Ethics

It is important to establish a research culture that is embraced by the community, rather than viewed with distrust

Ella Kris · Hylda Wapau · Allison Hempenstall

Fragmented patient care can lead to missed diagnoses, inappropriate prescribing and failure of preventive medicine

Jack Marjot · Georgie Haysom · Penny Browne

Medical students continue to be involved in legally and ethically concerning intimate examination practices Terra pericolosa was the cartographical term used to denote dangerous land — regions likely to put travellers in jeopardy. Despite the degree of governance and regulation in modern health care,1,2,3 medical literature,4 student‐authored ethics reports5,6 and the media7 continue to document medical students being involved in legally and ethically concerning intimate examination practices. This article summarises the ethico‐legal aspects of medical student involvement in patient care, and reviews international best practice and the factors which influence why medical students continue to find themselves in terra pericolosa situations. Ethico‐legal and governance issues Through most of its history, medical ethics maintained a utilitarian focus, usually demonstrating scant regard for patient autonomy, with non‐disclosure being the norm; it was not until the 1950s that the term “informed consent” was coined.8 The 1980s and 90s saw the first publications questioning the ethics and legality of medical students performing examinations without consent, with students often raising their concerns about the status quo.5,9 The legal implications of performing an examination without consent are significant. Each state and territory’s criminal codes define the elements that constitute an assault, as well as various categories, including sexual assault. In general, the term “assault” refers to both “common assault” and “battery”, even though the two offences remain distinct entities. Common assault typically involves intentionally or recklessly causing a person to apprehend the imminent infliction of unlawful force, while battery refers to the actual infliction of force. The legal classifications all include lack of consent as part of their wording. Consent to medical treatment is defined by Australian common law as having three conditions: it must be voluntary, be informed, and the individual must have capacity to provide consent.10 Consent may be given in writing, orally or be implied.3 An Australian Law Reform Commission report states: “If consent is not established, there may be legal consequences for health professionals. Under the law of trespass, patients have a right not [to] be subjected to an invasive procedure without consent or other lawful justification, such as an emergency or necessity.”10 Although there is no legal mandate for written consent to be obtained for medical student involvement in intimate examinations or procedures, the principles for consent are that the riskier or more potentially litigious the procedure, the higher the standard should be to ensure that the person fully understands the nature of the procedure and that their consent can be attested to in writing.3 The Australian Charter of Healthcare Rights11 notes that a health care recipient should “be treated as an individual, and with dignity and respect” and have “clear information about [their] condition, the possible benefits and risks of different tests and treatments, so [they] can give [their] informed consent”. There is no information about health professional student involvement in their care. The Medical Board of Australia code of conduct2 defines the standards of conduct for medical doctors in Australia. The code states that regarding medical students, good medical practice involves “Making the scope of the student’s role in patient care clear to the student, to patients and to other members of the health care team” and “Informing your patients about the involvement of medical students and obtaining their consent for student participation, while respecting their right to choose not to consent”. The Australian Medical Council provides a core curriculum for both medical students and all medical doctors in Australia.3 It states: “Access to patients and their cooperation is a privilege that must not be taken for granted. … Before approaching any patient, students should generally first seek permission from those responsible for the immediate care of the patient.” Regarding physical examination, the authors note that: … when conducting a physical examination, it may be appropriate to have a nurse or medical student present who is of the same gender as the patient. Under no circumstances should medical students conduct intimate examinations — including breast, genital or rectal examinations — without supervision or an accompanying nurse of the same gender as the patient. Students need to be specifically aware of the medical school policy in regard to intimate examinations.3 In 2018, the Medical Board of Australia published guidelines on sexual boundaries in the doctor–patient relationship.1 These guidelines recognise that a patient’s cultural values and beliefs may influence what they perceive to be an intimate examination, and that before conducting a physical examination, good medical practice involves “obtaining the patient’s permission if medical students or anyone else is to be present during an examination or consultation” and that an “unwarranted physical examination may constitute sexual assault. This includes conducting or allowing others, such as students, to conduct examinations on anaesthetised patients, when the patient has not given explicit consent for the examination”.1 In summary, although Australian law is clear on the importance of consent and the implications of this regarding assault, current Australian medical governance makes some assumptions about medical school policies for intimate examinations and allows discretion regarding the requirements for written consent. What we can learn from other countries The recognition that medical students may be involved in unconsented intimate examinations4,9,12 has resulted in the introduction of specific ethical codes and guidance in many jurisdictions. The United Kingdom and New Zealand have similar ethical codes to Australia.2,12,13 The UK also provides detailed guidance on good medical practice for students.13 NZ is the most prescriptive, with specific information regarding medical student involvement in patient care documented in a national consensus statement and their Code of Rights.6,12 The NZ experience provides useful insights into the challenges of protecting patient rights during intimate examinations or procedures. Malpas and colleagues6 demonstrated that despite the national consensus statement’s introduction and related legislation, students continue to be involved in unconsented intimate examinations. In response, the authors recommended the following system changes in NZ: review consent processes to include information for patients about health professional student involvement in their care, and include specific sections in procedural consent forms for student involvement; provide the public with more information about patients’ rights and consent processes; and change the culture through increased emphasis on ethical leadership by senior health professionals in modelling best practice, and ensure zero tolerance/disciplinary processes for those who commit serious ethical breaches.6 Future directions The UK General Medical Council states that “Professionalism is not about doing the minimum — it is about doing what is necessary to protect patients”.13 When judged against this standard, most health care systems appear to have gaps. An individual’s likelihood of engaging in a behaviour is influenced by three factors: their attitudes towards the behaviour, their perceptions of the social norms, and their perceived ability to perform the behaviour.14 Although contemporary medical education and ethics actively promote patient autonomy and informed consent, students can unfortunately find themselves working in what has been described as the “weak ethical climate within the clinical workplace”.4 Most medical education and psychological research indicates that students are strongly influenced by the cultural norms of their workplace and their supervisory relationships.4,6,14,15 Fifteen years after a landmark paper by Coldicott and colleagues,9 Malpas and colleagues6 and an accompanying student‐authored editorial5 reaffirmed that the most common problems with medical student involvement in intimate examinations and procedures are not aspects of rogue student behaviour, but continue to be students struggling with the “the incongruence of what is taught … and the reality and expectations of clinical practice”,5 with students narrating specific instances of being asked by their supervisors to conduct or remain present during intimate examinations without clear and/or adequately informed patient consent. The NZ recommendations6 should positively influence students, health professionals and public attitudes and behaviours. However, unless resources are embedded in health professional educational and clinical environments to promote and facilitate speaking up for patient safety, the evidence suggests that those at the bottom of the hierarchy rarely feel safe in speaking truth to power;4,5,6,14,15 students will continue to be led into jeopardy. The UK experience with the Francis enquiry16 and other patient safety system failures provided the impetus to promote patient safety at national, local and medical school levels through General Medical Council guidance and initiatives such as “Speaking up”.13,17 To assist and empower students, some medical schools have developed web portals for their students to raise concerns.18 The lessons from the NZ work in this area and the UK initiatives indicate that although policies, processes and pedagogy are important, Australian health care and medical education providers should also critically examine their clinical workplace cultures and consider whether they adequately protect both patients and students.

Paul M McGurgan · Katrina L Calvert

More research is needed to ensure safe and unimpeded access for eligible applicants and to inform practice

Cameron J McLaren · Greg Mewett

Laws requiring doctors to report consensual adolescent sexual activity present legal, clinical and ethical problems Many Australian teenagers engage in consensual sexual intercourse with similar aged peers.1 They require confidential medical care, including contraception and sexually transmitted infection testing. However, adolescents’ rights to access medical care may confront legal barriers. In several Australian states and territories, new criminal laws require adults to report sexual offences against children. Other criminal laws make it an offence for adolescents aged under 16 years to engage in sexual intercourse. Accordingly, a question for clinical practice is whether the new criminal law reporting duty applies to adolescents’ confidential communications regarding consensual sexual activity. Law, ethics and practice must protect children, but must not criminalise consensual peer sexual activity or compromise clinical care. Here, we review literature regarding adolescents’ lived experience, findings from developmental science, and analyses of consensual and lawful sexual activity. We conduct a comparative analysis of Australian criminal law reporting duties for child sexual offences. We identify situations where laws inappropriately require clinicians to report adolescent sexual activity, and we make recommendations for reform. Background A 2018 national survey found 47% of 14–18‐year‐olds engaged in vaginal or anal intercourse, including 34% of those in Year 10.1 For most Year 10s (aged 14–16 years), the most recent sexual partner was a peer aged under 17 years (92%). However, 6.5% of sexually active Year 10s reported their most recent partner was aged 18–19 years. Of Year 10 females, over one‐third (37%) had engaged in intercourse, and for 10% of these their most recent partner was aged 18 years or older. General practitioners were the most trusted source of sexual health information, from whom 40.6% of females sought clinical advice.1 Clinician engagement was further evidenced by 43.5% of females using the contraceptive pill. However, adolescents experience multiple barriers in accessing health services, including perceived lack of confidentiality, and youth friendly service guidelines recommend confidential care approaches.2,3,4 The Lancet commission on adolescent health acknowledged the complex interplay of adolescent neurodevelopment and legal principles of capacity.5 Australian legal milestones differ, indicating how laws attempt to attain policy goals while grappling with scientific knowledge: 10‐year‐olds can be liable for criminal offences; 15‐year‐olds can obtain a Medicare card; and 17‐year‐olds can drive. Developmental neuroscience has shown adolescents aged 15–16 years possess adult‐like cognitive ability,8,9 while psychosocial and neurobiological maturity continues into the mid‐20s.8 It has been shown that, especially when in “calm and emotionally‐neutral contexts”,5 adolescents possess cognitive capacity to weigh costs and benefits and make reasoned judgements about courses of action, including about consenting to medical treatments involving contraception and sexual health.6,7 Much consensual peer sexual activity occurs in such settings; even in more emotionally “hot” circumstances, the capacity to consent to sex with similar aged peers is consistent with findings from developmental neuroscience. Legal requirements for consent, and the age of consent Lawful consent to sex requires full, free and voluntary agreement, and the absence of threat, intimidation and abuse of power (Box 1). Social science models of child sexual abuse are similarly premised on consent requiring full, free, voluntary and uncoerced participation.10 Laws must navigate a tension between protecting the developing adolescent and respecting and promoting their capacity and autonomy.11,12 In this setting, legislatures, as the bodies in each state and territory able to pass and amend criminal laws (legislation), must protect children and youth from sexual abuse, while allowing consensual peer sexual activity in both heterosexual and same‐sex relationships. Currently, the legal age of consent prohibits intercourse with minors under a specified age, presuming that children under this age lack capacity to provide true consent. This age is 16 years in most jurisdictions (Box 2). Legal defences embody legislatures’ acknowledgement that sex between adolescents may be consensual and permissible. Criminal laws in five jurisdictions provide a close‐in‐age defence to offences where the act involves consenting people who are both minors aged under 16 years or are similar in age (Box 2). Prosecution guidelines Similarly, official guidelines in every jurisdiction13,14 regarding prosecution of criminal offences recommend against prosecuting consensual activity between minors. These guidelines acknowledge it is against the public interest to prosecute these cases, because of the oppressive consequences, and the trivial and merely technical nature of any breach. Victoria’s guidelines are particularly strong, and specifically refer to situations where both adolescents are under 16 years of age, and where they are aged 15 and 18 years: a prosecution is contraindicated where a young person “has committed an offence in the context of a consenting sexual relationship with another young person [including] sexual penetration of a child under 16 where the offender is 18 and the complainant is 15”.13 In such cases, prosecutors should consider: the adolescents’ ages and maturity; whether they are in a relationship; whether they consented; and whether the person wishes a prosecution to proceed.13 In our hypothetical clinical case of Anna and David (Box 3), a prosecutor should conclude that despite technical commission of an offence (due to Anna and David being 15 and 18, respectively), prosecution should not occur because they are mature, near aged peers in a consenting sexual relationship with no coercion. They were responsibly acting to obtain contraception and advice from a medical practitioner, and Anna would not want David prosecuted. Prosecution is against the public interest for reasons including adverse effects on adolescents’ willingness to seek medical advice, which may result in further consequences including unintended pregnancies, sexually transmitted infections, and effects on education, employability and health. Criminal law reporting duties Child protection legislation has long required professionals to report sexual abuse to child welfare agencies.15 Recent inquiries into institutional abuse and cover‐ups catalysed recommendations for new reporting duties in criminal law, applied to all adults.16,17 Victoria, New South Wales, the Australian Capital Territory and Tasmania have since enacted new reporting duties in criminal law, advancing social norms to protect children.15 Queensland has recently enacted a duty, which has not yet commenced. (Supporting Information, Table 1). These laws require adults to report information to police about a sexual offence committed against a child. To accommodate exceptional circumstances and navigate ethical tensions, exceptions apply to requests of non‐disclosure, and confidential disclosures (Supporting Information, Table 1). Comparative analysis: six dimensions of legal inconsistency and uncertainty The relevant laws differ between jurisdictions, and exceptions are of uncertain application. Comparative statutory analysis reveals that for medical practitioners treating adolescents in consensual peer relationships, the laws present six problems. First, only NSW expressly excludes medical practitioners from the duty to report sexual offences against children (Supporting Information, Table 1). This creates a clear inconsistency: NSW practitioners are exempt from the duty, while their counterparts elsewhere are not. However, exempting NSW practitioners may mean sexual offences are less likely to be reported. Second, three jurisdictions apply the duty to report sexual offences both to situations involving two minors aged under 16 and to situations involving a minor and an adult. In contrast, Victoria only applies the duty to situations involving a minor and an adult. Accordingly, Victoria’s duty is narrower, acknowledging that otherwise it may inappropriately embrace consensual behaviour; yet it is important not to discourage Victorian practitioners from reporting non‐consensual sexual offences between minors, so this limit may be suboptimal. The problem elsewhere is that the duty may capture consensual peer activity. Third, only Victoria excludes the duty where the adolescent “victim” aged 16 or 17 requests non‐disclosure. Elsewhere, this exemption applies only to requests by victims aged 18 or over. This creates inequality in recognising adolescent capacity and autonomy. Fourth, the concept of a “reasonable excuse” for non‐reporting is not exhaustively defined (Supporting Information, Table 1). It is unclear whether a reasonable excuse for non‐disclosure includes a medical practitioner’s choice not to report a confidential disclosure in a therapeutic setting of consensual acts constituting a sexual offence. This leaves practitioners in all jurisdictions unsure whether they would be legally protected for not reporting. Fifth, Victoria, NSW and Tasmania enable prosecution only if approved by the Director of Public Prosecutions. This suggests multiple situations do not warrant prosecution. However, it is not clear when approval would be given, leaving clinicians in doubt about exemptions to the duty. The ACT lacks this mechanism, indicating higher likelihood of prosecution. Sixth, health professionals may be exempt from the duty where a patient confidentially discloses a sexual offence (Supporting Information, Table 1). This exemption is founded on the concept of professional confidential relationship privilege. However, these exemptions are unclear, rely on networks of laws, and apply to different practitioners. Tasmania and the ACT lack clear confidentiality exceptions (Supporting Information, Table 2). NSW has a clear exemption. Victoria has an express exemption if the information is a “confidential communication” as defined by other legislation (Box 4). However, in Victoria, the exemption applies only to communications from the younger adolescent (Box 4). In Anna’s hypothetical case, David attending the consultation would technically trigger the GP’s duty to report (Box 3). Discussion The new duties in criminal law to report sexual offences against children are consistent with policy values in protecting children, and with bioethical principles of justice and beneficence. Requiring adults to report child sexual offences is justified by diminishing harm to individuals, and by enhancing community protection and a protective social fabric for vulnerable children.18 Sexual activity between adults and children should generally be considered abusive, due to absence of consent and presence of coercion.10 However, legislatures must ensure an appropriate balance between protecting children and youth from sexual offences, and recognising their capacity and promoting autonomy, privacy and freedom of expression.11,12 Genuinely consensual sexual activity between under‐aged minors is not abusive.10 In addition, a grey zone of cases may involve two adolescents aged almost 16, and 18. Here, where sexual activity may be genuinely consensual, ethical analysis, findings from developmental science, and clinical needs all suggest the duty should be moderated by nuanced individual consideration by clinicians (Box 3). In our view, the central concept that should inform legal principles and practice is consent, and its presence or absence in circumstances which do not involve threat, intimidation or abuse of authority. On our analysis, three conclusions seem clear. First, legislative reforms are required so that disclosures in therapeutic contexts of clearly consensual sexual activity between similar aged peers under 16 are expressly exempt from the reporting duty. This is consistent with policy animating Victoria’s law reform requiring adults to report “a serious indictable offence involving the abuse of a child”,16 and Royal Commission recommendations.17 If protected by such an exemption, clinicians consulting with adolescents who are having sex with similar aged peers can be unhindered in providing preventive health interventions including contraception for mature minors, and screening for sexually transmitted infections.18 Clinicians routinely enquire about age of sexual partners and otherwise consider risk of abuse and patient capacity when providing treatment.7 If they reasonably conclude the adolescents are consenting, confidential treatment should be provided and this is clearly incompatible with reporting to police. Such an exemption also allows clinicians to create a safe environment to encourage adolescent help‐seeking, check for other health risks,19 explore family dynamics, and connect the adolescent with parents or others to benefit wellbeing.18,19 Second, this legislative exemption could extend to clearly consensual activity between adolescents aged 15 and 18. Legal attribution of capacity to consent to sex using simple age cut‐offs is convenient, but sometimes incongruent with developmental science, lived experience and clinical scenarios.9 In situations of clearly consensual activity, a margin of error should favour patient autonomy and clinical care. This is consistent with prosecutorial guidelines and Tasmania’s similar age exemptions. Clinicians would prefer this slight extension of the exemption so they can promote health and encourage future help‐seeking. Our hypothetical patients Anna and David would be unwilling to seek future care if the GP reported David to police. Third, the different models for exempting clinicians as recipients of confidential information are complex, uncertain and unsatisfactory. Legislative reforms are required to create a clear, unified approach. Any legislature that seeks to include an exemption for confidential disclosures about abusive incidents made to medical practitioners within therapeutic contexts should enact a specific exemption, using the NSW model. This would solve difficulties ascertaining whether this constitutes a “confidential communication” or is protected by privilege. It would also solve problems in the requested non‐disclosure exemptions; for abusive incidents, application only to those over 18 is inconsistent with developmental science, which suggests Victoria’s age 16 is justifiable, and could be extended to those aged 15. This three‐pronged approach aligns with clinicians’ duty of confidentiality in codes of ethics,20 and organisational policy on sexual and reproductive health.21 National principles recognise medical practitioners’ central role in supporting sexual and reproductive health through confidential care, with youth a priority population.18,21 This medico‐legal context is increasingly complex. Our analysis has focused on adolescent peers in genuinely consensual relationships whose ages mean technically they are committing an offence, exemplified by peers aged 15 and 18 years (Box 1). We unequivocally support duties to report child sexual abuse,15,22 and do not here consider other situations where different outcomes may transpire. We also caution that where disclosures of abusive incidents may be exempt from the criminal duty, a clinician may have a separate overriding legal duty to report. For example, Victorian doctors may be exempt under s 327(7)(c) of the Crimes Act 1958 from disclosing a 10‐year‐old’s confidential disclosure of sexual assault, but must report under child protection legislation.15 Health practitioners therefore need to know their responsibilities under different laws, and need ongoing professional education to promote legal literacy. Progress towards reform may require several steps. Since legislative limitations differ, agencies representing medical practitioners could urge reform at state and territory level, informed by research and clinical experience. However, ideally, a harmonised national approach should be adopted. National medical regulatory bodies and government ministries could mobilise to support a single model law that balances the need to protect Australian children from sexual offences, while promoting adolescents’ rights to consensual sexual activity. Box 1 – Requirements of consent to sexual intercourse, by Australian states and territories Conditions for consent to sexual intercourse Jurisdiction Free and voluntary agreement Not by threat, intimidation, or abuse of authority Australian Capital Territory Crimes Act 1900, s 67 (not expressly defined) s 67(1): consent to sexual intercourse with another person is negated if that consent is caused: “(a) by the infliction of violence or force on the person, or on a third person …; or (b) by a threat to inflict violence or force on the person, or on a third person …; or (c) by a threat to inflict violence or force on, or to use extortion against, the person or another person; or (d) by a threat to publicly humiliate or disgrace, or to physically or mentally harass, the person or another person; or … (h) by the abuse by the other person of his or her position of authority over … the person” New South Wales Crimes Act 1900, s 61HE(2): “A person ‘consents’ to a sexual activity if the person freely and voluntarily agrees to the sexual activity” s 61HE(5)(c): A person does not consent to a sexual activity if the person consents “because of threats of force or terror (whether the threats are against, or the terror is instilled in, that person or any other person)” s 61HE(8): “The grounds on which it may be established that a person does not consent include … (b) if the person consents to the sexual activity because of intimidatory or coercive conduct, or other threat, that does not involve a threat of force, or (c) if the person consents to the sexual activity because of the abuse of a position of authority or trust” Northern Territory Criminal Code Act 1983, s 192(1): “consent means free and voluntary agreement” s 192(2): “Circumstances in which a person does not consent to sexual intercourse … include circumstances where: (a) the person submits because of force, fear of force, or fear of harm of any type, to himself or herself or another person” Queensland Criminal Code 1899, s 348(1): “consent means consent freely and voluntarily given by a person with the cognitive capacity to give the consent” s 348(2): “consent to an act is not freely and voluntarily given if it is obtained—(a) by force; or (b) by threat or intimidation; or (c) by fear of bodily harm; or (d) by exercise of authority …” South Australia Criminal Law Consolidation Act 1935, s 46(2): “a person consents to sexual activity if the person freely and voluntarily agrees to the sexual activity” s 46(3): a person does not freely and voluntarily agree to sexual activity if “(a) the person agrees because of (i) the application of force or an express or implied threat of the application of force or a fear of the application of force to the person or to some other person; or (ii) an express or implied threat to degrade, humiliate, disgrace or harass the person or some other person” Tasmania Criminal Code 1924, s 2A(1): “‘consent’ means free agreement” s 2A(2):”a person does not freely agree to an act if the person … (b) agrees or submits because of force, or a reasonable fear of force, to him or her or to another person; or (c) agrees or submits because of a threat of any kind against him or her or against another person; or … (e) agrees or submits because he or she is overborne by the nature or position of another person” Victoria Crimes Act 1958, s 36(1): “consent means free agreement” s 36(2): ”Circumstances in which a person does not consent to an act include, but are not limited to, the following—(a) the person submits to the act because of force or the fear of force, whether to that person or someone else; (b) the person submits to the act because of the fear of harm of any type, whether to that person or someone else” Western Australia Criminal Code Compilation Act 1913, s 319(2)(a): “consent means a consent freely and voluntarily given” s 319(2)(a): “a consent is not freely and voluntarily given if it is obtained by force, threat, intimidation, deceit, or any fraudulent means” Box 2 – Close‐in‐age defence for sex with a minor under the legal age of consent, where intercourse is consensual Jurisdiction Legislation Age of consent Express defence for intercourse with someone under the legal age of consent if similar in age, and consent is provided Australian Capital Territory Crimes Act 1900, s 55(2) 16 Yes — if accused was not more than 2 years older than the child, and the child was aged 10 or over: s 55(3)(b) New South Wales Crimes Act 1900, s 66C(3) 16 Yes — if accused was not more than 2 years older than the child, and the child was aged 14 or 15: s 80AG Northern Territory Criminal Code Act 1983, s 127(1) 16 No Queensland Criminal Code Act 1899, s 215(1) 16 No South Australia Criminal Law Consolidation Act 1935, s 49(3) 17 Yes — if accused was under 17, and child was 16: ss 49(4)(a) and (4)(b)(i) Tasmania Criminal Code Act 1924, s 124 17 Yes — age gap not more than 5 years, if child was aged at least 15: s 124(3)(a); and age gap not more than 3 years, if child was aged at least 12: s 124(3)(b) Victoria Crimes Act 1958, s 49B 16 Yes — if accused was not more than 2 years older than the child, and the child was aged 12 or over: s 49V Western Australia Criminal Code Act 1913, s 321(2) 16 No Box 3 – Hypothetical clinical case study Anna is 15 years of age and in Year 10 at a co‐educational high school in Victoria. She has been getting good grades and has a part‐time job at a supermarket. David is 18 years of age, in Year 12 at Anna’s school, and works at the same supermarket. They have been dating for 3 months. Anna presents to her general practitioner for contraceptive advice. She has become sexually active with David and wants contraception additional to condoms. Her GP confirms Anna is a mature minor, since she understands fully the range of contraceptive options open to her, how they work, and their side effects. She has carefully considered all options with David, and has chosen a long‐acting reversible contraceptive implant. She intends to inform her mother, but she is not quite ready yet. She is certain she does not want to experience an unintentional pregnancy. Anna describes her relationship with David as very positive. She feels completely safe with him and under no coercion. She feels she could stop the relationship at any time if she wanted to, and so could he. The age of consent for sexual intercourse in Victoria is 16. Where sex involves a minor aged 12–15, no offence is committed if the other person is less than 2 years older than the minor, and the sex is consensual. Technically, David is committing a sexual offence by having sex with Anna, because he is 3 years older than her; if he was 17 there would be no offence. However, the GP is satisfied this relationship is consensual, and previously would not have reported this situation under either criminal law or child protection law. However, the criminal law on failure to disclose that commenced in Victoria in 2014 has now presented a dilemma for the GP. These laws aim to protect children from sexual abuse and require adults to report knowledge of a sexual offence with a child under 16 years to police. Anna has not expressly stated to the GP that she does not want the situation reported to police, since it has not occurred to her that anything wrong has happened. The GP studies the government website on the new laws to understand what she should do. She is relieved to learn health practitioners are exempt from the criminal law duty to report if they are told about the offence in the course of a confidential consultation. However, because of other legal definitions (Box 4), this exemption only applies if consulting exclusively with the person against whom the offence has been committed. The next day, Anna and David consult the GP together for a baseline sexually transmitted infection screen. The GP was happy to see them, but was perplexed that the exemption did not apply if consulting with the offender, in this case David. She was very reluctant to call the police about David and Anna, due to her knowledge about the consensual nature of their relationship, and their responsible behaviour in obtaining contraception. The GP also understands that other adults who know about the situation, such as Anna’s and David’s parents and school teachers, would appear to be required to report by the criminal law duty, since no clear exemptions apply to them. Box 4 – Health Practitioner Regulation National Law: definitions and application In Victoria, a “confidential communication” is “a communication, whether oral or written, made in confidence by a person against whom a sexual offence has been, or is alleged to have been committed to a registered medical practitioner or counsellor in the course of the relationship of medical practitioner and patient or counsellor and client”: Evidence (Miscellaneous Provisions) Act 1958, s 32B. Under the Health Practitioner Regulation National Law Act 2009 (Qld) Schedule s 5, “health practitioner means an individual who practises a health profession”. A “registered health practitioner means an individual who (a) is registered under this Law to practise a health profession, other than as a student; or (b) holds non‐practising registration under this Law in a health profession”. A “health profession” is defined to include a list of 15 professions (including recognised specialties in these), and most relevantly here includes the following professions: medical, nursing, pharmacy, and psychology. In Victoria, a “registered medical practitioner” under the Health Practitioner Regulation National Law is defined through the application of the Health Practitioner Regulation National Law Act 2009 (Qld) Schedule s 5. Victoria incorporated the Queensland Act into Victorian law, through the Health Practitioner Regulation National Law (Victoria) Act 2009, s 4 (Application of Health Practitioner Regulation National Law). The Health Practitioner Regulation National Law is also incorporated into other jurisdictions’ laws: Health Practitioner Regulation National Law (Tasmania) Act 2010, s 4; Health Practitioner Regulation (Adoption of National Law) Act 2009 (NSW), s 4; Health Practitioner Regulation National Law (ACT) Act 2010, s 6.

Ben Mathews · Lena A Sanci

Understanding the mental shortcuts people make and the values they bring to weighing risks is critical to informing effective risk communication

Julie Leask · Samantha J Carlson · Katie Attwell · Katrina K Clark · Jessica Kaufman · Catherine Hughes · Jane Frawley · Patrick Cashman · Holly Seal · Kerrie Wiley · Katarzyna Bolsewicz · Maryke Steffens · Margie H Danchin

Is a policy of mandatory vaccination for health care workers permissible under Australian law?

Dev AS Kevat · Danielle CA Panaccio · Sam C Pang · Jessica M Dean · Caitlin C Farmer · Patrick D Mahar

Objectives: To investigate the perspectives of doctors involved with voluntary assisted dying in Victoria regarding the Voluntary Assisted Dying Act 2017 (Vic) and its operation. Design, setting, participants: Qualitative study; semi‐structured interviews with 32 doctors who had participated in the voluntary assisted dying system during its first year of operation (commenced 19 June 2019). Doctors were interviewed during April‒July 2020. Results: Three major themes related to problems during the first year of operation of the Act were identified: the statutory prohibition of health professionals initiating discussions with their patients about voluntary assisted dying; the Department of Health and Human Services guidance requirement that all doctor‒patient, doctor‒pharmacist, and pharmacist‒patient interactions be face‐to‐face; and aspects of implementation, including problems with the voluntary assisted dying online portal, obtaining documentary evidence to establish eligibility, and inadequate resourcing of the Statewide Pharmacy Service. Conclusions: Doctors reported only limited concerns about the Victorian voluntary assisted dying legislation, but have had some problems with its operation, including implications for the accessibility of voluntary assisted dying to eligible patients. While legislative change may resolve some of these concerns, most can be ameliorated by improving the processes and systems.

Lindy Willmott · Ben P White · Marcus Sellars · Patsy M Yates

A lack of clear protocols elevates risks for clinicians for the consequences of decisions that they have a professional duty to make in the interests of their community Clinicians, ethicists and lawyers have long debated the parameters of triage in response to the inevitable disasters that sporadically overwhelm the health care system. Almost universally, they have advocated for open, transparent and consultative triage protocols, guidelines and legislation to combat biases and to support clinicians making unavoidable decisions in the interests of the community as a whole. The coronavirus disease 2019 (COVID‐19) pandemic has highlighted the importance of transparent triage. While there is considerable debate about ethical aspects of triage protocols, including concerns that the traditional focus on utilitarianism is discriminatory, largely missing from this discussion in Australia is that triage protocols are also important from a legal perspective — as a mechanism to promote lawful decision‐making processes and as a justification or defence to support clinicians’ decisions if a matter is litigated. The purpose of this article is twofold. First, after providing an overview of current COVID‐19 triage policies in Australia, we assess their legal status. Second, we argue that beyond ethics, transparent policies are needed so their compliance with law can be tested, and to enable practitioners to better understand their obligations before making sometimes “impossible” decisions. Australian COVID‐19 triage policies Australian clinicians have seen numerous ethical and professional guidance documents addressing COVID‐19 triage.1,2,3 These documents anticipate that if Australia’s health care system is overwhelmed as in other countries, clinicians will need guidelines to allocate limited resources, including ventilators, beds and highly trained personnel. The umbrella term “triage policy” denotes: (i) broad ethical or operational guidelines with suggested decision‐making principles;1,2,3 and (ii) more specific triage protocols,4 with set inclusion and exclusion criteria, and a process to prioritise individual patients when the system is overwhelmed. Many Australian COVID‐19 triage policies are ethical guidelines, but some Australian hospitals have also developed triage protocols.5 Internationally, the availability and content of such protocols varies widely. In a study from the United States, over half of responding institutions lacked a COVID‐19 triage protocol.6 In 2020, Mitchell and colleagues exposed insufficient transparency and significant variation in Victorian protocols.5 In Australia, primary responsibility for the administration of hospital services lies with the states, which have the power to promote a statewide approach to triage. Although every Australian state and territory has disaster management plans,7 publicly available COVID‐19 triage protocols are lacking. From March 2020 to 27 November 2020, the lead author (EC) regularly searched health department websites for COVID‐19 triage policies, examining both the websites’ content dedicated to COVID‐19 and searching keywords alone and in various combinations (COVID; intensive care; critical care; ICU; triage; framework; guidelines; policy; ethical). These searches revealed few relevant documents (Box 1). New South Wales is the only state to mention a triage guideline, but its COVID‐19 framework does not link to it.8 Queensland Health released an extensive ethical framework for COVID‐19 in April 2020,5 which has since been removed.9 Western Australia has a four‐page ethical framework but no publicly accessible protocol.10 The Commonwealth Government’s COVID‐19 strategy indicates the Commonwealth will work with state and territory governments to “agree on novel coronavirus triage criteria (if required)”,11 but there are no such criteria to date. Given constitutional arrangements, there is no expectation that the Commonwealth Government would provide these. The National Health and Medical Research Council has conducted consultation on an ethics framework for pandemics, but this is limited to ethical guidance. Legal status of COVID‐19 triage policies The prospect of deciding between patients who would benefit from life‐sustaining treatment is distressing. Compounding this is the potential for legal liability. Many of the legal issues that arise in pandemic triage are untested, and various areas of law may be engaged and applied in complex, fact‐specific ways. As other work has detailed, health authorities have wide discretion in making resource allocation decisions, which are generally respected by the courts.12,13 However, in some circumstances, clinicians (and institutions) may be found liable, and decisions may also be challenged on public law grounds (Box 2).13,14,15 These concerns are not merely academic; after Hurricane Katrina one doctor faced possible murder charges and civil lawsuits after several patients died during a hospital evacuation.16 Overseas, some governments have enacted immunity or indemnity laws to protect clinicians making COVID‐19 triage decisions.14,15 No such laws exist in Australia, and they do not appear to have been considered. Absent such laws, triage protocols may provide the next strongest legal defence. Under civil liability legislation, a clinician will generally not be negligent if acting in a manner widely accepted in Australia by peer professional opinion as competent medical practice (professional practice defence).12,13 Concrete advice on the legal significance of triage policies is difficult because the relationship between law and professional guidance is complex and each case is evaluated according to its unique facts. Whether the professional practice defence applies generally depends on the guideline’s nature, author and purported authority.17,18 A policy may create additional obligations beyond those imposed by law (eg, a specific hospital COVID‐19 triage protocol that must be followed by its clinicians), which may inform the legal standard of care.18 However, policy is not necessarily determinative of the standard of care, especially when couched as broad guidance (eg, COVID‐19 ethical guidelines from a professional college).18 Rigid adherence to policy can also be problematic; to meet the standard of care (and broader public decision‐making standards), clinicians must use judgment appropriate to the circumstances.17 Moreover, while policy can establish obligations in addition to the law, law may also impose more onerous obligations than a policy.18 When this occurs the legal standard will prevail. In other words, COVID‐19 triage policies can shape a regulatory response but only within the boundaries of the law. COVID‐19 triage policies may infringe laws in various nuanced ways.14 Liddell and colleagues note that the utilitarian “save the most lives possible” principle underlying most triage policies can infringe patients’ legal rights, many of which are unchanged in a disaster.14 In the United Kingdom, a legal challenge to the National Institute for Health and Care Excellence (NICE) COVID‐19 critical care protocol was initiated on the basis that its heavy reliance on the Clinical Frailty Scale constituted unlawful discrimination.19 In response, NICE revised the protocol to reduce reliance on the Clinical Frailty Scale for some patients. These issues have significant implications for clinicians: Absent a COVID‐19 triage policy, not providing beneficial life‐sustaining treatment is potentially risky because it may be harder to establish the professional practice defence in a negligence action. An institution’s failure to promulgate a policy could also result in claims. Additionally, a triage protocol (with its greater degree of specificity) would generally provide more legal protection than ethical guidelines. While it is lawful for governments and professional bodies to issue COVID‐19 triage policies, these policies should rely on appropriate evidence and must comply with specific jurisdictional laws, such as guardianship and human rights legislation (Box 2). Triage policies promote quality and consistency in decision making and guide clinicians to consider appropriate factors. However, clinicians must still exercise judgment which is reasonable and responsive to individual circumstances. Policies should provide guidance for when an individual is denied life‐sustaining treatment, since the duty to exercise reasonable care remains. Where reasonably possible, this may include communicating to the patient (or family) the reasons for the decision, providing appropriate palliative care, and information about complaints or dispute resolution processes. Transparency — not just about ethics From an ethical perspective, legitimate triage decisions require “accountability for reasonableness” — a fair process based on relevant criteria, a publicly accessible rationale, and (to the extent possible given the urgency of decisions) mechanisms for appeal, review and enforcement.20 Transparency is also important from a legal perspective because it subjects triage policies to public scrutiny before public health emergencies reach crisis levels. While internal legal advice on triage policies may have been sought, the NICE example illustrates that public scrutiny, consultation and litigation play an important role in testing legal boundaries. In addition to protecting individual patients, this promotes rigorous policy development and evaluation, and also benefits clinicians who are then not relying on policy later found to be deficient.17 It may also alleviate stress caused by uncertainty about protocols. Disclosure of triage policies also delivers a measure of natural justice by providing notice to patients and their families of decision‐making criteria and processes. Conclusion So far, Australia has avoided the scale of pandemic that has overwhelmed health systems elsewhere. While in this context, governments’ reluctance to develop and/or release triage protocols until a crisis has arrived is politically understandable, such a course of action carries significant risks. Public confidence is enhanced when governments have the political courage to embark on these difficult public debates in advance of need. Prioritising some individuals over others when the demand for resources exceeds supply is confronting for clinicians and the community alike, and challenges us to reflect on our deeply held values as a society. When clinicians are allocating scarce resources, they need standards to support their decisions which have been subject to public consultation and rigorous legal review. Australia’s successful management of the COVID‐19 pandemic is offering us the luxury of time to consult and reflect. [Corrections added on 9 June 2021 after first online publication: an additional row was added to Box 1.] Box 1 – Australian triage protocols and ethical guidelines for resource allocation during the coronavirus disease 2019 (COVID‐19) pandemic Jurisdiction COVID‐19 triage protocol or ethical guidelines Type of guidance Publicly available Commonwealth Australian Health Ethics Committee of the National Health and Medical Research Council: An ethics framework for pandemics (in development). Ethical guidelines Anticipated Australian Capital Territory None located on ACT Health website (https://health.act.gov.au). New South Wales NSW Health provides a COVID‐19 framework entitled “NSW adult intensive care services pandemic response planning”.8 The framework indicates that the NSW guideline for resource‐based decision making includes the “use of allocation frameworks and tools” with a reference (but no link to) a document entitled the “NSW Health COVID‐19 intensive care guidance drawn from principles in the NSW Health Influenza Pandemic Plan (PD2016_016). Sydney: NSW Health; 2020”. This 2020 document is based on the NSW Health Influenza Pandemic Plan (PD2016_016), which references the NSW Health policy “Influenza Pandemic – Providing Critical Care (PD2010_028)”. PD2010_028 contains a triage tool (https://www1.health.nsw.gov.au/pds/Pages/a-z.aspx). However, as the updated COVID‐19 intensive care guidance is not publicly available, we cannot confirm that it contains the same guidance as PD2016_016 or the PD2010_028 triage tool. Triage protocol and ethical and operational guidelines No Northern Territory None located on the NT Health Department website (https://health.nt.gov.au). Queensland On 20 April 2020, Queensland Health released a comprehensive ethical framework (developed in consultation with numerous stakeholders) but this has since been removed from its website.9 Ethical guidelines No (initially available but subsequently recalled) South Australia None located on the SA Health website (https://www.sahealth.sa.gov.au). Tasmania None located on the Tasmanian Department of Health website (https://www.health.tas.gov.au). Victoria None located on the Victorian Department of Health and Human Services website (https://www.dhhs.vic.gov.au/clinical-guidance-and-resources-covid-19). Western Australia The WA Health Department website includes a framework to guide decision making on the appropriateness of intensive care management during the COVID‐19 pandemic (last updated 26 June 2020) in its section on COVID‐19 guidance for health professionals.10 Ethical guidelines Yes Box 2 – Examples of potential areas of legal risk in response to pandemic triage decisions* Civil law Withholding or withdrawing beneficial life‐sustaining treatment from one patient to provide it to a patient with a better prognosis could amount to a breach of the duty of care and liability in negligence (subject to the peer professional practice defence for clinicians and the resource allocation defence in the case of hospitals). Criminal law Withdrawing a ventilator from one patient who is stable to provide it to another patient with a greater chance of survival could lead to charges of murder or manslaughter if the first patient dies as a result (charges would be subject to prosecutorial discretion and jurisdiction‐specific defences such as necessity). Commonwealth and state antidiscrimination laws A triage protocol could violate state and territory antidiscrimination legislation if the decision was made on the basis of a protected attribute such as age, disability or race (although specific protections may apply under the legislation for decision makers). Guardianship legislation This applies to patients who lack decision‐making capacity; for example, because they are unconscious, sedated or have cognitive impairment. At common law, medical practitioners have no legal duty to provide treatment that is non‐beneficial. However, the Guardianship and Administration Act 2000 (Qld) makes it an offence to withhold or withdraw life‐sustaining treatment from patients who lack capacity without the consent of an appropriate decision maker, even if providing that treatment would be “inconsistent with good medical practice” (ie, even if that treatment is non‐beneficial). This may preclude some triage decisions in Queensland. A decision to withhold or withdraw beneficial life‐sustaining treatment from a patient who lacks capacity to provide it to someone with a better prognosis may violate state or territory guardianship legislation, which requires health care decisions to be made in a person’s best interests. (This could also result in an emergency application to the Supreme Court to intervene in its parens patriae jurisdiction to protect the patient’s best interests.) * This is a non‐exhaustive list of examples. For an expanded discussion of legal challenges in Australia, see Close et al.13 See further Liddell et al14 for the UK context, which has some similarities to Australia.

Eliana Close · Lindy Willmott · Tina Cockburn · Simon Young · Will Cairns · Ben P White

The COVID‐19 pandemic has necessitated rapid uptake and use of telehealth, unmasking a number of concerns potentially not previously contemplated by clinicians, patients and legislators In the physical distancing climate of coronavirus disease 2019 (COVID‐19), the ubiquity of virtual communications in medical practice generates a number of challenges. Consultation via telehealth allows for creation of audiovisual documentation of the clinical interaction as well as observation by unseen parties from each participant’s perspective, either in real time or subsequently via review of any recordings. It is necessary for clinicians to i) obtain informed consent for clinician‐led recordings, ii) be aware of potential patient‐generated recordings (both declared and undeclared), and iii) meet legal, privacy and storage requirements pertaining to health information arising from a virtual consultation. Consent to participation Observing next of kin or third parties to a virtual telehealth consultation must be introduced to the treating clinician in a manner consistent with an in‐person consultation, whereby such an individual would, with the patient’s consent, attend the consultation with the patient. In considering the clinician’s screen, consent for clinician participation is implied, but should be specifically broadened where appropriate to allow for the presence of clinical observers. Indeed, the clinician’s duty of confidentiality still applies to telehealth consultations, necessitating awareness of others within earshot or visual proximity to the consultation. Implications of virtual participation The benefits of a virtual consultation include participation and collaboration with members of the patient’s family previously unable to participate, as well as increased access to health care for patients with particular physical challenges or vulnerabilities, including vulnerability to infection with COVID‐19. Interviewing a patient in their home adds rare insights for a clinician not typically engaged in home visits, including opportunities for environmental observation, which may be of clinical value. The home setting allows for involvement of parties (seen and unseen) potentially contrary to the patient’s best interests. Pertinent examples include family violence or elder abuse contexts, where presence of offenders may jeopardise the clinical encounter and may pose direct risks to the patient in the periconsultation period and subsequently via covert audio or video footage. A 2020 article provided insights on screening questions for detecting and navigating potential abuse during telehealth consultations in the setting of a COVID‐19‐related domestic violence epidemic secondary to government‐imposed social restrictions.1 Beyond clinical value, novel forms of documentation (including audiovisual recording) generated within the consultation may benefit research, education, billing and coding, subject to appropriate ethical and consent obligations. The content of a traditional clinical consultation episode is limited to the parties in the room and, to a defined extent, other parties (via review of written documentation). In the telehealth context, a wide audience can potentially review video footage of the consultation, as if they were there, for an indefinite period. This may have implications for the practicalities and duration of storage required of such material, its latent role as discoverable documentary evidence in future litigation (particularly given the persuasive nature of audiovisual documentation), and in substantiation of episodic care funding. Clinical interactions may incorporate questions or discussions that, while appropriate sequentially, may appear inappropriate, deficient, discourteous or misleading if taken out of context or distilled to a single statement or query. Recordings, and their potential edits, could be used by patients in a maladaptive manner, engender abnormal illness behaviour, or make a participant consciously or unconsciously feel the need to perform or otherwise change clinical interactions. Recordings by the patient The likelihood of a patient recording a clinical encounter is much higher in the age of telehealth, when secret recording is increasingly possible. The legality of recording a private conversation without consent depends on the state or territory where the person undertaking the recording resides, as surveillance legislation is largely a matter for these jurisdictions (Box 1). In New South Wales, South Australia, Tasmania, Western Australia and the Australian Capital Territory, it is an offence to record a private conversation. This was upheld in NSW in Toth v Director of Public Prosecutions, where it was held that a patient secretly recording a consultation with a general practitioner was an offence.2 However, in Victoria, Queensland and the Northern Territory, it is lawful to record a private conversation without consent if you are a party to the conversation.3,4,5 In all jurisdictions, it is generally not permissible to publish or communicate information secretly recorded. However, exceptions exist; for example, in Victoria, the prohibition on publication or communication of information secretly recorded does not apply to subsequent use in the course of legal or disciplinary proceedings.6 Courts may be more receptive to the notion of undisclosed recordings for defensive purposes where there is a reasonable belief that a recording might be necessary to address a substantive harm. Thus, in certain jurisdictions, patients can secretly record a consultation without the consent of the clinician and this recording may be used in legal or disciplinary proceedings. These risks are best described as emerging given the widespread use of telehealth and the paucity of reported examples of recording. It should also be stressed that when practitioners are behaving professionally and meeting the appropriate standard of care, the medico‐legal risk of patient recordings is minimal. Practical measures to prevent patients from secretly recording screens include disabling the in‐built recording functions in telehealth platforms, using platforms lacking this recording option, and employing programs preventing screen recording or superimposing watermarks including publication preclusion. However, such measures will not prevent another party from recording a consultation with an additional device. Provision of documented restrictions to the patient at the time of any patient‐generated recording and co‐recording by the clinician (to ensure record integrity) may be of value. However, an automated message before consultation commencement expressly stating the clinician does not consent to screen recording (intending to effect a licence agreement or permit a gag order) is unlikely to achieve this in jurisdictions allowing patients to record without the clinician’s permission. Recordings by the clinician Key to understanding and managing both consent and any recordings is the status of these recordings at law. The definition of health information as defined by the Privacy Act 1988 (Cth) s 6FA is broad, including not only information pertaining to someone’s health but also personal information collected to provide, or in providing, a health service to an individual.7 Interpreted literally, any information pertaining to a patient that is recorded, irrespective of consent, may be considered health information with requirements for storage in compliance with the relevant state or territory health records and/or freedom of information legislation (Box 2). In Australia, under the Privacy Act 1988 (Cth) as well as relevant state and territory legislation, a patient’s medical records will generally be held and owned by the clinician or health care organisation, but patients are entitled to access and take a copy of their records. However, concepts of data sovereignty are changing.8 Patient‐driven and centralised health records (such as collaborative digital hospital files and My Health Record) are contemporary examples of this, with reduced clarity about the roles and responsibilities of potential contributors (including the patient) to a medical record as well as the ownership of that information. Various jurisdictions within Australia legislate minimum periods for medical record‐keeping, generally 7 years from the date of the last record entry for adults and until the age of 25 years for children. Many variations exist, based on state or territory, whether the records reside in a public or private institution, or relate to public health, quality improvement, disability, implants or artificial devices, sexual assault counselling, or child protection. Efficient and safe storage of electronic health information by clinicians, including telehealth recordings, is increasingly challenging. Considerations include provisions regulating onshore versus offshore and cloud‐based storage technicalities, including encryption inherent in the platform of choice, preventing evolving real‐time threats to health information security (including via insurance and strategic risk mitigation), and compliance with legislated security requirements. The omnipresence of personal digital devices, including smartphones, has irrevocably altered the role and prevalence of clinical photography, videography and digital team communication tools, constantly generating much data, not all of which are routinely stored by health services or clinicians relying on them to guide clinical decisions. Clear documentation of consent to recording of digital information by clinicians is important, and that consent should extend to the purpose of the recording. When the patient provides their consent, the use of the recording should be limited to that purpose.9 Recording of telehealth discussions between health care workers, including multidisciplinary meetings and case conferences, engenders further challenges. Recordings may be helpful for updating absent clinicians, minute taking, education or documentation. However, such recordings constitute health information, necessitating compliance with management and storage requirements applicable to a virtual consultation. In the public sector, patients may have access to recordings under freedom of information legislation, potentially resulting in significant alterations to the dynamic and tone of the discussion. This is a complex area of law which varies among jurisdictions but is worth keeping in mind. Where there is uncertainty, proactive discussion with medical indemnity providers may be invaluable, especially given the heterogeneity of legal obligations upon clinicians across jurisdictions. Conclusion In Australia, the COVID‐19 pandemic has necessitated rapid uptake and use of telehealth. This has unmasked a number of concerns potentially not previously contemplated by legislators, patients and clinicians, particularly concerning the recording of clinical consultations and thereby the creation of health information, with extensive associated data management and security compliance challenges. Recording of clinical conversations or processes may enhance patient and clinician participation, self‐reference, research, education and funding. In certain jurisdictions, however, clinical consultations or meetings may be lawfully recorded with or without participants’ knowledge, and may later be accessible to the patient, including for use in future legal or disciplinary proceedings, potentially stifling candid discussion. This and the challenging obligations relating to data management technicalities represent real risks for clinicians and health services. It is incumbent upon health care providers and lawmakers alike to consider these issues in a practical context, ensuring that telehealth is not only a useful tool but a safe and effective one. Box 1 – Legislation governing covert recordings State or territory Legislation pertaining to recording Australian Capital Territory Listening Devices Act 1992 (ACT) New South Wales Surveillance Devices Act 2007 (NSW) Northern Territory Surveillance Devices Act 2007 (NT) Queensland Invasion of Privacy Act 1971 (QLD) South Australia Listening and Surveillance Devices Act 1972 (SA) Tasmania Listening Devices Act 1991 (TAS) Victoria Surveillance Devices Act 1999 (VIC) Western Australia Surveillance Devices Act 1998 (WA) Box 2 – Legislation governing health information management Jurisdiction Legislation governing health information management (not including legislated regulations) Federal Privacy Act 1988 (Cth); Personally Controlled Electronic Health Records (Consequential Amendments) Act 2012 (Cth); My Health Records Act 2012 (Cth); Freedom of Information Act 1982 (Cth) State or territory Australian Capital Territory Health Records (Privacy and Access) Act 1997 (ACT) New South Wales Health Records and Information Privacy Act 2002 (NSW) Northern Territory Health Services Act 2014 (NT); Information Act 2002 (NT) Queensland Information Privacy Act 2009 (QLD); Right to Information Act 2009 (Qld); Public Records Act 2002 (QLD) South Australia Freedom of Information Act 1991 (SA); State Records Act 1997 (SA) Tasmania Personal Information Protection Act 2004 (TAS); Right to Information Act 2009 (TAS) Victoria Health Records Act 2001 (VIC); Privacy and Data Protection Act 2014 (VIC); Freedom of Information Act 1982 (VIC); Public Records Act 1973 (VIC) Western Australia Freedom of Information Act 1992 (WA); State Records Act 2000 (WA)

Caitlin C Farmer · Sam C Pang · Dev Kevat · Jessica Dean · Danielle Panaccio · Patrick D Mahar

Implementing voluntary assisted dying legislation demands respectful communication and collaboration between health professionals and community The Voluntary Assisted Dying Act 2017 (Vic) (VAD Act) was passed by the Victorian Parliament in November 2017 and came into effect on 19 June 2019.1 The VAD Act is the only legislation of its kind implemented in Australia, but there are several other international jurisdictions where comparable legislations apply.2,3,4 Victoria is the first state in Australia to implement voluntary assisted dying (VAD). There is a dearth of local evidence available which explores the implementation of assisted dying services into a hospital setting, although potential ethical challenges have been identified.2,5,6 This article aims to outline the experience of a tertiary public health service in Melbourne’s western suburbs which implemented VAD in 2019 and the resultant policies and procedures. With the enactment of the VAD Act, Victorian public health services were expected to develop policies and procedures which apply when a patient requests VAD or related information.7 As a tertiary public health service in Victoria, the health service used policies and guidelines suggested by the Department of Health and Human Services (DHHS) and shared documents from other metropolitan tertiary hospitals as a basis for developing local policies and procedures.7,8 The Victorian legislation provided the eligibility criteria and necessary steps required to access VAD, including timing of requests, medical assessments, medication prescription, reporting and professional requirements.1 In mid‐2018, the health service established a VAD Working Group with senior professional and executive representation, including the Chief Medical Officer; the General Counsel; the Executive Director, Nursing and Midwifery; relevant medical heads of units, senior nurses, allied health representatives, and the Senior Clinical Communications Advisor. The Clinical Communications Advisor conducted 1:1 consultations with the 25 Working Group members to explore the impact of VAD legislation on their professional group and clinical practice between September and December 2018. The outcomes of these consultations highlighted the systemic and ethical complexities inherent in implementing VAD and informed the next steps, including the need to engage with a range of appropriately skilled and experienced clinicians throughout the implementation phase.4 A key consideration during the implementation phase was balancing staff members’ right to conscientiously object to supporting patients when the assistance was related to VAD, with the expectation that health professionals would continue to provide care unrelated to VAD.5 Capacity for moral injury for staff for whom their beliefs and values were at odds with the employing organisation’s approach to VAD needed to be recognised and addressed throughout the implementation process.5,9 To assist with planning, the health service had to decide which VAD model of care pathway would be provided — either A, B or C10 (Supporting Information, appendix 1). The pathway selected by the health service was dependent on the number of suitably qualified medical professionals willing to perform VAD coordination and/or consultation roles, in line with VAD legislation requirements. In 2019, the hospital’s medical professionals were invited to complete an anonymous survey asking them to indicate their willingness to participate in VAD. This survey achieved 208 responses (a 17% response rate), 106 of those were from senior medical staff, with 72% of respondents supporting a patient’s access to VAD at the health service. In addition, eight senior medical staff members expressed a willingness to be involved in the facilitation of VAD. The survey results guided the health service’s management to determine Pathway A as the appropriate model of care for this health service. In parallel with this survey, training for VAD was provided by the DHHS‐led VAD Implementation Taskforce. During these sessions, the need for local VAD procedures were identified, as staff members required further guidance to navigate patients’ requests for VAD and to ensure the health service adhered to legislative requirements. Importantly, the procedures needed to support the right of staff to conscientiously object to VAD while fulfilling lawful access to care.5 The multidisciplinary Working Group met 12 times over an 8‐month period, with the first meeting occurring in November 2018. As implementation drew closer, the Working Group focused on a number of actions to operationalise the legislation, including the development of two VAD procedural flow charts for requesting and assessing VAD (Box 1) and for VAD medication and administration (Box 2). These procedural flow charts, as well as the organisation‐wide VAD policy and procedures and the DHHS guidelines, were distributed to all staff electronically and made available on the organisation’s intranet. The procedures developed applied to all staff, including agency and contract staff. Two open‐forums (“grand rounds”) were held to educate staff on VAD legislation, inform staff of the Pathway A model of care, and launch the hospital’s VAD policy and procedures (Supporting Information, appendices 2 and 3). All clinical staff were invited to attend. These forums attracted more than 500 participants and were part didactic and part panel‐led, with interactive audience discussion. Over 50 questions were received through the anonymous electronic tool Mentimeter (www.mentimeter.com) and verbal contributions were documented. A broad range of perspectives, concerns and clinical scenarios posed throughout these sessions prompted the development of a comprehensive frequently asked questions document, which provided further guidance regarding the integration of VAD into clinical practice. Despite the VAD Act coming into effect from June 2019, the health service wanted to provide adequate VAD advice and training before it became an option for patients. The health service thus determined that the VAD policy, procedures and flow charts would be enacted in July 2019. Challenges implementing voluntary assisted dying There were a number of challenges during the planning phase. Primarily, the health service needing to balance the guiding principles of the legislation, which focused on patient‐centred decisions, while embedding practices to mitigate organisational risk. One example surfaced when the Working Group were deciding where VAD medication would be stored during an inpatient stay. The patient’s autonomy was core, but other safety issues were factored in. In this instance, the decision was made to store the patient’s VAD medication box securely within the central pharmacy rather than on the ward or at the patient’s bedside. Perhaps the largest challenge was fulfilling the responsibility of a Pathway A public health service to provide VAD as an option while respecting the staff member’s decision to conscientiously object to facilitating or being involved in VAD. The need to consider each case individually was highlighted, as it was recognised that there is a spectrum of views in relation to conscientiously objecting. Broad consultation enabled a sensitive and considerate implementation plan, including the addition of known conscientious objectors in the Working Group. Processes were embedded to allow conscientious objectors to distance themselves when patients request VAD, including the provision of informed agency nursing staff to replace potential conscientious objectors on a shift, and the broad promotion of a single contact phone number, to which conscientious objectors could anonymously call and hand over this responsibility. Without comparable local evidence, the expected demand for VAD was inferred from international evidence, which predicted that a low number of people would request VAD.2,3 Over a 14‐month period (June 2019 to September 2020), the health service received 42 patient requests for VAD, with four patients progressing to a prescription of VAD medications and dying as a result. Three of these four patients died after receiving VAD as inpatients and one died at home after being discharged from the health service. Patients who requested VAD were cared for across a number of services and received concurrent palliative care as part of appropriate end‐of‐life care management. The patients who died after receiving VAD were cared for in the ward that was most familiar and suited to their needs; palliative care was provided by the treating team, with specialist input as required. Most VAD requests were from patients in the final weeks of their lives, who therefore did not survive the full length of the VAD assessment process. This observation made it imperative that VAD processes complemented end‐of‐life care, thus not denying the patient and their loved ones appropriate palliative and bereavement care respectively. Indeed, a core tenet of staff education was that progression of VAD may occur during end‐of‐life care; therefore, palliative and comfort care must continue concurrently with VAD processes. Implementing VAD in a hospital setting demanded sensitive, honest and respectful communication between multiple health professional groups and the community, particularly between individuals with opposing views. A significant amount of time was spent engaging with and listening to staff with a myriad of perspectives. The framework provided by the VAD legislation and the DHHS VAD Implementation Taskforce enabled the health service to develop local policy, procedures and resources that most appropriately serve the community. The multidisciplinary Working Group proved a useful forum to deal with the complex issues inherent in implementing a progressive legislation into a large health service. Since the implementation of VAD, statewide monitoring and surveillance of VAD has occurred through multisite data collection and mandated reporting. Locally, discussion of case studies, engagement in multisite research and staff consultation will continue to provide vital guidance to the health service when delivering VAD, improving its processes and responding to the needs of patients and staff. Box 1 – Voluntary assisted dying request and assessment procedural flow chart Source: Western Health. Figure reproduced with permission. Box 2 – Voluntary assisted dying medication and administration procedural flow chart EMR = electronic medical record; iPM = patient administration system. Source: Western Health. Figure reproduced with permission.

Sarah Booth · Paul Eleftheriou · Claire Moody

There is little legal recourse in Australia for someone who is denied care on resource grounds, particularly in the context of a pandemic

Michelle A Gunn · Fiona J McDonald

Difficulty in achieving proper informed consent for a complex screening test and the varying phenotypic outcomes leaves pregnant women in a precarious situation when results are abnormal The combined first trimester screening test for Down syndrome, involving a nuchal translucency scan and biochemistry at 11–13 weeks, improved detection rates to 90% when compared with the sensitivity of screening by age‐related a priori risk of around 30% for a false positive rate of 5%.1 The advent of non‐invasive prenatal testing (NIPT) in 2010 as a screening test for the common trisomies was revolutionary, with sensitivity, specificity and detection rates unmatched by the combined first trimester screening programs. NIPT was found to achieve a detection rate for Down syndrome of 99.7%, with a false positive rate of 0.04%.2 However, some NIPT providers now additionally offer extended panels and low resolution whole genome sequencing (WGS) including sex chromosome aneuploidies, rare autosomal aneuploidies, and subchromosomal deletions, duplications and recurrent microdeletions. This comes at a cost of a higher false positive rate and lower positive predictive value.3 Moreover, the expanded panels and WGS NIPT raise issues of clinical utility and ethical concerns.4,5 Clinical utility Screening not diagnosis NIPT is based on the detection of cell‐free fetal DNA in the maternal circulation. The placental origin of cell‐free fetal DNA means that NIPT can only be a screening test and is not diagnostic.6 NIPT findings can be confounded by confined placental mosaicism, cell‐free fetal DNA from a demised co‐twin placenta, maternal chromosomal changes or malignancy.6,7 Moreover, a NIPT result will be issued even if the fetus is demised. The current NIPT tests available are for specific chromosomal aneuploidy, extended panels of targeted conditions and low resolution WGS. Targeted and low resolution WGS NIPT Targeted NIPTs (Box 1) interrogate specific chromosomes: standard (usually 13, 18, 21, X and Y) or extended (specific recurrent microdeletions associated with known syndromes, such as 22q11.2 microdeletion [DiGeorge syndrome]).8 Many abnormalities that can be detected by targeted NIPT have varying clinical outcomes (eg, sex chromosome abnormalities and DiGeorge syndrome). Each of these conditions has varying sensitivity, specificity and positive predictive value. Other NIPTs interrogate every chromosome (by low resolution WGS). These tests can potentially screen for aneuploidy of every chromosome (all 22 autosomes and the sex chromosomes), and for subchromosomal gains and losses on every chromosome. There is potential utility in detecting rare or novel large subchromosomal imbalances, as they are likely to be associated with abnormal clinical phenotype when present in the fetus, and may indicate a familial balanced rearrangement. The clinical utility of screening for rare autosomal aneuploidies is less certain. Most rare autosomal aneuploidies (95%) are confined to the placenta, and those which are present in the fetus as well as the placenta often result in early fetal demise.9 The resolution of WGS NIPT is likely to increase as deeper sequencing becomes viable and cost‐effective. Whereas prenatal microarray testing of amniotic fluid in Australia is primarily used in the context of a fetal structural abnormality, higher resolution NIPT could become a general screening test. This would, however, increase both the number of variants of uncertain significance and the likelihood that they are detected in an apparently phenotypically normal fetus.3,10 Ethical concerns Respect for maternal autonomy is an important ethical principle in clinical guidelines for prenatal screening. Recommendation 2 of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists guidelines states: “Screening or diagnostic testing for fetal chromosomal and genetic conditions is voluntary and should only be undertaken as an informed decision by the pregnant woman”.11 In light of the issues surrounding clinical utility and complexity of expanded panels and WGS NIPT, care needs to be taken to ensure that autonomy is respected. Moreover, consent alone cannot be expected to do the ethical heavy lifting, because of (i) the challenges in providing adequate information arising from complexity of the tests; (ii) the risk of power imbalances and “normalisation” of testing; (iii) anxiety resulting from complex and potentially unnecessary medical decisions; (iv) the problem of screening for “normality” and genetic reductionism; and (v) the doctor’s responsibility in determining which NIPT test is clinically indicated. Complexity endangers informed consent Respect for autonomy requires that informed consent is obtained. From a medico‐legal perspective, consent must be given voluntarily. The individual must also be sufficiently informed regarding a test or procedure, including the associated risks and benefits. The requisite extent of information provision is generally determined in accordance with what information a reasonable person, in that person’s circumstances, would expect to receive. From an ethical perspective, however, it is the understanding of information that is important, not merely that a person was given the legally required information. Given the complexity of extended panels and WGS NIPT, ensuring understanding means that significant time needs to be invested. Power imbalances and normalisation Two additional factors could ethically undermine consent for all NIPT options. First, the power imbalance between a doctor and patient, whereby a patient simply agrees because “doctor knows best” and, second, the impression that NIPT is a normal part of care that it would be foolish to reject.12 The anxiety caused by uncertain results It is tempting to respect autonomy by being non‐paternalistic and non‐directive in counselling by giving parents all the information from prenatal testing regardless of its nature. However, this shifts the burden of the uncertain results and the resultant anxiety to the parents. Qualitative and quantitative research shows higher levels of decisional regret among parents whose results identified variation of uncertain significance. At least some parents would not have consented to the test if they had known what this would entail. The lack of certainty by clinicians about what these results might actually mean for a future child increased parental distress.13 The meaning of screening and the danger of genetic reductionism According to the synthesis of screening criteria offered by Andermann and colleagues (Box 2), screening should be used to identify an individual who is high risk for a specific disease or need, thereby filling the perceived gap between standard screening and invasive diagnostics.14 Screening is then followed up with diagnostic tests and appropriate treatment. The availability of extended panels and WGS NIPT (Box 1) increases the tendency away from screening for diseases guided by public health screening principles. It is difficult to identify a recognised need or define the objectives of the screening beyond merely looking to see if there is anything abnormal. Even if these principles were met, one may be detecting placental pathology, or clinical conditions with highly variable outcomes for the fetus. As the resolution of WGS NIPT increases, so does the likelihood of detecting variants of uncertain significance. Provision of extended panels and WGS NIPT should be seen in light of the bigger question of how we see genetic information in our society.15 Research shows that many genetic tests are in effect screening for “normality”, which partly explains the anxiety when variants of uncertain significance are reported.13 This approach potentially changes the purpose of screening from screening for a specific disease to screening for normality by identifying any abnormality in the genome. The error in this thinking is that it assumes that genetic variation is abnormal. Just because a genetic anomaly can be identified does not necessarily mean that it would be phenotypically expressed. Similarly, detection of genes associated with adult onset disease does not necessarily equate to disease, and the possible future development of therapies for currently untreatable conditions cannot be ruled out. Consent is not sufficient to justify a procedure of questionable clinical utility Screening should be recommended or chosen only if there is likely to be a proportionate benefit, and there is no disproportionate burden. What is proportionate rests on a number of objective and subjective factors, but the aforementioned public health screening principles provide a good starting point. We agree with national guidelines that recommend against routine screening for recurrent microdeletions, and recommend provision of in‐depth counselling before screening for sex chromosome abnormalities.11 Recommendations The following recommendations may address the clinical and ethical concerns outlined above. Informed consent is required for all NIPT tests, especially in the context of extended panels and WGS NIPT. Clinicians must understand the different abnormalities targeted by extended NIPT panels and be able to assess and communicate the clinical utility of screening in accordance with a particular patient’s needs, desires and circumstances (Box 1). If ordering WGS NIPT, given that there may be significant uncertainty as to the actual phenotypic or functional manifestation of a genetic variation in a particular child, the consent process should include helping to contextualise limitations and risks in the broader context of the human experience of risk and uncertainty. Genuine shared decision‐making models can empower patient autonomy by helping them to understand the implications of their possible decisions in relation to their values.16 Moreover, decision tools and algorithms that align a variety of scenarios with personal values can facilitate a high quality informed consent process. Higher resolution WGS NIPT should only be used for research purposes until we have robust data regarding its clinical utility. Box 1 – Non‐invasive prenatal testing (NIPT) options: current availability and main advantages and disadvantages CPM = confined placental mosaicism; PPV = positive predictive value; WGS = whole genome sequencing. Box 2 – Synthesis of screening criteria12 The screening program should respond to a recognised need. The objectives of screening should be defined at the outset. There should be a defined target population. There should be scientific evidence of screening program effectiveness. The program should integrate education, testing, clinical services and program management. There should be quality assurance, with mechanisms to minimise potential risks of screening. The program should ensure informed choice, confidentiality and respect for autonomy. The program should promote equity and access to screening for the entire target population. Program evaluation should be planned from the outset. The overall benefits of screening should outweigh the harm.

Joseph Thomas · James Harraway · David Kirchhoffer

Is the current genetics and insurance moratorium an effective long term regulatory solution for Australia? Genetic discrimination in life insurance is a longstanding issue in Australia,1,2 and has been the subject of two government inquiries.3,4 The use of genetic test results in underwriting continues to be self‐regulated by the life insurance industry.5 In 2019, following Parliamentary Joint Committee recommendations,4 the industry voluntarily introduced a moratorium restricting the use of genetic test results in life insurance underwriting for polices worth up to AU$500 000. Although the moratorium is an important step, concerns remain around the financial limits, public awareness, lack of government oversight and compliance monitoring. The impact and effectiveness of the moratorium needs evaluation to inform the planned 2022 review. A new research project has been funded by the Australian Government’s Genomic Health Futures Mission to serve that important function. Genomic testing has the potential to improve disease prevention and public health. For example, predictive testing of BRCA1/2 genes can identify women at high risk of developing breast and ovarian cancer, where risk can be mitigated through preventive surgery and/or screening. As genomic testing becomes more widespread, patients, general practitioners and other health professionals will increasingly be required to address issues related to privacy, data security, genetic discrimination and insurance.2,6 Although health insurance is community‐rated in Australia and therefore not subject to genetic discrimination,1 the use of genetic test results in life insurance is allowed under the Disability Discrimination Act 1992 (Cth). This means that life insurance companies can legally refuse coverage or increase premiums based on genetic test results. A number of ethical, social and medical implications arise when genetic test results are permitted to be used in insurance underwriting, especially predictive testing in otherwise healthy people.1,7 Previous studies show that fear of insurance discrimination deters individuals from taking clinically indicated genetic tests and participating in genetic research.1 In a study where predictive genetic testing for Lynch syndrome (which causes an increased risk of colorectal and other cancers) was offered, the proportion of people who declined testing when informed of the insurance implications was more than double the proportion who declined without knowledge of insurance implications.8 There are different concerns from the insurance industry perspective, including the possible actuarial implications of adding genomic information to risk models. Genomic test results can not only reveal risk (positive results), but also indicate reduced risk (negative results), potentially changing the dynamics of actuarial calculations. The notion of adverse selection, whereby individuals at high genetic risk may be more likely to take out insurance policies, is also raised by insurers. It is critical for the optimisation of genomic medicine that individuals can make informed choices about genetic testing and research participation without fear of insurance implications. Further, moral implications regarding the use of genetic information for insurance underwriting extend beyond actuarial fairness to include consideration of public interests such as justice, beneficence, autonomy and public health.7 Several governments internationally have therefore banned or restricted the use of genetic test results in risk‐rated insurance, including Canada, the United Kingdom and Europe, using various legal mechanisms.9 The National Health Genomics Policy Framework and Implementation Plan 2018–20216 is a strategic policy of the Council of Australian Governments, which recognises the potential of genomics for public health while acknowledging the need for ethical mechanisms for its delivery. Developing a national approach to issues including genetic discrimination was listed as a strategic priority for action in the Framework and listed as the first short term national priority in the implementation plan,6 making it one of the most significant ethical, legal and social issues facing genomic medicine in Australia. However, debate remains regarding the most effective mechanism of regulation. Following previous examination of these issues by the Australian Law Reform Commission and Australian Health Ethics Committee,3 a recent inquiry of the Parliamentary Joint Committee on Corporations and Financial Services into the life insurance industry considered the use of genetic test results in life insurance.4 The report expressed strong concerns about insurer access to genetic information and recommended that: a moratorium be implemented to “prohibit any life insurers from using the outcomes of predictive genetic tests at least in the medium term … as a matter of some urgency and [in] a form similar to the United Kingdom’s Moratorium”;4 the Financial Services Council (FSC), together with the Australian Genetic Non‐Discrimination Working Group (of which the authors are members), assess the consumer impact of a moratorium; and the federal government monitor the implementation of, and adherence to, such a moratorium, and if needed, implement legislation on the issue. The Australian Government has not yet responded to the Parliamentary Joint Committee recommendations. However, the FSC, Australia’s peak national body for life insurers, introduced an industry‐led moratorium in July 2019. Under the moratorium, Australian consumers need no longer disclose their genetic test results when applying for policies up to $500 000 for death/total permanent disability, $200 000 for trauma/critical illness, and $4000/month for income protection cover.10 The moratorium applies to all genetic test results, including research results and results obtained from internet‐based direct‐to‐consumer tests, which are increasingly resulting in clinical referrals.11 Above these financial limits (which are cumulative across multiple policies), life insurers can still ask for, and use, any existing genetic test result, which can lead to refused or delayed cover, exclusions or increased premiums. However, insurers must not require applicants to undergo a genetic test. Applicants can choose to disclose a favourable genetic test result (showing that an individual with a family history of a genetic condition does not have the familial genetic variant) to offset the effects on underwriting of an adverse family history. The FSC moratorium is a self‐regulated industry standard which is not legally enforceable — insurance companies’ legal right to discriminate on the basis of genetic test results remains. By contrast, the UK moratorium (which commenced in 2001) is an agreement between the UK government and the Association of British Insurers. It applies to all life insurance policies without any financial limits, with only one exception for Huntington disease, a progressive, neurodegenerative genetic disorder. Predictive genetic test results for Huntington disease must be disclosed by individuals in the UK only when applying for cover worth over £500 000 (about AU$900 000).12 All other individuals can make informed decisions about whether to have genetic testing or participate in genomic research without concerns about insurance implications. The FSC moratorium is an important step towards consumer protection, but concerns remain around its financial limits, interpretation of its terms, and lack of compliance monitoring. The FSC moratorium has no government or independent regulatory oversight, and as recommended by the Parliamentary Joint Committee, there is a critical need to monitor its implementation and effectiveness. The FSC will review the moratorium and its terms in 2022, to consider amendment and/or extension beyond its current 2024 end date.10 Currently, there are no mechanisms in place to collect independent evidence from different stakeholder perspectives to inform this review and the Australian Government has not indicated any intention to do so directly. A new research project, funded by the first competitive round of the Genomic Health Futures Mission, part of the Australian Government’s Medical Research Future Fund,13 has now commenced to serve that critical function until 2023. The A‐GLIMMER (Australian Genetics and Life Insurance Moratorium: Monitoring the Effectiveness and Response) project brings together leading researchers, clinicians, patient groups, and policy experts in Australia to answer the question of whether the FSC moratorium is an adequate and effective long term regulatory solution for Australia. The project aims to address this question by collecting a range of quantitative and qualitative data after the implementation of the moratorium, from different stakeholders including consumers, health care professionals, researchers and the insurance industry. In some cases, the data collected will be directly comparable to similar data collected and published before the moratorium.14,15 The project has widespread support across the community. More than 20 project partners, including the FSC, and other supporting bodies have provided written support and pledged resources towards the study. The project is endorsed by the Victorian Department of Health and Human Services, the Human Genetics Society of Australasia and Australian Genomics, a collaborative national network of clinical, research, academic and community organisations dedicated to implementation of genomics for health and the development of appropriate genomics policy. The overarching aim of A-GLIMMER is to ensure sufficient evidence is collected in the coming years to inform government and the 2022 FSC review, to help determine the effectiveness of the FSC moratorium as a long term regulatory solution in Australia. See the Box for a summary of project aims. A‐GLIMMER is divided into four work streams, which will collect data from consumers, health professionals, research studies and the insurance industry. A final report will be compiled at the conclusion of the project, and will be provided to the federal government to assist with future policy decisions. Although the project will not conclude until 2023, its findings will help inform the proposed FSC review in 2022. Achieving an adequate policy solution to this issue in Australia is essential for ensuring optimal integration of genomics into Australian health care, engendering public trust and consumer participation in genomics, and paving the way to realise the many benefits of genomic medicine for Australia. Box – Aims of A‐GLIMMER (Australian Genetics and Life Insurance Moratorium: Monitoring the Effectiveness and Response) A‐GLIMMER will: assess dissemination and awareness of the Financial Services Council moratorium following its implementation describe the impact of the moratorium on consumers, health care, research and financial services evaluate the effectiveness of the self‐regulated Financial Services Council moratorium as a long term regulatory solution

Jane Tiller · Ingrid Winship · Margaret FA Otlowski · Paul A Lacaze

Current Good Clinical Practice guidelines are bureaucratic and should align with less burdensome examples of international trial policy

Tanya Symons · Steve Webb · John R Zalcberg

In health care, we now need to be curators and disseminators of accurate and timely information, not solely producers, this includes digital sources

Rebecca A Szabo

Medicine in the pre‐antibiotic era offers lessons still relevant today, particularly regarding the prudent use of valuable medications The handwritten line on an archived envelope stored in a safe in The Children's Hospital at Westmead undercroft — “The first child in Australia to have ‘Penicillin’ therapy” (Box 1) — understates the remarkable story of how an experimental drug was requested, approved and delivered in secrecy during the Second World War for one child. The “Penicillin Papers”, rediscovered in 2018 by the Heritage Committee of The Children's Hospital at Westmead, highlight important questions of ongoing relevance. The story of the fortuitous discovery of penicillin by Alexander Fleming in 1928 has entered popular consciousness. What is less well known is how penicillin, which dramatically changed the course of medicine, came to be given to patients. The patient: a small boy in wartime Sydney On 17 June 1943, Peter, almost 7 years old, was admitted to the Royal Alexandra Hospital for Children with fever and increasing drowsiness. During the following 24 hours he reported headache, and a lumbar puncture found turbid cerebrospinal fluid (CSF) with an “uncountable number of leucocytes”, and Streptococcus pneumoniae “type 18” was cultured, a serotype that frequently caused meningitis.1 Sulfonamide drugs were manufactured in Australia in the 1940s, but between 1942 and 1945 stocks were strictly controlled, being reserved almost exclusively for military campaigns in New Guinea.2 Peter, diagnosed with pneumococcal meningitis, was treated with intravenous sulfapyridine for four days, and his fever resolved (Box 2); daily lumbar punctures showed CSF clearing. Treatment switched to oral sulfapyridine, but his fever and vomiting returned. Further intravenous sulfapyridine for one day was followed by extremely painful subcutaneous sulfadiazine infusions for 18 days, then by oral sulfathiazole for four days. Sulfadiazine was obtained from the 118th General Hospital of the United States Army, based in Herne Bay (now Riverwood) and staffed by health professionals from the Johns Hopkins University Hospital in Baltimore. Access to the restricted sulfa drugs was granted by Major McPherson Brown (1906–1989), a professor at the Johns Hopkins, suggesting early involvement of the US Army. By 10 July, however, Peter's CSF was again culture‐positive for S. pneumoniae and the outlook was “grave”. In 1943, penicillin was a highly experimental drug; clinical trials in US troops in Sicily were underway, and only two scientific articles on its clinical use had been published.3,4 In the US, the unenviable task of rationing the small supply for civilian use fell to Chester Keefer, professor of medicine at Boston University Hospital and chairman of the National Research Council Committee on Chemotherapy. Keefer personally vetted each penicillin request, restricting its use to cases in which all other treatments had failed.5 To better understand its potential and limitations, he collected detailed information on all patients given penicillin. Fortunately for Peter, his father was Lieutenant Commander Leo Harrison, a Navy surgeon working as a base medical officer in Sydney in 1943. It is likely that his father's connections with US Army doctors helped secure access to the treatment that ultimately saved his life. On the morning of Saturday, 10 July, Sir Alan Newton, chairman of the Medical Equipment Control Committee, cabled Washington to request urgent supply of penicillin for Peter. At 4:30 pm, one million units (600 mg) were despatched from Washington to San Francisco, together with documents stipulating that the penicillin was for research purposes only, and on the understanding that clinical notes would be provided to the National Research Council following treatment. The penicillin was transported by Liberator bomber from San Francisco to Hawaii, and from there via Brisbane to Sydney, arriving at the Royal Alexandra Hospital at midnight on Thursday, 15 July. The first dose was administered to Peter intramuscularly at 12:18 am on 16 July. Over ten days he received 15 000 units (9 mg) penicillin intramuscularly every four hours, and 10 000 units (6 mg) intrathecally. Today, 5 million units intravenous benzylpenicillin per day would be recommended for a boy of Peter's weight (almost 22 kg). Although Peter's condition improved dramatically, waking from “a stupor” to eat a full breakfast within 48 hours, the dose and treatment duration were inadequate. By 21 July, Peter was again febrile and CSF cultures were positive. Regretting that type‐specific pneumococcal antiserum had not also been requested, Newton had sent a second cable to Washington on 16 July. Rabbit anti‐pneumococcal (type 18) serum arrived and 100 000 units were administered intramuscularly each day from 23 July to 1 August, and oral sulfadiazine from 26 July to 8 August. On 18 September 1943, Peter was discharged home “cured”. Seventy‐five years later, he and his family (Box 3) were interviewed by ABC News reporter Tracy Bowden,6 after his case had been re‐discovered by The Children's Hospital at Westmead Heritage Committee. Research secrecy There are three references in the medical literature regarding this incredible case. The first was a report published in the Medical Journal of Australia in June 1944 by the treating physicians Donald Vickery and Lindsay Dey.7 The second, a short mention by Newton in a speech to the British Medical Association, was published in July 1944;2 the third, a letter by Dey's son in the MJA in August 1981,8 described his father's recounting of events that “would have made an excellent basis for a film”. The initial publication7 was delayed by the condition that details of the case be released only to the US National Research Council, effectively a non‐disclosure agreement. Discussions about research secrecy are as old as science itself.9 Proponents of openness argue that it promotes innovation and enhances productivity and efficiency of research. Openness is essential for testing hypotheses and fostering collaboration. Sharing information with the public fulfils moral obligations to provide evidence for shaping policy and to be accountable for the use of public funds. Conversely, research secrecy is often justified as protecting credit and intellectual property, shielding scientists and human research participants from stigmatisation or harassment, and minimising threats to national or international security. The financial interests of biotechnology and pharmaceutical companies further complicate the discussion. In 1943, arguments for secrecy about experimental penicillin treatments were compounded by the need to protect the limited supplies of the drug. It is pertinent here that the reverse of the envelope containing the Penicillin Papers was marked “Silence saves soldiers” (Box 1). Under the direction of Keefer, the Committee on Chemotherapy charged “accredited investigators” with assessing thousands of requests for penicillin.5 A strict allocation policy was adopted to ensure that decisions were made on clinical grounds. Only patients with severe infections caused by sulfonamide‐resistant, penicillin‐susceptible streptococci, gonococci and staphylococci, should receive penicillin, and only then if a cure could be expected. Access, compassionate and otherwise Equitable allocation of limited medical resources is a problem that often confronts clinicians and public authorities, particularly in resource‐constrained environments and during wartime, natural disasters,10 or epidemics.11 In 1943, Vickery and Dey did all they could to obtain the experimental drug penicillin for their patient. Wartime priorities in Australia did not include active control of therapeutic substances, although the National Health and Medical Research Council dealt with some medication access questions.12 In the US, the Food and Drug Administration (FDA) first addressed access to investigational drugs for therapeutic purposes in January 1963,13 three months after President Kennedy had approved the amendment of the Food, Drug, and Cosmetic Act that strengthened the FDA mandate to approve medications.14 The process of “expanded access”, the preferred FDA term for compassionate use — that is, of an unlicensed drug or device outside clinical trials — was formalised in 1987 in response to requests for access to investigational anti‐retroviral agents.13 In Australia, the Therapeutic Goods Administration (TGA) was established in 1989 as the national regulatory body; its Special Access Scheme, introduced in response to the 1991 Baume report,15 is the mechanism by which doctors can secure access to unlicensed drugs for selected patients. The 1962 American drug law amendments, passed in the wake of the thalidomide catastrophe, had the potential to make children “therapeutic orphans”, as many drugs have been tested only in adults.16 Paediatricians today regularly use medications off‐label, but the use of unlicensed drugs is less common and usually restricted to neonatal intensive care.17 Fortunately, the importance of including children in clinical trials is increasingly recognised internationally by research institutions and funding and regulatory agencies.18 Further, the FDA was empowered to provide financial incentives for including children in clinical trials and licensing applications by the 2007 Best Pharmaceuticals for Children and Pediatric Research Equity Acts.19 Lessons for the post‐antibiotic era from the pre‐antibiotic era Sulfonamides, the first effective antimicrobial agents, were available from the mid‐1930s, but drug resistance was widespread by the 1940s. One initial control on penicillin use was the requirement for demonstrated penicillin susceptibility and sulfonamide resistance: an early form of antimicrobial stewardship. As we approach the post‐antibiotic era because of rapidly increasing antimicrobial resistance, institutional, national and international antimicrobial stewardship programs are being implemented to protect the limited therapeutic options available for many infections. Multimodal programs incorporate pharmacokinetic and pharmacodynamic principles to avoid treatment failure through undertreatment, as experienced by Peter in 1943.20 In the future, strengthening these antimicrobial stewardship programs by integrating molecular technologies and high throughput screening methods will be critical. We also need to rediscover non‐antibiotic approaches to treating infections, including serotherapy21 and bacteriophage therapy.22 Both were widely and successfully employed in the early 20th century, and Peter's ultimate recovery in August 1943 appeared to require type‐specific anti‐pneumococcal serum treatment. However, our reliance on antibiotics over the past century has led to clinical and research neglect of alternative treatment modalities, although interest has revived in recent years, particularly in bacteriophage therapy.22 Greater investment in alternative treatment options is needed, as well as investigation of novel therapeutic and infection prevention strategies. Box 1 – The “Penicillin Papers”, retrieved from a safe in the basement of The Children's Hospital at Westmead in 2018, include letters and telegrams about the acquisition of penicillin from the United States and its use for treating Peter Harrison Source: The Penicillin Papers; courtesy of The Children's Hospital at Westmead. Box 2 – Details from transcribed observation charts for the first patient in Australia to be treated with penicillin, 1943 Source: The Penicillin Papers; courtesy of The Children's Hospital at Westmead. Box 3 – Peter Harrison (right), the first person in Australia to be treated with penicillin, pictured with his family in 2018, together with Bethany Robinson (second from right), the University of Sydney student who rediscovered the “Penicillin Papers”

Ameneh Khatami · Philip N Britton · Glendon Farrow · Megan Phelps · Alyson Kakakios

Should medically significant genetic results be offered to research participants or their at‐risk relatives? Australian research studies now generate genetic information on thousands of participants. Some genetic results, present in a small portion of participants (< 5%), are considered medically actionable, meaning they are associated with increased risk of adult‐onset diseases, where effective risk management, prevention or treatment exists (eg, inherited cancer or cardiac disorders).1 The National Statement on Ethical Conduct in Human Research,2 which considers genomic research at Chapter 3.3, now requires an ethically defensible plan for return (or non‐return) of genetic research results. Box 1 summarises the guidelines that are relevant to the return of genetic results to research participants.2 Returning genetic research results can be life‐saving, alerting participants to preventive steps that they would not otherwise have taken. Most participants identified in research studies have no clinical features or family history of the indicated disease, are unaware of their genetic risk, and would not qualify for publicly funded clinical criteria‐based genetic testing. Among the international genomics community, there is growing consensus that medically actionable genetic research results should be made available to participants.3 The American College of Medical Genetics and Genomics published a list of genes related to medically actionable conditions, in which results should be returned if identified during clinical testing.1 This gene list has been used to guide the return of research results in some United States studies,4 but has not been adopted by the National Health and Medical Research Council or other Australian bodies. However, the National Statement makes it clear at 3.3.41 that “researchers have an obligation to have a process in place for the return of findings that are of proven validity and of health significance to the participant, or relative, subject to participant consent”.2 However, even where participant consent has been obtained, not all Australian studies are returning medically actionable results, due to varying ethical and practical challenges. For example, research participants may provide samples for altruistic reasons, before research analysis, without expectation of re‐contact. Should results be returned to these individuals, especially those unaffected by indicated disease? Is there a legal or ethical requirement to make results available or liability for withholding them? The National Statement provides some guidance (Chapter 3.3) regarding which results should be returned,2 but ultimately researchers determine whether to return results. As the National Statement indicates, return of results should be limited to those genes with validity and utility (3.3.29 and 3.3.41).2 However, pathogenic variants in medically actionable genes are not fully penetrant, meaning that not all at‐risk variant carriers develop the disease.5 Risk estimates for many genes are still uncertain, complicating decisions around medical actionability and the time frame for returning results. Some participants may experience surprise or distress on learning about genetic risks. Returning results may also raise the possibility of out‐of‐pocket medical costs or increased insurance liabilities for younger participants. Genetic results should be delivered by a medical professional, with genetic counselling and clinical support provided, as noted by the National Statement (3.3.31 and 3.3.32).2 This requires time and resources, which are often limited. Thus, despite clear guidance in the National Statement, some research studies do not return results even where results are clinically valid and of undisputed relevance to participants’ and family members’ health, and the participant has consented to receive such results. To assist with these challenges, a national service to support the return of genetic results from research studies has recently been developed6 and is now operational. Research cohort case studies Here, we present two case studies from Australian epidemiological research (Box 2). Lifepool,7 a large community‐based study of women in the general population, and ASPREE (ASPirin in Reducing Events in the Elderly),8 a large cohort study of healthy older people, have both commenced genetic analysis and have been faced with decisions regarding the return of genetic results. These case studies highlight the challenges and opportunities related to this complex issue. ASPREE's older population particularly raises unique challenges.9 Lifepool has shown that return of genetic results prompts preventive interventions for women with variants in high risk breast cancer genes, most of whom would not have been identified through current clinical criteria‐based testing.7 To date, Lifepool has contacted 73 women previously unaware of their high risk variants. None of the women identified with a cancer‐causing variant would have been eligible for publicly funded testing through the Australian clinical system. Most women took proactive steps to mitigate risk after receiving genetic results. Of the 73 women, 23 so far have undergone risk‐reducing surgery (bilateral oophorectomy), mitigating their cancer risk.11 This could be life‐saving, given the high lifetime risk and low survival rates for ovarian cancer associated with high risk variants. The shared nature of DNA means genetic results are also relevant to participants’ blood relatives. Beyond participants who directly received results, 63 relatives were also tested through cascade testing, 32 of whom were also found to have a high risk variant. These relatives were, on average, substantially younger than the original participants (Box 3), making this information even more valuable for prevention. ASPREE biobank participants consented to re‐contact regarding genetic results relevant to personal or family health. In accordance with the National Statement (3.3.36 and 3.3.37),2 an ethically defensible plan outlining the return of genetic results was approved by the Alfred Hospital Human Research Ethics Committee in 2015.9 However, there is ongoing debate about the most appropriate strategy, given the age of the cohort (average, 75 years) and primary purpose of the study — an aspirin prevention trial (as opposed to genetic research study). ASPREE has returned other types of (non‐genetic) medically actionable research results, including abnormal magnetic resonance imaging, blood pathology and cognitive assessments. However, genetic results have been treated differently, with unique challenges. Many older ASPREE participants who carry medically actionable variants have seemingly outlived their increased risk, displaying no signs of indicated disease at 75 years of age and older.12 Is the information still medically actionable? Do participants still want to know? Should results be returned for the benefit of younger, potentially high risk family members? What about ASPREE participants who are in cognitive decline or deceased? Is ASPREE obliged to contact these individuals, or their relatives, to provide genetic results? Despite having detected genetic information through research analysis that is clinically valid and of clear relevance to personal or family members’ health, ASPREE has not yet commenced returning genetic results, seeking to achieve an appropriate harm–benefit balance.9 The applicable Human Research Ethics Committee recently discussed a possible strategy of offering results via an opt‐in model, where participants register interest following a newsletter notification. Although well intended, this approach is problematic. First, only a fraction of participants would receive or read the newsletter article, limiting the number who would be informed. Second, only about 1% of the cohort will have a medically actionable variant, meaning the likelihood that those participants will have opted‐in is very small. Finally, ASPREE participants have already consented to re‐contact on the basis of medically actionable genetic results, so re‐consent is not required. The proposed opt‐in model compromises equity in ensuring high risk participants are contacted and offered results ethically. The consequences of a passive approach to returning results are notable. For example, two male ASPREE participants were found through the study analysis to have high risk breast cancer variants. Neither participant had any relevant personal cancer history. Analysis of collected family history data showed that both had daughters (who have a 50% chance of having the same pathogenic variant) who developed breast cancer under the age of 50 during the ASPREE trial. These women did not have a family history of breast cancer required to prompt clinical genetic testing through clinical services. Yet their fathers’ results, if known, may have prompted genetic testing or high risk breast cancer screening for the daughters. This information was clinically significant and relevant to family health, despite its questionable health benefit to the male participants. Although the time for prevention has passed for those participants’ daughters, ASPREE must now consider the return of results to other participants with medically actionable results. Currently, there is no Australian legal requirement to inform research participants of medically actionable genetic results — any imperative to offer results is ethical. Whether any ethical imperative extends to preventing disease in participants’ relatives is unclear,13 although it is contemplated by the National Statement (3.3.32 and 3.3.41).2 A concern arising when considering return of results in ASPREE is that elderly research participants may not want to know about genetic results. However, other studies suggest that most research participants do want to receive genetic information, even if only for their family members’ benefit.14,15 A recent international survey on preferences for genetic results14 showed no significant difference between elderly and younger groups. Evidence suggests that older participants may be more interested in genetic results, especially if family members may benefit.14 Another challenge arises where participants with medically actionable genetic results are deceased or in cognitive decline. In these circumstances, the benefit of returning results to next‐of‐kin is for relatives. Several Australian research studies return genetic results purely for family members’ benefit, demonstrating the acceptability of this approach. The Australian Ovarian Cancer Study commenced returning genetic results of deceased women to next‐of‐kin more than ten years ago.16 Recently, the TRACEBACK study archived DNA samples of women who died from ovarian cancer, to identify genetic risk variants and notify at‐risk relatives.17 These programs conduct genetic testing on DNA of deceased people who cannot derive personal benefit, for the benefit of at‐risk relatives. Conclusion There is a growing consensus on the ethical imperative to offer research participants medically actionable genetic results. Studies show high acceptability for receiving genetic results, and the preventive health benefits are clear. Although the National Statement provides guidance, questions remain regarding the legal obligations and disclosure methods, particularly when research participants lack the capacity to make decisions about receiving genetic information. As genetic information becomes more pervasive and valuable to preventive medicine, the return of medically actionable genetic results will become increasingly important from ethical, legal and medical perspectives. Box 1 – National Statement on Ethical Conduct in Human Research: guidelines relevant to return of genetic results2 Guideline Content 3.3.26 In considering whether to return results of research, researchers should distinguish between individual research results and overall research results. Researchers should consider how these results will be provided to participants, how the process of returning results will be managed, and the risks of the return of individual research results and overall research results. 3.3.27 Return of findings and results relating to an individual participant depends on the contextual relevance of the findings; some genomic research findings must be returned, some findings may be returned, and some findings should not be returned. 3.3.29 Once there is sufficient evidence and agreement that a finding or result is clinically significant, participants should be advised that research results or findings that may be returned will first need to be confirmed according to applicable guidelines; eg, at a National Association of Testing Authorities accredited laboratory. 3.3.31 Any plan to return individual research results should include linkage with a clinical service and access to genetic counselling. The plan should specify any expertise to which the project team might require access. 3.3.32 The return of results or findings of significance for the health of the participant or relative is the responsibility of the appropriate clinical service or, where such a service is not available, the participant's clinician in consultation with the research team. 3.3.36 Researchers must prepare and follow an ethically defensible plan to manage the disclosure or non‐disclosure of genomic information of potential importance for the health of research participants or their relatives. 3.3.37 The ethically defensible plan must be approved by a Human Research Ethics Committee. Step 1: Determination of whether findings will be returned Genomic research falls into three categories: research with findings that must be returned; research with findings that may be returned; and research with findings that should not be returned. The relevant factors to be considered to determine whether findings must, may or should not be returned include: analytic (scientific) and clinical validity; significance to the health of the participants/relatives; and clinical utility. 3.3.41 Where there will be any return of findings to participants, they should be advised as to which findings will be returned and which will not be returned, as follows: that researchers have an obligation to have a process in place for the return of findings that are of proven validity and of health significance to the participant or relative, subject to participant consent; that if researchers plan to return findings during the project that are of proven validity but are not of health significance to the participant or relative, they will need to justify this plan; that there is no obligation on researchers to look at or assess findings outside of the scope of the research; and that there is no ongoing responsibility on researchers to review findings of a research project after the project has been completed in order to discover or assess findings that may have become returnable due to later scientific advances. Box 2 – Research cohort case studies Lifepool study7 ASPREE study8 Australian study aiming to improve women's health, particularly with respect to breast cancer Randomised, placebo‐controlled Australian trial for daily low‐dose aspirin, and ongoing observational cohort study of ageing Participants 50 000 women 19 000 healthy older men and women aged > 70 years Consent for genetic testing and return of results DNA samples were contributed to a “pool” of data and consent given for unspecified future research Participants were informed they would be contacted if information relevant to their health was found DNA samples were contributed to a biobank with consent for future genetic research Participants were informed they may be contacted if information relevant to their health was found An ethically defensible plan for re‐contacting participants with medically actionable results was approved by the applicable HREC9 Genetic testing conducted 14 799 samples were tested for changes in high risk breast cancer genes, which confer significantly increased risk of breast and ovarian cancer Risk can be mitigated through breast screening10 and/or preventive surgery11 13 131 samples were tested for changes in medically actionable genes, including high risk cancer genes Personal and family (first degree relatives) history of cancer was collected throughout the study Genetic results of relevance Following notification of women with high risk results: 97% made an appointment with a familial cancer centre to discuss results further 97% proceeded with confirmatory genetic testing 60% have undergone risk reducing oophorectomy An average of 3.3 relatives were tested per index case 51% of relatives tested also had the genetic variant 53 participants had a medically actionable result in high risk cancer genes12 No genetic results have been returned as yet At an estimated minimum of 3.3 cascade cases per index case,7 offering the return of results to 53 participants could reach a minimum of 175 Australians at high risk of developing familial cancer ASPREE = ASPirin in Reducing Events in the Elderly. Box 3 – Distribution of age among family members accepting cascade testing through a familial cancer centre (FCC) compared with index cases identified through Lifepool6 Although index cases identified through Lifepool often approach the age at which genetic risk is less relevant, a large proportion of the family members identified are considerably younger, at an age where preventive benefits can be maximised.

Jane Tiller · Alison H Trainer · Ian Campbell · Paul A Lacaze

There are legal considerations for both clinicians and patients when recording health care consultations Studies show that patients often have inaccurate recall of health care events and diagnoses.1 Concentration during a medical consultation may be “hampered by unspoken anxieties or pain, making it difficult to recall detail”.2 Audio recordings of consultations can be useful for patients and clinicians to assist memory and understanding. They have mainly been evaluated in oncology and paediatrics.3,4 Patients report that listening to their consultation recording increases knowledge and understanding of their illness, and recordings can assist with treatment decision making, increasing a sense of empowerment.5 Sharing recordings with family can facilitate support and understanding. Clinicians likewise recognise recordings’ benefits for patients and for improving the quality and efficiency of their care.6 Research in the United Kingdom found that 69% of patients wish to record consultations.7 Increasingly, patients are using smartphones to record consultations, either with permission or covertly.7,8 Recording systems have been developed by health services themselves, transformed by the ubiquitous use of smartphones and other flexible technologies.9,10,11 Examples include the Open Recording Automated Logging System (ORALS) software in the United States9 and telephone‐based digital recording in Denmark.11 In Australia, the Second Ears smartphone app, developed at the Victorian Comprehensive Cancer Centre in 2018, is designed to make recordings available to both the patient and the hospital health information management service.6,10 Patients can choose whether to download and use the app (either before their appointment or in the clinic), access the recordings on their smartphone, and share them with family and friends.6,10 Common design features of such health service‐led recordings address data security, file storage and patient consent. Whether the clinician or the patient controls the recording process may differ across technology platforms; for instance, in the Danish example above, the clinician initiated the recordings, whereas with Second Ears the patient would do so. The use of consultation recordings often raises legal questions.5,7,10,12 In this article, we compare the legal implications of overt and covert recordings of health care consultations and address key concerns identified by clinicians, notably the requirement for consent to record and share the recording, and the use of recordings in negligence claims.8,13,14,15 We distinguish between three recording types: Overt patient‐led recordings: for example, a patient recording a consultation with the clinician's consent. These recordings are akin to a patient's handwritten notes. Overt health service‐led recordings: for example, the Second Ears app, where both clinician and patient consent (actively or impliedly) to the recording; the app is facilitated by the health service and the primary version of the recording stored on their system. Covert patient‐led recordings: for example, a patient recording without the clinician's knowledge or consent. As each legal question is identified, we consider the law in the context of the Second Ears app. This article is general in nature and does not constitute legal advice. References to legislation are current at 13 October 2020. References to state or territory laws relate to the location of the recording or the place at which the sharing of the recording originated. We do not address the issue of intentional recording of private conversations by third parties, either overtly or covertly. Consent to record a consultation Clinician consent to patient‐led recordings Clinicians consider that their consent to be recorded is a key issue. Perhaps surprisingly, at law in many Australian jurisdictions, the patient need not obtain explicit consent from the clinician. In Victoria, Queensland and the Northern Territory, the law does not consider a recording of a conversation that is made by one of the parties (as opposed to a third party). In New South Wales, Tasmania and the Australian Capital Territory, patients can record their consultation without the clinician's consent (or, by extension, their knowledge) if the recording is only for the patient's own use (ie, to listen back to the recording later), or to protect their lawful interests (such as in a negligence claim). In South Australia and Western Australia, clinician consent is required (ie, two‐party consent) for recording a consultation for later listening‐back by the patient (Box 1). Patient consent to health service‐led recordings Where the recording is made on an app like Second Ears with data stored by the health service, this is an act of health information collection about an individual that requires the patient's express or implied consent. The patient's decision to download and install the app can act as implied consent; the app's terms and conditions could also include a clear statement about patient consent. Consent of other people captured incidentally in any overt recording A consultation recording — whether patient‐led or health service‐led — might accidentally capture another conversation, for instance from the clinic's reception desk. No consent of the third party is needed in this case, because they are not a party to the recorded conversation. Typically, Australian surveillance device laws do not regulate recordings of conversations occurring in circumstances in which the parties ought reasonably to expect to be overheard, such as in public or an open hospital ward. This means that if a patient is overtly recording their own consultation while in a curtained cubicle, their inadvertent capture of another clearly heard conversation in the next cubicle would not require the consent of those having that conversation. Consent when someone else joins any overt recording If another person, such as the patient's relative or another clinician, enters a room where a consultation is being recorded, but does not join in the conversation, the new person is not a party to it and that person's consent is therefore not needed. However, if the new person does join the conversation, they become a party to it. Box 1 indicates when that new party's consent to be recorded is required. In SA and WA it is usually required. In NSW, the ACT and Tasmania it is required if the patient makes the recording intending to share it with anyone else, but not if the recording is intended only for the patient to listen to. Consent, when required, can be either express or implied. An example of how this situation might be addressed could be a health service policy to have a door sign stating prominently that a recording is in progress and that by entering the room the new participant consents to be recorded. A person entering the room could then signal their non‐consent by verbally requesting the recording be stopped. This applies to health service‐led and patient‐led recordings. Covert recordings by patients Covert recording by patients is not uncommon; a survey conducted in the UK found that 15% of respondents self‐reported recording clinical encounters without permission. A further 35% of respondents would consider covert recordings in the future.7 In the US, a similar survey found that far fewer respondents recorded covertly (2.7%);8 possibly because some health services routinely provided permission for recording. Currently, the proportion of Australian patients who record covertly is unknown; anecdotally, however, clinicians report that it is occurring.16 Covert recording has been described as a topic of “significant legal ambiguity”.17 In Australia, as noted above, the law varies significantly by jurisdiction. Only SA and WA require two‐party consent and thus prohibit patients covertly recording for their own use (Box 1). Covert recordings: legal penalties Not all consultation recordings require consent. In SA and WA, where two‐party consent is required, a person making a covert recording for their own use is subject to legal penalties; for example, in SA, fines of up to $15 000 or imprisonment for up to 3 years. In Toth v DPP (NSW) [2014] NSWCA 133, a case concerning a patient's illegal covert recording, the magistrate imposed an 18‐month good behaviour bond. Dealing with unwanted recording If their consent is legally required but the clinician does not want to be recorded, they can simply ask the patient to discontinue the recording. Regardless of whether the act of recording legally requires their consent, a clinician's refusal to be recorded, or the exposure of covert recording by a patient, may lead to breakdown of the therapeutic relationship,14 necessitating transfer of care to another clinician as per the Medical Board of Australia's code of conduct (https://www.medicalboard.gov.au/codes-guidelines-policies/code-of-conduct.aspx). While discontinuing a relationship may be appropriate in the context of misuse of an audio recording or its use with malicious intent, it would be a drastic response to a simple request by the patient to record, given the benefits of doing so. Health service‐led systems such as Second Ears may overcome this problem by incorporating clear frameworks around participation, consent and sharing. Sharing recordings with others Health care organisations sharing recordings Recordings made by the health service with the patient's consent (eg, via the Second Ears app) form part of the medical record and the organisation can lawfully share the recording in various ways, which are broadly similar across Australian states and territories. These include: with the person's consent; without the person's consent for a directly related purpose as long as the person would “reasonably expect” the disclosure (eg, in transferring care to another provider at the same service: F v Medical Specialist [2009] PrivCmrA 8); to defend a legal claim; for research in the public interest (if certain privacy guidelines are met, such as those set out by the National Health and Medical Research Council18); and with an immediate family member of the patient for compassionate reasons or to provide the patient with care when the patient is incapable of providing consent. This mirrors other parts of the medical record such as written notes and scans. If the recording is de‐identified (which may be difficult because voice patterns are distinctive and health information discussed during consultations is often reasonably identifiable), it can usually be used without patient consent for communication training within the health service. Consent may provide a more appropriate legal basis for such use. Patients sharing recordings Apps such as Second Ears facilitate patients’ sharing of recordings with family and others for treatment decision making and care. The law relating to such sharing of recordings with third parties varies between jurisdictions and also turns upon the question of whether the original recording was overt or covert. Separate legislative provisions address the act of recording compared with the recordings’ subsequent use. Two‐party consent is generally, but not always, required for patients to lawfully share recordings with third parties (Box 2). In Queensland, Tasmania and the ACT, there is a distinction between patients sharing a recording with immediate family (which can be done without the clinician's consent to share) and sharing with the wider world (which requires the clinician's consent). In NSW, unusually, a recording that is originally lawfully made with only one party's consent but with no intention to share can be subsequently shared without restriction (eg, on social media) (Surveillance Devices Act 2007 (NSW), section 11). Clear communication and consent remain the most desirable mechanisms to frame patients’ expectations and choices around the sharing of recordings with others, even where consent is not legally required. For the avoidance of doubt, an agreement to create a recording — whether a clinician's oral agreement for a patient to record on their smartphone, or the terms and conditions built into an app — should explicitly address the extent to which a patient can share the recording with others. Such an agreement might, for instance, permit the patient to share the recording with family but not publish it at large, for example, on public social media. This could override any legislative entitlement to share a recording openly. If a patient distributed the recording in violation of the terms and conditions, the health service could pursue a legal claim for breach of contract. We are not aware of previous such claims. Health services would need to weigh up the financial and reputational costs of pursuing such a claim. The use of recordings in legal proceedings Recording the consultation does not change clinicians’ medico‐legal obligations to patients. Such recordings provide transparency of the discussion and could be used as evidence of appropriate information sharing with patients, thus meeting the clinician's required standard of care. Clinicians have a duty to provide sufficient information on inherent risks of treatment and alternative treatments, to enable patients to exercise a meaningful choice. A claim may lie in negligence if the patient can demonstrate a “failure to warn”, where the clinician did not meet the appropriate standard of care and the patient consequently made an uninformed choice about treatment which resulted in harm. The importance of patient‐centred communication was highlighted in the UK decision of Montgomery v Lanarkshire [2015] UKSC 11 and the Australian case Rogers v Whitaker [1992] HCA 58. In a claim for negligent non‐disclosure, where the patient states that the clinician did not provide information concerning material risks about the proposed procedure, the recording could be used to provide evidence of the consultation. In most states and territories, whether the recording itself was taken with both parties’ consent or by one party covertly does not affect its admissibility in court. In jurisdictions where covert recording is not lawful (Box 1), an exception typically exists permitting a person to covertly record a private conversation to protect their lawful interests. An example is where there is a serious dispute between two parties regarding different versions of an arrangement (Georgiou Building v Perrinepod [2012] WASC 72). The relevant lawful interest must exist at the time of the recording (Marsden v Amalgamated Television Services [2000] NSWSC 465). The recording's lawfulness is a separate issue to its admissibility. It has been established that tape recordings are admissible to provide primary evidence of the conversation or sounds recorded on the tape. In the case of Butera v Director of Public Prosecutions (Vic) [1987] HCA 58, it was held that the tape is “a part of the machinery by which the evidence is produced”. It would follow that the recording on an app such as Second Ears provides evidence of the conversation that took place between the clinician and patient. Such a recording is admissible in court if the content is relevant and otherwise admissible, the voices are properly identified, and the recording has provenance — it is authentic, accurate and has not been tampered with. In this instance, the voices recorded would fall within the category of hearsay evidence — that is, representations made out of court that are led as evidence of the truth of the fact. As audio recordings fall within the definition of “document” in the Evidence Act 1995 (Cth) (which is uniform with most state and territory Acts), they may be admissible if they conform to the statutory requirements. As an example, in Victoria courts have the discretion to admit recordings as evidence if the evidence is relevant (Evidence Act 2008 (Vic), sections 55 and 56) and if the desirability of admitting the evidence outweighs the undesirability of doing so (Evidence Act, section 138). The recording will form only part of the record of information flow between clinician and patient. Contemporaneous notes and other non‐recorded conversations will also be relevant to determine if the standard of care has been met. There is no evidence that audio or video recordings of consultations increase litigation.19,20 A study evaluating the provision of consultation video recordings to patients found that in the high risk specialty of neurosurgery, none of the 2807 patients recorded used the video in a legal action.19 Recordings might actually reduce conflict and litigation because they overcome differences in recollection between two parties.21 Ownership of recordings Traditionally, the law has not conceived of information as property (Boardman v Phipps [1967] 2 AC 46). In Australia, patients have no proprietary interest in a doctor's medical notes (Breen v Williams [1996] HCA 57) (although legislation provides a right to access them). Nor do doctors have any proprietary interest in a patient's handwritten notes, or by extension, an overt patient‐led recording. However, a health service‐led recording such as one made using the Second Ears app could be said to be jointly created. As there are two copies of it, one held by the patient and one by the health service, it could be argued that each has some proprietary interest. A recent exploration of this position posited that there may be multiple rights holders of health data.22 This view has yet to be tested in the courts. It is appropriate to focus instead on the obligations of the different parties to protect and store the recording data. Data security and storage of overt recordings A recording made on a system such as Second Ears forms part of the medical record and the organisation must take reasonable steps to protect it from misuse, loss and unauthorised access or disclosure. Any contract with a third‐party organisation (eg, a cloud storage provider) should also reflect these requirements and address issues of security and access. Health records must be retained for a specified period; in Victoria, NSW and the ACT, this is 7 years after the patient last received care from the organisation, after which the records should be destroyed if they are no longer needed. By comparison, patients need neither keep nor protect their own copy of a recording. If the recording is made using a third‐party app, the terms and conditions of that app are relevant, adding further complexity in relation to custodianship and data protection. Conclusion Health service‐led recording technologies, of which Second Ears is an example, can draw on a framework that makes explicit all parties’ rights and responsibilities, and ensure that an authenticated version of the recording is maintained securely. Such an approach promotes shared expectations between patients and clinicians and is likely to reduce miscommunication. Our analysis found surprising diversity in Australian legislation pertaining to consultation recording, leading us to conclude that, to avoid confusion, expressly articulated permissions around the act of recording and the extent of sharing recordings are desirable. While covert recording is not uniformly unlawful in Australia, transparency promotes trust and enhances the clinician–patient relationship. There is some evidence that concerns about a heightened litigation risk as a consequence of recording are unfounded; rather, the existence of a recording should minimise conflicting recollections and enhance a sense of collaboration. While the act of recording does not alter a clinician's duty to disclose relevant information to a patient, communication skills training may be a way to alleviate concerns about being recorded.10 Box 1 – Patient‐led recordings: when is consent from the other party required for the act of recording? Jurisdiction Patient makes recording for unspecified purpose Patient makes recording intending it for personal use only Patient makes recording that is reasonably necessary for the protection of their own lawful interests Legislation Victoria, Queensland, Northern Territory Consent not required Consent not required Consent not required Surveillance Devices Act 1999 (Vic): no relevant provision Invasion of Privacy Act 1971 (Qld), s 43(2)(a) Surveillance Devices Act 2007 (NT): no relevant provision New South Wales, Australian Capital Territory, Tasmania Consent required Consent not required Consent not required Surveillance Devices Act 2007 (NSW), s 7(3) Listening Devices Act 1992 (ACT), s 4(1)(b), (3) Listening Devices Act 1991 (Tas), s 5(1)(b), (3)(b) South Australia, Western Australia Consent required Consent required Consent not required Surveillance Devices Act 2016 (SA), s 4 Surveillance Devices Act 1998 (WA), s 5 Box 2 – Can a patient share their lawfully made recording with third parties for general purposes* without the clinician's consent for the sharing? Jurisdiction Sharing with immediate family and friends† Sharing with public at large Legislation Victoria, Northern Territory No (clinician consent for sharing required) No (clinician consent for sharing required) Surveillance Devices Act 1999 (Vic), s 11(2)(a) Surveillance Devices Act 2007 (NT), s 15(2)(a) Western Australia No (clinician consent for sharing required) No (not even with clinician consent) Surveillance Devices Act 1998 (WA), s 9(2)(a)(ii), (3) Queensland, Tasmania, Australian Capital Territory Yes‡ No (clinician consent for sharing required) Invasion of Privacy Act 1971 (Qld), s 45(2)(a), (d) Listening Devices Act 1991 (Tas), s 10(2)(a), (d) Listening Devices Act 1992 (ACT), s 5(2)(b), (e) New South Wales, South Australia Yes§ Yes§ Surveillance Devices Act 2007 (NSW), ss 7(3)(b), 11(1). Surveillance Devices Act 2016 (SA), ss 4(2)(a)(i), 12(1). * Legislation usually deals separately with the sharing of recordings for different purposes, such as “in the public interest”, for protecting the “lawful interests” of the person who is sharing the recording, “in the course of legal proceedings”, “in the performance of a duty”, or as authorised by law. This table solely addresses when clinician consent is required for the sharing of a recording with a family member or with the public at large when the purpose of the sharing is not specified. This may include for the patient's health and wellbeing. It does not address sharing for other purposes. † This is typically expressed in legislation as: persons who have, or are believed on reasonable grounds by the person who is communicating or publishing the recording to have, such an interest in the private conversation (ie, the health care consultation) as to make the sharing reasonable under the circumstances. ‡ In these jurisdictions, the original recording may be lawfully made covertly by the patient for their own use, and then shared with family, without the clinician's consent. § Section 11 of the Surveillance Devices Act 2007 (NSW) is silent about the sharing (publication or communication) of recordings that were made lawfully. A recording that is made by one party without an original intention that the recording be published or otherwise disseminated is lawful in NSW: section 7(3)(b)(ii). Section 12 of the Surveillance Devices Act 2016 (SA) is silent about the sharing of recordings that were made lawfully, such as a recording made with the consent of both parties under section 4(2)(a)(i).

Megan Prictor · Carolyn Johnston · Amelia Hyatt

Objective: To assess long term graft and patient survival after donor liver retransplantation in children in Australia and New Zealand during 1986–2017; to determine the factors that influence survival. Design: Retrospective cohort analysis (registry data). Setting, participants: Australia and New Zealand Liver Transplant Registry data for all liver retransplantations in children (under 18 years of age), 1986–2017, in all four paediatric and six adult liver transplantation centres in the two countries. Main outcome measures: Graft and patient survival at one, 5, 10 and 15 years. Results: 142 liver retransplantations were undertaken in children (59 during 1986–2000, 83 during 2001–2017). Kaplan–Meier survival analysis indicated that survival was significantly greater during 2001–2017 than 1986–2000 (P < 0.001). During 2001–2017, graft survival one year after retransplantation was 84%, at 5 years 75%, at 10 years 70%, and at 15 years 54%; patient survival was 89% at one year, 87% at 5 years, 87% at 10 years, and 71% at 15 years. Median time between transplantations was 0.2 years (IQR, 0.03–1.4 years) during 1986–2000, and 1.8 years (IQR, 0.1–6.8 years) during 2001–2017 (P = 0.002). The proportion of graft failures that involved split grafts was larger during 2001–2017 (35 of 83, 42%) than 1986–2000 (10 of 59, 17%). Graft type, cause of graft failure, and number of transplants did not influence survival following retransplantation. Conclusion: Survival for children following retransplantation is excellent. Graft survival is similar for split and whole grafts. Children on the liver waiting list requiring retransplantation should have the same access to donor grafts as children requiring a first transplant.

Angus W Jeffrey · Gary P Jeffrey · Michael Stormon · Gordon Thomas · Edward O'Loughlin · Albert Shun · Winita Hardikar · Robert Jones · John McCall · Helen Evans · Graham Starkey · Peter Hodgkinson · Looi C Ee · David Moore · Catherine Mews · Geoff W McCaughan · Peter W Angus · Alan J Wigg · Michael Crawford · Jonathan Fawcett

A recent High Court decision directs and reassures medical and other practitioners in clinical and community settings that no parent or individual can compel this unlawful procedure

Ben Mathews · Elizabeth Dallaston