Digital Nudges for Privacy Awareness: From consent to informed consent?
Research Paper
Kristoffer Bergram, Valéry Bezençon, Paul Maingot, Tony Gjerlufsen, Adrian Holzer
Association for Information Systems, 15 June 2020
Open Access
Abstract
Maintaining a private life in our digital world is gradually becoming harder. With Internet services having ever increasing access to personal data, it is crucial to raise user awareness about what privacy guarantees they offer. Regulations have recently been enacted such as the European General Data Privacy Regulation (GDPR). Yet, online service providers still have terms and privacy policies to which users tend to agree without ever viewing or reading them. By using digital nudges, this paper explores how small changes in the choice architecture can be designed to increase the informed consent and privacy awareness of users. The results from a double-blind online experiment (n = 183) show that phrasing the agreement differently and providing a highlights alternative to the existing quick-join choice architecture can significantly increase the number of users who view and read the terms and privacy policy. However, these digital nudges seem to not increase the users’ recollection of what they have agreed to. The experimental results are complemented by a field test using one of the proposed designs in the IKEA Place app (n = 81’431).

Shared decision making and consent post-Montgomery, UK Supreme Court judgement supporting best practice
Discussion
Joel Ward, Dilraj Kalsi, Anirudh Chandrashekar, Bill Fulford, Regent Lee, Jonathan Herring, Ashok Handa
Patient Education and Counseling, 15 May 2020
Abstract
The UK Supreme Court Montgomery judgement marks a decisive shift in the legal test of duty of care in the context of consent to treatment from the perspective of the clinician (as represented by Bolam rules) to that of the patient. This has important implications in the surgical field worldwide, where informed consent is critical. This paper aims to explain the ruling and how it impacts the consent process.

The case and ruling are outlined and summarised as pertaining to consent and requirements for validity; a shift from the clinician’s interpretation about what would be best for patients to the values of the particular patient concerned in the decision in question. A sample of recent commentaries is reviewed.

Four examples illustrate some of the practical applications of the Montgomery ruling on consent and how the ruling can empower doctors and patients to make mutually beneficial shared decisions. Future consent should be obtained using a Montgomery compliant strategy in accordance with the principles of shared decision making.

Risk disclosure and informed consent: practice caveats in the post‐Montgomery era
Original Article
Danny WH Lee, Paul BS Lai
Surgical Practice, 1 April 2020
Abstract
The UK Supreme Court decision in Montgomery v Lanarkshire Health Board has overturned the use of the “accepted practice test” (Bolam) in deciding breach of duty cases related to risk disclosure and informed consent. Following Montgomery, a doctor is under a legal duty to take reasonable care to ensure his patient is aware of any material risks involved in the recommended treatment, and of any reasonable alternative or variant treatments. Based on Montgomery and a number of relevant published cases, this article highlighted some practice caveats for surgeons to take note of when they participate in the consent process with the following headings: the objective and subjective elements of the legal test of materiality of risks; postoperative risks, follow‐up and management; timing and adequacy of risk disclosure; withholding information and therapeutic exception; and the incorporation of Montgomery into local professional code and case law. In order to minimize legal risks, surgeons are also encouraged to keep abreast of the medico‐legal development in this area, to reflect on their own practices, and to take proactive steps to enhance their interactions with patients.

Implementation of Common Rule Changes to the Informed Consent Form: A Research Staff and Institutional Review Board Collaboration
Grace Gartel, Heather Scuderi, Christine Servay
Ochsner Journal, March 2020; 20(1) pp 76–80
Open Access
Abstract
Background
The Common Rule, which governs federally funded clinical research involving human subjects, formally defines the requirements for institutional review board (IRB) membership, functions and operations, and review of research, as well as the requirements for obtaining informed consent from research participants. The revisions to the Common Rule effective in January 2019 changed some content requirements for informed consent forms.
Methods
This article summarizes the history of informed consent requirements, the changes made to the requirements by the revision to the Common Rule, and the ways in which IRBs and research staff work together to develop informed consent forms that comply with the regulations and provide all the information potential research subjects need to decide whether to participate in a study.
Results
Clinical research coordinators, under their investigators’ supervision, are responsible for ensuring that research consent forms comply with the requirements of the federal regulations and the institution. Many IRBs have provided education regarding these new requirements, as well as consent templates that contain all the required elements. To ensure that the Common Rule’s requirements are met, the IRB reviews each study submission, including the consent form. The IRB panel makes revisions to the consent forms as needed and returns the approved consent form to the investigator and clinical research coordinator.
Conclusion
Research coordinators play an essential role in developing consent forms and providing the required review information to the IRB. In turn, through optimizing and standardizing consent forms and ensuring that all requirements of the Common Rule are followed, IRBs ensure that the rights of participants are protected and upheld.

Editor’s note: The Ochsner Journal is a peer-reviewed quarterly medical journal.

Revised Common Rule Changes to the Consent Process and Consent Form
Leah L LeCompte, Sylvia J Young
Ochsner Journal, March 2020; 20(1) pp 62-75
Open Access
Abstract
Background
The Federal Policy for the Protection of Human Subjects—the Common Rule—was revised in 2017 to reduce administrative burdens for low-risk research while enhancing protections for human subjects enrolled in greater-than-minimal-risk trials. These enhanced protections involve changes to the consent process.
Methods
We review the general requirements applicable to the consent process, as well as the additional elements of consent mandated by the revisions to the Common Rule. The regulations apply to federally funded studies and are optional for non–federally funded studies.
Results
Two new general requirements for the consent process, one basic required element for the consent form, and three optional additional elements for the consent form were added in an effort to improve potential subjects’ understanding of research studies and to facilitate the exchange of information between the research staff and potential subjects. Important information about the study should be extracted into a concise key information section to help potential subjects make informed decisions regarding participation.
Conclusion
The revisions to the Common Rule are intended to enhance human subject protection by providing more information in an understandable form during the consent process. The new consent elements aim to increase transparency and help improve clarity.

Understanding Broad Consent
John W Maloy, Pat F Bass III
Ochsner Journal, March 2020; 20(1) pp 81–86
Open Access
Abstract
Background
The 2018 revisions to the Common Rule that were effective in January 2019 introduced a new category of informed consent: broad consent.
Methods
Investigators and institutional review board (IRB) members need to understand (1) what broad consent is, (2) the role of broad consent under the revised Common Rule, (3) how and when broad consent can be used, (4) exempt research categories that relate to broad consent, and (5) the scope of limited IRB review as it relates to broad consent.
Results
Under the prior regulations, researchers had two consent options: obtain study-specific informed consent or request the IRB to waive the requirement to obtain informed consent. The revision to the Common Rule introduced the third option of broad consent, but its applicability is limited. Broad consent can only be used to obtain an individual’s consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. The regulatory authority for broad consent is at 45 CFR §46.116(d). None of the required elements of broad consent can be omitted or altered because each element is considered essential. Broad consent shares many of the requirements for study-specific informed consent, but several elements are unique: a description of the types of secondary research that may be conducted; statements describing the private information or biospecimens that might be used in research, whether sharing of the information or biospecimens might occur, and the types of institutions or researchers that might conduct research with the information or biospecimens; information on how long the information or biospecimens may be stored, maintained, and used; a statement that subjects will or will not be informed of the details of any subsequent research; a statement that research results will or will not be disclosed to subjects; and contact information for obtaining answers to questions about the subjects’ rights regarding storage and use of information or biospecimens and whom to contact regarding research-related harm.
Conclusion
Broad consent provides flexibility that did not exist prior to the revision, giving researchers the option to obtain broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. With an understanding of the regulations, an investigator can plan how best to organize his or her research plan and decide whether to obtain study-specific informed consent, to apply for a waiver of consent, or to obtain broad consent.

EU Coordination of Serious Cross-Border Threats to Health: The Implications for Protection of Informed Consent in National Pandemic Policies
Hannah Van Kolfschooten
European Journal of Risk Regulation, October 2019; 10(4) pp 635-651
Open Access
Abstract
This article discusses the development of a more supranational EU approach to regulate risks of “serious cross-border threats to health” such as pandemic disease outbreaks. It argues that the EU’s public health measures to prevent and tackle pandemics could affect individual patients’ rights, because the rights of individual European citizens are balanced against the importance of protecting the European community as a whole. This results in a tension between public health and individual rights in the EU, especially with regard to the right to informed consent, a central right in health law. In response to the 2013–2016 Ebola outbreak in West Africa, the EU introduced several preventive and responsive measures in the Member States to prevent the pandemic from spreading to the EU. The case study analysis of Dutch pandemic policies established in reaction to this outbreak shows that national pandemic policies are substantially shaped by EU actions, which has implications for the protection of the individual right to informed consent in the Member States.

The effect of the Montgomery judgment on settled claims against the National Health Service due to failure to inform before giving consent to treatment
D S Wald, J P Bestwick, P Kelly
QJM, 19 March 2020
Abstract
Background
A landmark legal judgment in March 2015 (Montgomery) changed the test for determining negligence due to failing to inform patients before consent, by moving away from asking what a reasonable doctor should disclose and asking instead what a reasonable patient would expect to know.
Aim
We sought to determine the effect Montgomery has had on settled claims due to failure to inform compared with claims for other reasons and whether legal firms are adding contributory claims of failure to inform to other principal allegations of negligence.
Methods
A Freedom of Information request to NHS Resolution provided data on the number of settled claims against the NHS (2005–19) for any cause and where failure to inform before consent was the principal or contributory cause. Time-series regression was used to compare trends before and after 31 March 2015.
Results
The trend in claims/year increased 4-fold for failure to inform (an increase of 9.8/year before 2015 vs. 39.5/year after 2015, P < 0.01), 2.7-fold when failure to inform was the principal cause (7.9/year vs. 21.2/year, P = 0.02) and 9.9-fold as a contributory cause (1.9/year vs. 18.3/year, P < 0.01). There was no material difference in claims due to other causes (334/year vs. 318/year, P = 0.84).
Conclusions
Montgomery has led to a substantial increase in settled claims of failure to inform before consent, with no coincident change in claims for other causes. The increase in contributory compared with principal causes suggests that lawyers are using the judgment to increase the chances of a successful claim against the NHS.

Editor’s note: QJM is a general medical journal affiliated with the Association of Physicians of Great Britain & Ireland. It focuses on internal medicine and publishes peer-reviewed articles which promote medical science and practice.

Rules on informed consent and advance directives at the end of-life: the new Italian law
Commentary
R V Viola, N Di Fazio, Z Del Fante, V Fazio, G Volonnino, S Romano, A Quattrocchi, M Arcangeli
La Clinica terapeutica, March-April 2020; 171(2) e94-96
Open Access
Abstract
End-of-life decisions are an emergent issue for bioethical debates and practical concerns among health professionals. On December 2017, Italy enacted a new law named “Rules about informed consent and advance directives”, which promotes the relationship of care in a fiduciary sense through the implementation of a correct and exhaustive information. It is also prescribed to record in writing all the patients’ decisions about consent or refusal. Furthermore, the law explicitly forbids unreasonable therapeutic obstinacy for terminal patient, legitimizing deep palliative sedation. Finally, the law establishes the use of “advance directives” as a written document by which adults and capable people can express their wishes regarding health treatments and diagnostic tests in anticipation of a possible future incapacity. The law provides that doctors must comply with these directives, unless they appear clearly incongruous or not corresponding to the patient’s current clinical condition.

Editor’s note: We take note of the phrase “unreasonable therapeutic obstinacy” in the abstract.

[An ethical evaluation of presumed consent for organ donation in Switzerland]
Clavien C.
Revue médicale Suisse, 19 February 2020; 16(682) pp 370-373
Abstract
Following a current trend in European countries, Switzerland is about to decide to adopt (or reject) a presumed consent legislation for organ donation. In such a system, every citizen is considered as a potential organ donor except in case of expressed refusal during lifetime. The presumed consent system raises ethical and practical issues that need to be carefully understood and weighed before deciding on its fate. This article reviews the most pressing ethical issues and provides the empirical data necessary for assessing the presumed consent legislation in Switzerland. At the end of the analysis, the reader will be able to form her own informed opinion on the issue.

Editor’s note: This is a French language publication.