Adolescent Consent for HPV Vaccine: Ethical, Legal, and Practical Considerations
Gregory D. Zimet, Ross D. Silverman, Robert A. Bednarczyk, Abigail English
The Journal of Pediatrics, 20 January 2021
Abstract
Healthy People 2020 set a goal of 80% series completion for HPV vaccine. The 2019 National Immunization Survey-Teen shows that 54.2% of adolescents aged 13-17 years were up-to-date with the vaccine series. Although this coverage level represents an incremental increase over 2018, it remains well-below the Healthy People goal. Furthermore, HPV vaccine ordering and administration have dropped dramatically during the COVID-19 pandemic.
Preoperative Education and Informed Consent in Young Adults Undergoing Bariatric Surgery: Patients’ Perspectives on Current Practice
Preoperative Education and Informed Consent in Young Adults Undergoing Bariatric Surgery: Patients’ Perspectives on Current Practice
Wouter K.G. Leclercq, Daniëlle S. Bonouvrie, Charlotte E.J.M. Dohmen, Martine Uittenbogaart, Johan Legemaate, Laurents P.S. Stassen, and François M.H. van Dielen
Bariatric Surgical Practice and Patient Care, 31 December 2020
Abstract
Background
Preoperative education is part of the informed consent process and should enable patients to make an informed decision. Aim of this study was to gain a more detailed insight in the perceptions and experiences of the informed consent process of young adults undergoing bariatric surgery.
Methods
Fifty-five young adults, aged 18–25 years, who underwent bariatric surgery, were invited to participate in a semistructured interview. The interview covered three main topics: education of specific informed consent domains, perioperative expectations and experiences, and personal (un)certainties related to undergoing bariatric surgery.
Results
Twenty-seven patients participated in a semistructured interview. Mean age was 23.1 ± 1.6 years. All consent domains were remembered by the patients, but 24/27 patients could not recall one or more complications. Inadequate weight loss was not recalled by 6/27 patients. Common remarks were that the preoperative education focused mainly on the positive results. Negative effects were inadequately educated.
Conclusions
Physicians should educate patients more about the negative effects of a treatment and should focus more on specific age-related problems and social interactions. Improved preoperative education, including possible outcome scenarios to assess risks and lifetime consequences, should be developed to improve informed consent in these patients.
Digital Age of Consent and Age Verification: Can They Protect Children?
Digital Age of Consent and Age Verification: Can They Protect Children?
Liliana Pasquale, Paola Zippo, Cliona Curley, Brian O’Neill, Marina Mongiello
IEEE Software, 15 December 2020
Abstract
Children are increasingly accessing social media content through mobile devices. Existing data protection regulations have focused on defining the digital age of consent, in order to limit collection of children’s personal data by organizations. However, children can easily bypass the mechanisms adopted by apps to verify their age, and thereby be exposed to privacy and safety threats. We conducted a study to identify how the top 10 social and communication apps among underage users apply age limits in their Terms of Use. We also assess the robustness of the mechanisms these apps put in place to verify the age of their users. Moreover, we discuss how automated age recognition techniques can be adopted to increase the effectiveness of the age verification process. Finally, we provide recommendations to app providers and developers to specify the Terms of Use and implement robust age verification mechanisms.
Editor’s note: IEEE Software delivers software development information. The articles in this journal are peer reviewed in accordance with the requirements set forth in the IEEE PSPB Operations Manual.
Communication in Psychiatric Coercive Treatment and Patients’ Decisional Capacity to Consent [BOOK CHAPTER]
Communication in Psychiatric Coercive Treatment and Patients’ Decisional Capacity to Consent [BOOK CHAPTER]
Gabriele Mandarelli, Giovanna Parmigiani
Springer – Empathy, Normalization and De-escalation, 29 January 2021; pp 113-132
Abstract
Effective communication and the acquisition of a valid consent are central to a good doctor-patient relationship and a clinician’s ethical obligation in order to respect patients’ autonomy, as well as their right to be involved in treatment decisions. However, often clinicians face several issues in performing this task, among which the most frequently reported are the fear of hurting the patient by communicating a bad diagnosis or not knowing how to manage the patient’s emotional reactions. In addition, there are vulnerable populations, such as those represented by psychiatric patients, who are at higher risk of decisional incapacity. Especially for those patients, it is in fact particularly difficult for clinicians to find the proper balance between respecting the right of capable patients to make choices about their treatment and the right of incapable patients to be protected from the possible harmful consequences of their improper decisions. However, nor the presence of a severe psychiatric disorder nor a status of “involuntary hospitalized patient” has been reported to be a label for incapacity. Several tools have been developed to assist clinicians in patients’ decisional capacity evaluations, together with interventions aimed at enhancing informed consent acquisition in order to achieve shared decision-making and lead the patient to become actively involved in his/her treatment decisions. Such an approach would lead to a decrease in the perceived coercion, often reported in mental healthcare settings and also from patients who are not involuntarily hospitalized, and to an increase in patients’ adherence to treatment.
Equality in the Informed Consent Process: Competence to Consent, Substitute Decision-Making, and Discrimination of Persons with Mental Disorders
Equality in the Informed Consent Process: Competence to Consent, Substitute Decision-Making, and Discrimination of Persons with Mental Disorders
Matthé Scholten, Jakov Gather, Jochen Vollmann
Journal of Medical Philosophy, 25 January 2021; 46(1) pp 108-136
Open Access
Abstract
According to what we propose to call “the competence model,” competence is a necessary condition for valid informed consent. If a person is not competent to make a treatment decision, the decision must be made by a substitute decision-maker on her behalf. Recent reports of various United Nations human rights bodies claim that article 12 of the Convention on the Rights of Persons with Disabilities involves a wholesale rejection of this model, regardless of whether the model is based on a status, outcome, or functional approach to competence. The alleged rationale of this rejection is that denying persons the right to make their own treatment decisions based on an assessment of competence necessarily discriminates against persons with mental disorders. Based on a philosophical account of the nature of discrimination, we argue that a version of the competence model that combines supported decision-making with a functional approach to competence does not discriminate against persons with mental disorders. Furthermore, we argue that status- and outcome-based versions of the competence model are discriminatory.
The importance of consent in case reports
The importance of consent in case reports
Ross J Thomson, C Fielder Camm
European Heart Journal – Case Reports, 4 January 2021
Open Access
Excerpt
…The Committee on Publication Ethics and the International Committee of Medical Journal Editors have issued guidelines on the publication of case reports. These state that, with limited exceptions, consent from the patient should be obtained prior to publication of a case report. When obtaining informed consent authors must advise their patients not only that their case will be placed in the public domain but that despite every effort at anonymisation there exists a possibility that they may be identified, and that their consent is irrevocable after (but not before) publication. As part of the consent process, the patient should have the opportunity to read the manuscript and view any images accompanying it…
The patient’s right to informed consent in the US Legal System. Genesis, development, foundations and brief questioning comparison with the Spanish model
The patient’s right to informed consent in the US Legal System. Genesis, development, foundations and brief questioning comparison with the Spanish model
Noelia Martinez-Doallo
Derecho y Salud, 2020; 30(2) pp 57-83
Abstract
A legal analysis on the informed consent of the patient primarily requires considering the common law, regardless of solutions provided by the malpractice statutes and a promising constitutional protection route, despite the ascertainment of some preventable shortcomings. This paper aims to offer a comprehensive review on the genesis, advancement and basis of the U.S. legal protection of the informed consent in the healthcare extent, to afterwards carry out a brief comparative study with the Spanish regulation.
Indigenous Peoples’ Free, Prior and Informed Consent (FPIC) and the World Bank Safeguards: Between Norm Emergence and Concept Appropriation
Indigenous Peoples’ Free, Prior and Informed Consent (FPIC) and the World Bank Safeguards: Between Norm Emergence and Concept Appropriation
Stéphanie de Moerloose
World Comparative Law, 2020; 53(3) pp 223-244
Abstract
The question of the consent of indigenous peoples is at least as old as colonization. Indeed, the consent of indigenous peoples was already an issue at the heart of treaty-making between colonial settlers and indigenous peoples. The issue of indigenous peoples’ consent, understood as their Free, Prior and Informed Consent (FPIC), has been re-emerging and gaining acceptance internationally in international Human Rights law over the last 30 years. When the new World Bank safeguards were adopted in 2016, one of the most discussed topics during the consultation rounds had been the integration in the safeguards of the concept of the FPIC of indigenous peoples, as it had been notoriously absent from the previous safeguards. Finally, FPIC was made part of the new safeguards. This paper first maps the concept of FPIC under international law from a postcolonial perspective. Then, it attempts to analyze the processes of operationalization of the concept by the World Bank in the new safeguards, drawing on Human Rights and on law and development literature. The paper argues that there is a tension between the re-emergence of FPIC as a customary norm and the fragmentation of the interpretations of the concept of consent by different actors. The operationalization of the concept of FPIC, understood as a negotiated process rather than a process of self-determination, may in fact limit its remedial objective and diminish its quality as a resistance tool.
Ethical Dimensions in Research – Informed Consent and Female Gender in Nigeria [BOOK CHAPTER]
Ethical Dimensions in Research – Informed Consent and Female Gender in Nigeria [BOOK CHAPTER]
Olufunke Olufunsho Adegoke
Africa’s Radicalisms and Conservatisms; Brill, 15 January 2021; Chapter 17 pp 321-340
Abstract
Women in any society are germane to its continual existence and development. Their contribution to development cannot be neglected and undermined. However, there is the persistence of gender inequality in many places in Africa (carried over perhaps from traditional African societies). Such inequality marginalizes the societies from the gains of development. The inequality manifests itself in many areas including in research. This chapter postulates that there has to be a re-evaluation of female gender status quo on informed consent in research. There are issues of contention which arises in the context of the local environment, spousal consent and of importance is the level of education with the contextual understanding of the informed consent in any research. It is a system of social stratification and differentiation on the basis of sex, which provides material advantages to men while simultaneously placing severe constraints on the roles and activities of women. Evidence based researches have disclosed that women are not well informed and this over shadows their judgment on appropriate decision making. This observation calls for the need of culturally competent and sensitive approaches that addresses identity specific barriers in research when designing consent forms. There is the need for gender mainstreaming in research implementation and ethical process especially informed consent. The attainment of gender equality is not only seen as an end itself and human right issues, but as a prerequisite for the achievement of sustainable development.
Challenges of Obtaining Informed Consent in Poorly Coordinated and Funded Healthcare Services: Papua New Guinea Situation
Challenges of Obtaining Informed Consent in Poorly Coordinated and Funded Healthcare Services: Papua New Guinea Situation
Alfred P. Minei, Sam O. Kaipu
Journal of Health Science, July-August 2020; 8(4)
Open Access
Abstract
During a semi-structured interview we ask the participants several questions based on the perceived role of the interviewee within the informed consent process. We asked questions pertaining to how informed consent unravels itself across barriers. Few question topics included how the issue of socio-economic, geography and custom of the people are addressed, and how the medical professionals deal with different groups of people and how the interviewees understood informed consent. Interviews for each group were asked with different sets of questions and were open enough to allow for probing questions in order to gain additional information when the opportunity presented itself. The data were analyzed using interpretative approaches and the various themes and concepts from each question and response qualitatively counted and uncovered patterns in the various group perspectives. We examined the participants’ perspectives and opinions using a visual table for comparing themes and concepts, and we presented the interviewees’ views.
Center for Informed Consent Integrity 