Consent is an organizational behavior issue
Vanessa K.Bohns, RachelSchlund
Research in Organizational Behavior, 18 August 2021
Abstract
Consent is central to many organizational interactions and obligations. Employees consent to various terms of employment, both formal (contractual obligations) and informal (extra-role responsibilities, interpersonal requests). Yet consent has traditionally been considered a legal matter, unrelated to organizational behavior. In this article, we make a case for why, and how, organizational behavior scholars should undertake the study of consent. We first review scholarship on the legal understanding of consent. We argue that the traditional legal understanding is an incomplete way to think about consent in organizations, and we call for a more nuanced understanding that incorporates psychological and philosophical insights about consent—particularly consent in employer-employee relationships. We then connect this understanding of consent to traditional organizational behavior topics (autonomy, fairness, and trust) and examine these connections within three organizational domains (employee surveillance, excessive work demands, and sexual harassment). We conclude with future directions for research on consent in organizations.
ICME: an informed consent management engine for conformance in smart building environments [CONFERENCE PAPER]
ICME: an informed consent management engine for conformance in smart building environments [CONFERENCE PAPER]
Chehara Pathmabandu, John Grundy, Mohan Baruwal Chhetri, Zubair Baig
ESEC/FSE 2021: Proceedings of the 29th ACM Joint Meeting on European Software Engineering Conference and Symposium on the Foundations of Software Engineering, August 2021; pp 1545–1549
Open Access
Abstract
Smart buildings can reveal highly sensitive insights about their inhabitants and expose them to new privacy threats and vulnerabilities. Yet, convenience overrides privacy concerns and most people remain ignorant about this issue. We propose a novel Informed Consent Management Engine (ICME) that aims to: (a) increase users’ awareness about privacy issues and data collection practices in their smart building environments, (b) provide fine-grained visibility into privacy conformance and infringement by these devices, (c) recommend and visualise corrective user actions through “digital nudging”, and (d) support the monitoring and management of personal data disclosure in a shared space. We present a reference architecture for ICME that can be used by software engineers to implement diverse end-user consent management solutions for smart buildings. We also provide a proof-of-concept prototype to demonstrate how the ICME approach works in a shared smart workplace. Demo: <a>https://youtu.be/5y6CdyWAdgY</a>
Communication and Libertarianism [BOOK]
Communication and Libertarianism [BOOK]
Pavel Slutskiy
Springer, 3 August 2021
Editor’s note: In Communication and libertarianism, which covers a range of themes, the four chapters below were relevant to consent.
Communicating Consent
Abstract
The libertarian non-aggression principle rests on two concepts: the concept of property rights, which defines the borders of individual autonomy, and the concept of consent, which defines unwarranted intrusion. Both concepts depend on communication—borders of property need to be publicly manifested on the one hand, and consent needs to be expressed in order to exist in the reality of human action on the other. Unless consent is manifested, it remains hypothetical, and hypothetical consent is never valid. Even if an action based on hypothetical consent coincides with the preferences of the consent-giver, it happens to be so only by coincidence. Counting on such hypothetical consent is risky, and the actor who takes the risk bears full responsibility for potential mistakes which may lead to uninvited interference. Hypothetical consent needs to be separated from tacit and implied consent, both of which can be valid. Internal “mental” aspects of consent may be important felicity conditions for consent, but they are not enough for a successful performance of the act of consenting. It is “external” or expressive aspects of consenting which are crucial for making the preferences of the consent-giver identifiable to another agent, thus changing the status of his actions. Only communicated consent is capable of performing the “magic” of making actions permissible, and only communicated consent can be used by actors to defend against potential accusations in rights violation.
Communication Ethics: Consent as the Foundation of Non-aggression
Abstract
One of the major challenges for political philosophy is the postulated impossibility of building a sound theory without a solid foundation in ethics. Ethical questions of what is good and what is bad arise within the context of social interactions—in relation to actions unto other people. But judgements on what is good and what is bad are necessarily subjective. This, however, does not mean that this subjective judgement is not true. Man’s opinion about what is a bad action unto him is a correct evaluation of the action in question. For an acting agent, the opinion of the action’s recipient is thus the source of the correct ethical assessment of the action. This assessment can only become known to the acting agent by the means of communication. Communicating a subjective value judgement on what is good and what is bad gives the other agent knowledge about the ethical value of the intended action. Acting unto another man against his consent thus implies wrongdoing.
Manipulation of Consent
Abstract
This chapter examines several criticisms of non-fraudulent commercial speech. According to critics, even if business propaganda does not constitute fraud by intentionally misleading consumers, it still may be illegitimate for other reasons. Advertising is accused of coercion through manipulative persuasion, exaggeration and puffery. Other charges include accusations of promoting products and services that are harmful for consumers who therefore later regret purchasing them, and this regret invalidates the consent given at the moment of making the purchase. These accusations are examined from the property rights perspective as well from the communication perspective.
The Role of Property Rights in the Ethics of Consent
Abstract
Consent is what allows us to tell others whether their actions unto us are acceptable from our point of view. Proceeding with an action without our consent, or after consent has been refused, would constitute a moral wrongdoing. However, consent is only required for giving moral evaluation to actions that are directed towards other actors and affect them. An action can be considered as intended towards another person if it interferes with this person’s “zones of control”—borders of physical objects with which one creates a particular relationship. This relationship is ownership—it assumes that any hindrance to the use of the object without the consent of the owner is a wrongdoing. Ownership comes from the direct control of bodies, and original appropriation of external objects and voluntary transfers forms the foundation of property rights—violation against property is a violation against the owner. A legal system based on the idea that property rights violations constitute an offence recognises the validity of the non-aggression principle. The non-aggression principle prohibits the initiation of force, which is understood as an action of border crossing without the owner’s consent. The concept of consent and the concept of borders are ontologically based on communication, which means that communication is the basis of the non-aggression principle.
Informed Consent: A Monthly Review
___________________________
August 2021
This digest aggregates and distills key content addressing 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_August 2021
Editor’s Note:
Informed Consent in the Council for International Organizations of Medical Sciences (CIOMS) guidance on Clinical research in resource-limited settings, held on July 21st 2021, was the latest webinar in the Center’s continuing series. David Curry opened the call with a high-level overview of the guidance. Paige Fitzsimmons followed with a brief summary of how informed consent is treated in the guidance. Getnet Yimer then provided observations and reflections on this guidance and associated challenges with implementation from a field research and ethics review board perspective. Dónal O’Mathúna closed the discussion by examining how community engagement is treated in the new guidance.
COVID-19 Vaccination of Minors Without Parental Consent; Respecting Emerging Autonomy and Advancing Public Health
COVID-19 Vaccination of Minors Without Parental Consent; Respecting Emerging Autonomy and Advancing Public Health
Viewpoint
Larissa Morgan, Jason L. Schwartz, Dominic A. Sisti
JAMA Pediatrics, 12 July 2021
Excerpt
In May 2021, the Pfizer-BioNTech COVID-19 vaccine received emergency use authorization from the US Food and Drug Administration in adolescents aged 12 to 15 years, with authorization for younger children expected later this year.1 Despite reported clinical trial data indicating that the vaccine is safe and 100% efficacious for this age range, some parents and guardians may remain hesitant or outright opposed to vaccinating their children, particularly in politically and culturally conservative communities… Children and adolescents have the capacity to understand and reason about low-risk and high-benefit health care interventions. State laws should therefore authorize minors to consent to COVID-19 vaccination without parental permission…
Implications and advice on getting COVID-19 vaccine consent: How to support people with learning disabilities to get vaccinated
Implications and advice on getting COVID-19 vaccine consent: How to support people with learning disabilities to get vaccinated
Jonathan Beebee
Learning Disability Practice, 2021; 10-12
Abstract
Vaccinations against COVID-19 are not mandatory and where people can give or refuse consent we have a responsibility to ensure consent is sought. Many people with learning disabilities will be unable to consent, but others will be able to consent if given the right support. Nurses, carers and families should begin planning as soon as possible, so they are prepared when the invitation to receive the vaccine arrives.
Implementation of documented and written informed consent for clinical trials of communicable diseases: Lessons learned, barriers, solutions, future directions identified during the conduct of a COVID-19 clinical trial
Implementation of documented and written informed consent for clinical trials of communicable diseases: Lessons learned, barriers, solutions, future directions identified during the conduct of a COVID-19 clinical trial
Patricia Woods, Maura Flynn, Paul Monach, Karen Visnaw, Sara Schiller, Erika Holmberg, Sarah Leatherman, Ryan Ferguson, Westyn Branch-Elliman
Contemporary Clinical Trials Communications, September 2021, 23
Abstract
Background and objective
The communicable nature of many infectious diseases, including SARS-CoV-2, creates challenges for implementing and obtaining regulatory-compliant written informed consent. The goal of this project was to identify and evaluate processes that address these barriers while maintaining clinical and research staff safety.
Methods
We reviewed Federal Drug Administration (FDA), World Health Organization (WHO), and VA Office of Research and Development (ORD) guidance about informed consent during the COVID-19 pandemic, and identified and pilot-tested several mechanisms for obtaining regulatory-compliant consent during our COVID-19 therapeutics clinical trial.
Results
Several processes were identified. These included a standard face-to-face consent with a plan for maintaining a paper copy of the signed consent form, a phone or video chat consent process that included taking a picture of the signed consent form or a screen shot of the signed document during a video chat, integration of the consent forms into software embedded within the electronic health record, and secure software programs with electronic signature. These processes are FDA-compliant but time-intensive, often requiring four or more hours of coordination between the clinical team, research staff, patients, and legally authorized representatives.
Conclusions
Future studies could evaluate how to improve efficiency, and whether some elements of the consenting process, such as the requirement for documented written signed consent, rather than a witnessed oral consent, is an acceptable standard for research participants with communicable diseases.
Ethical and legal requirements for biomedical research involving health data in the context of the Covid-19 pandemic: is informed consent still playing the leading role?
Ethical and legal requirements for biomedical research involving health data in the context of the Covid-19 pandemic: is informed consent still playing the leading role?
Federico de Montalvo Jääskeläinen
BioLaw Journal, February 2021
Open Access
Abstract
The current pandemic could have accelerated a change of the traditional paradigm about the secondary use of health data. The traditional one has been based on the faculty of the individuals about accepting or not that use of their health data through the main role of informed consent. The new paradigm considers the current value of that secondary use for the improvement of the health of community and its individuals, through the possibilities offered by Big Data and AI. Therefore, the need of a balance between individual rights and the common good is indispensable. Pseudonymization could be the way to find this balance.
Editor’s note: This article notes that pseudonymization is understood as the processing of personal data in such a way that they can no longer be attributed to an interested party without using additional information.
The Impact of a Digital Vaccine Consent Form in a Large Community Pharmacy Chain
The Impact of a Digital Vaccine Consent Form in a Large Community Pharmacy Chain
Aylin Unal, Amy Sparkman, Pramit Nadpara, Jean-Venable R. Goode
Innovations in Pharmacy, 26 July 2021; 12(3)
Abstract
Background
A large community pharmacy chain implemented a new digital platform to eliminate the need for patients to fill out a traditional vaccine consent form in the pharmacy. The new digital vaccine consent form allowed patients to complete the form online, where it was transmitted directly to the pharmacy’s network.
Objectives
To identify the characteristics of patients who used an online digital vaccine consent form to receive vaccinations and to evaluate patient satisfaction and confidence in utilizing the digital vaccine consent form to receive pharmacy services.
Methods
This three-month prospective study was conducted in the Mid-Atlantic division of a large community pharmacy chain. A 16-question survey was developed using information from the literature to collect demographic information and patient confidence and satisfaction with the digital vaccine consent form. An email was sent to pharmacy staff containing instructions on the procedure for posting a recruitment flyer, distributing the survey post-vaccination, and how to return completed surveys. Univariate and bi-variate analysis were conducted.
Results
Thirty-six participants responded to the survey, majority of participants were female (56%). Two patients used the digital vaccine consent form; both used because it was more convenient and were likely to use the form again. For those who did not use the digital vaccine consent form, 32% feel somewhat unconfident in using digital technologies for pharmacy services. A majority of patients prefer to be notified about new online services by email (39%) or advertisements in the pharmacy (31%). When asked the likelihood of using the digital vaccine consent form in the future, majority stated unlikely (34%) or neutral (25%).
Conclusions
Most participants did not utilize the new digital vaccine form. This provides an opportunity to further engage patients on the availability and use of the digital vaccine consent form in order to advance digital technologies for pharmacy services.
The CORBEL matrix on informed consent in clinical studies: a multidisciplinary approach of Research Infrastructures Building Enduring Life-science Services
The CORBEL matrix on informed consent in clinical studies: a multidisciplinary approach of Research Infrastructures Building Enduring Life-science Services
Research Article
Cinzia Colombo, Michaela Th. Mayrhofer, Christine Kubiak, Serena Battaglia, Mihaela Matei, Marialuisa Lavitrano, Sara Casati, Victoria Chico, Irene Schluender, Tamara Carapina, Paola Mosconi
BMC Medical Ethics, 17 July 2021; 22(95)
Open Access
Abstract
Background
Informed consent forms for clinical research are several and variable at international, national and local levels. According to the literature, they are often unclear and poorly understood by participants. Within the H2020 project CORBEL—Coordinated Research Infrastructures Building Enduring Life-science Services—clinical researchers, researchers in ethical, social, and legal issues, experts in planning and management of clinical studies, clinicians, researchers in citizen involvement and public engagement worked together to provide a minimum set of requirements for informed consent in clinical studies.
Methods
The template was based on a literature review including systematic reviews and guidelines searched on PubMed, Embase, Cochrane Library, NICE, SIGN, GIN, and Clearinghouse databases, and on comparison of templates gathered through an extensive search on the websites of research institutes, national and international agencies, and international initiatives. We discussed the draft versions step-by-step and then we referred to it as the “matrix” to underline its modular character and indicate that it allows adaptation to the context in which it will be used. The matrix was revised by representatives of two international patient groups.
Results
The matrix covers the process of ensuring that the appropriate information, context and setting are provided so that the participant can give truly informed consent. It addresses the key topics and proposes wording on how to clarify the meaning of placebo and of non-inferiority studies, the importance of individual participants’ data sharing, and the impossibility of knowing in advance how the data might be used in future studies. Finally, it presents general suggestions on wording, format, and length of the information sheet.
Conclusions
The matrix underlines the importance of improving the process of communication, its proper conditions (space, time, setting), and addresses the participants’ lack of knowledge on how clinical research is conducted. It can be easily applied to a specific setting and could be a useful tool to identify the appropriate informed consent format for any study. The matrix is mainly intended to support multicentre interventional randomized clinical studies, but several suggestions also apply to non-interventional research.