Comparison of information delivery methods for informed consent for blood transfusions
April Jones, Krishna Badami
New Zealand Journal of Medical Laboratory Science, August 2020; 74(2) pp 149
Abstract
Objectives: Informed consent is a process in which patients are educated about their treatment options, allowing them to make autonomous decisions about whether they consent to treatment. Blood transfusions are a treatment option associated with a multitude of risks which require patient consent. There is evidence the information provided for informed consent, particularly around the risks associated with blood transfusions, is not adequately understood by patients. This project aimed to investigate whether the process of patient education can be improved by use of an information sheet. Methods: A randomised controlled trial was performed using members of the public and medical staff. Participants were randomly assigned to the control or intervention group. The control group received an audio recording replicating the current education process. The intervention group received an A4 sheet of information. Understanding and recall of the information provided was assessed using a questionnaire. The mode for each group was calculated and used to compare the survey results. Results: The results implied neither form of information was adequate in promoting understanding of the risks associated with blood transfusions. There was some evidence suggesting the intervention improved understanding and recall of the frequency of transfusion associated risks. The severity of such events appeared to be unclear irrespective of the type of information received. Conclusion: With further development of the information given, routine use of supplementary paper based information could assist understanding of the frequency and severity of transfusion associated risks through reinforcement of information given during a discussion.

Researching consent in veterinary practice: The use of interpretive description as a multidisciplinary methodology
Carol A Gray
Methodological Innovations, September-December 2020
Open Access
Abstract
Informed consent in the veterinary sphere has been surprisingly under-researched, despite it being a professional ethical requirement. As consent is given by animal owners on behalf of patients who are unable to consent for themselves, its underpinning ethical basis cannot exactly mirror consent given by adult human patients with capacity. Any attempt to research consent in the veterinary context requires consideration of its legal, ethical and practical applications. This investigation of consent practices in veterinary settings in the United Kingdom was undertaken using interpretation of medicolegal cases, together with three discrete empirical studies comprising the textual analysis of consent forms, consent discussions for the elective neutering of companion animal patients, and interviews with key participants in the consent process. The chosen approach required a methodology that would facilitate triangulation between empirical data analysis and doctrinal legal research. Here, I describe the first use of interpretive description as a methodology of veterinary socio-legal studies, in the context of practice-based research. With foundations in traditional social science methodologies such as hermeneutics, grounded theory, ethnography and symbolic interactionism, interpretive description provided a multi-disciplinary methodological perspective. Its underpinning methodologies informed the methods that were used for data collection, and for subsequent analysis. I combined interpretation of legal decisions and professional ethical guidance with thematic surveys of empirical data to reach higher levels of analysis. The resulting conceptual description of consent in veterinary practice enabled the production of normative guidance appropriate for those in practice, thus fulfilling the methodological aims of interpretive description. Specifically, the key findings were that the consent form should act as a fuller record of the consent discussion, that attention should be paid to achieving an appropriate balance between client autonomy and patient ‘best interests’ and that consent should provide protection to all three parties (client, patient and veterinary professional).

More than consent for ethical open-label placebo research
Original Research
Laura Specker Sullivan
BMJ Medical Ethics, 3 September 2020
Abstract
Recent studies have explored the effectiveness of open-label placebos (OLPs) for a variety of conditions, including chronic pain, cancer-related fatigue and irritable bowel syndrome. OLPs are thought to sidestep traditional ethical worries about placebos because they do not involve deception: with an OLP, patients or subjects are told outright that they are not given an active substance. As deception is framed as the primary hurdle to ethical placebo use, the door is ostensibly opened to ethical studies of OLPs. In this article, I suggest that even though OLPs seemingly do not involve deception, there are other ethical considerations in their clinical investigation and subsequent use. Research ethics often focusses on informed consent—of which, deception and honesty are a piece—as a means to justify research practices with human subjects. Yet, it is but one of the ethical considerations that should be taken into account. With research into placebo effects in particular, I argue that the history of clinical placebo use grounds special considerations for OLP research that go beyond respect for the autonomy of individual patients through informed consent and encompass structural concerns about the type of patient for whom a placebo has historically been thought appropriate.

The Cohen problem of informed consent
William Simkulet
BMJ Medical Ethics, 26 August 2020; 46(9) pp 617-622
Abstract
To avoid potential abuse and respect patient autonomy, physicians have a moral obligation to obtain informed consent before performing any significant medical intervention. To give informed consent, a patient must be competent, understand her condition, options and their expected risks and benefits and must freely and expressly consent to one of those options. Shlomo Cohen challenges this conception of informed consent by constructing cases based on Edmund Gettier’s classic counterexamples to traditional theories of knowledge. In this paper, I argue Cohen-style cases are not genuine threats to the concept of informed consent, however they provide an interesting challenge to theories of conscientious objection.