Improving informed consent by enhancing the role of nurses
Research Article
Daniel A Wilkenfeld, Grace Campbell
Nursing Ethics, 28 October 2020
Abstract
From a legal perspective, before a physician engages in a serious medical intervention they must obtain informed consent. In this paper, we argue that there are serious deficits in our processes of obtaining informed consent; it is often seen as just a bureaucratic hurdle, and people agree to interventions without being in an appropriate epistemic state. We explore some possible reasons for this, including ignorance, trust in physicians’ authority, and the minimal time physicians spend with patients. We trace many of these issues to one central cause, which is that in the United States obtaining informed consent is the purview of physicians. We argue that a simple shift in how we obtain informed consent can help to ameliorate these issues. Specifically, we argue that obtaining informed consent should be the responsibility of nurses rather than physicians. While there are several reasons for this, the central ideas are that (1) since nurses are the ones who know the patient, they will be in better position to tell when patients are genuinely informed, and (2) patients will be more comfortable asking questions and admitting ignorance to nurses rather than physicians. While we focus on US law, our conclusions are more broadly applicable.

Patient Consent Management by a Purpose-Based Consent Model for Electronic Health Record Based on Blockchain Technology
Original Article
Dara Tith, Joong-Sun Lee, Hiroyuki Suzuki, W. M. A. B. Wijesundara, Naoko Taira, Takashi Obi, Nagaaki Ohyamaz
Healthcare Informatics Research, 21 August 2020
Open Access
Abstract
Objectives
Currently, patients’ consent is essential to use their medical records for various purposes; however, most people give their consent using paper forms and have no control over it. Healthcare organizations also have difficulties in dealing with patient consent. The objective of this research is to develop a system for patients to manage their consent flexibly and for healthcare organizations to obtain patient consent efficiently for a variety of purposes.
Methods
We introduce a new e-consent model, which uses a purpose-based access control scheme; it is implemented by a blockchain system using Hyperledger Fabric. All metadata of patient records, consents, and data access are written immutably on the blockchain and shared among participant organizations. We also created a blockchain chaincode that performs business logic managing patient consent.
Results
We developed a prototype and checked business logics with the chaincode by validating doctors’ data access with purpose-based consent of patients stored in the blockchain. The results demonstrate that our system provides a fine-grained way of handling medical staff’s access requests with diverse intended purposes for accessing data. In addition, patients can create, update, and withdraw their consents in the blockchain.
Conclusions
Our consent model is a solution for consent management both for patients and healthcare organizations. Our system, as a blockchain-based solution that provides high reliability and availability with transparency and traceability, is expected to be used not only for patient data sharing in hospitals, but also for data donation for biobank research purposes.

Troubleshooting AI and Consent [BOOK CHAPTER]
Elizabeth Edenberg, Meg Leta Jones
The Oxford Handbook of Ethics of AI
Oxford University Press, 2020; pp 347-362
Abstract
As a normative concept, consent can perform the “moral magic” of transforming the moral relationship between two parties, rendering permissible otherwise impermissible actions. Yet, as a governance mechanism for achieving ethical data practices, consent has become strained—and AI has played no small part in its contentious state. In this chapter we will describe how consent has become such a controversial component of data protection as artificial intelligence systems have proliferated in our everyday lives, highlighting five distinct issues. We will then lay out what we call consent’s “moral core,” which emphasizes five elements for meaningful consent. We next apply the moral core to AI systems, finding meaningful consent viable within a particular digital landscape. Finally, we discuss the forces driving some commentators away from individual consent and whether meaningful consent has a future in a smart world.

Informed Consent: A Monthly Review
___________________________

November 2020

This digest aggregates and distills key content adressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_November 2020

What Do you Mean by “Informed Consent”? Ethics in Economic Development Research
Featured Article
Anna Josephson, Melinda Smale
Applied Economic Perspectives and Policy, 27 October 2020
Open Access
Abstract
The ethical conduct of research requires the informed consent and voluntary participation of research participants. Institutional Review Boards (IRBs) work to ensure that these ethical standards are met. However, incongruities in perspective and practice exist across regions. In this article, we focus on informed consent as practiced by agricultural and applied economists, with emphasis on research conducted in low income and/or developing countries. IRB regulations are clear but heterogeneous, emphasizing process rather than outcome. The lack of IRBs and institutional reviews in some contexts and the particulars of the principles employed in others may fail to adequately protect research participants.

Philosophical and Cognitive Elements of Risk Communication in Informed Consent [BOOK CHAPTER]
Daniele Chiffi
Clinical Reasoning: Knowledge, Uncertainty, and Values in Health Care, 2 October 2020; pp 145-157
Abstract
There is growing scientific interest in studying the multidisciplinary aspects of risk. Still, no universally accepted definition of risk has been agreed upon. When dealing with the sector of health-related risk, there should be an essential interplay between risk perception and risk communication. The present chapter argues that the effectiveness of risk communication in the health domain can be considerably improved by taking into consideration the cognitive and emotional biases along with all the factors affecting risk perception. I contend that risk communication is effective when based on the negotiation of meanings and therapeutic options in the clinical encounter, which is essential in the context of informed consent and in a person-centred and humanistic perspective in health care.

Informed Consent: A Monthly Review
___________________________

October 2020

This digest aggregates and distills key content adressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_October 2020

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.