Stop agonising over informed consent when researchers use crowdsourcing platforms to conduct survey research
Jonathan Lewis, Vilius Dranseika, Søren Holm
Clinical Ethics, 2023; 18(4)
Abstract
Research ethics committees and institutional review boards spend considerable time developing, scrutinising, and revising specific consent processes and materials for survey-based studies conducted on crowdsourcing and online recruitment platforms such as MTurk and Prolific. However, there is evidence to suggest that many users of ICT services do not read the information provided as part of the consent process and they habitually provide or refuse their consent without adequate reflection. In principle, these practices call into question the validity of their consent. In this paper we argue that although the ‘no read problem’ and the routinisation of consent may apply to research participants’ consent practices for studies on crowdsourcing platforms, this is not a serious problem. Furthermore, given that the informational requirements for informed consent in these contexts are minimal, we argue that these participants are, nevertheless, sufficiently informed to give valid consent. We conclude that research ethics committees and institutional review boards should only agonise over the precise details of the informed consent process and materials in those rare cases where appreciable risks to research participants need to be managed.

Consent
Book Chapter
Elizabeth Groeneveld, Carrie Rentschler
Rethinking Women’s and Gender Studies, 2023 [Routledge]
Abstract
This chapter examines liberal, affirmative, and critical consent frameworks that inform constructions of this term, after a review of the circulation of consent as a keyword in Women’s and Gender Studies (WGS). Feminist theory starts from the premise that social relationships are, by-and-large, unequal, critiquing liberal models of consent precisely for their failures to address power. Many feminists have critiqued the liberal model of consent for its failures to address structural conditions of oppression along the axes of gender, race, class, age, and ability, all of which shape the very conditions. The focus of the affirmative consent model on the negotiation of mutual pleasure and the setting of limits in sexual situations—an ideal many of us do invest in—when codified into law may serve the criminal justice system more than anyone else. In contrast to affirmative consent, critical, ethical, and trauma-informed consent practice reveals power as something that is both always present and something that can be negotiated in relationship.

Informed Consent: A Monthly Review
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October 2023 :: Issue 58

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: Center for Informed Consent Integrity – A Monthly Review_October 2023

We will selectively include calls for public consultation from multilateral agencies, governments, INGOs and other sources where there is a clear intersection with consent/assent. This might be obvious from the title of the draft guidance, regulations, etc., but more often, it will be a thematic area or topic – if properly addressed at all. If you would like to explore participation with our working group developing submissions for these calls, please contact us [david.r.curry@ge2p2global.org].

Public Consultation: ICH E6(R3) [GCP] Principles, Annex 1 and Annex 2
ICH – The E6(R3) EWG is working on the revision of the E6(R2) Guideline “Good Clinical Practice” (GCP) with a view to addressing the application of GCP principles to the increasingly diverse trial types and data sources being employed to support regulatory and healthcare related decision-making on drugs, and provide flexibility whenever appropriate to facilitate the use of technological innovations in clinical trials.

   Public consultation dates:
Health Canada, Canada – Deadline for comments by 20 October 2023

  Earlier consultation dates:
HSA, Singapore – Deadline for comments by 30 September 2023
EC, Europe – Deadline for comments by 26 September 2023
Swissmedic, Switzerland – Deadline for comments by 26 September 2023
MHLW/PMDA, Japan – Deadline for comments by 9 September 2023
FDA, United States – Deadline for comments by 5 September 2023
ANVISA, Brazil – Deadline for comments by 31 August 2023
MHRA, UK – Deadline for comments by 31 August 2023
NMPA, China – Deadline for comments by 31 August 2023
TFDA, Chinese Taipei – Deadline for comments by 31 August 2023

A troubling foundational inconsistency: autonomy and collective agency in critical care decision-making
Stowe Locke Teti
Theoretical Medicine and Bioethics, 28 March 2023; 44 pp 279–300
Abstract
‘Shared’ decision-making is heralded as the gold standard of how medical decisions should be reached, yet how does one ‘share’ a decision when any attempt to do so will undermine autonomous decision-making? And what exactly is being shared? While some authors have described parallels in literature, philosophical examination of shared agency remains largely uninvestigated as an explanation in bioethics. In the following, shared decision-making will be explained as occurring when a group, generally comprised of a patient and or their family, and the medical team become a genuine intentional subject which acts as a collective agent. Collective agency can better explain how some medical decisions are reached, contrary to the traditional understanding and operationalization of ‘autonomy’ in bioethics. Paradoxically, this often occurs in the setting of high-stakes moral decision-making, where conventional wisdom would suggest individuals would most want to exercise autonomous action according to their personally held values and beliefs. This explication of shared decision-making suggests a social ontology ought to inform or displace significant aspects of autonomy as construed in bioethics. It will be argued that joint commitments are a fundamental part of human life, informing and explaining much human behavior, and thus suggesting that autonomy – conceived of as discrete, individuated moral reasoning of a singular moral agent – is not an unalloyed ‘good.’

Informed Consent: A Monthly Review
_________________

September 2023 :: Issue 57

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: Center for Informed Consent Integrity – A Monthly Review_September 2023

Autonomy with responsibility: is informed consent just a signature on a paper? Evaluation in patients who underwent spine surgery
Jorge H. Nuñez Camarena, David Bosch Garcia, Berta Escudero
The Spine Journal, September 2023; 23(9)
Abstract
Background Context
Despite the relevance of informed consent in spine surgery, and all type of surgeries, and its daily use, there are very few studies that have checked if this document really accomplishes its duty.
Purpose
The aim of this study is to evaluate the real information that patients who went under spine surgery receive and know, after signing the informed consent.
Study Design/Setting
Retrospective study.
Patient Sample
Patients who underwent spine arthrodesis or spine discectomy between 2017 and 2019 were analyzed. Surgical technique and risks were explained before they were accepted to be on the surgery waiting list. They were given a copy of the informed consent.
Outcome Measures
Within the studied variables, we have asked patients if they have read the informed consent before surgery, if they could recall the surgical technique, spinal segment operated (cervical, thoracic, or lumbar) and vertebral levels operated. We added if they knew about surgical risks and if they looked for information about their procedure from other sources.
Methods
Answers were analyzed by age and educational level.
Results
From 458 total patients, only 51.9% of them answered all the questions. Also, 63% of patients agreed to have read the informed consent before surgery; 91.6% of patients knew about the spine segment operated; however, only 73.5% of patients remembered the surgical technique and 63.9% of patients could recall the vertebral levels. In addition, 39.1% of patients did not know about surgical risks and only 16.0% of patients mentioned to have looked for additional information using other sources. A significant statistical result was obtained between the search of additional information and younger patients (p < 0.001) and superior educational formation (p = 0.023).
Conclusions
Even though informed consent is an important procedure to get patients informed before spinal surgery, almost 40% of our patients underwent surgery without reading this document and not being aware of surgical risks.

The language of consent: do we take or does the patient give?
Opinion
Simon M Everett
BMJ Endoscopy, 3 August 2023
Excerpt
… The other thing I hear frequently is how best to ‘take consent’. Let us be clear, we cannot ‘take consent’. The only action that deems consent to be legal is that it is ‘freely given’ and that is the basis on which we should talk to our patients. The patient gives us their consent and we receive it, but we do not take it.

Is this just pointless pedantry? Maybe, but if we are using words that describe the consent process incorrectly, it is likely that we are not allocating the time and space that this discussion requires. If we continue to use incorrect terminology, we will continue in the paternalistic way of thinking. Too often in medical practice consent is seen as a time- consuming barrier to doing the things that we believe to be best for our patients. Yes, it can be time consuming, but the more I avail patients of my time, the more I find they need it…

Informed Consent: A Monthly Review
_________________

August 2023 :: Issue 56

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: Center for Informed Consent Integrity – A Monthly Review_August 2023

Consent
Iain Mactier, Paul McConnell
Anaesthesia & Intensive Care Medicine, 13 July 2023
Abstract
Consent is a fundamental ethical and legal principle in good medical practice. A patient must have capacity to provide informed consent. There are four key principles that need to be satisfied when establishing if a patient has capacity. For consent to be valid, the patient must be made aware of all associated risks to which they would attach significance. Information provided to patients should be individualized, objective and include all reasonable alternatives. It should be made clear if a procedure is optional, for example, an analgesic regional nerve block. Questions should be encouraged and answered honestly. Patients need adequate time to consider all the information provided. The consent process should be documented but a separate signed consent form is not required for most anaesthetic interventions. Some patients may have an advance care directive or a legally appointed power of attorney and these must be respected. When a patient has not made such arrangements and does not have capacity, treatment should be provided in accordance with their best interests. This must be individualized and consider multiple factors. Specialist advice should be sought in circumstances where there is uncertainty.