Informed Consent: A Monthly Review
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 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:
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_June 2020
COVID-19 and its impact on informed consent: What should health professionals tell their patients or their proxies?
D J McQuoid-Mason
South African Journal of Bioethics Law, 13 May 2020; 13(1)
Given the increasing number of ethical and legal issues arising from the impact of the COVID-19 epidemic on informed consent by patients, it is necessary for health professionals to explain to patients how the measures taken to combat the spread of the virus impact on their right to give informed consent. Patients need to be reassured that wherever possible, health professionals are ethically bound to obtain informed consent from patients before they subject them to diagnostic testing and treatment, but at the same time, have to comply with the demands of the law. While the South African Constitution, statutory law and the common law all recognise a person’s right to consent before being subjected to treatment or surgical operations, it is necessary to take remedial steps, because of the dangers of spreading the potentially fatal COVID-19 virus, to prevent this. Such steps may involve compelling patients to be screened, tested and treated – sometimes without their consent. Guidance is given to healthcare professionals on how they should counsel their patients, and what they should tell patients about the impact of the COVID-19 regulations on healthcare professionals’ ethical and legal duties regarding the obtaining of informed consent, as well as on whether, if asked, employers can compel their employees to undergo testing without consent, and what to tell patients about this.
Modelling Consent in the Time of COVID-19
Bartha Maria Knoppers, Michael J S Beauvais, Yann Joly, Ma’n H Zawati, Simon Rousseau, Michaël Chassé, Vincent Mooser
Journal of Law and the Biosciences, 8 May 2020
Effective responses to the COVID-19 pandemic require novel solutions for research and responsible data sharing. Biobanking presents itself as a key priority in furthering our understanding of COVID-19. In this article, we propose a tripartite approach to consent to create resources for research relating to COVID-19. The approach aims to link three levels of participation: COVID-19 patient, respiratory/infectious disease patients, and longitudinal study participants. We explore the potential approaches that can be taken to consent processes with these three participant groups. We furthermore describe an access model for both single-site and multi-site data and sample storage. Through dealing with these topics at a high level, the model may be adapted to local legal and ethical requirements while still pursuing its ultimate goal: the creation of a research infrastructure that supports transparent, strong, and open science.
A rationale and framework for seeking remote electronic or phone consent approval in endovascular stroke trials – special relevance in the COVID-19 environment and beyond
Ansaar T Rai, Donald Frei
Journal of NeuroInterventional Surgery, 28 April 2020
Enrollment in time-sensitive endovascular stroke trials can be challenging because of an inability to consent a debilitated patient. Often the legally authorized representative is not on site. Remote consent procedures in the US are inconsistent with the majority of sites shunning these approaches. The current pandemic with visitor restrictions highlights the need for enhancing these options.
Remote electronic and phone consent procedures specifically for endovascular stroke trials from two comprehensive stroke centers (CSC) are presented. An overview of the genesis of informed consent procedures in the US is also included. Results The two CSCs identified as Institution-1 and Institution-2 are large tertiary systems. Institution-1 is a non-profit university-affiliated academic medical center in rural geography. Institution-2 is an HCA hospital in an urban environment. Both serve patients through a spoke-and-hub network, have participated in multiple randomized endovascular stroke trials, and have successfully used these remote options for enrollment. A tiered approach is employed at both institutions with an emphasis on obtaining informed consent in person and resorting to alternatives methods when efforts to that are unsuccessful. A rationale for electronic and phone consent is included, followed by step-by-step illustration of the process at each institution.
Two examples of remote electronic or phone consent procedures from institutions in different geographic environments and organization structures demonstrate that these options can be successfully used for enrollment in stroke trials. The current pandemic highlights the need to enhance these approaches while maintaining appropriate adherence to ethical and legal frameworks.
Informed Consent for Surgery During COVID-19
Indian Journal of Surgery, 24 April 2020
Informed consent has become a challenging issue when surgery at the time of novel corona virus disease 2019 (COVID-19) is to be performed, in view of increased risk of the need of intensive care unit (ICU) in the post-operative period and the associated high mortality if a patient exhibits COVID-19 symptoms in the post-operative period. We have devised a new informed consent format for all patients undergoing surgery incorporating a few points specific for the disease.
The genomic data deficit: On the need to inform research subjects of the informational content of their genomic sequence data in consent for genomic research
Computer Law & Security Review, July 2020; 37
Research subject consent plays a significant role in the legitimation of genomic research in Europe – both ethically and legally. One key criterion for any consent to be legitimate is that the research subject is ‘informed’. This criterion implies that the research subject is given all relevant information to allow them to decide whether engaging with a genomic research infrastructure or project would be normatively desirable and whether they wish to accept the risks associated with engagement. This article makes the normative argument that, in order to be truly ‘informed’, the research subject should be provided with information on the informational content of their genomic sequence data. Information should be provided, in the first instance, prior to the initial consent transaction, and should include: information on the fact that genomic sequence data will be collected and processed, information on the types of information which can currently be extracted from sequence data and information on the uncertainties surrounding the types of information which may eventually be extractable from sequence data. Information should also be provided, on an ongoing basis, as relevant and necessary, throughout the research process, and should include: information on novel information which can be extracted from sequence data and information on the novel uses and utility of sequence data. The article argues that current elaborations of ‘informed’ consent fail to adequately address the requirements set out in the normative argument and that this inadequacy constitutes an issue in need of a solution. The article finishes with a set of observations as to the fora best suited to deliver a solution and as to the substantive content of a solution.
To explore the experience of research nurses who obtain consent from adults in emergency settings to participate in clinical trials, either prospectively or post enrolment
Brown P, Newham R, Hewison A
Journal of Clinical Nursing, 22 May 2020
To explore the understanding and experiences of research nurses who obtain informed consent from adult patients participating in emergency care research.
Qualitative phenomenographic descriptive study.
Ten research nurses from six hospitals in England were recruited. Data were collected using semi-structured face-to-face and telephone interviews between January 2019 and March 2019. Interviews were transcribed verbatim and analysed thematically, informed by phenomenography. COREQ was followed.
Three main themes were identified (1) Emergency research is different (2) Protecting the patient and (3) Experience and confidence with recruitment. It was found that obtaining patient consent in emergency care research was challenging and timing of the process was crucial. Nurses with more experience of emergency care were more confident in approaching patients and their families. There was variability in out-of-hours recruitment which was a consequence of the range of informed consent processes used and the different levels of engagement of clinical teams.
There is a variety of organisational cultures, processes and procedures which affect the way consent is obtained in emergency care research. A team approach was evident in the hospitals where consent rates were high and was more successful than those reliant solely on the presence of a research nurse. Organisations were able to recruit successfully to emergency care research studies irrespective of size and configuration. Further investigation of their models of working and strategies for engagement is needed. Experienced research nurses made a positive difference to recruitment and were more likely to approach patients to obtain consent.
Relevance to Clinical Practice
The understanding and experiences of recruitment to clinical trials in emergency care research by research nurses can help identify barriers to recruitment. This study provides useful insights for healthcare practitioners, clinical trials coordinators and sponsors about how best to develop protocols and policies to increase recruitment to emergency care research.
Patient and Surrogate Postenrollment Perspectives on Research Using the Exception From Informed Consent: An Integrated Survey
Ethics/brief research report
Victoria M. Scicluna, Michelle Biros, Deneil K. Harney, Elizabeth B. Jones, Andrea R. Mitchell, Rebecca D. Pentz, Robert Silbergleit, Candace D. Speigheit, David W. Wright, Neal W. Dickert
Annals of Emergency Medicine, 21 May 2020
It is important for researchers interested in trials using the exception from informed consent to understand the views and experiences of enrolled individuals. Previous studies have shown that patient and surrogate attitudes are generally positive. These studies were small and did not include pediatric patients, and interviews were often conducted long after trial enrollment. This study sought to explore attitudes toward exception from informed consent in a larger sample and more contemporaneous setting.
A 10-item paper-and-pencil survey was integrated into the Established Status Epilepticus Treatment Trial, a randomized trial of 3 treatments for benzodiazepine-refractory status epilepticus in pediatric and adult patients. Primary domains included attitudes toward trial enrollment, exception from informed consent, and community consultation. Simple descriptive statistics, χ2, and Fisher’s exact tests were conducted.
Of 317 patients and surrogates, 90% agreed with or were neutral about the statement “I am glad that I/my family member was included in the Established Status Epilepticus Treatment Trial research study,” whereas 10% disagreed. Twenty-seven percent disagreed with enrollment in the study without prospective consent. Black participants were more likely than white, other race, and unknown-race participants to disagree with enrollment without prospective consent (36% versus 23%, 14%, and 14%, respectively). Participants indicated that patients (81%), their families (65%), and those at risk for seizures (51%) were most important to include in community consultation.
This study aimed to explore attitudes toward exception from informed consent enrollment among participants at all sites in a large, multicenter exception from informed consent trial. General acceptance of trial enrollment was high; acceptance of exception from informed consent specifically was somewhat lower, especially among black participants. Our findings provide further support for targeted community consultation focusing on individuals with connections to the disease under study. Future research should focus on communication in the postenrollment period, especially with individuals who may have concerns about exception from informed consent.
IRB Policies for Obtaining Informed Consent from Non‐English‐Speaking People
Ethics & Human Research, 18 May 2020
United States regulations for the protection of human research subjects prescribe parameters for documentation of valid informed consent, which include the stipulation that the process be in a “language understandable to the subject.” While significant energy has been devoted to improving the readability of consent documents, supplemental educational tools, and nuanced measurements of individual decisional capacity, there is little guidance about how to best meet the informational needs of adults with decisional capacity who do not speak English. This article reviews the institutional review board policies from the twenty‐one research centers that received the most funding from the National Institutes of Health in 2018 and compares their guidelines for obtaining informed consent from non‐English speakers. Inconsistent practices suggest the need for more assertive federal direction on what parameters constitute valid consent for this population. These practices also indicate a reluctance to directly engage the ethical underpinnings of consent policies for non‐English speakers.
Can Consent to Participate in Clinical Research Involve Shared Decision Making?
Case and Commentary
Haley Moulton, Benjamin Moulton, Tim Lahey, Glyn Elwyn
AMA Journal of Ethics, May 2020
Shared decision making honors patient autonomy and improves patient comprehension and therefore should be a part of every clinical decision a patient makes. Use of shared decision making in research informed consent conversations is more complicated due to diverse and potentially divergent investigator and patient interests, along with the presence of clinical equipoise. This article clarifies these different interests and discusses ways in which shared decision making can be applied in research. Provided there is transparency about competing interests, patient-centered and values-focused communication approaches embodied in shared decision making can support the ethical recruitment of patients for clinical research.