Gaining Consent to Survey Respondents’ Partners: The Importance of Anchors’ Survey Experience in Self administered Modes
Tobias Gummer, Pablo Christmann, Tanja Kunz
Comparative Population Studies, 6 July 2023; 48 pp 281-306
Open Access
Abstract
Dyadic surveys aim to interview pairs of respondents, such as partners in a relationship. In dyadic surveys, it is often necessary to obtain the anchors’ consent to contact their partners and invite them to a survey. If the survey is operated in self-administered modes, no interviewer is present to improve the consent rate, for example, by providing convincing arguments and additional information. To overcome the challenges posed by self-administered modes for dyadic surveys and to improve consent rates, it is important to identify aspects that positively influence the likelihood of anchors giving consent to contact their partners. Ideally, these aspects are in the hands of the researchers, such as the survey design and aspects of the questionnaire. Thus, in this study, we analyzed the relationship between anchors’ survey experience and their willingness to consent to surveying their partners in self-administered modes. Based on data from the German Family Demography Panel Study (FReDA), we found that the anchors’ perceptions of the questionnaire as “interesting” or “too personal” were related to consent rates. These relationships were consistent across different survey modes and devices. Effects of other aspects of the questionnaire, such as “important for science” and “diverse” varied between modes and devices. We concluded with practical recommendations for survey research and an outlook for future research.

Informed Consent: A Monthly Review
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July 2023 :: Issue 55

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_July 2023

To find out how knowledgeable patients at tertiary care institutions are about giving informed consent and receiving counseling
Original Research
Mohammad Sufyan
Journal Of Cardiovascular Disease Research, 26 March 2023; 4(14)
Abstract
Aim
The purpose of this study is to find out how knowledgeable patients at tertiary care institutions are about giving informed consent and receiving counseling.
Material and Methods
Two groups made up the whole of the research: the first group consisted of fifty surgical trainees from general surgery, orthopaedics, obstetrics, and ENT, while the second group included fifty patients who had had a variety of surgical procedures. Both groups were exposed to the identical conditions over the same time period of the research. For the purpose of determining whether or not the counselling session addressed all of the essential components of providing informed consent for the surgical treatment, we have developed a systematic questionnaire.
Results
The final analysis took into account each of the 50 residents as well as the 50 patients. The risks and repercussions of the procedure were described in detail by 45 (or 90%) of the resident physicians as one of the most important aspects of the informed consent process. Natural history, the progression of the illness, and the prognosis were discussed by 19 resident physicians (38 percent), but alternative therapies and the name of the procedure were cited by 17 (34 percent) and 15 (30 percent), respectively. The patients themselves gave their permission in 37 (74%) of the instances, while their spouses gave their consent in 13 (26%) of the cases. Verbal permission was selected by 35 surgeons (70%) while written consent was selected by 15 surgeons (30%) as the technique of choice for getting agreement for minor operations and local anesthesia.
Conclusion
By adding patient counseling and intensifying patient selection, it is possible to increase both the overall happiness of patients and the results overall. A template for informed consent that includes all of the necessary information and leaves flexibility for customization needs to be established so that the process of obtaining informed consent may be completed more quickly.

Chapter 4 Capacity-Increasing Technologies and the Problems of Informed Consent
Book Chapter
Military Ethics and the Changing Nature of Warfare, 2023 [Brill]
Jean-François Caron
Abstract
Obtaining informed consent from members of the armed forces prior to their use of capacity-increasing technologies or medicines is plagued by numerous hurdles. This chapter argues that there are reasons to rethink the relevance of this criterion in favor of rethinking how these technologies and medicines ought to be tested in their developmental phase.

Informed Consent: A Monthly Review
_________________

June 2023 :: Issue 54

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_June 2023

Introducing Empowered Consent to Deal With the Current Challenges in Applied Sport Psychology
Niels Boysen Feddersen
Journal of Clinical Sport Psychology, 12 May 2023
Abstract
There has been a paucity of literature discussing how to address consent procedures as part of ethics, practitioner development, and best practice in applied sport psychology. Several researchers have addressed ethical challenges (e.g., out-of-session contact, overidentification, time, and space). However, none have substantially considered the sport-specific issues related to consent, which sits at the heart of best practice. The scarcity of discussing consent is limiting sport psychology’s potential to establish itself as a more recognized profession. This article highlights some contextual issues that challenge the idea and efficacy of informed consent. It proposes adapting consent procedures in the collaboration between sport psychology practitioners and clients to better address the current contextual challenges in applied sport psychology. In doing so, the current paper introduces Empowered Consent, which is specifically designed to empower athletes and address challenges related to choosing interventions, contractual obligations, visibility in the environment, and staff trying to gain insights into confidential information. The author offers a model to enhance applied practice for those collaborating with athletes and other clients in sport.

Consent, Background Justice and Patterned Privacy Principles
Molly Powell
Political Studies, 27 April 2023
Open Access
Abstract
Notice and consent approaches, being the most prevalent legal frameworks, have in recent years come under fire. I suggest they fail because they rest on a historical approach to privacy justice, whereby the justice of a particular state of affairs is a function of whether each transaction on the way was just. Instead, I make use of a background justice framing. Even where consent is present it is inadequate to secure the values at stake. When we only assess the fairness or freedom of individual information transactions, we fail to see the way many can undercut the very values we seek to secure by requiring consent for disclosures in the first place. I propose a patterned principle to regulate the distribution of individual control over privacy, and to set the background against which individual notice and consent can still play a role, albeit a limited one.

A Structure, Understanding, Recent Developments and New Definition for Consent
ResearchGate, April 2023
Scott McLachlan, Kudakwashe Dube, Yvonne Choi, Samir Saidi, Louise Rose, Norman Fenton
Abstract
Consent to medical intervention is a core legal concept that is ubiquitous and yet continues to frustrate governments, organisations, researchers and the wider community. Most requests for consent incorporate only those elements immediately required to meet ethics review board or organisational definitions, absent a holistic view of all elements that make up the concept of true fully informed consent. As a consequence, most methods and applications of consent could be characterised as incomplete, possibly because there are few works that have sought to consolidate our understanding of consent, the consent process, and the methods used in different applications. This paper addresses this gap by reviewing and consolidating the literature, characterising and redefining consent and exploring the ways in which consent is obtained. We present a new consent framework synthesised from philosophical, practical and application models. This framework is presented in the context of contemporary events of global importance. We define consent as “Revocable words or actions freely performed by a person who is capable and aware that create agreement with another party to permit some specific act”. This paper contributes to our ongoing understanding and future development of consent as a normative medico-legal process and provides a definitive framework which enables those involved in the consent process to ensure that all aspects necessary for fully informed consent are addressed.

Informed Consent: A Monthly Review
_________________

May 2023 :: Issue 53

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_May 2023

We include a spotlight section which highlights articles appearing in each edition which the editorial team has assessed to be strategically important and well aligned to our thematic focus areas of governance, ethics, policy and practice. The full citation/abstract for each spotlight item appears just below this summary.

In Exploring the Ethical and Moral Implications of Requiring Informed Consent to Determine Death by Neurologic Criteria Hibbs et al. discuss the role of consent in the declaration of brain death. While assessing and declaring brain death have been widely discussed, consent has been largely absent from this conversation to date.

In the article Explanation before Adoption: Supporting Informed Consent for Complex Machine Learning and IoT Health Platforms Eardley et al. write about explaining complex health technology platforms to non-technical audiences. A sufficiently comprehensive understanding of these systems is integral to gaining informed consent, and is becoming increasingly important with continuous technological integration in routine healthcare.

Jeyabalan et al. discuss consent for the use of drones in healthcare in their article To Obtain Informed Consent or Not to Obtain Informed Consent? Drones for Health Programs in the Grey Zone between Research and Public Health. In this article, the authors consider consent at both an individual and community level when using drones to map remote communities for health hazards, risks and safety concerns.

And finally, in Practical issues in pragmatic trials: the implementation of the Diuretic Comparison Project Ferguson et al. highlight the work of the US Department of Veterans Affairs Point of Care Clinical Trial Program. This study had a large patient population and worked to customize procedures to align with local clinical practice.

Exploring the Ethical and Moral Implications of Requiring Informed Consent to Determine Death by Neurologic Criteria
Matthew J. Hibbs, Morgan C. Arnold, Mark S. Beveridge
Journal of Pain and Symptom Management, May 2023; 65(5)
Abstract
Background
The American Academy of Pediatrics published guidelines in 1987 providing criteria for the declaration of brain death for children. Multiple societies, including neurology and critical care, renewed these guidelines in 2011 to further standardize the brain-death exam. Despite clear guidelines, laws regarding brain death vary among states, including whether consent is required to perform neurologic testing.
Objective
To examine the role of parental consent in brain-death testing from an ethicolegal perspective as well as its potential to create clinician distress.
Design/Method
Case report
Results
Patient is a 3-year-old, previously healthy male who suffered a tragic submersion injury requiring prolonged cardiopulmonary resuscitation. During the subsequent hospitalization, his clinical exam, head CT scan, and electroencephalogram demonstrated devastating, irreversible neurologic injury concerning for brain death. The family refused formal brain-death testing, instead requesting more time to allow for a miraculous recovery. The patient remains on life support after 5 weeks and is beginning to experience multiorgan dysfunction.
Discussion
Many physicians feel that brain-death testing should not require parental consent. Despite this, states vary in their requirements for parental consent for brain-death testing. When legally permissible, there are competing ethical principles governing a family’s request to delay or refuse brain-death testing.The principle of informed consent reflects the culture change from a paternalistic physician-patient relationship to a collaborative, family-centered approach. However, the argument remains that brain-death testing offers no therapeutic benefit and has the potential to cause harm via apnea testing, thereby requiring informed consent. This case presentation will illustrate the varied legal landscape surrounding pediatric brain-death testing, the ethical principles involved, and the moral injury that can result.

Explanation before Adoption: Supporting Informed Consent for Complex Machine Learning and IoT Health Platforms
Research Article
Rachel Eardley, Emma L. Tonkin, Ewan Soubutts, Amid Ayobi, Gregory J. L. Tourte, Rachael Gooberman-Hill, Ian Craddock, Aisling Ann O’Kane
Association for Computing Machinery: Human-Computer Interaction, 16 April 2023
Open Access
Abstract
Explaining health technology platforms to non-technical members of the public is an important part of the process of informed consent. Complex technology platforms that deal with safety-critical areas are particularly challenging, often operating within private domains (e.g. health services within the home) and used by individuals with various understandings of hardware, software, and algorithmic design. Through two studies, the first an interview and the second an observational study, we questioned how experts (e.g. those who designed, built, and installed a technology platform) supported provision of informed consent by participants. We identify a wide range of tools, techniques, and adaptations used by experts to explain the complex SPHERE sensor-based home health platform, provide implications for the design of tools to aid explanations, suggest opportunities for interactive explanations, present the range of information needed, and indicate future research possibilities in communicating technology platforms.

To Obtain Informed Consent or Not to Obtain Informed Consent? Drones for Health Programs in the Grey Zone between Research and Public Health
Vyshnave Jeyabalan, Lorie Donelle, Patrick Meier, Elysée Nouvet
Drones 2023, 2 April 2023; 7(4)
Abstract
Drones are increasingly being introduced to support healthcare delivery around the world. Most Drones for Health projects are currently in the pilot phase, where frontline staff are testing the feasibility of implementing drones into their healthcare system. Many of these projects are happening in remote localities where populations have been historically under-served within national healthcare systems. Currently, there exists limited drone-specific guidance on best practices for engaging individuals in decision-making about drone use in their communities. Towards supporting the development of such guidance, this paper focuses on the issue of obtaining community and individual consent for implementing Drones for Health projects. This paper is based on original qualitative research involving semi-structured interviews (N = 16) with program managers and implementation staff hired to work on health-related projects using drone technologies. In this paper, we introduce a scenario described by one participant to highlight the ethical and practical challenges associated with the implementation and use of drones for health-related purposes. We explore the ethical and practical complexities of obtaining informed consent from individuals who reside in communities where Drones for Health projects are implemented.

Practical issues in pragmatic trials: the implementation of the Diuretic Comparison Project
Research Article
Ryan E Ferguson, Sarah M Leatherman, Patricia Woods, Cynthia Hau, Robert Lew, William C Cushman, Mary T Brophy, Louis Fiore, Areef Ishani
Society for Clinical Trials, 29 March 2023
Abstract
Background/Aims
The US Department of Veterans Affairs Point of Care Clinical Trial Program conducts studies that utilize informatics infrastructure to integrate clinical trial protocols into routine care delivery. The Diuretic Comparison Project compared hydrochlorothiazide to chlorthalidone in reduction of major cardiovascular events in subjects with hypertension. Here we describe the cultural, technical, regulatory, and logistical challenges and solutions that enabled successful implementation of this large pragmatic comparative effectiveness Point of Care clinical trial.
Methods
Patients were recruited from 72 Veterans Affairs Healthcare Systems using centralized processes for subject identification, obtaining informed consent, data collection, safety monitoring, site communication, and endpoint identification with minimal perturbation of the local clinical care ecosystem. Patients continued to be managed exclusively by their clinical care providers without protocol specified study visits, treatment recommendations, or data collection extraneous to routine care. Centralized study processes were operationalized through the application layer of the electronic health record via a data coordinating center staffed by clinical nurses, data scientists, and statisticians without site-based research coordinators. Study data was collected from the Veterans Affairs electronic health record supplemented by Medicare and National Death Index data.
Results
The study exceeded its enrolled goal (13,523 subjects) and followed subjects for the 5-year study duration. The key determinant of program success was collaboration between researchers, regulators, clinicians, and administrative staff at the site level to customize study procedures to align with local clinical practice. This flexibility was enabled by designation of the study as minimal risk and determination that clinical care providers were not engaged in research by the Veterans Affairs Central Institutional Review Board. Cultural, regulatory, technical, and logistical problems were identified and solved through iterative collaboration between clinical and research entities. Paramount among these problems was customization of the Veterans Affairs electronic health record and data systems to accommodate study procedures.
Conclusions
Leveraging clinical care for large-scale clinical trials is feasible but requires a rethinking of traditional clinical trial design (and regulation) to better meet requirements of clinical care ecosystems. Study designs must accommodate site-specific practice variation to reduce the impact on clinical care. A tradeoff thus exists between designing trial processes tailored to expedite local study implementation versus those to produce a more refined response to the research question. The availability of a uniform and flexible electronic health record in the Department of Veterans Affairs played a major role in the success of the trial. Conducting Point of Care research in other healthcare systems without such research-friendly infrastructure presents a more formidable challenge.