The role of authentic choices in medical consent [PhD Thesis]
Alexander Villafranca
University of Manitoba Electronic Thesis, 23 December 2019
Open Access
Abstract
This dissertation investigates whether the “authenticity” of a patient’s choice (i.e. its correspondence with important markers of the patient’s identity), should be part of a model of valid medical consent. This research question was addressed across three manuscripts using philosophical and empirical methods. Manuscript one is a philosophical manuscript defending my thesis that the standard model of valid consent may be improved by including the “authenticity” of a patient’s choice as an additive condition, thereby forming what I call the “authenticity-informed model of valid consent”. In this manuscript, I present seven procedural practices stemming from this new model. I argue that these practices should be considered for inclusion in the existing procedural recommendations of the Canadian Medical Protective Association (CMPA), which draw heavily from the standard model. The new practices could help physicians to i) more accurately evaluate the decisional capacity of patients; ii) more accurately evaluate the autonomy of patient choices, and iii) better support the psychological and physical well-being of patients. I also created vignettes to assess empirically whether the end goal of promoting authentic and autonomous patient choices would have instrumental value above choices that are solely autonomous. In manuscript two, I introduce the use of pretesting to evaluate and enhance the rigor of vignettes studies used in empirical ethics research. This manuscript includes an illustrative example of how data collected through a respondent debriefing procedure can be used to measure numerous desirable vignette characteristics. Manuscript three uses the vignettes to evaluate the instrumental value of shifting from a choice that is solely autonomous to one that is both authentic and autonomous in a single, but consequential, clinical scenario. This study confirms that shifting from a solely autonomous choice to an authentic and autonomous choice can substantially decrease anticipated decisional regret and increase both anticipated decisional satisfaction and compliance with postoperative instructions. In conclusion, there are plausible reasons to believe that adding authenticity may improve the standard model of valid consent and its associated procedural practices. Consequently, consideration should be given to modifying the procedural recommendations of the CMPA to reflect the addition of authenticity.
Rethinking Informed Consent in a Relational Perspective
Rethinking Informed Consent in a Relational Perspective
Fabio Macioce
notizie di POLITEIA, 2019; pp. 111-128 111
Open Access
Abstract
The article takes the interplay between autonomy and vulnerability into consideration, arguing that the informed consent procedures should be rethought in a relational perspective, so as to improve patients’ right to self-determination. The article aims to demonstrate that communicative contexts and power relations are as relevant as the quantity or the quality of information provided, as well as their form, modality, and effects. In order to discuss this topic, the recent Italian Act No. 219/2017 is analysed: more than other legal instruments, it explicitly asks to take the specific condition of every person into account, and to adapt the informative process to the needs of the patient. The precondition of a free and informed consent, besides the information received, is the relationship of trust between the parties involved, and the consistency between their modes of interaction and the necessity to keep a mutual trust. In that sense, the information is adequate and relevant as a function of the kind of relationship between the parties. The article argues that even if such a goal is largely outside the reach of the legislator, the legal system can settle the condition to make the relationship of trust possible.
Informed Consent: A Monthly Review
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January 2020
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_January 2020
Why parents consent to their children’s participation in genetic research: A study of parental decision making
Why parents consent to their children’s participation in genetic research: A study of parental decision making
Kumari S, Bhatia T, Mishra NN, Kumari N, Narayanan SS, Malik D, Deshpande SN
Indian journal of medical ethics, October-December 2019
Abstract
Parents need to be asked to provide informed consent on behalf of their child for participation in genetic research. Decision making for such parents is difficult because ethical challenges in paediatric genetic research studies are different from similar adult studies. This paper focuses on interviews conducted with parents who were asked to consent to their children’s participation (or not) in a genetic research study of intellectual disability and/or autism.
Navigating the Informed Consent Process When Using Innovative Surgery
Navigating the Informed Consent Process When Using Innovative Surgery
Research Article
Daniel Wehrmann, Glenn E. Green, MD, Kevin J. Weatherwax, Andrew G. Shuman
Otolaryngology–Head and Neck Surgery, 24 December 2019
Excerpt
… Expanded access (EA), also referred to as “compassionate use,” is a Food and Drug Administration (FDA) mechanism by which patients with serious or life-threatening conditions for which there is no approved treatment may access novel investigational drugs, biologics, or medical devices. The benefits of the proposed drug/device must outweigh the risks to that patient or group of patients… Obtaining informed consent in this setting is complicated due to the conflation of clinical care and research, with each directed at different primary goals. Traditionally, clinicians are expected to solely focus on the best possible outcome for the patients they are treating. Researchers, on the other hand, are primarily focused on creating generalizable knowledge to help all patients. Of course, these goals may be more or less divergent, especially when surgeon-scientists are acting in both capacities… Surgical innovation using the EA program represents a thoughtful balance between patient/family choices, our duty to potential future patients, and the regulatory landscape in which we practice. The informed consent process represents an amalgam of standard clinical components, as well as clinical research regulations that necessarily meet a higher standard and level of scrutiny. As such, our obligations as researchers, clinicians, and our dual roles as both, highlight the need for us to uphold the highest levels of morality, ethics, and professionalism.
Parental opinions regarding consent for observational research of no or minimal risk in the pediatric intensive care unit
Parental opinions regarding consent for observational research of no or minimal risk in the pediatric intensive care unit
Research
Jessica Hodson, Christiana Garros, Jodie Jensen, Jonathan P. Duff, Gonzalo Garcia Guerra, Ari R. Joffe
Journal of Intensive Care, 16 December 2019; 7(60)
Open Access
Abstract
Background
The aim of the study was to determine opinions and knowledge regarding the process of obtaining informed consent to participate in observational research in pediatric intensive care.
Methods
Survey 1 asked decision makers what model(s) of consent was acceptable for each type of observational research both before and after background information. Survey 2 asked decision makers about the experience of being asked for consent to observational research, and knowledge regarding the consent process both before and after background information.
Results
Cooperation rate was 100/117 (85%). The proportion in favor of any of the offered alternatives to signed informed consent for observational research, after receiving all the background information, was 74-80%, lowest for observational prospective research with a minimal risk intervention 37/50 (74%; 95% CI 60–84%). The proportion who agreed they felt overwhelmed by being approached for consent to observational research was 26 (52%; 95% CI 39-65%). Most respondents (from 60 to 74%) felt they understood the concepts regarding observational research; however, after reading background information, most (from 60 to 74%) felt their understanding had improved “a great deal”.
Conclusion
Understanding of risk, practical difficulties, consent bias, and Research Ethics Board safeguards was poor. Future study is needed to confirm our finding that most agreed with alternative methods of consent for observational research.
Reporting of ethical approval and informed consent in clinical research published in leading nursing journals: a retrospective observational study
Reporting of ethical approval and informed consent in clinical research published in leading nursing journals: a retrospective observational study
Research Article
Yanni Wu, Michelle Howarth, Chunlan Zhou, Mingyu Hu, Weilian Cong
BMC Medical Ethics, 5 December 2019; 20(94)
Open Access
Abstract
Background
Ethical considerations play a prominent role in the protection of human subjects in clinical research. To date the disclosure of ethical protection in clinical research published in the international nursing journals has not been explored. Our research objective was to investigate the reporting of ethical approval and informed consent in clinical research published in leading international nursing journals.
Methods
This is a retrospective observational study. All clinical research published in the five leading international nursing journals from the SCI Journal Citation Reports between 2015 and 2017 were retrieved to evaluate for evidence of ethical review.
Results
A total of 2041 citations have been identified from the contents of all the five leading nursing journals that were published between 2015 and 2017. Out of these, 1284 clinical studies have been included and text relating to ethical review has been extracted. From these, most of prospective clinical studies (87.5%) discussed informed consent. Only half of those (52.9%) reported that written informed consent had been obtained; few (3.6%) reported oral consent, and few (6.8%) used other methods such as online consent or completion and return of data collection (such as surveys) to denote assent. Notably, 36.2% of those did not describe the method used to obtain informed consent and merely described that “consent was obtained from participants or participants agreed to join in the research”. Furthermore, whilst most of clinical studies (93.7%) mentioned ethical approval; 92.5% of those stated the name of ethical committee and interestingly, only 37.1% of those mentioned the ethical approval reference. The rates of reporting ethical approval were different between different study type, country, and whether financial support was received (all P < 0.05).
Conclusion
The reporting of ethics in leading international nursing journals demonstrates progress, but improvement of the transparency and the standard of ethical reporting in nursing clinical research is required.
Dual consent? Donors’ and recipients’ views about involvement in decision-making on the use of embryos created by gamete donation in research
Dual consent? Donors’ and recipients’ views about involvement in decision-making on the use of embryos created by gamete donation in research
Research Article
Baía, C. de Freitas, C. Samorinha, V. Provoost, S. Silva
BMC Medical Ethics, 2 December 2019; 20(90)
Open Access
Abstract
Background
Reasonable disagreement about the role awarded to gamete donors in decision-making on the use of embryos created by gamete donation (EGDs) for research purposes emphasises the importance of considering the implementation of participatory, adaptive, and trustworthy policies and guidelines for consent procedures. However, the perspectives of gamete donors and recipients about decision-making regarding research with EGDs are still under-researched, which precludes the development of policies and guidelines informed by evidence. This study seeks to explore the views of donors and recipients about who should take part in consent processes for the use of EGDs in research.
Methods
From July 2017 to June 2018, 72 gamete donors and 175 recipients completed a self-report structured questionnaire at the Portuguese Public Bank of Gametes (response rate: 76%). Agreement with dual consent was defined as the belief that the use of EGDs in research should be consented by both donors and recipients.
Results
The majority of participants (74.6% of donors and 65.7% of recipients) were willing to donate embryos for research. Almost half of the donors (48.6%) and half of the recipients (46.9%) considered that a dual consent procedure is desirable. This view was more frequent among employed recipients (49.7%) than among non-employed (21.4%). Donors were less likely to believe that only recipients should be involved in giving consent for the use of EGDs in research (25.0% vs. 41.7% among recipients) and were more frequently favourable to the idea of exclusive donors’ consent (26.4% vs. 11.4% among recipients).
Conclusions
Divergent views on dual consent among donors and recipients indicate the need to develop evidence-based and ethically sustainable policies and guidelines to protect well-being, autonomy and reproductive rights of both stakeholder groups. More empirical research and further theoretical normative analyses are needed to inform people-centred policy and guidelines for shared decision-making concerning the use of EGDs for research.
Authority and the Future of Consent in Population-Level Biomedical Research
Authority and the Future of Consent in Population-Level Biomedical Research
Mark Sheehan, Rachel Thompson, Jon Fistein, Jim Davies, Michael Dunn, Michael Parker, Julian Savulescu, Kerrie Woods
Public Health Ethics, 30 October 2019; 12(3) pp 225–236
Abstract
Population-level biomedical research has become crucial to the health system’s ability to improve the health of the population. This form of research raises a number of well-documented ethical concerns, perhaps the most significant of which is the inability of the researcher to obtain fully informed specific consent from participants. Two proposed technical solutions to this problem of consent in large-scale biomedical research that have become increasingly popular are meta-consent and dynamic consent. We critically examine the ethical and practical credentials of these proposals and find them lacking. We suggest that the consent problem is not solved by adopting a technology driven approach grounded in a notion of ‘specific’ consent but by taking seriously the role of research governance in combination with broader conceptions of consent. In our view, these approaches misconstrue the rightful location of authority in the way in which population-level biomedical research activities are structured and organized. We conclude by showing how and why the authority for determining the nature and shape of choice making about participation ought not to lie with individual participants, but rather with the researchers and the research governance process, and that this necessarily leads to the endorsement of a fully articulated broad consent approach.
Experimental infections in humans—historical and ethical reflections
Experimental infections in humans—historical and ethical reflections
G. Metzger, H.‐J. Ehni, P. G. Kremsner, B. G. Mordmüller
Tropical Medicine & International Health, 26 October 2019
Open Access
Abstract
Vaccine efficacy and prophylactic treatment of infections are tested best when the vaccinated or treated individual is challenged through deliberate infection with the respective pathogen. However, this trial design calls for particular ethical caution. Awareness of the history of challenge trials is indispensable, including trials that were problematic or even connected to abuse. We briefly introduce historical aspects of experimental infections in humans and the ethical debate around them and give estimates of the numbers of volunteers participating in human experimental infection models. Challenge models can offer a great chance and benefit for the development of medical interventions to fight infectious diseases, but only when they are appropriately controlled and regulated.
Center for Informed Consent Integrity 