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)

“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)