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.
Informed Consent: A Monthly Review
___________________________
April 2020
This digest aggregates and distills key content around 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_April 2020
Parental consent undermines the right to health of adolescents
Parental consent undermines the right to health of adolescents
Update
UNAIDS, 16 March 2020
Open Access
Many countries have laws or policies that prevent adolescents from accessing essential health services without the consent of a parent or guardian. The original intention may have been to protect minors, but these stipulations often have the opposite effect and increase the risk of HIV and other health problems among adolescents.
A large proportion of countries across all regions restrict access to HIV testing and treatment for adolescents. In 2019, for instance, adolescents younger than 18 years needed explicit parental consent in 105 of 142 countries in order to take an HIV test. In 86 of 138 reporting countries, they needed such consent to access HIV treatment and care. These kinds of laws and policies also may complicate or hinder adolescent access to pre-exposure prophylaxis (PrEP), a highly effective prevention tool.
Research in sub-Saharan Africa shows that in countries where the age of consent is 15 years or lower, adolescents are 74% more likely to have been tested for HIV in the past 12 months compared with countries where the age of consent is 16 years or higher—with girls especially benefiting from the easier access.
Country-level details on which countries have consent laws can be viewed on the UNAIDS Laws and Policies Analytics web page.
NIH-funded effort may help people with intellectual disability participate in clinical studies
NIH-funded effort may help people with intellectual disability participate in clinical studies
Media Advisory
National Institues of Health, 24 February 2020
Open Access
What
The NIH Toolbox Cognitive Battery — an assessment of cognitive functioning for adults and children participating in neuroscience research —can be adapted to people with intellectual disabilities by modifying some test components and making accommodations for the test-takers’ disabilities, according to researchers funded by the National Institutes of Health. The adaptations ensure that the battery can be used to assess the cognitive ability of people with intellectual disabilities who have a mental age of 5 years and above, providing objective measures that could be used in a wide variety of studies.
The research team, led by David Hessl, Ph.D., of the University of California Davis Medical Center, published their findings in Neurology. The work was funded by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and National Center for Advancing Translational Sciences, as well as the Administration for Community Living.
The battery is administered on a computer tablet and measures memory, vocabulary, reading and executive functioning, which includes skills such as the ability to shift from one thought to another, pay attention and control impulses. The researchers adapted the battery by reducing the complexity of the instructions and including developmentally appropriate starting points. They also developed a structured manual to guide test administrators.
The researchers validated the battery and its modifications by assessing 242 people ages 6 through 25 with fragile X syndrome, Down syndrome or other disabilities. They found that the battery produced reliable and valid results for those with a mental age of 5 years and above. The authors called for additional research to adapt the battery to people with lower mental ages and to older adults with intellectual disability who may be experiencing cognitive decline or dementia.
Ethical standards for research during public health emergencies: Distilling existing guidance to support COVID-19 R&D
Ethical standards for research during public health emergencies: Distilling existing guidance to support COVID-19 R&D
WHO, 2020
Open Access
Excerpt
…What are the requirements for informed consent in emergencies?
Individual informed consent is a fundamental ethical requirement for research. Prospective research participants must be able to weigh the risks and benefits of participation. This can be particularly challenging in a public health emergency because of uncertain risks and the perception that any research-related intervention must be ‘better than nothing’. Consequently, researchers and review bodies have an obligation to ensure that research activities do not proceed unless there is a reasonable scientific basis to believe that the study intervention is likely to be safe and efficacious and that risks to participants have been minimized to the extent reasonably possible.
Cultural and linguistic differences, as well as confusions about the dual role of the clinician/researcher, may be heightened for research conducted in this context, and so processes for obtaining informed consent, including the wording of documents and methods of obtaining and recording consent, should be developed in consultation with local communities. Finally, researchers should inform potential participants about the circumstances under which their data or samples might be shared…
Center for Informed Consent Integrity 