Informed consent and compulsory medical device registries: ethics and opportunities
Daniel B. Kramer, Efthimios Parasidis
Journal of Medical Ethics, 19 February 2021
Abstract
Many high-risk medical devices earn US marketing approval based on limited premarket clinical evaluation that leaves important questions unanswered. Rigorous postmarket surveillance includes registries that actively collect and maintain information defined by individual patient exposures to particular devices. Several prominent registries for cardiovascular devices require enrolment as a condition of reimbursement for the implant procedure, without informed consent. In this article, we focus on whether these registries, separate from their legal requirements, have an ethical obligation to obtain informed consent from enrolees, what is lost in not doing so, and the ways in which seeking and obtaining consent might strengthen postmarket surveillance in the USA.

Informed Consent: A Monthly Review
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February 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_February 2021

Editor’s Note:
The latest webinar in the Center’s continuing series was held on January 20^th 2021 and included a presentation from Pat Furlong and Ryan Fischer, both of Parent Project Muscular Dystrophy, titled PPMD Gene Therapy Preference Study: Eliciting patient and caregiver preference for emerging gene therapies. The presentation focused on their work on the quantification of patient and caregiver preferences in gene therapy studies to help inform research and researchers and how this impacts the understanding of informed consent in rare disease, specifically Duchenne Muscular Dystrophy. The presentation was followed by a discussion with call participants. Full information and the webinar recording can be found here on the Center for Informed Consent Integrity website.

Ethical Challenges and Dynamic Informed Consent [BOOK CHAPTER]
Loreta Tauginienė, Philipp Hummer, Alexandra Albert, Anna Cigarini, Katrin Vohland
Springer – The Science of Citizen Science, 12 January 2021; pp 397-416
Abstract
This chapter uses informed consent as a point of departure for the description of multiple ethical facets in citizen science. It sets out an overview of general ethical challenges in citizen science, from conceptual issues around social imbalances and power relations, to practical issues, such as how to deal with privacy for participants as well as data protection, intellectual property rights and other emergent issues. The chapter goes on to describe the different types of informed consent, particularly focusing on dynamic informed consent as the solution to the challenges described. Finally, practice-oriented recommendations about how to tackle some of the ethical issues raised in the chapter are set out.

Passive consent for passive participation?
Perspectives
Berge Solberg, Hilde Eikemo
Tidsskr Nor Legeforen 2021, 11 January 2021
Open Access
Excerpt
Passive consent meets important ethical concerns and ought to be more applied in certain types of medical and health-related research. The purpose of the Health Research Act is to promote good and ethically sound research. A key approach to this effect is to instruct the researchers to obtain consent from the participants. One challenge, however, is that the Act stipulates only two categories – either active consent or exemption from consent. We believe that there are good ethical reasons to commend passive consent and give it a clearer role to play…

Fewer Mistakes and Presumed Consent
Alexander Zambrano
The Journal of Medicine and Philosophy, 2 January 2021; 46(1) pp 58–79
Abstract
“Opt-out” organ procurement policies based on presumed consent are typically advertised as being superior to “opt-in” policies based on explicit consent at securing organs for transplantation. However, Michael Gill (2004) has argued that presumed consent policies are also better than opt-in policies at respecting patient autonomy. According to Gill’s Fewer Mistakes Argument, we ought to implement the procurement policy that results in the fewest frustrated wishes regarding organ donation. Given that the majority of Americans wish to donate their organs, it is plausible that a presumed consent policy would result in fewer frustrated wishes compared to the current opt-in policy. It follows that we ought to implement a policy of presumed consent. In this paper, I first consider and find wanting an objection to the Fewer Mistakes Argument developed recently by Douglas MacKay (2015). I also consider an objection put forth by James Taylor (2012) but argue that there is a methodological reason to prefer my own argument to Taylor’s. Finally, I argue for two theses: first, that Gill’s major argument in favor of the crucial premise of the Fewer Mistakes Argument is flawed, and second, that the major premise of the Fewer Mistakes Argument is false.

Informed Consent: A Monthly Review
___________________________

January 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_January 2021

Editor’s Note:
The latest webinar in the Center’s continuing series was held on December 16th 2020 and included a presentation titled COVID-19 Immunization under Emergency Use:: Consent/Refusal, Mandates, Certificates. Foundation President & CEO David Curry led the discussion, which included a rich exchange with call participants. Full information and the webinar recording can be found here on the Center for Informed Consent Integrity website.

Further to this webinar theme, the Foundation recently released An Informed Choice/Consent/Right-to-Refuse Imperative :: Statement on Immunization Involving COVID-19 Vaccines Under Emergency Use Authorization/Listing [EUA/L]. This statement argues that immunization involving COVID-19 vaccines available under emergency use mechanisms or expanded access/compassionate use triggers an imperative to assure that individuals receive the information required to support free exercise of meaningful informed choice/consent, with a right to refuse such vaccination for any reason or no reason. Visit the statement website to read the full text and to consider adding your endorsement.

Consenting patients – what do we really need to tell them?
Sonal Gandhi, Rebecca Exley, Khalid Begeni, Michael Perry
British Journal of Oral Maxillofacial Surgery, 1 December 2020; 58(10)
Abstract
Consent issues are a major factor in litigation. Shortfalls often make defence of a claim difficult. Arguably this has been made more difficult with the relatively recent Montgomery ruling. Unfortunately current guidelines are subject to personal interpretation and application (i.e. what do we define as a “serious” complication and how common is “common”). Thus consenting for procedures can be problematic. Whilst a surgeon’s perspective of relevant risks is important, the significance and likelihood of complications may be viewed differently by patients. We aimed to identify those risks patients may consider to be relevant and which should be routinely discussed. This study was undertaken for five common procedures.

Should Donors Consent to Export Their Corneas? Examination of Eye Tissue and Eye Care Sector
Opinion
Heather Machin, Gerard Sutton, Paul N. Baird
Cornea, 1 December 2020
Abstract
Purpose
Corneal tissue international activity is only possible because of the willingness of export populations to donate their corneas on their death. Current predonation public education campaigns and at-the-point-of-donation consent practice generally includes consent for transplantation, research, and/or training. It is unclear whether a consent-for-export step is universally included in the consent process or, indeed, whether it should. We interviewed eye tissue and eye care professionals from around the world, who exported, imported, or did neither to understand current consent-for-export awareness and determine opinion on future practice.
Method
During wider qualitative grounded-theory semistructured interviews with sector experts, to determine whether Australia should export, we captured sector opinion on consent-for-export. We used saturation and sentiment methods to determine opinion and χ2 correlation coefficients to examine association, using an α of P = 0.05.
Results
We interviewed 92 individuals, 83 of whom discussed consent-for-export. Of those, 51% (42/83) demonstrated some awareness of the practice; however, there were contradictions between interviewees from the same location. Regardless of current awareness, 57% (41/72) believed donors should be informed or consented for export. Their approval did not extend to donor-directed decisions, which would allow donors to decide which nation their donation should be sent, with 62.5% (45/72) opposing that notion.
Conclusions
Our research indicates that the consent-for-export practice is not universally applied by exporting nations and that eye tissue and eye care professionals have limited awareness of the practice. Universally implementing a consent-for-export step within general consent practice would improve awareness, reduce confusion, and support donor wishes.

Consent in Pelvic Care
Review
Stephanie Tillman
Journal of Midwifery & Women’s Health, 1 December 2020
Abstract
Consent is a clear dialogue between individuals to engage in a specific activity. Expectations for consent to intimate examinations in health care should be equal to, if not exceed, expectations for intimate interactions in society. In reality, current definitions of consent in health care vary. These blurry definitions lead to individualized interpretation, incomplete fulfillment, and opportunities for misunderstanding by both patient and health care provider. If a patient does not believe they have consented to an examination or procedure, they are likely to rightfully identify with one of consent’s antonyms, assault. Within the field of gynecology, a history of misogyny, racism, and classism illuminates abhorrent contexts of assault disguised as care. Similar practices persist in the modern application of pelvic care, ranging from overt sexual assault to coercion disguised as guidance. Health care providers and students who seek to improve consent practices can look to evidence‐based frameworks such as trauma‐informed care and shared decision making, both of which are embraced widely by professional organizations. These approaches often take precedence during the first pelvic examination; care for people who are lesbian, bisexual, queer, transgender, or nonbinary; and care for anyone with a known history of sexual assault; they can be easily extrapolated to all intimate examinations. Beyond obtaining consent for the examination itself, health care providers must also intentionally obtain consent to include students in care and openly discuss new universal recommendations for chaperone presence. Scripting for common procedures, such as bimanual examinations for pelvic care or cervical examinations in labor, allows health care providers to practice trauma‐informed language, include evidence‐based guidance, and avoid unintentional bias. Contemporary providers of intimate pelvic care must work to understand and strengthen the definition of consent and ensure its realization in practice.

The impact of organ donation specialists on consent rate in challenging organ donation conversations
Sam Radford, Rohit D’Costa, Helen Opdam, Mark McDonald, Daryl Jones, Michael Bailey, Rinaldo Bellomo
Critical Care and Resuscitation, December 2020; 22(4)
Abstract
Background
Consent rates for organ donation conversations (ODCs) vary. We hypothesised that a simple grading system could identify challenging ODCs. We further hypothesised that challenging ODCs would have higher consent rates when conducted by ODC specialists.
Objectives
We aimed to study the utility of a grading system for ODCs and test the hypothesis that any training effect would be associated with improved consent rates in ODCs graded as most challenging.
Methods
We stratified 2017 Australian DonateLife Audit aggregate consent and donation discussion data into four ODC grades based on Australian Organ Donor Register (AODR) status and person first raising the topic of organ donation. Grade I: “yes” present on AODR and family-raised organ donation; Grade II: “yes” present on AODR, and clinician-raised organ donation; Grade III: no registration on AODR but family-raised organ donation; and Grade IV: no registration on AODR, and clinician-raised organ donation.
Results
Grade I ODCs were uncommon 7.7% (109/1420), with a consent rate of 95.4% (104/109). Grade IV ODCs were frequent (60.4%, 857/1420), with a consent rate of 41.4% (355/857). However, in Grade IV ODCs, organ donation specialist consent rate was 53.5% (189/353), significantly greater than for other trained staff at 33.1% (88/266) (P < 0.005; odds ratio [OR], 2.33; 95% CI, 1.68- 3.24) or untrained requestors at 32.8% (78/238; P < 0.005; OR, 2.36; 95% CI. 1.68-3.33).
Conclusion
The likelihood of consent can be predicted using readily available variables. This allows prospective identification of Grade IV ODCs, which carry low but potentially modifiable likelihood of consent. Involving donation specialists was associated with more consents for organ donation when applied retrospectively to Australian audit data.