Informed Consent: A Monthly Review
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July 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_May 2021

Editor’s Note:
The latest webinar in the Center’s continuing series, Closing the loop on consent: from initial decision, continued participation, through to sharing of results, was held on June 16th 2021. Dr. Katie Gillies of the University of Aberdeen spoke about her work to strengthen the informed consent by developing an understanding of what information matters most to trial participants. She then spoke about how this understanding can lead to increased participant retention and further work to be done.

Lessons Learned for Identifying and Annotating Permissions in Clinical Consent Forms

Lessons Learned for Identifying and Annotating Permissions in Clinical Consent Forms
Elizabeth E. Umberfield, Yun Jiang, Susan H. Fenton, Cooper Stansbury, Kathleen Ford, Kaycee Crist, Sharon L. R. Kardia, Andrea K. Thomer, Marcelline R. Harris
Applied Clinical Information, 23 June 2021; 12(3) pp 429-435
Abstract
Background
The lack of machine-interpretable representations of consent permissions precludes development of tools that act upon permissions across information ecosystems, at scale.
Objectives
To report the process, results, and lessons learned while annotating permissions in clinical consent forms.
Methods
We conducted a retrospective analysis of clinical consent forms. We developed an annotation scheme following the MAMA (Model-Annotate-Model-Annotate) cycle and evaluated interannotator agreement (IAA) using observed agreement (A o), weighted kappa (κw ), and Krippendorff’s α.
Results
The final dataset included 6,399 sentences from 134 clinical consent forms. Complete agreement was achieved for 5,871 sentences, including 211 positively identified and 5,660 negatively identified as permission-sentences across all three annotators (A o = 0.944, Krippendorff’s α = 0.599). These values reflect moderate to substantial IAA. Although permission-sentences contain a set of common words and structure, disagreements between annotators are largely explained by lexical variability and ambiguity in sentence meaning.
Conclusion
Our findings point to the complexity of identifying permission-sentences within the clinical consent forms. We present our results in light of lessons learned, which may serve as a launching point for developing tools for automated permission extraction.

“No Consent, No Access” The Indigenous-Environmentalist Middle Ground in Protests against the Arctic Railway in Sápmi [DISSERTATION]

“No Consent, No Access” The Indigenous-Environmentalist Middle Ground in Protests against the Arctic Railway in Sápmi [DISSERTATION]
Eeva-Maija Kakko
University of Helsinki, Masters Thesis, 2021
Abstract
     The Arctic is home to many Indigenous peoples, including the Sámi. It is also an economically attractive area for governments and companies. Arctic Railway has been planned by the Finnish government and private parties to span over Sápmi, the Sámi homeland. Sámi youth association Suoma Sámi Nuorat, Sámi art collective Suohpanterror, and environmental NGO Greenpeace Finland have collaborated to fight against the railway and organized demonstrations and other campaigning.
The goals of this thesis are to find out what kind of themes have been present in these Sámi organizations and Greenpeace’s protests and communication related to the Arctic Railway. Shared priorities and differences in their priorities are also determined. Moreover, this thesis explores how the Sámi are portrayed in the protests against the Arctic Railway. The data of this thesis is derived from public media sources, including news articles, social media content, and press releases. Case study is used as a research approach, and qualitative content analysis is used as a method. A middle ground concept functions as an analytical tool. It refers to a creative process where groups from different cultures find ways to work together. Indigenous peoples and environmentalists have often built strategic alliances, although also having differences in their priorities. In the middle ground, Indigenous peoples are recognized as active, creative agents, but also the use of stereotypes of Indigenous peoples have been present in these kinds of alliances.
The results of this thesis show that the Sámi organizations have discussed the railway´s impacts on the Sámi livelihoods, lands, and culture, affecting their future as a people. They have also brought up that the railway has been planned without their consent, and the project has violated both Finnish law and international Indigenous rights. Greenpeace has focused on protecting the northern forests while raising awareness of Sámi issues and appearing as a supporter of Sámi people. They have had their unique middle ground where both priority differences and convergences have been present.  In the protests against the Arctic Railway, the Sámi are portrayed as active agents. They have taken action in different ways: through demonstrations, participation in international events, art, and social media activism. This research can raise awareness about the potential of Indigenous-environmental alliances in promoting Indigenous rights and environmental protection and help build better alliances in the future. Further research could look at how these kinds of alliances have been negotiated.

Informed Consent: A Monthly Review
___________________________

June 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_June 2021

Informed Consent—We Can and Should Do Better

Informed Consent—We Can and Should Do Better
Invited Commentary – Ethics
Stefan C. Grant
JAMA Network Open, 28 April 2021; 4(4)
Open Access
Excerpt
…Informed consent generally is understood to represent a process, with the informed consent document having a central role. The characteristics of a well-designed consent form are well known: the document must contain information, some statutorily defined, necessary to allow a participant to make an informed decision; be written at a reading level appropriate for its audience; and be of a length that enables complete and thorough reading. Yet, the content and structure of this document has been the subject of discussion for at least 3 decades, with a consistent consensus throughout this time that these documents are too difficult to read, too complex, and too long and, as a result, frequently fail to facilitate truly informed consent by study participants. While much of the blame for the failure to provide sufficiently detailed, readable, and brief consent forms has been laid at the feet of sponsors and investigators, the reality is that, while it is possible to incorporate 2 of these 3 elements into a consent form, it is all but impossible to incorporate all 3, ie, concise, sufficiently detailed yet easily readable, for anything but the simplest of clinical trials…

Consent Notices and the Willingness-to-Sell Observational Data: Evidence from User Reactions in the Field [CONFERENCE PAPER]

Consent Notices and the Willingness-to-Sell Observational Data: Evidence from User Reactions in the Field [CONFERENCE PAPER]
Stefan Mager, Johann Kranz
European Conference on Information Systems, 2021; Marrakech
Abstract
Privacy regulations like the EU’s General Data Protection Regulation (GDPR) require e-commerce shops to request opt-in consent for usage data collection from EU website visitors. Despite the regulation’s intentional strengthening of consumer rights, consent notices are often regarded as burdensome by consumers and shops alike. Thus, ever more consumers turn to consent-automating browser extension tools, which decreases opt-in rates for e-commerce shops. To investigate potential for a win-win solution, we examined in cooperation with a fashion retailer in Germany how consumers react when they are presented a coupon for the website’s shop in the moment of cookie consent decision. Using the Becker-DeGroot-Marschak mechanism, we elicited consumers’ willingnesses-to-sell (WTS) for cookie consent. Our unique field dataset of 1274 participants allows us to derive the WTS of consumers for any desired consent rate. For instance, 65.05 % of consumers are ready to trade their consent to cookies for a 10€-coupon value.

Artificial Intelligence, Personal Decisions, Consent, and the Confucian Idea of Oneness [BOOK CHAPTER]

Artificial Intelligence, Personal Decisions, Consent, and the Confucian Idea of Oneness [BOOK CHAPTER]
Pak-Hang Wong
Harmonious Technology, [Routledge 2021]
Abstract
The pervasiveness of artificial intelligence (AI) systems has brought forth a new background condition labeled by the author as “the interconnectedness condition”, where every individual is tightly and seamlessly interconnected. In this chapter, the author shows that personal decision-making and consent have acquired new moral significance due to the changing moral character of these acts in the interconnectedness condition. In particular, he argues that personal decision-making and consent are transformed from self-regarding acts to other-regarding acts, and that the transformation introduces a new moral responsibility for individuals qua users AI systems to account for others’ values and interests in making personal decisions and giving consent. However, the author also admits that the new responsibility can be difficult for Western ethics and political philosophy to understand and accept. Accordingly, he turns to the Confucian idea of oneness to make sense of the new responsibility in the interconnectedness condition.

Informed Consent: A Monthly Review
___________________________

May 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_May 2021

Editor’s Note:
Posting of Informed Consent Content on Clinical Trials Registries was the latest webinar in the Center’s continuing series held on April 21st 2021. Foundation president David Curry opened the call with a short presentation followed by a panel discussion with Barbara Redman, Director of the Center for Informed Consent Integrity, and Jan Jaeger, Fellow of the GE2P2 Global Foundation. The discussion was focused on issues and opportunities around the posting of informed consent content [ICFs+] on clinical trial registries as a means to enhance transparency and strengthen consent in trials overall.

 

To consent, or not to consent? The publicness effect on citizens’ willingness to grant access to personal data in the face of a health crisis

To consent, or not to consent? The publicness effect on citizens’ willingness to grant access to personal data in the face of a health crisis
Nicola Belle, Paola Cantarelli, R. Paul Battaglio
Journal of European Public Policy, 16 April 2021
Abstract
This study contributes to the nascent behavioral governance scholarship by experimentally testing whether individuals’ likelihood of lifting their privacy rights in the face of a health crisis varies based on the public versus private nature of the entity accessing their personal data and the length of time during which records can be used. We run an online, randomized control trial with 1,500 citizens representative of the Italian general adult population. Results show a significant increase in subjects’ willingness to grant access to personal records when the entity analyzing data is public rather than private. Further, the propensity to consenting is higher when access to personal data is granted for a limited rather than an unlimited period of time. We discuss how these patterns of results change remarkably across geographic areas within the country.

Medical images, social media and consent

Medical images, social media and consent
Comment
Jonathan P. Segal, Richard Hansen
Nature Reviews Gastroenterology & Hepatology, 23 April 2021
Excerpt
The popularity of social media amongst medical professionals has led to widespread use for both networking and education. Limited professional guidance exists on the sharing of medical imagery on these platforms. This Comment explores consent and offers reflective advice on the use of medical images on social media…