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

I appreciate the author's efforts in clarifying their proposal and in accommodating the received comments. To me at least, the proposal is sufficiently clear at this point. A few minor suggestions:

- Regarding the family veto. This term is typically reserved for cases where the deceased has registered as a donor; the family refuses and the latter is decisive.But it is, of course, still true that family refusals are an important source for people's organs not being utilized.

- Author write 'As such, even under an opt-out system, families may still have significant reservations about consenting to organ donation on behalf of a deceased relative. Therefore, it may be culturally insensitive to implement a presumed consent system that may appear to disregard the wishes of the next of kin, which could risk public acceptance. '

This seems to be two different problems written as one. It might be culturally insensitive to implement an opt-out system that disregards next of kind, but then if we try to accomodate this through a soft opt-out system, we risk that next of kin will not consent to donation (But that is not because they are disregarded, if they were they would not be given the choice.

Regarding mandated choice. Might be worth highlighting the impressive share of the population that uses the app. Right now you just mention the absolute number, but some readers will not know how larges a proportion of the citizens that is.

One important specification that I found lacking is in what sense the choice is going to be mandated. Traditionally, mandated choice policies meant that you HAD to choose. If you did not choose you would loose something of value (i.e. access to a drivers licence).

Is this mandated choice in the same sense? What is lost here. The ability to use the app? If so, how big a deal that is depends on how important it is. Is it the only way to access something important? Will not having the app be inconvenient, or something worse?

If not much is at stake, then the proposal becomes more of what some call  an active choice policy (or incomplete mandated choice policy), where people are asked to choose (but not forced to do so).

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

This article interestingly presents the organ donation system in Saudi Arabia, and discuss various alternatives to the current model. In the end it recommends a policy change towards a mandated choice model. The arguments for this are partly normative (i.e. referring to weaknesses with alternative models, such as opt-in and opt-out), and partly of a more contextual nature, where it is argued that mandated choice is a better fit for Saudia Arabia than the alternatives (especially compared to opt-out). The authors write that mandated choice' could balance the respect for individual autonomy and the cultural role of families in Saudi Arabia'.

I appreciate this kind of contribution and understand that there are clear limits to what can be done in the space of an article. Despite this, I think that there are still room for improvement both in terms of how the existing theoretical debate is presented and in terms of how the more context-based argument is made.

Opt-in

In the discussion of opt-in (status quo) it would be worth mentioning that the register has only been in place for a few years, so we know little about its potential in the Saudi Arabian context – we do know, however, that it is often the case that many people don't register their preferences.

It would improve this reader's understanding of the current system, if the family's role was described a bit more. Do they, for example, hold a so-called family veto? (That is, is the family allowed to over rule, even when people have registered their wish to donate?)

Opt-Out

In the discussion of opt-out you could also cite Saunders' influential argument that people can provide tacit consent under such legislation (Saunders 2012). On such accounts, consent is not presumed.

In terms of the effect of opt-out, most newer studies find that opt-out countries tend to do better than opt-in countries (Costa-Font, Rudisill, and Salcher-Konrad 2021; Steffel, Williams, and Tannenbaum 2019; Ugur and Molina Pérez 2023) – but much of this research is done on European data – so I would, at any rate – not want to use those findings to say something definitive about what to expect in Saudi Arabia (just like the authors do not want to do so).
Author's write that opt-out 'might be unfeasible due to ethical considerations pertaining to the role of families' but this is unclear to me. Opt-out policies can be implemented in many different ways and can provide many different roles to the family (for a very useful overview, see (Molina-Pérez et al. 2022). Consider so-called soft opt-out legislation, where the family is allowed to decide if consent is presumed/tacit, but not when it is explicitly given. For example, the legislation in Wales (Albertsen 2018; Douglas and Cronin 2015). Note that many opt-out countries retain an organ donation register, and therefore, the possibility of opting-in. To make this argument convincing authors need to say more about the kind of reservations they have in mind among family members. For the argument to work, these reservations must hold across all specifications of an opt-out legislation, not just some.
Another critique of opt-out is that it sends a signal about what the right thing to do is (Beraldo and Karpus 2021)

Mandated Choice

Just to clarify: Would the proposed mandated choice policy only apply to this app's users? If so, what would happen with non-app users? Would there then just be an opt-in system for them?

Authors write about the Australian example: 'the discontinuation of that policy was partially due to the public's opposition to this system's potential to increase the number of donors.' I don't quite understand what this means.

What does it mean that people have not been given the opportunity to opt-out? Authors write: 'Furthermore, individuals are less likely to opt-out while alive if they have not been given the option of doing so, which may cause their families to consent after their deaths. 'And I don't see how the empirical claim in the following sentence is relevant for this. Please elaborate.

I think the ethical concerns with mandated choice policies are addressed briefly. And please provide a Sunstein reference to the idea of a right not to choose (Sunstein 2014, 2015). Authors write, ' In terms of ethical concerns, opposing views of mandated choice argue that requiring people to make a choice could undermine autonomy by taking away the right not to choose.'

The reply is that 'this system makes the two choices readily available; it increases a person's likelihood of making an autonomous choice and encourages self-determination.' But this does not change the fact that you are, forced to make a choice? Authors should recognize this. If you want to go deeper into the discussion about when such policies are autonomy-promoting, I have written an article about this (Thaysen and Albertsen 2021)

In sum: This is an interesting and important article. More should be done to strengthen the arguments, and clarify certain elements both in terms of how the current system is portrayed and how the theoretical debate over alternatives is described.

Minor:
I've learned that some find the term 'cadaveric donors' offensive and prefer deceased donors

This is an improved version of the article. I appreciate the authors’ effort to address my concerns. However, several important issues remain. In particular, the justification for the recommendation to change the consent model to a mandatory choice system is confused from an argumentative point of view. Furthermore, the article does not provide sufficient evidence or good enough reasons to support the potential effectiveness of this change in achieving its objective.

First, the recommendation of changing the consent system to address organ shortage is not sufficiently justified. 

In the introduction, the article states that "family refusal is a major obstacle limiting donation" (33% of family consent in 2019) and that the "unknown wish of the donor is one of the reasons for the families' refusal to consent". Although this second claim is not based on studies of the Saudi population, it is very plausible. [By the way, a systematic review of bioethics in Saudi Arabia, including 33 studies on organ donation and transplantation, was published very recently and might contain relevant data to support this second claim (Woodman et al. 2022). I encourage the authors to consult this review if they have not already done so.] The article then states that "to overcome this issue, improvements should be made in documenting potential donors' consent in organ donation registries".

So far, the rationale seems to be that since the shortage of transplantable organs is partly caused by high rates of family refusal, which is partly caused by unknown individual wishes, then improving the registration of individuals’ wishes may decrease family refusal rates and might, as a consequence, increase organ procurement. So far, so good.

Then, the article introduces opt-in, opt-out and mandatory choice and states that "This paper aims to analyze the different types of consent systems to address the issue of the high rate of family refusal […]". There is an argumentative gap here. It is as if changing the consent model is the only possible solution to mitigate the problem of family refusals caused by unknown individual wishes. However, we know there are alternative policies that could be implemented. So, why are the authors focusing on this one alone? Is it supposed to be more effective, or easier to implement, or cheaper than alternative policies?

In other words, among all the policies that could be implemented to try to increase individual registration and decrease family refusals, why is the article focusing only on changing the consent system?

Second, the recommendation to move to a mandatory choice system is not adequately justified. 

We will consider the three main reasons to move from opt-in to mandatory choice: effectiveness, ethics, and public support.

Effectiveness

First, the article correctly mentions that the opt-in system is arguably not the most effective (in terms of converting willing donors into actual donors) because, in Saudi Arabia as in several other countries, many individuals do not document their willingness to donate.

Then, the article suggests that the opt-out system is more effective by citing Rithalia and colleagues’ (2009) systematic review of the impact of opt-out. However, the article fail to mention that this study does not necessarily lead to this conclusion. According to Rithalia and colleagues: "The available evidence suggests that presumed consent is associated with increased organ donation rates, even when other factors are accounted for. However, it cannot be inferred from this that the introduction of presumed consent legislation per se will lead to an increase in organ donation rates." (Rithalia 2009, p.7)

There are more recent studies and reviews on this topic. Some support the idea that moving from opt-in to opt-out contributes to increasing organ donation rates. Others don’t. At this time, this issue is not settled yet.

Finally, the article mentions that implementing a mandated choice system and using the Tawakkalna app for this could increase the number of registered donors. The article also warns that "there is sparse evidence on the effectiveness of a mandated choice system in increasing the number of registered donors". Then, the article mentions a mandated choice policy in Australia that was discontinued because it was not successful.

It is quite obvious that individuals who want to donate their organs are more likely to register their consent in a mandatory choice system than in an opt-in system, because they are required to register their wishes. As a consequence, families are more likely to know the deceased’s wishes. However, individuals who do not want to donate are also more likely to register their refusal in a mandatory choice system than in an opt-in system. Although registered consents will increase, registered refusals will increase too. Therefore, there is no guarantee that moving from opt-in to mandatory choice will lead to increased organ donation rates. 

The recommendation of this article works on the paper, but it may not work in the real life. This article does not provide sufficient arguments or evidence to suggest that it might actually work. Arguably, changing legislation should not be a game of trial and error. As said in the abstract: "more research should be dedicated to investigating the Saudi public's current culture and perceptions of organ donation to ensure feasibility."
 
Ethics

The article claims that a mandatory choice system might be the optimal solution in terms of balance between the respect for individual autonomy and the cultural role of the family in Saudi Arabia. So, why is it better than opt-in and opt-out?

When examining the opt-in system from this perspective, the authors write the following:

"Some argue that an opt-in system respects personal autonomy since this policy can ensure that the individual's wishes to become a donor is acknowledged (Farsides, 2012; Taylor, 2005). On the other hand, opponents of opt-in policies state that it could undermine autonomy by harvesting organs from unwilling donors who did not document their wishes. (Gill, 2004)."

The second sentence is wrong: under an opt-in system those individuals who did not document their wishes are not considered as potential organ donors, because by definition in order to be considered as a potential donor, they must have opted in. By contrast, it is true that, under an opt-out system, organ can be procured from individuals who didn’t want to donate but failed to express their refusal.

When examining the opt-out system, the authors write the following: 

"A presumed consent system is ethically sound and may not violate autonomy; nevertheless, there are some concerns."

There is a heated debate in the literature with regard to the ethical acceptability of presumed consent and whether or not it is respectful of individual autonomy. The very idea that someone’s consent could be presumed is problematic. Therefore, I wonder what reasons lead the authors to claim that presumed consent is ethically sound and may not violate autonomy.

The article then mentions that "the presumption of consent is ’morally no worse than not removing organs from the bodies of people who did want them removed’ (Gill, 2004)". This sentence confuses two distinct issues. On the one hand, Michael Gill shows that there is presumption on both sides: opt-out presumes willingness to donate, opt-in presumes unwillingness to donate. There is no particular moral issue there. On the other hand, Gill argues that removing organs from the bodies of people who did not want them removed (opt-out) is "morally no worse than not removing organs from the bodies of people who did want them removed".

Eventually, the article mentions the following: 

"However, applying a presumed consent policy in the context of Saudi Arabia might be unfeasible due to ethical considerations pertaining to the role of families. In many cases, the family trumps an individuals' autonomy (Al-Shahri, 2002). Therefore, it may be culturally insensitive to implement a presumed consent system that disregards the wishes of the next of kin completely, which could risk public acceptance."

There is a leap of argument between the second sentence and the third. The second sentence mentions the fact that the family can overrule the deceased’s wishes (trump an individual’s autonomy). This is actually quite common around the world and not specific to Saudi Arabia (Rosenblum et al. 2012; Delgado et al. 2019). The third sentence mentions that an opt-out system that disregards the wishes of the next of kin completely could risk public acceptance. Ok, but what about implementing an opt-out system that does not disregard the wishes of the next of kin? These soft opt-out systems are very common worldwide (Rosenblum et al. 2012; Delgado et al. 2019). If the family in Saudi Arabia is allowed to have the last word in the decision-making process under the opt-in system, the family may be allowed to have the last word under an opt-out system too. Besides, the authors’ remark would also apply to a mandated choice system that disregards the wishes of the next of kin completely.

When examining the mandated choice system, the article mentions that "requiring people to make a choice could undermine autonomy by taking away the right not to choose" and that "nevertheless […], it increases a person's likelihood of making an autonomous choice and encourages self-determination". So, mandated choice encourages self-determination by taking away people’s right not to decide. Whether this is morally better or worse than the opt-in system is debatable.

Public support

Finally, the article mentions that "a study conducted in Saudi Arabia ranked mandated choice as the most favored consent system", but warns that "the study was limited to a single tertiary hospital, and nation-wide studies must be conducted to further validate this finding".

Summary

To summarise the rationale used in this article to recommend a mandated choice system: (1) It is unclear whether or not a mandated choice system would be more effective in increasing organ donation; (2) It is debatable whether a mandated choice system is morally better than opt-in; and (3) there is some but insufficient evidence to support that people in Saudi Arabia would prefer a mandated choice system better than opt-in, opt-out.

This is not a compelling rationale.


MINOR ISSUES

"This result was partially due to the opposition to this system's potential to increase the number of donors who opt-out of being a donor."
--> I don't understand this sentence.

"One of the main obstacles to obtaining family consent in Saudi Arabia is family refusal."
--> I don't know what this sentence is supposed to mean. That "family refusal is the main obstacle to family consent" is analytically true.

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.