Informed consent within a learning health system: A scoping review
Research Report
Annabelle Cumyn, Adrien Barton, Roxanne Dault, Anne‐Marie Cloutier, Rosalie Jalbert, Jean‐François Ethier
Learning Health Systems, 4 December 2019
Open Access
Abstract
Introduction
A major consideration for the implementation of a learning health system (LHS) is consent from participants to the use of their data for research purposes. The main objective of this paper was to identify in the literature which types of consent have been proposed for participation in research observational activities in a LHS. We were particularly interested in understanding which approaches were seen as most feasible and acceptable and in which context, in order to inform the development of a Quebec‐based LHS.
Methods
Using a scoping review methodology, we searched scientific and legal databases as well as the gray literature using specific terms. Full‐text articles were reviewed independently by two authors on the basis of the following concepts: (a) LHS and (b) approach to consent. The selected papers were imported in NVivo software for analysis in the light of a conceptual framework that distinguishes various, largely independent dimensions of consent.
Results
A total of 93 publications were analysed for this review. Several studies reach opposing conclusions concerning the best approach to consent within a LHS. However, in the light of the conceptual framework we developed, we found that many of these results are distorted by the conflation between various characteristics of consent. Thus, when these characteristics are distinguished, the results mainly suggest the prime importance of the communication process, by contrast to the scope of consent or the kind of action required by participants (opt‐in/opt‐out). We identified two models of consent that were especially relevant for our purpose: metaconsent and dynamic consent.
Conclusions
Our review shows the importance of distinguishing carefully the various features of the consent process. It also suggests that the metaconsent model is a valuable model within a LHS, as it addresses many of the issues raised with regards to feasibility and acceptability. We propose to complement this model by adding the modalities of the information process to the dimensions relevant in the metaconsent process.

Informed Consent: A Monthly Review
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December 2019

This digest aggregates and distills key content around 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 GE2P2 Global Foundation’s Center for Informed Consent Integrity, which is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Fellow
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org

Publisher
David R. Curry
President & CEO
GE2P2 Global Foundation
david.r.curry@ge2p2global.org

PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_December 2019

Meaningful Consent From a Willfully Noninformed Patient
Michael E. Bowdish, Peter F. Crookes
The Annals of Thoracic Surgery, December 2019; 108(6) pp 1613-1614
Abstract
The cornerstone of contemporary medical practice is the belief that the patient has a right to self-determination.1 A doctor who performs a procedure in the absence, or in defiance, of the patient’s expressed wishes is guilty of battery. This is rare nowadays. It is more common for it to be alleged that the potential downside of treatment was not explained clearly enough, and that if it had been, the patient would not have consented to the procedure. Or that, because no alternatives were offered, there was de facto coercion to undergo a particular procedure.

Waived Consent in Perinatal/Neonatal Research—When Is It Appropriate?
Review Article
Wade D. Rich, Anup C. Katheria
Fronteirs in Pediatrics, 26 November 2019
Open Access
Abstract
Informed consent is a process ensuring that subjects enrolled in research are appropriately informed of the risks and benefits. While this process is well-defined when it is possible and practical to obtain consent prior to the research intervention, it can be less clear in cases of deferred or waived consent. Defining minimal risk, such as when research is attempting to determine which of two currently practiced interventions is safest and/or most effective, is critical to moving forward in establishing appropriate care in newborns. For perinatal/neonatal research the challenge lies between the ethical justification for approaching women in labor or under medication vs. the scientific integrity of excluding a number of subjects that may potentially benefit the most from an intervention. Researchers must work with their IRBs as well as families who have participated in trials to determine the most appropriate method for obtaining informed consent from expectant parents. Clinical researchers and IRBs ultimately need to find a middle ground for the appropriate use of deferred or waived consent.

Vulnerability and the Consenting Subject: Reimagining Informed Consent in Embryo Donation
Rebecca Hewer
Feminist Legal Studies, 14 November 2019; 27(3) pp 287-310
Open Access
Abstract
Informed consent is medico-legal orthodoxy and the principal means by which research encounters with the body are regulated in the UK. However, biomedical advancements increasingly frustrate the degree to which informed consent can be practiced, whilst introducing ambiguity into its legal significance. What is more, feminist theory fundamentally disrupts the ideologically liberal foundations of informed consent, exposing it as a potentially inadequate mode of bioethical regulation. This paper explores these critiques by reference to a case study—embryo donation to health research, following fertility treatment, as regulated by the HFEA 1990—and contends that informed consent cannot adequately respond to the material realities of this research encounter. Thereafter, by drawing on feminist theories of vulnerability, this paper proffers an alternative bioethical approach, which calls for structural reform in recognition of the fundamentally bilateral constitution of self and society and a renewed appreciation for the affective/dispositional tenor of lived experience.

Informed Consent: A Monthly Review
___________________________

November 2019

This digest aggregates and distills key content around 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 GE2P2 Global Foundation’s Center for Informed Consent Integrity, which is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Fellow
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org

Publisher
David R. Curry
President & CEO
GE2P2 Global Foundation
david.r.curry@ge2p2global.org

PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_November 2019

Informed Consent [BOOK CHAPTER]
Sarah A. Markham, Dominick Gadaleta
Quality in Obesity Treatment, 16 October 2019; pp 353-364
Abstract
Informed consent is a complex process that has evolved over time, both in medical and legal practice. Rooted in the same ethical tenets as medicine, informed consent exists to protect both patients and physicians. It has evolved over time from a “reasonable physician” standard to a “reasonable patient” standard, reflecting the change in medicine from paternalism to patient autonomy. The current trend is toward “shared decision-making,” which involves an open discussion between the patient and his/her surgeon about the patient’s diagnosis, the natural history of the disease without treatment, various treatment options with their risks and benefits, and the expected outcomes. In this model, the surgeon and patient collaborate to select the intervention which best aligns with the patient’s goals and values. This is especially vital in the field of bariatric surgery, where the long-term outcome is predominately patient-driven. Patients pursuing weight loss surgery for an “easy fix” to obesity will be severely disappointed after surgery and may not recognize complications if they have not had comprehensive discussions with their surgeons. Research has shown that many patients continue to lack a clear understanding after informed consent, which can be improved by multimedia consent processes and repeat-back.

Production of Evidence-Based Informed Consent (EBIC) With Meaning Equivalence Reusable Learning Objects (MERLO): An Application on the Clinical Setting
Myrtha Elvia Reyna Vargas, Wendy Lou, Ron S. Kenett
Pedagogy for Conceptual Thinking and Meaning Equivalence: Emerging Research and Opportunities, November 2019; Chapter 5 pp 86-116
Abstract
Apparently, during an informed consent, patients remember little of the information given and their comprehension level is often overestimated by physicians. This study measures level of understanding of informed consent for elective cesarean surgery using an evidence-based informed consent (EBIC) model based on six MERLO assessments. MERLO recognition and production scores and follow-up interviews of 50 patients and their partners were recorded. Statistical comparison of scores within couples was performed by weighted kappa agreement, t-tests, and Ward’s hierarchical clustering. Recognition score means were high for patients and partners with low standard deviation (SD), while production scores means were lower with higher SD. Clustering analysis showed that only 70% (35/50) of couples were assigned to the same cluster and t-test yields significant difference of scores within couple. Kappa yields moderate agreement levels on all items except for items D and C, which are lower. Follow-up interviews show that participants consider MERLO assessments to be helpful in improving comprehension.

Can a ‘consent to contact’ community help research teams overcome barriers to recruitment? The development and impact of the ‘Research for the Future’ community
Debate
Katherine Grady, Martin Gibson, Peter Bower
BMC Medical Research Methodology, 22 October 2019; 19(195)
Open Access
Abstract
Background
Recruitment to health research remains a major challenge. Innovation is required to meet policy commitments to help patients take part in health research. One innovation that may help meet those policy goals is the development of ‘consent to contact’ systems, where people give generic consent to be contacted about research opportunities. Despite their potential, there are few empirical assessments of different ways of recruiting patients to such communities, or of the value of such communities to local research teams.
Main text
We describe the development of the ‘Research for the Future‘consent to contact community, outline the recruitment of patients to the community, and present data on their participation in research.
Discussion
Over 5000 people have been registered across 3 clinical areas. A range of recruitment strategies have been used, including direct recruitment by clinicians, postal invitations from primary care, and social media. In a 1 year period (2016–2017), the community provided over 1500 participants for a variety of research projects. Feedback from research teams has generally been positive.
Summary
The ‘Research for the Future‘consent to contact community has proven feasible and useful for local research teams. Further evaluation is needed to assess the cost-effectiveness of different recruitment strategies, explore patient and researcher experience of its advantages and disadvantages, and explore how the community can be more reflective of the wider population.

Informed Consent From Adults
Martyn Hammersley
SAGE Research Methods Foundations, 9 September 2019
Excerpt
Informed consent is widely regarded as a highly desirable, or even essential, basis for people’s participation in social research projects. This is true whether the participants are adults or children. It involves people deciding whether or not they are willing to participate, researchers giving them all the relevant information required to make a sound decision, and allowing them to withdraw from participation at any time. In the case of children, and some categories of “vulnerable” adults (e.g., those with learning difficulties), there can be challenging issues about how, and from whom, informed consent should be sought. However, there are also some more general questions about whether obtaining informed consent is always required, what it entails, and what function it serves. This entry focuses specifically on …