge would also likely decrease. Question is: first, is this the best way to increase organ donation rates and, second, how many family refusals are actually caused by lack of knowledge in Saudi Arabia?

To answer these questions, it would be good to give some perspective. According to the Global Observatory on Donation and Transplantation, Saudi Arabia had a deceased organ donation rate of 3.3 pmp in 2019 and 1.9 pmp in 2020, which is relatively low although not in the lower end of the ranking. In 2017, according to the same source, Saudi Arabia had a population of 32.2 M and a total of 92 deceased donors, that is, a rate of 2.9 donors pmp; 333 family interviews were conducted asking for authorisation, out of which 230 (69%) refused. The article mentions that, according to a 2009 study of Saudi University students, "about 70% of participants are willing to become donors". If this figure was representative of the general population, if all individuals had registered their wishes, if all families of those willing to donate authorised organ procurement, and if all potential donors were eventually converted into actual donors, the total number of donors in 2017 would have been 92 + (333 x 70%) = 325, increasing the donors rate to 10% which is much better (comparable to that of Germany that same year). [Another study (Alnasyan et al. 2019) also cited in the article but whose figures on willingness to donate are not mentioned by the article says that 77.7% of the general public expressed a willingness to donate, although 29.1% were willing to donate only to their relatives]

The problem is that we don’t know how likely is such a scenario. There are no data provided in the article regarding how many of the family refusals were caused by lack of knowledge or by other reasons such as those cited in Palmer 2012: Not wishing for surgery to the body/having concerns regarding disfigurement; Feelings that the patient had suffered enough; Disagreements among the family group; Religious/cultural reasons; Dissatisfaction with healthcare staff and process; Concerns over delay to funeral/burial process; Unable to accept death, or lack of understanding of brain death; Concerns regarding the integrity of process e.g. unfair organ allocation of organs and organ selling; Relatives deciding themselves that organs would not be suitable; Longstanding negative views on organ donation; Relatives were emotionally exhausted.

Actually, the article itself mentions that some unknown proportion of the family refusals may not be caused by lack of knowledge: "It is important to note that, under the current policy, families still have the right to veto that decision despite their loved one’s consent to become a donor." Also: "In many cases, the family trumps an individual’s autonomy (Al-Shahri, 2002)" The reference here cited (Al-Shahri, 2002) says "In Saudi culture, the authority of the family overrules the individuals’ autonomy. Decisions taken by patients can often be altered according to the views of the family". I am thus curious to know the proportion of families who veto the deceased’s consent as well as their reasons to do so, because this is not caused by lack of knowledge of the deceased’s wishes, and some of the families who do lack knowledge may share the same reasons to refuse as those who don’t.

Is the discussion on the implications clearly and accurately presented and does it cite the current literature?

The discussion on the implications is quite clear but it lacks accuracy and it does not cite enough updated and relevant literature.

For example, the authors mention that "According to a news article, the number of registered donors increased from 20,000 to 200,000, which is a 115% increase after the launch of the donor registration feature". This is a ten-fold increase and definitely not a 115% increase. Something is wrong. I checked (using an automated translator) the news article cited here and it seems that these figures are actually mentioned. I failed to see any sources cited in the news article. This tells me that this news article is not reliable and thus it is not worth citing in a scientific article. Anyway, even if the 20,000 to 200,000 increase in registrations was true, compared to more than 34 M inhabitants in 2021, this represents only 0.6% of the total population. This is much better, but still anecdotal.

Another example. The article claims that "after adopting a hard opt-out policy in Austria, the rate of donations quadrupled within eight years (Zink et al., 2005). On the other hand, a soft approach to the policy did not impact donation rates in Spain, which indicates that a hard opt-out policy could be more effective." There are several problems here. First, the reference cited with regard to Austria does not provide any evidence for the claim but cites two other sources, one of which¹⁵ makes this claim without any evidence or references provided. This claim may be true or it may not, but the reference cited here is not sufficient to support the claim. Second, with regard to Spain, the policy is soft in clinical practice but hard according to the law. Third, what did impact donation rates in Spain was not the implementation of an opt-out policy in 1979, but the creation of the National Transplant Organisation (ONT) in 1989. Fourth, it is odd to claim that a hard opt-out policy (such as in Austria) could be more effective than a soft opt-out policy (such as in Spain) considering that Spain has a much higher donation rate (49.6 pmp in 2019) than Austria (23.4 pmp in 2019) according to the GODT. Fifth, several studies, including systematic reviews, have explored the impact of presumed consent policies. They should be cited.

One more example. The article mentions "a study in the Netherlands, a country that adopted a mandated choice, concluded that this system generated more registered donors than both informed and presumed consent systems (Van Dalen & Henkens, 2014)." First, the Netherlands had not adopted a mandated choice policy but an opt-in system (as the authors of the cited study clearly state in their article). Second, the Netherlands have recently implemented an opt-out system. Third, the cited study does not assess the actual performance of a mandated choice system in the country but compares, in an experimental setting using counterfactuals, whether people would register as donors (hypothetically) if they moved to a region with presumed consent, explicit consent, or mandated choice. Fourth, the results from this study show that people would be more willing to register as donors under a mandated choice system (66%), but this result is only 4 points higher than presumed consent (62%) and many more people would also refuse to donate under a mandated choice system (34%) than under a presumed consent system (18%). In other words, mandated choice would increase donors by 4% and non-donors by 16% when compared to presumed consent.

Are the recommendations made clear, balanced, and justified on the basis of the presented arguments?

The first recommendation is changing the method of obtaining consent from opt-in to mandated choice. Considering the comments above, it is not sufficiently justified. The authors may want to look at a similar recommendation made in other countries, such as a law proposal (unsuccessful) made by members of the German Parliament (see http://dip21.bundestag.de/dip21/btd/19/110/1911087.pdf, text in German), as well as the report on organ donation by the Swiss National Human Medical Ethics Commission (see https://www.nek-cne.admin.ch/inhalte/Themen/Stellungnahmen/fr/NEK-Stellungnahme_Organspende_FR.pdf, text in French).

The second recommendation refers to modifying the Tawakkalna App. The proposed modifications may be useful, provided that more people register their organ donation preferences in the app. 

The third recommendation or part of it is sensible: "more research dedicated to assessing the feasibility of implementing a new consent system", as well as "understanding the current Saudi context" to predict [I would say, estimate] its success.