Background Several jurisdictions, including Singapore, Australia, New Zealand and most recently Ireland, have a public interest or public good criterion for granting waivers of consent in biomedical research using secondary health data or tissue. However, the concept of the public interest is not well defined in this context, which creates difficulties for institutions, institutional review boards and regulators trying to implement the criterion. Main text This paper clarifies how the public interest criterion can be defensibly deployed. We first explain the (...) ethical basis for requiring waivers to only be granted to studies meeting the public interest criterion, then explore how further criteria may be set to determine the extent to which a given study can legitimately claim to be in the public interest. We propose an approach that does not attempt to measure magnitude of benefit directly, but rather takes into account metrics that are more straightforward to apply. To ensure consistent and justifiable interpretation, research institutions and IRBs should also incorporate procedural features such as transparency and public engagement in determining which studies satisfy the public interest requirement. Conclusion The requirement of public interest for consent waivers in secondary biomedical research should be guided by well-defined criteria for systematic evaluation. Such a criteria and its application need to be periodically subject to intra-committee and intra-institution review, reflection, deliberation and amendment. (shrink)

Therapeutic privilege is a defence that may be available to doctors who fail to disclose to the patient relevant information when seeking informed consent for treatment if they have a reasonable belief that providing that information would likely cause the patient concerned serious physical or mental harm. In a landmark judgement, the Singapore Court of Appeal introduced a novel interpretation of TP, identifying circumstances in which it might be used with patients who did not strictly lack capacity but might be (...) inclined to refuse recommended treatments. In this paper, we explore the conceptual and practical challenges of this novel interpretation of TP. We propose that more emphasis should be placed on forms of shared and supported decision-making that foster the autonomy of patients with compromised mental capacity while being mindful of the need to safeguard their well-being. The kind of privilege that doctors might need to invoke is one of time and supportive expertise to ensure a flexible, responsive approach calibrated to the individual patients’ needs. The provision of such service would extinguish the need for the novel TP proposed by the Singapore Court of Appeal. (shrink)

Family involvement in healthcare decision-making for competent patients occurs to varying degrees in many communities around the world. There are different attitudes about who should make treatment decisions, how and why. Legal and professional ethics codes in most jurisdictions reflect and support the idea that competent patients should be enabled to make their own treatment decisions, even if others, including their healthcare professionals, disagree with them. This way of thinking contrasts with some cultural norms that put more emphasis on the (...) family as a decision-making entity, in some circumstances to the exclusion of a competent patient. Possible tensions may arise between various combinations of patient, family members and healthcare professionals, and healthcare professionals must tread a careful path in navigating family involvement in the decision-making process. These tensions may be about differences of opinion about which treatment option is best and/or on who should have a say or influence in the decision-making process. While some relevant cultural, legal and policy considerations vary from community to community, there are ethical issues that healthcare professionals need to grapple with in balancing the laws and professional codes on decision-making and the ethical principle of respecting patients and their autonomy. This paper will highlight and propose that a partial resolution to these issues may lie in relational understandings of autonomy, which in principle justify interventions by healthcare professionals and family that support patients in decision-making. (shrink)

“At-own-risk discharges” or “self-discharges” evidences an irretrievable breakdown in the patient–clinician relationship when patients leave care facilities before completion of medical treatment and against medical advice. Dissolution of the therapeutic relationship terminates the physician’s duty of care and professional liability with respect to care of the patient. Acquiescence of an at-own-risk discharge by the clinician is seen as respecting patient autonomy. The validity of such requests pivot on the assumptions that the patient is fully informed and competent to invoke an (...) at-own-risk discharge and that care up to the point of the at-own-risk discharge meets prevailing clinical standards. Palliative care’s use of a multidisciplinary team approach challenges both these assumptions. First by establishing multiple independent therapeutic relations between professionals in the multidisciplinary team and the patient who persists despite an at-own-risk discharge. These enduring therapeutic relationships negate the suggestion that no duty of care is owed the patient. Second, the continued employ of collusion, familial determinations, and the circumnavigation of direct patient involvement in family-centric societies compromises the patient’s decision-making capacity and raises questions as to the patient’s decision-making capacity and their ability to assume responsibility for the repercussions of invoking an at-own-risk discharge. With the validity of at-own-risk discharge request in question and the welfare and patient interest at stake, an alternative approach to assessing at-own-risk discharge requests are called for. The welfare model circumnavigates these concerns and preserves the patient’s welfare through the employ of a multidisciplinary team guided holistic appraisal of the patient’s specific situation that is informed by clinical and institutional standards and evidenced-based practice. The welfare model provides a robust decision-making framework for assessing the validity of at-own-risk discharge requests on a case-by-case basis. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Legal CommentarySumy Menon, Senior Associate in ResearchThis case involves the balancing of a young person’s right to autonomy and the desire to protect her from harm. No Singapore court decision has determined whether the doctor owes a duty to the parents of the doctor’s 16-year-old patient, to warn them that their child is engaging in sexual activities, and who subsequently has had an abortion. Similarly, the issue of whether (...) the doctor has a duty to protect the minor in such circumstances has also not been tested in the Singapore courts. Nonetheless, it is very unlikely that either duty will be found in this case.The general rule is that doctors owe a duty of confidentiality to their patients. This duty extends to children, and although no Singapore court has ruled on the matter, the law in England is clear.1 It is enshrined in section 4.2.3.1 of the Ethical Code & Ethical Guidelines of the Singapore Medical Council. It is not absolute and a number of exceptions have been carved out. The confidentiality duty can be overridden by legislation, court order, the public interest, or other justifiable circumstances that the doctor believes warrants disclosure.The age of consent for non-commercial consensual sexual activities in Singapore is 16.2 Therefore, there is no statutory responsibility on Dr. C under the criminal law to report the patients’ sexual activities to the authorities or anyone else. There is no other legislation or court order that compels disclosure. It is highly unlikely that the public interest would be served by disclosure. The consequences of such disclosure to the public interest were aptly put in a recent English case, when J. Silber held that if a confidentiality duty was not imposed, it “would probably or might well deter young people [End Page 262] from seeking advice and treatment on contraception, sexually transmitted diseases and abortion, and this would have undesirable and troubled consequences”.3 The last exception offers the greatest latitude for doctors to disclose if they believe there are other justifiable circumstances that would shift the balance in favour of disclosure. There are strong reasons to maintain confidentiality in Miss M’s case and although an argument can be made for disclosure, that argument is relatively weak.Miss M’s parents are understandably worried about her but Dr. C should not breach the duty of confidentiality owed to the patient even though she is only 16 years old. It is irrelevant that Miss M’s parents are paying for their daughter’s treatment. The doctor-patient relationship is between Dr. C and Miss M, and her parents have never been involved in the consultations or treatment decision-making process. They have not insisted on attending the consultations with their daughter, nor did they appear to object to Miss M consenting to treatment. Prior to their complaint, they had not sought any update or information about their daughter’s condition from Dr. C. Miss M specifically asked Dr. C not to reveal the contents of their conversations to her parents at the first consultation and the doctor agreed after attempting to convince her that it would be preferable to include her parents in the consultations. Miss M was obviously concerned about confidentiality and sought clarification from Dr. C. It appears as though Dr. C determined that Miss M had the capacity to exclude her parents from the consultations, and later to make her own treatment decisions, as a mature minor, and their doctor-patient relationship proceeded on that basis.It may be in the public interest for Dr. C to disclose confidential information about Miss M, even if she refuses to consent to it, if the doctor believes it is necessary to protect her from serious harm. Any such decision must be made with the patient’s best interests in mind. Examples of such harm include situations where the patient is at risk of serious physical abuse or has voiced a desire to commit suicide. Engaging in sexual activity with an older boy is unlikely to result in such serious harm, although harm may result. In this case, that harm manifested itself in an unwanted pregnancy... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Legal CommentarySumy Menon, Senior Associate in ResearchThe principle of autonomy must be balanced against the need to protect the person from harm. The question is how to strike that balance and what tips it over to either side. In this case, the right for Mdm. W to make her own decision whether to undergo electroconvulsive therapy (ECT) must be balanced against the concern of the doctors and her relatives (...) regarding the possible consequences of not receiving the treatment. However, this question does not even arise if Mdm. W has capacity to make that decision. Mdm. W is the decision-maker for ECT treatment if she has capacity to make that decision.1The statutory regime that underpins decision-making for persons who may lack capacity is the Singapore Mental Capacity Act (SMCA).2 It is grounded in five Statutory Principles.3 The first three are the presumption the person has capacity, has the right to make an unwise decision, and the requirement that all practicable steps be taken to help the person make a decision. The fourth principle requires decisions made on behalf of the person lacking capacity to be taken in his or her best interests, and the final one states that the less restrictive option must be selected when making decisions for persons lacking capacity.The best practice is for the doctor to conduct a formal mental capacity assessment to determine whether Mdm. W can refuse consent for ECT. A formal assessment is appropriate in these circumstances because the decision is an important one concerning serious medical treatment.4 A trained specialist should conduct this assessment. The two-stage test for mental capacity is laid out in the SMCA.5 The first stage appears to be met because it requires the person to be suffering from an impairment or disturbance that affects the function of [End Page 227] the mind or brain, and Mdm. W has bipolar disorder. The second stage requires the bipolar disorder to render Mdm. W unable to make a decision at the time the decision needs to be made. The SMCA states that a person is unable to make a decision if he or she cannot understand the information, weigh up the information, remember the information or communicate the decision.6If the formal assessment concludes that Mdm. W lacks capacity to refuse ECT treatment, then the decision should be taken in her best interests.7 Mdm. W ’s relatives have no legal right to make decisions on her behalf unless she has appointed one or more of her relatives to be her healthcare proxy under a valid Lasting Power of Attorney (LPA).8 If she made such an LPA, then the appointed proxy is the final decision-maker unless the treatment is life-sustaining or the doctor reasonably believes the treatment is necessary to prevent a serious deterioration in Mdm. W’s health.9 It is arguable that a clear and present danger of suicide may be reasonably classified by the doctor as a serious deterioration in Mdm. W’s health, although this issue has not been tested in the Singapore courts, which would mean that the appointed proxy would have to yield to the doctor as the final decision-maker. If Mdm. W did not make such an LPA, then the decision must be taken in her best interests, and is likely to be taken jointly between the healthcare team and the relatives.The best interests test involves a holistic appraisal of factors,10 balancing the benefits and burdens of the proposed ECT. The relevant factors that should be considered here include whether, when or if Mdm. W is likely to regain capacity, her beliefs and values, her past and present wishes, and the views of her relatives.11 We do not have any information about the first two factors but we do know Mdm. W rejected ECT and her relatives think she should have ECT. Another relevant factor is that Mdm. W is unlikely to cooperate with the pre-treatment fasting requirements or agree to undergo general anaesthesia. Therefore, Mdm. W will need to be restrained for eight hours before each treatment. There will be a total of six... (shrink)

“At-own-risk discharges” or “self-discharges” evidences an irretrievable breakdown in the patient–clinician relationship when patients leave care facilities before completion of medical treatment and against medical advice. Dissolution of the therapeutic relationship terminates the physician’s duty of care and professional liability with respect to care of the patient. Acquiescence of an at-own-risk discharge by the clinician is seen as respecting patient autonomy. The validity of such requests pivot on the assumptions that the patient is fully informed and competent to invoke an (...) at-own-risk discharge and that care up to the point of the at-own-risk discharge meets prevailing clinical standards. Palliative care’s use of a multidisciplinary team approach challenges both these assumptions. First by establishing multiple independent therapeutic relations between professionals in the multidisciplinary team and the patient who persists despite an at-own-risk discharge. These enduring therapeutic relationships negate the suggestion that no duty of care is owed the patient. Second, the continued employ of collusion, familial determinations, and the circumnavigation of direct patient involvement in family-centric societies compromises the patient’s decision-making capacity and raises questions as to the patient’s decision-making capacity and their ability to assume responsibility for the repercussions of invoking an at-own-risk discharge. With the validity of at-own-risk discharge request in question and the welfare and patient interest at stake, an alternative approach to assessing at-own-risk discharge requests are called for. The welfare model circumnavigates these concerns and preserves the patient’s welfare through the employ of a multidisciplinary team guided holistic appraisal of the patient’s specific situation that is informed by clinical and institutional standards and evidenced-based practice. The welfare model provides a robust decision-making framework for assessing the validity of at-own-risk discharge requests on a case-by-case basis. (shrink)