How do opt-in versus opt-out settings nudge patients toward electronic health record adoption? An exploratory study of facilitators and barriers in Austria and France.

BACKGROUND: Electronic health records (EHR) are becoming an integral part of the health system in many developed countries, though implementations and settings vary across countries. Some countries have adopted an opt-out policy, in which patients are enrolled in the EHR system following a default nudge, while others have applied an opt-in policy, where patients have to take action to opt into the system. While opt-in systems may exhibit lower levels of active user requests for access, this contrasts with opt-out systems where a notable percentage of users may passively retain access. Thus, our research endeavor aims to explore facilitators and barriers that contribute to explaining EHR usage (i.e., actively accessing the EHR system) in two countries with either an opt-in or opt-out setting, exemplified by France and Austria. METHODS: A qualitative exploratory approach using a semi-structured interview guideline was undertaken in both countries: 1) In Austria, with four homogenously composed group discussions, and 2) in France, with 19 single patient interviews. The data were collected from October 2020 to January 2021. RESULTS: Influencing factors were categorized into twelve subcategories. Patients have similar experiences in both countries with regard to all facilitating categories, for instance, the role of health providers, awareness of EHR and social norms. However, we highlighted important differences between the two systems regarding hurdles impeding EHR usage, namely, a lack of communication as well as transparency or information security about EHR. CONCLUSION: Implementing additional safeguards to enhance privacy protection and supporting patients to improve their digital ability may help to diminish the perception of EHR-induced barriers and improve patients' health and commitment in the long term. PRACTICAL IMPLICATIONS: Understanding the differences and similarities will help to develop practical implications to tackle the problem of low EHR usage rates in the long run. This problem is prevalent in countries with both types of EHR default settings.

Revealing misattributed parentage through the integration of genetic information into the electronic health record.

The integration of genetic information (GI) into the electronic health record (EHR) seems inevitable as the mainstreaming of genomics continues. Such newly provided accessibility to GI could be beneficial for improving health care, as well as for supporting clinical decision-making and health management. Notwithstanding these promising benefits, the automatic integration of GI into the EHR, allowing unrestricted access to one's GI through patient portals, carries various knowledge-related risks for patients. This article is focused on the potential case of inadvertently revealing misattributed parentage through such practice. The article aims to identify key clinical and ethical implications of such revelation for adult patients. Clinical implications include, for example, altering the physician-patient interaction and the need to enhance physician's genetic literacy to improve genetic-information-specific communication skills. Ethical implications yield arguments supporting disclosure of MP, such as autonomy, individuals' right to know medical information pertaining to them, and the right to know one's genetic origins. Arguments opposing disclosure of MP centre on the right not to know GI and concerns for post-disclosure family relationships. Following the clinical and ethical analyses of these respective implications, we consider how such integration of GI into the EHR ought to be carried out, ethically. We therefore suggest a solution, featuring an autonomy-based approach, built around EHR users' right not to know. Our solution of nuanced consent options (including a 'genetic ignorance option') is designed to enable patients' informed exposure to GI through the EHR, allowing them some control over their self- and familial narrative.

How Large is the Potential of Brain Dead Donors and what Prevents Utilization? A Multicenter Retrospective Analysis at Seven University Hospitals in North Rhine-Westphalia.

Organ donation after brain death is constantly lower in Germany compared to other countries. Instead, representative surveys show a positive attitude towards donation. Why this does not translate into more donations remains questionable. We retrospectively analyzed all potential brain dead donors treated in the university hospitals of Aachen, Bielefeld, Bonn, Essen, Düsseldorf, Cologne and Münster between June 2020 and July 2021. 300 potential brain dead donors were identified. Donation was utilized in 69 cases (23%). Refused consent (n = 190), and failed utilization despite consent (n = 41) were reasons for a donation not realized. Consent was significantly higher in potential donors with a known attitude towards donation (n = 94) compared to a decision by family members (n = 195) (49% vs. 33%, p = 0.012). The potential donor´s age, status of interviewer, and the timing of the interview with decision-makers had no influence on consent rates, and it was comparable between hospitals. Refused consent was the predominant reason for a donation not utilized. Consent rate was lower than in surveys, only a known attitude towards donation had a significant positive influence. This indicates that survey results do not translate well into everyday clinical practice and promoting a previously documented decision on organ donation is important.

The ethical significance of consent to postmortem organ retrieval.

Supporters of opt-in organ procurement policies typically claim that the absence of consent to postmortem transplantable organ retrieval is a normative barrier to such retrieval. On this ground, justification of opt-out policies is demanded. The paper shows that postmortem organ retrieval is normatively different from live organ removal, and so the doctrine of informed consent does not apply to it in the way it does in other types of cases. First, seen as the instrument of protection of autonomy or the right to self-determination, informed consent cannot be relied on in the case of dead persons; secondly, viewed as an instrument of annulment of harm or wrong to the dead (volenti non fit injuria), informed consent relies on indefensible accounts of posthumous harm or wrong. Postmortem organ retrieval in cases of absence of the decedent's consent and refusal is governed by other norms than those related to consent. Such norms include, among others, respectful treatment of human remains (such as those found in regulations of medicine, law enforcement, and research) and avoidance of inherently wrong contexts and purposes (such as killing for the purpose of organ retrieval or trade in the human body or its parts). It is concluded that the onus probandi is on the supporters of opt-in, rather than opt-out, policies of posthumous organ retrieval.

Opt-In and Opt-Out Consent Procedures for the Reuse of Routinely Recorded Health Data in Scientific Research and Their Consequences for Consent Rate and Consent Bias: Systematic Review.

BACKGROUND: Scientific researchers who wish to reuse health data pertaining to individuals can obtain consent through an opt-in procedure or opt-out procedure. The choice of procedure may have consequences for the consent rate and representativeness of the study sample and the quality of the research, but these consequences are not well known. OBJECTIVE: This review aimed to provide insight into the consequences for the consent rate and consent bias of the study sample of opt-in procedures versus opt-out procedures for the reuse of routinely recorded health data for scientific research purposes. METHODS: A systematic review was performed based on searches in PubMed, Embase, CINAHL, PsycINFO, Web of Science Core Collection, and the Cochrane Library. Two reviewers independently included studies based on predefined eligibility criteria and assessed whether the statistical methods used in the reviewed literature were appropriate for describing the differences between consenters and nonconsenters. Statistical pooling was conducted, and a description of the results was provided. RESULTS: A total of 15 studies were included in this meta-analysis. Of the 15 studies, 13 (87%) implemented an opt-in procedure, 1 (7%) implemented an opt-out procedure, and 1 (7%) implemented both the procedures. The average weighted consent rate was 84% (60,800/72,418 among the studies that used an opt-in procedure and 96.8% (2384/2463) in the single study that used an opt-out procedure. In the single study that described both procedures, the consent rate was 21% in the opt-in group and 95.6% in the opt-out group. Opt-in procedures resulted in more consent bias compared with opt-out procedures. In studies with an opt-in procedure, consenting individuals were more likely to be males, had a higher level of education, higher income, and higher socioeconomic status. CONCLUSIONS: Consent rates are generally lower when using an opt-in procedure compared with using an opt-out procedure. Furthermore, in studies with an opt-in procedure, participants are less representative of the study population. However, both the study populations and the way in which opt-in or opt-out procedures were organized varied widely between the studies, which makes it difficult to draw general conclusions regarding the desired balance between patient control over data and learning from health data. The reuse of routinely recorded health data for scientific research purposes may be hampered by administrative burdens and the risk of bias.

Human papillomavirus self-sampling with mRNA testing benefits routine screening.

High risk human papillomavirus (hrHPV) based screening provides the possibility of vaginal self-sampling as a tool to increase screening attendance. In order to evaluate the impact and feasibility of opt-in self-sampling in the Finnish setting, we invited a randomized population of 5350 women not attending screening after age group invitation or after reminder, to attend HPV self-sampling-based screening in the autumn of 2018 in Helsinki. Out of those, 1282 (24.0%) expressed their interest and ordered the sampling package. Eventually 787 women (14.7% of the total invited population) took part in screening, 770 women by providing a vaginal sample within 2 months from invitation and 17 by providing a pap smear in the laboratory. Self-taken samples were collected in Aptima Multitest vials and tested using the Aptima HPV mRNA assay. A high proportion, 158/770 (20.5%) of the samples were positive in the Aptima HPV assay. One hundred and forty-one samples were further submitted to Aptima HPV Genotyping and extended genotyping by a Luminex based assay. Of those, 23 samples (16.3%) were HPV 16 positive and 7 (5.0%) were positive for HPV 18/45; extended genotyping revealed multiple high-risk and low-risk HPV genotypes. At follow-up seven cases of high-grade squamous intraepithelial lesion (HSIL) were diagnosed, which represents 4.4% of HPV positive women and 0.9% of screened women, whereas the rate was 0.5% in routine screening. Our findings suggest that self-sampling with HPV mRNA testing is a feasible approach to improve screening efficacy in a high-risk population among original nonattendees.

Operational experiences from the general implementation of HPV self-sampling to Danish screening non-attenders.

The Danish cervical cancer screening program is a cost-free cancer prevention program for all Danish resident women aged 23-64 years. The coverage is 73%, but screening attendance is slowly declining. Notwithstanding, almost half of all newly diagnosed cervical cancers are found amongst screening non-attenders. To increase screening attendance, the Capital Region of Denmark implemented HPV self-sampling as an alternative offer to women not attending the regular screening offer. This was an opt-in offer to 57,717 screening non-attending women in 2017-2018. They received an invitation letter and could opt-in by letter, phone, e-mail, or website. Invitation and return-of-kit reminders were used in the set-up. HPV positive women were recommended to go to their General Practitioner (GP) for a follow-up sample. HPV negative women returned to the ordinary screening program. Of all invited women, 15,501 opted-in (27%). The purpose designed website was the most frequent used method of response, 63% opted in by the HPV-self sampling website. Use of invitation and return-of-kit reminders generated 8.6% and 6.1% additional responses and participation, respectively, underlining the importance of timely communication. Overall, 17% returned the HPV self-sampling kit for analysis. In addition, 14% had a regular clinician collected screening sample after receiving the invitation for self-sampling, leading to a total screening of 31% of the invited women. HPV prevalence was 15% and 92% of the women positive for HPV adhered to the recommended follow-up.

Changing to an Opt Out System for Organ Donation-Reflections From England and Netherlands.

Recently England and Netherlands have changed their consent system from Opt In to Opt Out. The reflections shared in this paper give insight and may be helpful for other nation considering likewise. Strong support in England for the change in legislation led to Opt Out being introduced without requiring a vote in parliament in 2019. In Netherlands the bill passed by the smallest possible majority in 2018. Both countries implemented a public campaign to raise awareness. In England registration on the Donor Register is voluntary. Registration was required in Netherlands for all residents 18 years and older. For those not already on the register, letters were sent by the Dutch Government to ask individuals to register. If people did not respond they would be legally registered as having "no objection." After implementation of Opt Out in England 42.3% is registered Opt In, 3.6% Opt Out, and 54.1% has no registration. In contrast in Netherlands the whole population is registered with 45% Opt In, 31% Opt Out and 24% "No Objection." It is too soon to draw conclusions about the impact on the consent rate and number of resulting organ donors. However, the first signs are positive.

Research based on existing clinical data and biospecimens: a systematic study of patients' opinions.

BACKGROUND: The aim of the present survey was to investigate newly discharged hospital patients' opinions on secondary use of their hospital data and biospecimens within the context of health research in general and, more specifically, on genetic research, data sharing across borders and cooperation with the health industry. METHODS: A paper questionnaire was sent to 1049 consecutive newly discharged hospital patients. RESULTS: The vast majority of the respondents preferred to be informed (passive consent) or to receive no notification at all for secondary research on their health data and biospecimens (88% and 91% for data and biospecimens respectively). The rest wanted to be asked for active consent. The same trend applied for the other aspects also. 81% of respondents were positive towards genetic research without active consent. 95% were positive towards cooperating with the health industry, and 90% were positive towards data sharing. CONCLUSIONS: These results suggest that hospital patients generally are very positive to secondary research and support the concept of opting out rather than opting in.

Testing Enhanced Active Choice to Optimize Acceptance and Participation in a Population-Based Colorectal Cancer Screening Program in Malta.

Opt-out strategies have been shown to improve participation in cancer screening; however, there are ethical concerns regarding the presumed consent. In this study, we tested an alternative opt-in strategy, called: "enhanced active choice," in which the response options summarize the consequences of the decision. The study was conducted as part of the Maltese colorectal cancer screening program, which offers men and women, aged 60-64, a "one-off" fecal immunochemical test (FIT). A total of 8349 individuals were randomly assigned to receive either an invitation letter that featured a standard opt-in strategy (control condition), or an alternative letter with a modified opt-in strategy (enhanced active choice condition). Our primary outcome was participation three months after the invitation was delivered. Additionally, we also compared the proportion who said they wanted to take part in screening. We used multivariable logistic regression for the analysis. Overall, 48.4% (N = 4042) accepted the invitation and 42.4% (N = 3542) did the screening test. While there were no statistically significant differences between the two conditions in terms of acceptance and participation, enhanced active choice did increase acceptance among men by 4.6 percentage points, which translated to a significant increase in participation of 3.4 percentage points. We conclude that enhanced active choice can improve male screening participation. Given the higher risk of CRC in men, as well as their lower participation screening, we believe this to be an important finding.

Full Reciprocity: An Essential Element for a Fair Opt-Out Organ Transplantation Policy.

In this paper, I argue for the following points. First, all of us have a presumptive moral obligation to be organ donors if we are in the relevant medical circumstances at the time of death. Second, family members should not have the right to interfere with the fulfillment of that obligation. Third, the ethical basis for that obligation is reciprocity. If we want a sufficient number of organs available for transplantation, then all must be willing donors. Fourth, that likelihood is diminished if individuals are entirely free to refuse to be organ donors but still would demand to be organ recipients. Fifth, although individuals would be ethically obligated to be organ donors, we still need to permit them to refuse to be organ donors. Sixth, to encourage individuals to stay within the organ donation system, we should have as a just and ethically justified policy denying individuals an organ transplant in the relevant medical circumstances if they have chosen to exit the organ donation system. Individuals would not be permitted to be organ recipients if they were unwilling to be organ donors. This is what it means to be part of what Rawls in Political liberalism (15-22) would refer to as a "fair system of social cooperation." We refer to this as the "reciprocity requirement."

Informing National Health Service patients about participation in clinical research: A comparison of opt-in and opt-out approaches across the United Kingdom.

OBJECTIVE: Recruitment to clinical research in the National Health Service remains challenging. One barrier is accessing patients to discuss research participation. Two general approaches are used in the United Kingdom to facilitate this: an 'opt-in' approach (when clinicians communicate research opportunities to patients) and an 'opt-out' approach (all patients have the right to be informed of relevant research opportunities). No evidence-based data are available, however, to inform the decision about which approach is preferable. This study aimed to collect information from 'opt-in' and 'opt-out' Trusts and identify which of the two approaches is optimal for ensuring National Health Service patients are given opportunities to discuss research participation. METHOD: This sequential mixed methods study comprised three phases: (1) an Appreciative Inquiry across UK Trusts, (2) online surveys and (3) focus groups with National Health Service staff and patients at a representative mental health Trust. RESULTS: The study was conducted between June and October 2019. Out of seven National Health Service Mental Health Trusts contacted (three 'opt-out' and four 'opt-in'), only four took part in phase 1 of the study and three of them were 'opt-out' Trusts. Benefits of an 'opt-out' approach included greater inclusivity of patients and the removal of research gatekeepers, while the involvement of research-active clinicians and established patient-clinician relationships were cited as important to 'opt-in' success. Phases 2 and 3 were conducted at a different Trust (Oxford Health NHS Foundation Trust) which was using an 'opt-in' approach. Of 333 staff and member survey responders, 267 (80.2%) favoured moving to an 'opt-out' approach (phase 2). Nineteen staff and 16 patients and carers participated in focus groups (phase 3). Concern was raised by staff regarding the lack of time for clinical research, with clinical work taking precedence over research; patients were concerned about a lack of research activity; all considered research to be beneficial and were supportive of a move to 'opt-out'. CONCLUSION: Findings suggest that 'opt-out' is more beneficial than 'opt-in', with the potential to vastly increase patient access to research opportunities and to enable greater equality of information provision for currently marginalised groups. This should ensure that healthcare research is more representative of the entire population, including those with a mental health diagnosis.

Changing to Deemed Consent for Deceased Organ Donation in the United Kingdom: Should Australia and New Zealand Follow?

During 2020 new legislation in England and Scotland will come into force, which adopts a Welsh reform implemented in 2015, changing the law on deceased organ donation from an "opt-in" regime, based on the explicit consent of the deceased donor during their lifetime or that of their family, to a model of soft, "opt-out," whereby the deceased's consent to donate will be "deemed" unless they have registered or made known an objection during their lifetime. This column examines the ethical case for both regimes and analyses the law reform and its implications. A key issue is whether the controversial practice in soft opt-in systems of the family override, even where the deceased had opted in, will continue under the new regime. The sole aim of the law reform is to increase the supply of organs from deceased donors for transplantation to meet ever-increasing demand. Notwithstanding that taskforces in Australia and New Zealand have recently rejected introducing opt-out systems and New Zealand has not yet even introduced a dedicated organ donation register, evidence of increased donation rates following the UK reform may revive an issue which is currently off the reform agenda in this part of the world.

Consent to data linkage in a large online epidemiological survey of 18-23 year old Australian women in 2012-13.

BACKGROUND: Consent to link survey data with health-related administrative datasets is increasingly being sought but little is known about the influence of recruiting via online technologies on participants' consents. The goal of this paper is to examine what factors (sociodemographic, recruitment, incentives, data linkage information, health) are associated with opt-in consent to link online survey data to administrative datasets (referred to as consent to data linkage). METHODS: The Australian Longitudinal Study on Women's Health is a prospective study of factors affecting the health and well-being of women. We report on factors associated with opt-in consent to data linkage at the end of an online survey of a new cohort of 18-23 year old Australian women recruited in 2012-13. Classification and Regression Tree analysis with decision trees was used to predict consent. RESULTS: In this study 69% consented to data linkage. The provision of residential address by the individual, or not (as a measure of attitudes towards privacy), was the most important factor in classifying the data into similar groups of consenters (76% consenters versus 47% respectively). Thereafter, for those who did not provide their residential address, the incentives and data linkage information that was offered was the next most important factor, with incentive 2: limited-edition designer leggings and additional information about confidentiality showing increases in consent rates over Incentive 1: AUD50 gift voucher: 60% versus 37%. CONCLUSIONS: In young Australian women, attitudes towards privacy was strongly associated with consenting to data linkage. Providing additional details about data confidentiality was successful in increasing consent and so was cohort appropriate incentives. Ensuring that prospective participants understand the consent and privacy protocols in place to protect their confidential information builds confidence in consenting to data linkage.

What Determines Support for Donor Registration Systems? The Influence of Sociopolitical Viewpoint, Attitudes Toward Organ Donation, and Patients' Need.

BACKGROUND: In forming opinions about donor registration systems such as opt-in versus opt-out, the sociopolitical implications of these systems may be confounded with attitudes toward organ donation itself, causing people to talk at cross purposes. The goal of the present research was to examine the interactive effects of sociopolitical viewpoint, attitude toward donation (as evidenced by current registration status in study 1 and registration intention of unregistered individuals in study 2), and patients' need for organs on people's support for a particular system. METHOD: In study 1, we randomly assigned registered donors, registered nondonors, and nonregistered individuals to one of three sociopolitically inspired solutions to reducing the organ shortage, distinguishing between solutions based on autonomy, coercion by the state, and reciprocity, respectively. In study 2, we concentrated specifically on young and unregistered people in order to examine how prior donation intentions or indecision with respect to donor registration affect responses to the three different sociopolitical viewpoints. In both studies, we also manipulated salience of patients' need. RESULTS: Registered donors in study 1 and unregistered individuals with donation intention in study 2 (high in sympathy, low in anxiety) were highly and equally supportive of a solution based on autonomy and coercion. In contrast, registered nondonors in study 1 and unregistered and undecided individuals in study 2 (lower in sympathy, higher in anxiety) were less supportive of a solution based on coercion than autonomy. Study 2 also found that, for undecided individuals, a more salient need state was associated with a drop in anxiety and stronger support for coercion. Results for a system based on reciprocity were more difficult to interpret. CONCLUSION: Individuals most concerned with the need of patients waiting for an organ are relatively indifferent with respect to the sociopolitical implications of a registration system, while those strongly objecting to a coercive role for the state express reservations against organ donation itself. In order to help people to form balanced opinions about organ donation systems, we recommend to make the prosocial and sociopolitical aspects equally salient and deserving of debate.

Respect for autonomy in systems of postmortem organ procurement: A comment.

In 2015 Robert Veatch published the second edition of his Transplantation ethics, this time together with Lainie Ross. The chapters on postmortem organ procurement distinguish between 'giving' and 'taking' systems, and argue that 'taking' systems may promise a greater yield of organs for transplantation, but inevitably violate a requirement of respect for the deceased's autonomy. That argument has been very influential, and is also representative of a way of thinking that is widespread in the literature and in public debate. In this paper I contend that it is conceptually flawed in a number of important respects. These concern the understanding of both the concept of 'consent' and the requirement of respect for autonomy, the role of the relatives in any procurement system, and the factors that actually determine the extent to which a system respects autonomy, under any interpretation of that requirement.

Family-Based Consent and Motivation for Cadaveric Organ Donation in China: An Ethical Exploration1.

This essay indicates that Confucian family-based ethics is by no means a stumbling block to organ donation in China. We contend that China should not change to an opt-out consent system in order to enhance donation because a "hard" opt-out system is unethical, and a "soft" opt-out system is unhelpful. We argue that the recently-introduced familist model of motivation for organ donation in mainland China can provide a proper incentive for donation. This model, and the family priority right that this model supports, is ethically justifiable in terms of Confucian family-based ethics.

Lives and choices, give and take: Altruism and organ procurement.

In 2015, Wales introduced a deemed consent: soft opt-out system for organ procurement in order to address the chronic shortage of organs for transplant. Early statistical evidence suggests that this has had a positive impact on cadaveric organ donation. Such a system for procurement has previously been dismissed by the Organ Donation Taskforce, who suggested that opting out could potentially undermine the concept of donated organs as gifts and this could then negatively impact the number of organs offered for transplant. Considerable weight was placed upon the need to retain the altruistic gift element associated with an opt-in system. This article will consider the role of altruism in an organ procurement policy. A broad utilitarian approach will be taken when putting forward the arguments in favour of adopting a weak altruism position in a soft opt-out system for procurement with a combined registry.

A qualitative study on the voluntariness of counselling and testing for HIV amongst antenatal clinic attendees: do women have a choice?

BACKGROUND: Mother-to-child transmission (MTCT) of the Human Immunodeficiency -Virus (HIV) is a serious public health problem, contributing up to 90% of childhood HIV infections. In Tanzania, the prevention-of-mother-to-child-transmission (PMTCT) feature of the HIV programme was rolled out in 2000. The components of PMTCT include counselling and HIV testing directed at antenatal clinic attendees. It is through the process of Provider Initiated Counseling and Testing (PITC) that counselling is offered participant confidentiality and voluntariness are upheld and valid consent obtained. The objective of the study was to explore antenatal clinic attendees' experiences of the concept of voluntariness vis- a- vis the implementation of prior counseling and subsequent testing for HIV under the PITC as part of their antenatal care. METHODS: In-depth interviews were conducted with17 antenatal clinic attendees and 6 nursing officers working at the Muhimbili National Hospital (MNH) antenatal clinic. The study data were analyzed using qualitative content analysis. RESULTS: Antenatal clinic attendees' accounts suggested that counselling and testing for HIV during pregnancy was voluntary, and that knowledge of their HIV status led them to access appropriate treatment for both mother and her newborn baby. They reported feeling no pressure from nursing officers, and gave verbal consent to undergo the HIV test. However, some antenatal clinic attendees reported pressure from their partners to test for HIV. Healthcare providers were thus faced with a dilemma of disclosure/ nondisclosure when dealing with discordant couples. CONCLUSION: Antenatal clinic attendees at MNH undertook the PITC for HIV voluntarily. This was enhanced by their prior knowledge of HIV, the need to prevent mother- to- child transmission of HIV, and the effectiveness of the voluntary policy implemented by nursing officers.

Opt-in or opt-out to increase organ donation in South Africa? Appraising proposed strategies using an empirical ethics analysis.

Utilising empirical ethics analysis, we evaluate the merits of systems proposed to increase deceased organ donation in South Africa (SA). We conclude that SA should maintain its soft opt-in policy, and enhance it with 'required transplant referral' in order to maximise donor numbers within an ethically and legally acceptable framework. In SA, as is the case worldwide, the demand for donor organs far exceeds the supply thereof. Currently utilising a soft opt-in system, SA faces the challenge of how to increase donor numbers in a context which is imbued with inequalities in access to healthcare, multiplicitous personal beliefs and practices, distrust of organ transplant and varying levels of education and health literacy. We argue that a hard opt-in, opt-out or mandated consent system would be problematic, and we present empirical data from Gauteng Province illustrating barriers to ethically sound practice in soft consent systems. Ultimately, we argue that in spite of some limitations, a soft opt-in system is most realistic for SA because its implementation does not require extensive public education campaigns at national level, and it does not threaten to further erode trust at a clinical level. However, to circumvent some of the clinical-level barriers identified in our empirical study, we propose a contextually sensitive option for "enabling" soft opt-in through "required transplant referral". We argue that this system is legally defensible, enhances ethical practice and could also increase donor numbers as it has in many other countries.