Changing the method of consent to increase the numbers of cadaveric donors in Saudi Arabia: the autonomy paradox [version 3; peer review: 2 not approved]

Background: In Saudi Arabia, the gap between the demand and availability of organs persists, with a total of 13,731 patients who remain on the waiting list in 2019. Family refusal is a major obstacle limiting donation since their consent must be obtained prior to the retrieval of organs. The cause of family refusal is mainly due to the unknown wishes of their loved one to become a donor. This analysis aimed to compare three systems of obtaining consent in terms of effectiveness, respect for personal autonomy, and the cultural role of families in Saudi Arabia to ensure feasibility and effectiveness in increasing the number of donors. Policy alternatives and implications: The consent systems include opt-in (explicit consent), opt-out (presumed consent), and mandated choice systems. The mandated choice policy might be the optimal solution to investigate since it could balance the respect for individual autonomy and the cultural role of families in Saudi Arabia. Conclusions and recommendations: Mandated choice could be an option that ensures the respect of personal autonomy while influencing the next of kin's decision to donate the organs. Nevertheless, more research should be conducted to support adopting this policy in the Saudi context. Additionally, a recommendation to decision makers is to utilize the Tawakkalna app to send alerts to the next of kin when a user registers as a donor with the user's consent.

There are two main types of donors: 1) living-related and nonrelated; and 2) cadaveric donors. Cadaveric donors are the main source of organs in Saudi Arabia; therefore, the shortage might not be resolved by utilizing living donors (Alsebayel et al., 2004). The current process for organ procurement in Saudi Arabia requires the intensive care unit (ICU) staff, or in some cases, the emergency room (ER) or the surgical unit staff, to identify possible cadaveric donors. A nurse assigned by SCOT notifies the center about the potential deceased donor and documents it. Then, clinical examinations are performed to ensure that the donor meets the brain death criteria developed by SCOT and the Saudi Ministry of Health (MOH). After the process is complete and the declaration of brain death is officially obtained, the ICU physician is required to approach the donor's family to obtain written consent using an official consent form (Al-Dossary et al., 2013).
Possible obstacles that hinder this process include health providers not reporting cases of possible cadaveric donors, family refusal to consent, medical causes, and lack of awareness on the part of hospital staff in donor hospitals. Family refusal is a major obstacle limiting donation, with only 33% of approached families consenting to donate their loved one's organs in 2019 (Saudi Center for Organ Transplantation, 2019). The unknown wish of the donor is one of the reasons for the families' refusal to consent (Kentish-Barnes et al., 2019; Walker et al., 2013). To overcome this issue, improvements should be made in documenting potential donors' consent in organ donation registries.
There are three known systems of obtaining consent to register donors namely: opt-in, mandated choice, and opt-out systems (Al-Dossary et al., 2013). This paper aims to analyze the different types of consent systems to address the issue of the high rate of family refusal while taking the cultural and ethical context into consideration. 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.
Policy alternatives and implications Opt-in system (status quo) The current method of registering donors in Saudi Arabia is an opt-in system where individuals voluntarily state that they wish to become donors upon death. Originally, there was no organ donation registry in the Kingdom, and donors were encouraged to fill out donor cards issued by SCOT to document their wishes to be donors upon death. The lack of a registry made it difficult to identify the deceased decision to notify the family unless the donor card was found at the time of death. 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 (Al-Dossary et al., 2013).

REVISED Amendments from Version 2
We made the following minor changes: -We made an acknowledgment that the policy requires further research.
-Other minor errors and clarifications were made as suggested by the peer-reviwer.
Any further responses from the reviewers can be found at the end of the article Donor cards were recently replaced with online registration on SCOT's website as well as the Tawakkalna app. The App was developed by the Saudi Data and Artificial Intelligence Authority (SDAIA) to display the users' coronavirus disease 2019 (COVID-19) status upon entry to public places following government regulations. Due to most of the Saudi public downloading the App, SCOT collaborated with SDAIA to allow users to register to become donors through it (Tawakkalna, 2020).
After merely 26 days of launching this feature on the App, over 194 thousand users have registered as organ donors. This rapid number of registered donors was attributed to the App's ease of use and accessibility (Saudi Press Agency, 2021).
Nevertheless, when it comes to an opt-in system, there is still a likelihood that willing donors may not register. This issue is prevalent in several countries around the world with a similar opt-in system. For instance, in the United States, 95% of adults support organ donation, while merely 54% are registered as donors (Anderson, 2017). There are limited studies on this obstacle in Saudi Arabia; nonetheless, one study investigated the willingness of Saudi University students to become donors upon death. According to the results, about 70% of participants are willing to become donors; however, none of them carried donor cards (Al-Ghanim, 2009).
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 organs can be obtained from individuals who did not explicitly refuse to donate, but did not express their willingness to do so (Gill, 2004).

Presumed consent system
In a presumed consent system, an individual is assumed to be a donor unless they specifically opt-out. Opponents of this policy argue that it could lead to the removal of organs from individuals who did not want to become donors. On the other hand, the presumption of consent is "morally no worse than not removing organs from the bodies of people who did want them removed" (Gill, 2004).
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. Additionally, a presumed consent system was found to be the least favored by the Saudi public (Hammami et al., 2012).

Mandated choice system
Another possible solution is to replace the current policy with a mandated choice system, where citizens are required to either opt-in or opt-out of becoming organ donors. This system can be implemented in Saudi Arabia by utilizing the preexisting organ donation registration feature on the Tawakkalna app. Currently, the App offers the option to sign up to register as a donor voluntarily; nevertheless, users can unknowingly leave it blank. By implementing a mandated choice system, the App can require individuals to fill out their choice along with the rest of their medical information. 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. Nevertheless, this system makes the two choices readily available; it increases a person's likelihood of making an autonomous choice and encourages self-determination. In other words, this system eliminates the presumption involved, and each individual could explicitly state their wishes before death.
Moreover, religion and culture play an important role in determining how society perceives autonomy (Fundamentals of Research on Culture and Psychology: Theory and Methods, 2016). According to an Islamic belief, a good deed must be done with intent by the individual, which may not be the case in a system that makes you a donor by default (Hammami et al., 2012). Additionally, due to the accessibility of the App, individuals can opt-out at any time, which could further ensure the next of kin that this was their loved one's wish with more confidence (Steffel et al., 2019).

Actionable recommendations
In addition to existing efforts to boost the number of donors, implementing a mandated choice policy could enhance the donor registration feature on the Tawakkalna App. This policy would eliminate the presumption barrier by allowing individuals to explicitly express their desire to be a donor prior to their passing. This approach is more likely to be practical in Saudi Arabia due to the cultural significance that families hold in the Kingdom. Nevertheless, more studies need to be conducted to investigate this policy's feasibility in Saudi Arabia, given its cultural, religious, and social context to ensure its success (Al-Khader et al., 2003).
In addition to changing the method of obtaining consent, there are several other recommendations to maximize the benefits of implementing a mandated choice system. The Tawakkalna App could be modified to send alerts to notify the next of kin once a user selects their donation decision with the users' permission. Additionally, the users can be asked why they chose to opt-out of donation to investigate the underlying factors influencing donation registration rates.

Conclusion
One of the main obstacles to procuring organs in Saudi Arabia is family refusal. The method of obtaining consent could influence the next of kin's decision, especially if it accurately reflects the donor's decision. Due to the cultural role of families in Saudi Arabia, obtaining consent must carefully balance respect for individual autonomy and the role of families. Therefore, we urge decision-makers to support further research on mandated choice policies as a potentially viable solution to optimize the organ donor registration feature in the Tawakkalna App.

Data availability
No data are associated with this article. This is an improved version of the article. I appreciate the authors' effort to address my concerns.

References
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 optout 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 ). 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.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.
Author Response 21 Jun 2023

Deema AL Shawan
Dear Peer Reviewer, Thank you for taking the time to review our policy brief. Once again, we appreciate your thoughtful feedback and are glad to hear that you found the brief well-written.
We acknowledge that the evidence on the effectiveness of different registration consent methods is inconclusive. However, our brief aimed to frame the issue in a simplified manner and highlight implications for further research, specifically to collect more evidence on the effectiveness of mandated choice in Saudi Arabia.
We would also like to clarify that our brief's aim was not to provide a comprehensive, indepth ethical analysis but rather to provide a brief overview of the different considerations concerning Saudi culture.
Nonetheless, we have incorporated some of your valuable suggestions into the revised version of the brief. We hope these revisions have addressed your concerns and improved the quality of our work.
We appreciate your constructive criticism and feedback.
Best regards,

Dr. Deema Saad Al Shawan
The following is point-by-point response to your concerns: -First, the recommendation of changing the consent system to address organ shortage is not sufficiently justified.
-Second, the recommendation to move to a mandatory choice system is not adequately justified.
Thank you for your input.
We aimed to provide implications for further research since this topic is very understudied in Saudi Arabia. We did not claim this was the only option. This paper highlights a window of opportunity that can occur by optimizing organ registration on the Twaklna App. The different efforts of the Saudi Center for Organ Donation are mentioned in the Background section of the memo, including awareness campiness.
-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.
We appreciate the feedback, and we have updated the manuscript to acknowledge that.
-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. Thank you for pointing this out. The phrasing of the second sentence was corrected. Another article was cited with the correct clarification.
Thank you, we have made the correction as suggested.

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.
Thank you, we have made the edits as suggested and clarified the manuscript.
The increase from 20,000 to 200,000 is not "115%" as the authors claim. This needs to be corrected.

2.
When the authors write "…115% increase after the launch of the donor registration feature" do they mean that this 115% increase was immediate after the launch, and then numbers further increased, or do they mean to claim that the increase to 200,000 occurred in the total time after the launch? (The former construal would be compatible with there being an initial increase of 115% and then an greater increase subsequently.) 3.

Issue 2:
"As for ethical considerations, the current opt-in system respects an individual's autonomy. According to Immanuel Kant, undermining a person's autonomy is to treat that person as a mere means to an end without regard for the individual's own goals. Based on Kant's theory, organs from a deceased individual should not be harvested if the person's wish was not to be a donor, even if it intends to save others." There are three points that should be made with respect to the claims in this sentence. The authors should distinguish between personal autonomy and Kantian autonomy. On a theory of personal autonomy a person is autonomous with respect to her desires and actions if they flow from her motivational set in a way that ensures that they originate from her, rather than from elsewhere (where the requirements for what counts as originating from her are spelled out in the theory of personal autonomy that one adopts). On a Kantian account of autonomy a person is autonomous if (roughly) she acts out of respect for the moral law. These are distinct accounts of autonomy, and since the former is often of primary interest in discussions of organ procurement the authors would do well to focus on it rather than its Kantian alternative.

1.
Why couldn't an opt-out approach to organ procurement also respect a person's (personal) autonomy? The authors should see here Michael Gill's "Presumed Consent, Autonomy, and Organ procurement," Journal of Medicine and Philosophy 29, 1 (2004): 37 -59 1 .

2.
Merely claiming that Kant would hold that a person's organs should not be harvested after her death if she did not agree to this is insufficient. The authors need to argue that Kant (or Kantians) are committed to holding that persons have duties to respect the wishes of the dead.

Issue 3:
The authors should note that the differences in the effectiveness of the Austrian and Spanish systems might also be a product of differing infrastructure that is in place to secure available organs, and not merely the result of their different approaches to opt-out systems. The authors also need to provide better sources for their claims here.

Issue 4:
"According to a study conducted in Saudi Arabia in 2018, most participants support organ donation…" -What percentage is captured by "most"?

Issue 5:
"As for ethical considerations, a mandated choice system makes the two choices readily available; it increases a person's likelihood of making an autonomous choice and encourages selfdetermination." Why does requiring persons to make a choice between two alternatives increase her "…likelihood of making an autonomous choice and encourages self-determination"? Indeed, couldn't requiring that a person choose between two alternatives decrease the degree to which she is autonomous with respect to her relevant choices, insofar as it removes from her the option not to choose -an option which some persons might have preferred? The authors need to do much more to support their claims here, especially since they appear prima facie implausible.

Are the recommendations made clear, balanced, and justified on the basis of the presented arguments? Partly
Competing Interests: No competing interests were disclosed.

Reviewer Expertise:
The ethics of organ procurement, autonomy theory, and the metaphysics of death.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.
Author Response 05 Jul 2022

Deema AL Shawan
Dear Professor Taylor, Thank you for your insightful comments and suggestions. We have incorporated the edits to our manuscript. Additionally, we have a point-by-point response below.
Comment: "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." "Is there a better source for these figures than a news article? Have the authors examined the original source on which this news article was based? How accurate is this claim?" When the authors write "…115% increase after the launch of the donor registration feature" do they mean that this 115% increase was immediate after the launch, and then numbers further increased, or do they mean to claim that the increase to 200,000 occurred in the total time after the launch? (The former construal would be compatible with there being an initial increase of 115% and then an greater increase subsequently.)

Response:
This was a error on part of the news article itself, therefore, we have corrected the information and replaced it with a more reliable source.
Comment: "The authors should distinguish between personal autonomy and Kantian autonomy. On a theory of personal autonomy a person is autonomous with respect to her desires and actions if they flow from her motivational set in a way that ensures that they originate from her, rather than from elsewhere (where the requirements for what counts as originating from her are spelled out in the theory of personal autonomy that one adopts). On a Kantian account of autonomy a person is autonomous if (roughly) she acts out of respect for the moral law. These are distinct accounts of autonomy, and since the former is often of primary interest in discussions of organ procurement the authors would do well to focus on it rather than its Kantian alternative.

Response:
We thank you for the insightful comment, we agree and we have made the suggested correction to focus on personal autonomy. We made the clarification in the background, analysis sections.
Comment: "Why couldn't an opt-out approach to organ procurement also respect a person's (personal) autonomy? The authors should see here Michael Gill's "Presumed Consent, Autonomy, and Organ procurement," Journal of Medicine and Philosophy 29, 1 (2004): 37 -591." Response: Thank you for the insightful comment and sharing this reference. We have incorporated your suggestion into our manuscript and expressed the other potential concerns. For one thing, there is a risk that organs could be removed from bodies of individuals who did not want their organs removed. On the other hand, we do agree with (Gill, 2004) that "it is morally no worse than not removing organs from the bodies of people who did want them removed." However, as stated in the manuscript this method is not favored by the Saudi public due to religious reasons. (Hammami et al., 2012) Which is why we recommended that decision makers support investigating mandated choice as an option, since it could be a balance between the risk of removing organs from individuals who did not wish to be donors and the risk of not harvesting organs from willing donors. The clarification was made in the manuscripts and additional references were added.
Comment: "Merely claiming that Kant would hold that a person's organs should not be harvested after her death if she did not agree to this is insufficient. The authors need to argue that Kant (or Kantians) are committed to holding that persons have duties to respect the wishes of the dead."

Response:
We have updated to individual autonomy as recommended in a previous comment and provided further explanations and evidence.

Comment:
The authors should note that the differences in the effectiveness of the Austrian and Spanish systems might also be a product of differing infrastructure that is in place to secure available organs, and not merely the result of their different approaches to opt-out systems. The authors also need to provide better sources for their claims here.

Response:
The sources were updated accordingly.
Comment: "According to a study conducted in Saudi Arabia in 2018, most participants support organ donation…" -What percentage is captured by "most"?

Response:
The percentage was added as suggested.
Comment: "Why does requiring persons to make a choice between two alternatives increase her "…likelihood of making an autonomous choice and encourages selfdetermination"? Indeed, couldn't requiring that a person choose between two alternatives decrease the degree to which she is autonomous with respect to her relevant choices, insofar as it removes from her the option not to choose -an option which some persons might have preferred? The authors need to do much more to support their claims here, especially since they appear prima facie implausible." Response: That is a valid argument, however, we took into consideration that religion and culture play an important role in determining how autonomy is perceived. We made this recommendation considering the applicability to Saudi Arabia's culture role of families, religion, public acceptance. Due to religious beliefs for organ donation to be a considered good deed there must be intent by the individual to be a donor. Due to this belief, clearly knowing the next of kin wish could influence the families to approve of the donation. Furthermore, according to a study we have added to the manuscript, mandated choice was the most favored option by the public. Lastly, due to the accessibility of the App, users have the option to opt-out at any moment.
We look forward to hearing back from you and please let us know if you have any further inquiries and comments you may have.

Sincerely, Dr. Deema S. Al Shawan
Competing Interests: No competing interests were disclosed.
Reviewer Report 20 January 2022 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 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. 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 which 15 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 optout 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 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.

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? No
Is the discussion on the implications clearly and accurately presented and does it cite the current literature? No Are the recommendations made clear, balanced, and justified on the basis of the presented arguments? Partly We thank you for taking the time to provide constructive feedback on our policy brief. We have incorporated the suggested edits to reflect your valuable input into our resubmitted manuscript. Additionally, we have a point-by-point response below: Comment: "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."

Response:
We agree, and to support the claim, we have replaced the (Palmer, 2012) article with one of your suggested sources Comment: "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" "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. " Response: Due to the lack of up-to-date evidence in Saudi Arabia we have added evidence from another country as well as a survey about the Saudi publics acceptance towards this policy. Additionally, we have edited the recommendation to investigating it as a potential viable and feasible solution given the country's culture.
Comment: "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"

Response:
We have acknowledged that there is a need to combine the proposed consent system with other methods to ensure it's effectiveness to increase its effectiveness in reducing the shortage of organs Comment: "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. " Response: Thank you for pointing that out, we have corrected the wording accordingly.
Comment: "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."

Response:
We appreciate the suggestion, even though we have not included a study that discusses the overall impact of consent systems on organ donation rates. We have included evidence on the effectiveness of each of the types of consent mechanisms throughout the policy brief.
Comment: "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?" Response: Thank you for your comment to clarify, the article does not claim that this is the best or the only approach but it is one of the main factors identified and it is also one of the most understudied. Additionally, as stated previously, we recommended the incorporation of other interventions, such as educational campaigns, since changing the method of consent alone may not be as effective (justification and evidence were included in the manuscript). As for the second question, there are no up to date published statistics on the exact number of family refusal due to the lack of knowledge. Nevertheless, we have included a study by (Kentish-Barnes et al., 2019; Walker et al., 2013) that states that one of the causes of family refusal is not knowing their loved ones' wish to donate.
Comment: "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.

Response:
The article was replaced with on of the few reliable published sources. The information was also edited to demonstrate the rapid registrations after the launch of the app instead of the claim that the app has increased the number of donors due to the lack of evidence. This was to further support the objective of the paper which is to urge decisionmakers to take the opportunity to optimize the newly launched feature in the app in the future Comment: "the reference cited with regard to Austria does not provide any evidence for the claim but cites two other sources, one of which 15 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. " "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.
"several studies, including systematic reviews, have explored the impact of presumed consent policies. They should be cited." Response: As recommended, the study was replaced by by a systematic review that investigated the impact of the presumed consent policy in different countries. The other other findings were also corrected as suggested.
Comment: "the Netherlands had not adopted a mandated choice policy but an opt-in 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