Contested Organ Harvesting from the Newly Deceased: First Person Assent, Presumed Consent, and Familial Authority
Mark J Cherry
The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine, 16 September 2019; 44(5) pp 603–620
Abstract
Organ procurement policy from the recently deceased recasts families into gatekeepers of a scarce medical resource. To the frustration of organ procurement teams, families do not always authorize organ donation. As a result, efforts to increase the number of organs available for transplantation often seek to limit the authority of families to refuse organ retrieval. For example, in some locales if a deceased family member has satisfied the legal conditions for first-person prior assent, a much looser and easier standard to satisfy than informed consent, organ retrieval may proceed despite the family’s objections. Some countries have replaced voluntary consent to organ donation with forms of organ conscription. Often referred to under the misnomer “presumed consent,” such policies legalize the harvesting of organs at death, unless individuals exercise official options to opt out. As this article explores, however, there are good grounds for affirming the authority of the family to consent to or to deny organ donation on behalf of recently deceased family members, as well as to reject first-person assent and “presumed consent” policies of organ procurement. Insofar as individuals have failed clearly and competently to provide informed consent to organ donation, moral authorization for the use of the person and his body ought to be grounded on the foundational authority of the family, rather than the state’s supposed interests in obtaining organs for transplantation.

Public knowledge and attitudes towards consent policies for organ donation in Europe. A systematic review
Alberto Molina Pérez, David Rodríguez-Arias, Janet Delgado-Rodríguez, Myfanwy Morgan, Mihaela Frunza, Gurch Randhawa, Jeantine Reiger-Van de Wijdeven, Eline Schiks, Sabine Wöhlke, Silke Schicktanz
Transplantation Reviews, 2019;  33(1) pp 1-8
Abstract
Background: Several countries have recently changed their model of consent for organ donation from opt-in to opt-out. We undertook a systematic review to determine public knowledge and attitudes towards these models in Europe. Methods: Six databases were explored between 1 January 2008 and 15 December 2017. We selected empirical studies addressing either knowledge or attitudes towards the systems of consent for deceased organ donation by lay people in Europe, including students. Study selection, data extraction, and quality assessment were conducted by two or more reviewers independently. Findings: Awareness of the consent model was lower in opt-out countries than in opt-in countries. A majority of the public agrees with opt-in, regardless of the law in their own country. There are ambivalent attitudes regarding the opt-out system. The public tend to prefer opt-in and mandatory choice over opt-out when several options are offered. Interpretation: The assumption that people in opt-out countries are aware of the legal requirements to be excluded from the pool of potential donors is not supported by the results of this review. This is a concern, since ignorance hinders people’s autonomy regarding organ donation decision-making. Higher awareness of consent model in opt-in countries may reflect greater efforts to inform the public through campaigns to motivate donation. Legal moves towards opt-out are at odds with people’s expressed preferences. Main limitations of this review are the lack of data from some countries, study population heterogeneity, and methodological shortcomings.

Vaccine Controversies: the Case for Freedom and Informed Consent
Guest Editorial
Jane M. Orient
Journal of American Physicians and Surgeons, September 2019; 24(3)
Excerpt
…There is increasing pressure to add HPV vaccine to the long list of vaccines already mandated for school attendance, and to reduce exemptions for all vaccines. In California, which already eliminated all exemptions except medical ones, proposed legislation would severely constrain permitted contraindications and subject physicians who write for exemptions to intense scrutiny. AAPS has written letters to several state legislatures concerning the need for informed consent for all medical interventions, including vaccines, and a statement to congressional committees opposing federal vaccine mandates.5 Other than AAPS and a new organization, Physicians for Informed Consent (https://physiciansforinformedconsent.org/), medical organizations generally do not oppose mandates…

(Un)informed Consent: Studying GDPR Consent Notices in the Field
Christine Utz, Martin Degeling, Sascha Fahl, Florian Schaub, and Thorsten Holz. 2019
2019 ACM SIGSAC Conference on Computer and Communications Security (CCS ’19), November 11–15, 5 September 2019
Abstract
Since the adoption of the General Data Protection Regulation (GDPR) in May 2018 more than 60 % of popular websites in Europe display cookie consent notices to their visitors. This has quickly led to users becoming fatigued with privacy notifications and contributed to the rise of both browser extensions that block these banners and demands for a solution that bundles consent across multiple websites or in the browser. In this work, we identify common properties of the graphical user interface of consent notices and conduct three experiments with more than 80,000 unique users on a German website to investigate the influence of notice position, type of choice, and content framing on consent. We find that users are more likely to interact with a notice shown in the lower (left) part of the screen. Given a binary choice, more users are willing to accept tracking compared to mechanisms that require them to allow cookie use for each category or company individually. We also show that the widespread practice of nudging has a large effect on the choices users make. Our experiments show that seemingly small implementation decisions can substantially impact whether and how people interact with consent notices. Our findings demonstrate the importance for regulation to not just require consent, but also provide clear requirements or guidance for how this consent has to be obtained in order to ensure that users can make free and informed choices.

Concise Consent Forms Appreciated—Still Not Comprehended: Applying Revised Common Rule Guidelines in Online Studies
Research Article
Evan K. Perrault, Seth P. McCullock
Journal of Empirical Research on Human Research Ethics, 6 June 2019; 14(4)
Abstract
As informed consent documents have historically gotten lengthier, recent revisions to federal Common Rule guidelines now require consent forms that are “concise” and presented in ways that “facilitate comprehension.” The current research sought to apply these guidelines by developing a consent process for an online study that was only 71 words and also allowed participants a choice to either continue directly to the study or learn more about the study to which they were consenting. All participants (100%, N = 429) decided to continue directly to the study, choosing to forgo additional information about the study and the institutional review board (IRB) approval process. Participants indicated they liked this streamlined consent process, even though on average they only comprehended about half of the information this streamlined process contained. A plurality of participants indicated they would like to see this style of streamlined consent continued in future online studies. However, if we want to continue referring to informed consent as informed, future research should be welcomed and supported by IRBs to seek ways to apply the newest Common Rule guidelines while increasing comprehension; otherwise, informed consent will likely always remain an oxymoron.

Broad-scale informed consent: A survey of the CTSA landscape
Redonna Chandler, Kathleen T. Brady, Rebecca N. Jerome, Milton Eder, Erin Rothwell, Kimberly A. Brownley, Paul A. Harri
Journal of Clinical and Translational Science, 27 June 2019
Open Access
Abstract
Introduction
Research opportunities associated with the proliferation of the electronic health record (EHR), big data initiatives, and innovative approaches to trial design can present challenges for obtaining and documenting informed consent. Broad-scale informed consent (a term used herein to describe institutional models, rather than the Common Rule’s strict regulatory definition for “broad consent”) may facilitate the use of existing data and samples and speed the pace of research by minimizing barriers to consent. We explored the use of broadscale informed consent within the Clinical Translational Science Award (CTSA) Program Network.
Methods
We surveyed CTSA Hubs concerning policies, practices, experiences, and needs within three domains of broad-scale informed consent: (1) participant recontact; (2) biospecimens; and (3) clinical data sharing.
Results
Of 61 CTSA Hubs surveyed, 37 (61%) indicated ongoing work related to at least 1 domain of broad-scale informed consent; 18 Hubs (30%) reported work in all 3 domains. The EHR predominated as the implementation system across all three domains. Research and IT leadership and the Institutional Review Board were most commonly endorsed as institutional drivers, while systems/technical issues and impact on clinical workflow were the most commonly reported barriers.
Conclusions
While survey results indicate considerable variability in the implementation of broad-scale informed consent across the CTSA consortium, it is clear that all CTSA Hubs are actively considering policy and process related to these concepts. Next steps cluster within three areas: training and workforce development, streamlined policies and templates, and implementation strategies that facilitate integration into clinical workflow.

A History of Physician “Truth Telling,” Informed Consent, Legal and Religious Perspectives on End-of-Life Care [BOOK CHAPTER]
Russell Searight
Ethical Challenges in Multi-Cultural Patient Care, 14 August 2019; pp 29-44
Abstract
While patients’ and family preferences for nondisclosure of life-threatening illness found among contemporary Native Americans and Asian Americans may seem to be a cultural anomaly, a brief review of physician practices and legal rulings in the 20th century suggests that disclosure of this information to patients is a relatively recent practice.

Consent is everybody’s business; Why banks need to act on free, prior and informed consent
Shona Hawkes
Oxfam Library, August 2019
Open Access
Summary
A community’s choice to give, or withhold, their free, prior and informed consent (FPIC) to a project or activity planned to take place on their land is a recognized right of Indigenous peoples under international law. It is also a best practice principle that applies to all communities affected by projects or activities on the land, water and forests that they rely on. Free, prior and informed consent has additional benefits for banks involved in such projects, and their clients, in helping to avoid a diverse array of potential risks…

Editor’s note: This paper is published by Oxfam International as a “part of a series of papers written to inform public debate on development and humanitarian policy issues.”

Getting youth PrEPared: adolescent consent laws and implications for the availability of PrEP among youth in countries outside of the United States
Taggart T, Bond KT, Ritchwood TD, Smith JC
Journal of the International AIDS Society, July 2019; 22(7)
Open Access
Abstract
Introduction
Youth under the age of 25 are at high risk for HIV infection. While pre-exposure prophylaxis (PrEP) has the potential to curb new infections within this population, it is unclear how country-specific laws and policies that govern youth access to sexual and reproductive health (SRH) services impact access to PrEP. The purpose of this review was to analyse laws and policies concerning PrEP implementation and SRH services available to youth in countries with a high HIV incidence. To the best of our knowledge this is the first systematic assessment of country-level policies that impact the availability of PrEP to adolescent populations.
Methods
We conducted a review of national policies published on or before 12 June 2018 that could impact adolescents’ access to PrEP, SRH services and ability to consent to medical intervention. Countries were included if: (1) there was a high incidence of HIV; (2) they had active PrEP trials or PrEP was available for distribution; (3) information regarding PrEP guidelines were publicly available. We also included a selected number of countries with lower adolescent HIV incidence. Internet and legal database searches were used to identify policies relevant to adolescent PrEP (e.g. age of consent to HIV testing).
Results and Discussion
Fifteen countries were selected for inclusion in this review. Countries varied considerably in their respective laws and policies governing adolescents’ access to PrEP, HIV testing and SRH services. Six countries had specific polices around the provision of PrEP to youth under the age of 18. Five countries required people to be 18 years or older to access HIV testing, and six countries had specific laws addressing adolescent consent for- and access to- contraceptives.
Conclusion
Adolescents’ access to PrEP without parental consent remains limited or uncertain in many countries where this biomedical intervention is needed. Observational and qualitative studies are needed to determine if and how adolescent consent laws are followed in relation to adolescent PrEP provisions. Intensified efforts to amend laws that limit adolescent access to PrEP and restrict the establishment of national guidelines supporting adolescent PrEP are also needed to address the epidemic in this group.

Consent for data processing under the General Data Protection Regulation: could ‘dynamic consent’ be a useful tool for researchers?
J. Kaye, H. Teare, J. Bell
Journal of Data Protection and Privacy, 19 July 2019
Abstract
The General Data Protection Regulation (GDPR) sets a high bar for consent for the processing of personal data. In the UK, researchers have been directed to rely on legal bases other than consent for processing personal data for research purposes. Informed consent nonetheless, and despite certain shortcomings, holds a central position in ethical research practice, as well as at common law, and in a range of other legislation dealing with research involving humans.

This paper evaluates the place of informed consent in research following the GDPR’s implementation, arguing that a fresh approach to consent – specifically the concept known as ‘dynamic consent’ – could provide a way for researchers to meet the new European regulatory requirements for data processing whilst adhering to the highest ethical standards for research conduct. It analysis dynamic consent according to specific GDPR requirements and reflects on practical examples that could inform future implementation of the approach, while remaining aware of the need for further empirical research.