Improving the Effectiveness of the Informed Consent Process in Elective Aesthetic Procedures [POSTER]

Improving the Effectiveness of the Informed Consent Process in Elective Aesthetic Procedures [POSTER]
Hagopian, Chelsea Olivia; Ades, Teresa B.; Hagopian, Thomas Martin; Wolfswinkel, Erik; Stevens, Grant
Virginia Henderson Global Nursing e-Repository, 14 February 2019
Abstract
Informed consent is commonly reduced to a legal formality rather than upholding its ethical ideal of being a process of shared decision-making. We present a multiphase development process model for creating a patient decision aid prototype to replace the traditional informed consent documents for primary breast augmentation surgery.

Informed-Consent Taking Procedure for Elective Surgery in Gaza strip: Patient’s Satisfaction with Doctor’s Communication

Informed-Consent Taking Procedure for Elective Surgery in Gaza strip: Patient’s Satisfaction with Doctor’s Communication
Khamis Elessi, Mohammed Elifranji, Zuhdi Elifranji
Islamic University Gaza Journal of Natural Studies, 12 March 2017; 26(1) pp 18-29
Background
Widespread dissatisfaction and mistrust exists among patients in the Gaza Strip towards doctors. A sense of a lack of sufficient information regarding diagnosis, risks and benefits of interventions and subsequent management plans is present among patients. All of these areas are considered essential components in the surgical consent process. A gap between patients’ actual understanding and that perceived by doctors has been shown to exist in different settings.1 Unfortunately, no former study has been done on this topic in the GazaStrip.
Objectives
This study aims to assess the satisfaction of patients in Gaza with the information provided to them during the consent process prior to an invasive procedure and compare this to the current practice and attitudes of surgeons.
Methods
A five-section self-designed questionnaire was administered using convenience sampling to the first 60 patients and first 60 surgeons who met the selection criteria in the two hospitals in the Gaza Strip: Al-Shifa Hospital and the European Gaza Hospital.
Findings
Among the surgeons surveyed, 55% answered that informed consent should be obtained by doctors only, 3% thought that it can be obtained by nurses only, while 45% stipulated either doctors or nurses can obtain it. In total only 38% of those healthcare professionals taking the consent from the patient, actually performed the procedure. During consent procedures, 73% of surgeons reported providing written documents 30% drawings explaining the procedure, 3% giving videos or animations and 8% suggesting website links for more information. The survey of patients revealed that only 25% of surveyed surgeons identified themselves to their patients, and 12% asked for the patients’ signature without a complete discussion of the intervention. Around 35% of surgeons depended on verbal communication only. Surgeons identified barriers for best practice as time constraints, as well as lack of hospital policies and informational resources. However, 87% of surgeons believed that informed consent has an impact on patient wellbeing. A total of 90% of surveyed patients thought they received the right treatment and were satisfied. While 43% of patients prefer to travel overseas to get treatment, 77% of these because of a perceived lack of medical equipment and facilities.

Consent Recommender System: A Case Study on LinkedIn Settings

Consent Recommender System: A Case Study on LinkedIn Settings
Rosni K V, Manish Shukla, Vijayanand Banahatti, Sachin Lodha
Central Europe Workshop Proceedings, 18 March 2019; 2335 pp 53-60
Abstract
Privacy is an increasing concern in the digital world, especially when it has become a common knowledge that even high profile enterprises process data without data-subject’s consent. In certain cases where data-subject’s consent was taken, it was not linked to the proper purpose of processing. To address this growing concern, newer privacy regulations and laws are emerging to empower a data-subject with informed and explicit consent through which she can allow or revoke usage of her personal data. However, it has been shown that privacy self-management does not provide the expected results. This is mainly due to information overload as data-subjects use multiple services entailing variety of purposes, and hence, resulting in a very large number of consent requests. This may lead to consent fatigue as data-subject is now expected to provide informed consent for each associated purpose. The consent fatigue in data-subjects can lead to either incorrect decision making or opting for default values provided by the enterprise, and thus, defeating the purpose of new data privacy regulations. In this work, we discuss the factors influencing the informed consent of a data-subject. Further, we propose a ‘consent recommender system’ based on Factorization Machines (FMs) to assist the data-subject and thereby avoiding consent fatigue. Our consent recommender system effectively models the interaction between the different factors which influence a data-subject’s informed consent. We discuss how this setup extends for cold start data-subjects facing the decision problem with consent requests from multiple enterprises. Additionally, we demonstrate the scenario of consent recommendation as a prediction problem with minimum attributes available from LinkedIn’s privacy settings.

Informed consent (IC), randomized controlled trial digital vs conventional IC

Informed consent (IC), randomized controlled trial digital vs conventional IC
Galve La Hoz, J. Rioja, E. Salas, L. Enguita, M. Sanz Del Pozo, D. Corbatón, C. Gareta, S. Ezquerro, M. Muñoz, T. Cabañuz, P. Gil, M.J. Gil
European Urology Supplements, March 2019; 18(1) pp e847
Introduction& Objectives
In order to satisfy the informed consent process, patients must understand the information they receive. We know have support tools, like hyperrealistic simulations, which improve the understanding of informed consent. The objective of the study is to demonstrate that digital informed consent, with hyperrealistic simulations, improved the understanding of information and, therefore, informed consent.
Materials& Methods
The study included 84 participants who underwent a transurethral resection of the bladder, transurethral resection of the prostate or ureterostomy in our department. Participants were randomly assigned to either intervention or control group using the closed envelopes method. Informed consent was obtained in the outpatient clinic and patients were included in the study at hospital admission, when they were informed again. Intervention group watched a hyper realistic simulation from IURO app, consecutive, and completed a validated questionnaire. The control group completed the questionnaire without watching any simulation. The primary outcomes was subjective information perception. We used Mann-Whitney U test for statistical analysis.
Results
42 participants were assigned to each group. 4 participants in the intervention group did not complete the questionnaire versus 5 in the control group. Th intervention group, called digital consent, showed a higher subjective information perception than the control group, called the conventional group (figure 1 p= 0,001). The anxiety level in both groups was similar. In the subgroup analysis we observed that participants who had a basic level in the study or educational showed a higher subjective information perception in th digital group than the conventional group (p=0.006). We did not observe these differences in the subgroup with a higher level of study or educational.

Decisional Capacity for Informed Consent in Males and Females with Fragile X Syndrome

Decisional Capacity for Informed Consent in Males and Females with Fragile X Syndrome
Anne C. Wheeler, Amanda Wylie, Melissa Raspa, Adrienne Villagomez, Kylee Miller, Anne Edwards, Margaret DeRamus, Paul S. Appelbaum, Donald B. Bailey Jr.
Journal of Autism and Developmental Disorders, 1 March 2019; pp 1–23
Abstract
Although informed consent is critical for all research, there is increased ethical responsibility as individuals with intellectual or developmental disabilities (IDD) become the focus of more clinical trials. This study examined decisional capacity for informed consent to clinical trials in individuals with fragile X syndrome (FXS). Participants were 152 adolescents and adults (80 males, 72 females) with FXS who completed a measure of decisional capacity and a comprehensive battery of neurocognitive and psychiatric measures. Females outperformed males on all aspects of decisional capacity. The ability to understand aspects of the clinical trial had the strongest association with the ability to appreciate and reason about the decision. Scaffolding improved understanding, suggesting researchers can take steps to improve decisional capacity and the informed consent process.

Indigenous Processes of Consent: Repoliticizing Water Governance through Legal Pluralism

Indigenous Processes of Consent: Repoliticizing Water Governance through Legal Pluralism
Deborah Curran
Water, 19 March 2019; 11(3) pp 571
Abstract
While international instruments and a few state governments endorse the “free, prior and informed consent” of Indigenous peoples in decision-making about the water in their traditional territories, most state water governance regimes do not recognize Indigenous water rights and responsibilities. Applying a political ecology lens to the settler colonialism of water governance exposes the continued depoliticizing personality of natural resources decision-making and reveals water as an abstract, static resource in law and governance processes. Most plainly, these decision-making processes inadequately consider environmental flows or cumulative effects and are at odds with both Indigenous governance and social-ecological approaches to watershed management. Using the example of groundwater licensing in British Columbia, Canada as reinforcing colonialism in water governance, this article examines how First Nations are asserting Indigenous rights in response to natural resource decision-making. Both within and outside of colonial governance processes they are establishing administrative and governance structures that express their water laws and jurisdiction. These structures include the Syilx, Nadleh Wut’en and Stellat’en creating standards for water, the Tsleil-Waututh and Stk’emlúpsemc te Secwépemc community assessments of proposed pipeline and mining facilities, and the First Nations of the Nicola Valley planning process based on their own legal traditions. Where provincial and federal environmental governance has failed, Indigenous communities are repoliticizing colonial decision-making processes to shift jurisdiction towards Indigenous processes that institutionalize responsibilities for and relationships with water.

Barriers and Facilitators to Obtaining Informed Consent in a Critical Care Pediatric Research Ward in Southern Malawi

Barriers and Facilitators to Obtaining Informed Consent in a Critical Care Pediatric Research Ward in Southern Malawi
Lucinda Manda-Taylor, Alice Liomba, Terrie E. Taylor, Kristan Elwell
Journal of Empirical Research on Human Research Ethics, 13 March 2019; 14(2) pp 152–168
Abstract
Informed consent is an ethical requirement in clinical research. Obtaining informed consent is challenging in resource-constrained settings. We report results of a formative qualitative study that examined factors that facilitate and hinder informed consent for clinical research among critically ill children in Malawi. We argue that truly informed consent in a pediatric intensive care unit (PICU) is challenged by parental distress, time constraints when balancing care for critically ill patients with research-related tasks, and social hierarchies and community mistrust toward certain research procedures. We interviewed health care providers and parents of children attending a critical care unit to identify potential challenges and solicit strategies for addressing them. Providers and caregivers suggested practical solutions to enhance research participant understanding of clinical trial research, including the use of visual materials, community engagement strategies, and using patients as advocates in promoting understanding of research procedures.

Moving Forward on Consent Practices in Australia

Moving Forward on Consent Practices in Australia
Lisa Eckstein & Rebekah McWhirter
Journal of Bioethical Inquiry, 2018; 15(2) pp 243-257
Abstract
Allowing persons to make an informed choice about their participation in research is a pre-eminent ethical and legal requirement. Almost universally, this requirement has been addressed through the provision of written patient information sheets and consent forms. Researchers and others have raised concerns about the extent to which such forms—particularly given their frequent lengthiness and complexity—provide participants with the tools and knowledge necessary for autonomous decision-making. Concerns are especially pronounced for certain participant groups, such as persons with low literacy and Indigenous persons. Multimedia strategies have the potential to usefully supplement current consent practices in Australia; however, information is needed about the need for supplementary consent practices, along with drivers for and barriers against adoption. This study initiates the required evidence base through an audit of informed consent practices for medical research in the Australian state of Tasmania to assess the need for, and current uptake of, supplementary consent strategies. Drivers for and barriers against adoption of multimedia consent practices were explored in detail through interviews with key stakeholders, including researchers, HREC chairs and members, and research participants, including Indigenous participants.

How Democracy Can Inform Consent: Cases of the Internet and Bioethics

How Democracy Can Inform Consent: Cases of the Internet and Bioethics
Carol C. Gould
Journal of Applied Philosophy, 22 March 2019; Special Issue 
Abstract
Traditional conceptions of informed consent seem difficult or even impossible to apply to new technologies like biobanks, big data, or GMOs, where vast numbers of people are potentially affected, and where consequences and risks are indeterminate or even unforeseeable. Likewise, the principle has come under strain with the appropriation and monetisation of personal information on digital platforms. Over time, it has largely been reduced to bare assent to formalistic legal agreements. To address the current ineffectiveness of the norm of informed consent, I suggest that we need a notion of structural injustice (on a distinctive interpretation, elaborated here, which takes account of unequal power and property relations). I then argue that in order to protect and enhance people’s freedom, we have to go beyond traditional applied ethics and introduce perspectives from democratic theory and social philosophy. I attempt to show how applications of the ‘all‐affected principle’, together with new forms of democratic participation, deliberation, and representation can helpfully frame the narrower principle of informed consent. There is an important role for what we could call collective consent, and informed consent can only succeed in increasing individual agency if it is situated within enhanced forms of democratic decision‐making.

Democracy as Uninformed Non‐Consent

Democracy as Uninformed Non‐Consent
Jason Brennan
Journal of Applied Philosophy, 14 March 2019; Special Issue
Abstract
Carol Gould argues that democratic institutions can serve as mechanisms of informed consent or could at least facilitate creating regulations and other structures which facilitate informed consent in bioethics, medicine, and elsewhere. I am sceptical. I argue that democracies cannot serve as vehicles of consent, let alone informed consent. Further, the problems of democratic ignorance and irrationality created significant barriers to democratic deliberation helping to produce better regulations or conditions for informed consent. Democracy is not a good surrogate for consent.