Consenting patients – what do we really need to tell them?
Sonal Gandhi, Rebecca Exley, Khalid Begeni, Michael Perry
British Journal of Oral Maxillofacial Surgery, 1 December 2020; 58(10)
Abstract
Consent issues are a major factor in litigation. Shortfalls often make defence of a claim difficult. Arguably this has been made more difficult with the relatively recent Montgomery ruling. Unfortunately current guidelines are subject to personal interpretation and application (i.e. what do we define as a “serious” complication and how common is “common”). Thus consenting for procedures can be problematic. Whilst a surgeon’s perspective of relevant risks is important, the significance and likelihood of complications may be viewed differently by patients. We aimed to identify those risks patients may consider to be relevant and which should be routinely discussed. This study was undertaken for five common procedures.

Should Donors Consent to Export Their Corneas? Examination of Eye Tissue and Eye Care Sector
Opinion
Heather Machin, Gerard Sutton, Paul N. Baird
Cornea, 1 December 2020
Abstract
Purpose
Corneal tissue international activity is only possible because of the willingness of export populations to donate their corneas on their death. Current predonation public education campaigns and at-the-point-of-donation consent practice generally includes consent for transplantation, research, and/or training. It is unclear whether a consent-for-export step is universally included in the consent process or, indeed, whether it should. We interviewed eye tissue and eye care professionals from around the world, who exported, imported, or did neither to understand current consent-for-export awareness and determine opinion on future practice.
Method
During wider qualitative grounded-theory semistructured interviews with sector experts, to determine whether Australia should export, we captured sector opinion on consent-for-export. We used saturation and sentiment methods to determine opinion and χ2 correlation coefficients to examine association, using an α of P = 0.05.
Results
We interviewed 92 individuals, 83 of whom discussed consent-for-export. Of those, 51% (42/83) demonstrated some awareness of the practice; however, there were contradictions between interviewees from the same location. Regardless of current awareness, 57% (41/72) believed donors should be informed or consented for export. Their approval did not extend to donor-directed decisions, which would allow donors to decide which nation their donation should be sent, with 62.5% (45/72) opposing that notion.
Conclusions
Our research indicates that the consent-for-export practice is not universally applied by exporting nations and that eye tissue and eye care professionals have limited awareness of the practice. Universally implementing a consent-for-export step within general consent practice would improve awareness, reduce confusion, and support donor wishes.

Consent in Pelvic Care
Review
Stephanie Tillman
Journal of Midwifery & Women’s Health, 1 December 2020
Abstract
Consent is a clear dialogue between individuals to engage in a specific activity. Expectations for consent to intimate examinations in health care should be equal to, if not exceed, expectations for intimate interactions in society. In reality, current definitions of consent in health care vary. These blurry definitions lead to individualized interpretation, incomplete fulfillment, and opportunities for misunderstanding by both patient and health care provider. If a patient does not believe they have consented to an examination or procedure, they are likely to rightfully identify with one of consent’s antonyms, assault. Within the field of gynecology, a history of misogyny, racism, and classism illuminates abhorrent contexts of assault disguised as care. Similar practices persist in the modern application of pelvic care, ranging from overt sexual assault to coercion disguised as guidance. Health care providers and students who seek to improve consent practices can look to evidence‐based frameworks such as trauma‐informed care and shared decision making, both of which are embraced widely by professional organizations. These approaches often take precedence during the first pelvic examination; care for people who are lesbian, bisexual, queer, transgender, or nonbinary; and care for anyone with a known history of sexual assault; they can be easily extrapolated to all intimate examinations. Beyond obtaining consent for the examination itself, health care providers must also intentionally obtain consent to include students in care and openly discuss new universal recommendations for chaperone presence. Scripting for common procedures, such as bimanual examinations for pelvic care or cervical examinations in labor, allows health care providers to practice trauma‐informed language, include evidence‐based guidance, and avoid unintentional bias. Contemporary providers of intimate pelvic care must work to understand and strengthen the definition of consent and ensure its realization in practice.

The impact of organ donation specialists on consent rate in challenging organ donation conversations
Sam Radford, Rohit D’Costa, Helen Opdam, Mark McDonald, Daryl Jones, Michael Bailey, Rinaldo Bellomo
Critical Care and Resuscitation, December 2020; 22(4)
Abstract
Background
Consent rates for organ donation conversations (ODCs) vary. We hypothesised that a simple grading system could identify challenging ODCs. We further hypothesised that challenging ODCs would have higher consent rates when conducted by ODC specialists.
Objectives
We aimed to study the utility of a grading system for ODCs and test the hypothesis that any training effect would be associated with improved consent rates in ODCs graded as most challenging.
Methods
We stratified 2017 Australian DonateLife Audit aggregate consent and donation discussion data into four ODC grades based on Australian Organ Donor Register (AODR) status and person first raising the topic of organ donation. Grade I: “yes” present on AODR and family-raised organ donation; Grade II: “yes” present on AODR, and clinician-raised organ donation; Grade III: no registration on AODR but family-raised organ donation; and Grade IV: no registration on AODR, and clinician-raised organ donation.
Results
Grade I ODCs were uncommon 7.7% (109/1420), with a consent rate of 95.4% (104/109). Grade IV ODCs were frequent (60.4%, 857/1420), with a consent rate of 41.4% (355/857). However, in Grade IV ODCs, organ donation specialist consent rate was 53.5% (189/353), significantly greater than for other trained staff at 33.1% (88/266) (P < 0.005; odds ratio [OR], 2.33; 95% CI, 1.68- 3.24) or untrained requestors at 32.8% (78/238; P < 0.005; OR, 2.36; 95% CI. 1.68-3.33).
Conclusion
The likelihood of consent can be predicted using readily available variables. This allows prospective identification of Grade IV ODCs, which carry low but potentially modifiable likelihood of consent. Involving donation specialists was associated with more consents for organ donation when applied retrospectively to Australian audit data.

Informed Consent for Blood Transfusion: Physicians’ Perceptive at a Tertiary Healthcare Hospital
Original Article
EI Obi, C Diete-spiff, KE Belema
Western Journal of Medical & Biomedical Sciences, 30 November 2020; 1(2)
Abstract
Blood transfusion have the potential to save lives and frequently provide considerable benefits, but it has associated risks. Notwithstanding, the process of obtaining permission for blood transfusion may not be done satisfactorily. The study was carried out to evaluate physicians’ opinion, attitude and practice of the transfusion consent process at Federal Medical Centre, Yenagoa, Bayelsa State, Nigeria. Physicians from distinct departments were beckoned to fill out an unidentified questionnaire on transfusion consent. A total of 141 physicians replied to the study. More than 90% of the participants acknowledged the significance of the transfusion consent process. An aggregate of 123 (87.2) participants had prescribed blood, out of which 119 (84) obtained informed consent before blood transfusion.  The advantages and hazards of blood transfusion was interpreted routinely by 108(90.8) and 81(68.1) of the study participants, respectively. Contrarily, a lower proportion of the participants 56(47.1) explained the available options to blood transfusion. The likelihood to decline consent after receiving education on blood transfusion was the most identified limitations to the practice of informed consent in transfusion at the studied institution. This study demonstrates decisive perspective of the evaluated physicians on the value of transfusion consent. Nonetheless, strategies should be set up to ensure that options to blood transfusion are included systematically in the transfusion consent process.

In Vitro Fertilization Informed Consent: Revisited, Empirically
Ilona Voskoboynikov-Ugortsev, Yaakov Rosenfeld, Lital Keinan Boker
The Israel Medical Association journal, November 2020; 11(22) pp 681-683
Open Access
Abstract
Background
A thorough informed consent (IC) process is required before in vitro fertilization (IVF) treatments can begin because these treatments are by and large elective and they have expectable and preventable complications, such as ovarian hyper-stimulation syndrome and multi-fetal pregnancies.
Objectives
To empirically examine whether patient knowledge and understanding of potential hazards associated with IVF treatment are better after the IC process compared to before. The authors hypothesized that patients’ better understanding of potential complications would be translated and expressed as rational choices of treatment alternatives.Z
Methods
Responses of 48 IVF patients after IC process (study group) from two IVF units in northern Israel were compared to those of 46 patients before IVF (control group). Only women undergoing IVF for first time who were older than 18 years of age were eligible for the study.
Results
Socio-demographic parameters were found to be quite similar between the study group and the control group. Contrary to our expectations, in the study group 12 women (25.5%) considered delivery of a single baby as their optimal result, compared to 15 (32.6%) in the control group. Furthermore, preferences shifted toward triplets: eight patients (17%) after IC considered this option as their best result, compared to only five patients (11%) before IC.
Conclusions
IC process goals are not achieved under current practices, at least as far as IVF treatment are concerned. New tools and incentives should be implemented to meet the requirements dictated by the laws regarding patient rights.

Consent to treatment
Mary E. O’Hara
Journal of the European Wound Management, 2020; 21(1)
Open Access
Abstract
Patients’ valid consent to treatment must be gathered prior to providing treatment to ensure the protection of a person’s rights. This article discusses the key components of a valid consent to treatment, as well as different forms of consent. Two case scenarios also consider pertinent consent issues related to wound care provision. Using a human-rights-based approach, the Fairness, Respect, Equality, Dignity and Autonomy (FREDA) principles, linked to the Convention of the Rights of People with Disabilities (2006), provide a useful guiding framework and resource for clinical decision-making.

Consent Through the Lens of Semantics: State of the Art Survey and Best Practices
Anelia Kurteva, Tekraj Chhetri, Harshvardhan J. Pandit, Anna Fensel
Semantic Webb, 11 December 2020
Open Access
Abstract
The acceptance of the GDPR legislation in 2018 started a new technological shift towards achieving transparency. GDPR put focus on the concept of informed consent applicable for data processing, which led to an increase of the responsibilities regarding data sharing for both end users and companies. This paper presents a literature survey of existing solutions that use semantic technology for implementing consent. The main focus is on ontologies, how they are used for consent representation and for consent management in combination with other technologies such as blockchain. We also focus on visualisation solutions aimed at improving individuals’ consent comprehension. Finally, based on the overviewed state of the art we propose best practices for consent implementation.

A Blockchain-Based Consent Platform for Active Assisted Living: Modeling Study and Conceptual Framework
Original Paper
Journal of Medical Internet Research, 4 December 2020; 22(12)
Pedro Elkind Velmovitsky, Pedro Augusto Da Silva E Souza Miranda, Hélène Vaillancourt, Tania Donovska, Jennifer Teague, Plinio Pelegrini Morita
Open Access
Abstract
Background
Recent advancements in active assisted living (AAL) technologies allow older adults to age well in place. However, sensing technologies increase the complexity of data collection points, making it difficult for users to consent to data collection. One possible solution for improving transparency in the consent management process is the use of blockchain, an immutable and timestamped ledger.
Objective
This study aims to provide a conceptual framework based on technology aimed at mitigating trust issues in the consent management process.
Methods
The consent management process was modeled using established methodologies to obtain a mapping of trust issues. This mapping was then used to develop a conceptual framework based on previous monitoring and surveillance architectures for connected devices.
Results
In this paper, we present a model that maps trust issues in the informed consent process; a conceptual framework capable of providing all the necessary underlining technologies, components, and functionalities required to develop applications capable of managing the process of informed consent for AAL, powered by blockchain technology to ensure transparency; and a diagram showing an instantiation of the framework with entities comprising the participants in the blockchain network, suggesting possible technologies that can be used.
Conclusions
Our conceptual framework provides all the components and technologies that are required to enhance the informed consent process. Blockchain technology can help overcome several privacy challenges and mitigate trust issues that are currently present in the consent management process of data collection involving AAL technologies.