Informing MS Patients on Treatment Options: A Consensus on the Process of Consent Taking
Brief Communication
C Tortorella, C Solaro, P Annovazzi, L Boffa, M C Buscarinu, F Buttari, M Calabrese, P Cavalla, E Cocco, C Cordioli, G De Luca, M Di Filippo, R Fantozzi, D Ferraro, A Gajofatto, A Gallo, R Lanzillo, A Laroni, S Lo Fermo, S Malucchi, G T Maniscalco, M Moccia, V Nociti, D Paolicelli, I Pesci, L Prosperini, P Ragonese, V Tomassini, V L A Torri Clerici, M Rodegher, M Gherardi, C Gasperini, RIReMS Group
Neurological sciences, 2 Apr 2020
Abstract
In the last years, change in multiple sclerosis (MS) therapeutic scenario has highlighted the need for an improved doctor-patient communication in advance of treatment initiation in order to allow patient’s empowerment in the decision-making process. AIMS: The aims of our project were to review the strategies used by Italian MS specialists to inform patients about treatment options and to design a multicentre shared document that homogenizes the information about disease-modifying treatment (DMTs) and the procedure of taking informed consent in clinical practice. RESULTS: The new resource, obtained by consensus among 31 neurologists from 27 MS Centres in Italy with the supervision of a medico-legal advisor, received the aegis of Italian Neurological Society (SIN) and constitutes a step toward a standardized decision process around DMTs in MS.
Year: 2020
Mainstream consent programs for genetic counseling in cancer patients: A systematic review
Mainstream consent programs for genetic counseling in cancer patients: A systematic review
Review
Tahlia Scheinberg, Alison Young, Henry Woo, Annabel Goodwin, Kate L. Mahon, Lisa G. Horvath
Asia-Pacific Journal of Clinical Oncology, 29 February 2020; pp 1–15
Open Access
Abstract
As demand for germline genetic testing for cancer patients increases, novel methods of genetic counseling are required. One such method is the mainstream consent pathway, whereby a member of the oncology team (rather than a genetic specialist) is responsible for counseling, consenting, and arranging genetic testing for cancer patients. We systematically reviewed the literature for evidence evaluating mainstream pathways for patients with breast, ovarian, colorectal, and prostate cancer. Medline, EMBASE, and Cochrane Library were searched for studies that met inclusion and exclusion criteria. Article references were checked for additional studies. Trial databases were searched for ongoing studies. Of the 13 papers that met inclusion criteria, 11 individual study groups were identified (two study groups had two publications each). Ten of the 11 studies evaluated the acceptability, feasibility, and impact of BRCA testing for patients and/or clinicians in different clinical settings in breast and ovarian cancer, while the final study explored the attitudes of colorectal specialists toward genetic testing for colorectal cancer. None involved prostate cancer. Overall, mainstream pathways were acceptable and feasible. Medical oncologist and nurse-driven pathways were particularly successful, with both patients and clinicians satisfied with this process. Although the content of pretest counseling was less consistent compared with counseling via the traditional model, patients were largely satisfied with the education they received. Further research is required to evaluate the mainstream pathway for men with prostate cancer.
The Importance of Physician Directed Informed Consent
The Importance of Physician Directed Informed Consent
Neena Oza
Journal of Health Care Finance, 2020
Open Access
Abstract
The process and scope of procedural/surgical informed consent has changed dramatically with emerging technologies, expanding medical knowledge, updated outcomes data and increased recognition of patient autonomy. With the paradigm shifting towards ethical considerations of patient care and active involvement of patient’s in their treatment, medical practices and laws have evolved to guide communication standards between the patient and physician. The delivery of all relevant information should enable the patient to make an informed decision regarding the procedure, while preserving the core principles of patient understanding and free consent, devoid of coercion or manipulation.[1],3 Additionally, education and counseling delivered during the informed consent should relieve the patient’s safety concerns related to procedures and to address patient knowledge deficiencies, present other alternative plans or procedures, as well as any possible perceived coercion related to noninvasive and invasive procedures. The intent of this article will be to further explain the rationale for the performing provider, attending physician or surgeon, to be the sole person ultimately responsible for providing the patient with the goals, risks and benefits of the proposed treatment or intervention; and for the words and actions of any other medical team member (such as medical students or residents) that may assisting during the informed consent process.
Information Disclosure in Informed Consent
Information Disclosure in Informed Consent
Review Article
Lydia Aiseah Ariffin
Malaysian Journal of Medicine and Health Sciences, May 2020
Open Access
Abstract
Informed consent has been recognised as an essential part of clinical practice, giving ethical and legal legitimacy to medical intervention. There is no universal standard on the amount and type of information that a patient is entitled to and needs to be adequately disclosed. This article proposes nine information that will assist the doctor in providing adequate information for a patient to evaluate whether to authorise medical intervention. The recommended information are: (i) diagnosis, prognosis and its uncertainties; (ii) nature of proposed medical intervention; (iii) the expected benefit of proposed medical intervention; (iv) the potential risk of proposed medical intervention; (v) alternative to proposed medical intervention; (vi) progress of proposed medical intervention; (vii) opportunity for a second medical opinion and to seek further details; (viii) costs of proposed and alternative medical intervention; and (ix) the person responsible for implementing medical intervention.
Exploring solutions to the privacy paradox in the context of e‑assessment: informed consent revisited
Exploring solutions to the privacy paradox in the context of e‑assessment: informed consent revisited
Original Paper
Ekaterina Muravyeva, José Janssen, Marcus Specht, Bart Custers
Ethics and Information Technology, 24 April 2020
Open Access
Abstract
Personal data use is increasingly permeating our everyday life. Informed consent for personal data use is a central instrument for ensuring the protection of personal data. However, current informed consent practices often fail to actually inform data subjects about the use of personal data. This article presents the results of a requirements analysis for informed consent from both a legal and usability perspective, considering the application context of educational assessment. The requirements analysis is based on European Union (EU) law and a review of current practices. As the main outcome, the article presents a blueprint which will be the basis for the development of an informed consent template that supports data controllers in establishing an efective and efcient informed consent form. Because the blueprint, and subsequently, the template, distinguishes between legal and usability requirements, it also provides the basis for the mapping of legal requirements in other (non-European) contexts
The myth about consent forms
The myth about consent forms
Advice
Russell Heathcote-Curtis
BDJ In Practice, 6 April 2020
Open Access
Excerpt
…The consent process is not about creating legal protection for the clinical team that will be providing treatment. It is a communication process that reflects the autonomy of the patient who will be receiving that treatment. Any consent form that you have asked the patient to sign, should be regarded as just one small part of the overall record of the communication that has taken place between patient and clinician in advance of treatment being provided. The larger part of the record needs to capture the essence of the information provided to the patient, the issues raised by any of the treatment options and the clinician’s response along with the patient’s final decision about their preferred choice from the options discussed…
Rethinking consent in mHealth: (A) moment to process [BOOK CHAPTER]
Rethinking consent in mHealth: (A) moment to process [BOOK CHAPTER]
Iris Loosman
Aging between Participation and Simulation
Walter de Gruyter GmbH, 6 April 2020; Chapter 10
Abstract
The field of mobile health promises a transformation of the healthcare industry, by providing health-related information and services directly to individuals, through digital mobile devices. This presents society with new platforms for persuasive systems for healthy behavior change. Before such systems’ full potential can be utilized, however, the question of how to consent to their use needs to be addressed. In this paper, I argue that one-off all-encompassing consent moments at the start of use of persuasive mobile health services do not suffice, given the functions they present, and the context in which they are used. Persuasive mobile health services are not only data-intensive, they are also designed to influence the user’s behavior and health. Informed consent should be temporally distributed, in order to improve the quality of the user’s autonomous authorization, that this context requires.
Informed Consent and Ethical Research [BOOK CHAPTER]
Informed Consent and Ethical Research [BOOK CHAPTER]
Margit Sutrop, Kristi Lõuk
Handbook of Research Ethics and Scientific Integrity
Springer, 2 April 2020; pp 213-232
Abstract
Although today valid informed consent is considered key to ethical research, there is no agreement on what constitutes adequate informed consent. Problems ensue firstly from the circumstance that a principle adopted in one area of inquiry (biomedicine) cannot be extended literally to other areas of science. In addition, new areas of scholarly inquiry and changing research contexts contribute to the emergence of new forms of consent (open, broad, dynamic, meta-consent). A second difficulty derives from an overly narrow understanding of the concept of autonomy, resulting in an absolutizing of individual freedom and choices and relegating more collective values such as reciprocity, responsibility, and solidarity to the background.
In this chapter, we explain the origin of the concept of informed consent, what it consists of, and what forms it can take. We will then analyze what has caused shifts in the understanding of the informed consent principle: how much is due to advancements in science and technology and how much to changing ethical frameworks. Finally, we will show why it is important to develop a contextual approach by taking into account differences in research fields as well as types of research.
Informed Consent and Health: A Global Analysis [BOOK]
Informed Consent and Health: A Global Analysis [BOOK]
Edited by Thierry Vansweevelt and Nicola Glover-Thomas
Global Perspectives on Medical Law Series
Edward Elgar, 1 April 2020
Abstract
Informed consent is the legal instrument that purports to protect an individual’s autonomy and defends against medical arbitrariness. This illuminating book investigates our evolving understanding of informed consent from a range of comparative and international perspectives, demonstrating the diversity of its interpretations around the world. Chapters offer a nuanced analysis of the problems that impede the understanding and implementation of the concept of informed consent and explore the contemporary challenges that continue to hinder both the patient and the medical community.
Subsequent Consent and Blameworthiness
Subsequent Consent and Blameworthiness
Jason Chen
HEC Forum, 28 March 2020
Abstract
Informed consent is normally understood as something that a patient gives prior to a medical intervention that can render it morally permissible. Whether or not it must be given prior to the intervention is debated. Some have argued that subsequent consent-that is, consent given after a medical intervention-can also render an otherwise impermissible act permissible. If so, then a patient may give her consent to an intervention that has already been performed and thereby justify a physician’s (paternalistic) act retroactively. The purpose of this paper is to argue that even if subsequent consent can render an otherwise impermissible act permissible, doctors are still blameworthy if they rely on it when prior consent could be given, because they would be banking on the justification of their interventions. Since doctors can only guess if patients will consent after the fact, they would be placing their patients at unreasonable risk of being disrespected as persons.
Center for Informed Consent Integrity 