Informed Consent: A Monthly Review

July 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 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_July 2020

Consent in the time of COVID-19

Consent in the time of COVID-19
Helen Lynne Turnham, Michael Dunn, Elaine Hill, Guy T Thornburn, Dominic Wilkinson
Journal of Medical Ethics, 15 May 2020
Open Access
The COVID-19 pandemic crisis has necessitated widespread adaptation of revised treatment regimens for both urgent and routine medical problems in patients with and without COVID-19. Some of these alternative treatments maybe second-best. Treatments that are known to be superior might not be appropriate to deliver during a pandemic when consideration must be given to distributive justice and protection of patients and their medical teams as well the importance given to individual benefit and autonomy. What is required of the doctor discussing these alternative, potentially inferior treatments and seeking consent to proceed? Should doctors share information about unavailable but standard treatment alternatives when seeking consent? There are arguments in defence of non-disclosure; information about unavailable treatments may not aid a patient to weigh up options that are available to them. There might be justified concern about distress for patients who are informed that they are receiving second-best therapies. However, we argue that doctors should tailor information according to the needs of the individual patient. For most patients that will include a nuanced discussion about treatments that would be considered in other times but currently unavailable. That will sometimes be a difficult conversation, and require clinicians to be frank about limited resources and necessary rationing. However, transparency and honesty will usually be the best policy.

Leveraging Tele-Critical Care Capabilities for Clinical Trial Consent

Leveraging Tele-Critical Care Capabilities for Clinical Trial Consent
Kristina M. Ieronimakis, Janell A. Cain, Michael S. Switzer, David D. Odineal, Thomas K. Deacy, Michael T. O.  Stein, Rhonda E. Colombo, Christopher J. Colombo
Critical Care Explorations, July 2020; 2(7) e0167
Open Access
A severe coronavirus disease 2019 patient admitted to our institution for medical management was enrolled in a randomized placebo-controlled trial of an investigational therapeutic for coronavirus disease 2019. We leveraged existing video-telecommunication equipment to obtain informed consent. We found video-telecommunication use closely mirrored person-to-person contact for research consent by maintaining engagement and ensuring understanding. Video-telecommunication use facilitated clinical research while minimizing unnecessary exposure to coronavirus disease 2019 and conserving personal protective equipment. Prior to the coronavirus disease 2019 pandemic, research regulatory agencies were essentially silent on the matter of video-telecommunication consent. Regulatory guidance became available during the pandemic in response to increased isolation and social distancing practices. Virtual health and telemedicine use expanded greatly during the pandemic, and this increase will likely persist after the pandemic ends. We anticipate video-telecommunication adoption and implementation for research consent will also continue to grow after the coronavirus disease 2019 pandemic is over.

Risks of COVID‐19 for surgical cancer patients: The importance of the informed consent process

Risks of COVID‐19 for surgical cancer patients: The importance of the informed consent process
Alberto Julius Alves Wainstein, Ana Paula Drummond‐Lage, Reitan Ribeiro, Héber Salvador de Castro Ribeiro, Rodrigo Nascimento Pinheiro, Glauco Baiocchi, Paulo Henrique de Sousa Fernandes, Marciano Anghinoni, Gustavo Andreazza Laporte, Manoel Jesus Coelho Junior, Vinicius Negri Dall’Inha, Alexandre Ferreira Oliveira
Journal of Surgical Oncology, 20 June 2020
Open Access
Since the World Health Organization (WHO) declared novel coronavirus disease‐2019 (COVID‐19) a global pandemic in March 2020, its rapidly spreading outbreak imposes an unprecedented burden on the effectiveness and sustainability of the health care system all over the world. The global debate regarding the safety and feasibility of continuing to perform elective surgery made most surgical societies suggest that nonessential elective surgery should be postponed. However, now, it is clear that cancer surgery, in general, should not be delayed for most patients. As part of the patients’ preparation for surgery, the traditional informed consent now must also address the risks of COVID‐19.

It is unquestioned that, despite the infection effect on practice, the consent process should keep the patient as the main focus. Taking that into consideration, it is the Brazilian Society of Surgical Oncology’s (BSSO) objective to present the main aspects that must be covered in a surgical Informed Consent Form (ICF) to properly inform patients how this pandemic has influenced their cancer surgery and perioperative care. Supplement 1 provides the BSSO suggested ICF, adjusted to Brazilian laws and regulations…

Research on COVID-19 in South Africa: Guiding principles for informed consent

Research on COVID-19 in South Africa: Guiding principles for informed consent
J de Vries, T Burgess, M Blockman, N A B Ntusi
South African Medical Journal, 5 June 2020
Open Access
Research is imperative in addressing the COVID-19 epidemic, both in the short and long term. Informed consent is a key pillar of research and should be central to the conduct of COVID-19 research. Yet a range of factors, including physical distancing requirements, risk of exposure and infection to research staff, and multiple pressures on the healthcare environment, have added layers of challenges to the consent process in COVID-19 patients. Internationally, the recognition that consent for COVID-19 research may be imperfect has led to a range of suggestions to ensure that research remains ethical. Drawing on these guidelines, we propose a consent process for COVID-19 research in the South African context that combines individual consent with delayed and proxy consent for individuals who may be temporarily incapacitated, combined with key principles that should be considered in the design of a consent process for COVID-19 research.

Urological surgery in the COVID-19 era: Patient counselling and informed consent

Urological surgery in the COVID-19 era: Patient counselling and informed consent
Elsayed Desouky
Arab Journal of Urology, 17 May 2020; 18(2) pp 62-64
Open Access
The current coronavirus disease 2019 (COVID-19) pandemic is massively affecting our daily practice. Elective surgical service has been significantly altered, i.e. reduced overall service provision, special operating theatres’ precautions, as well as considerations for testing patients before surgery. The process of counselling patients and obtaining their consent is a must before any surgical intervention. Several factors can affect this process particularly amid the current pandemic crisis. Only with a full understanding of all the relevant facts, including risks and available alternatives, can patients give an ‘informed consent’. Therefore, we urologists need to be aware of the impact of the current COVID-19 situation on how to consent our patients.

Protecting Privacy and Consent Online

Protecting Privacy and Consent Online
Barnaby Lewis
International Standards Organisation, 23 June 2020
For everyone concerned about online privacy, ISO/IEC 29184 has just been published…
Devices such as these collect and process your personal data. That might include geographical and biometric data, or the frequency and timing of interactions with the device. That’s legitimate, and useful for those who want to be able to get an objective insight into, say, their sleeping habits. But it also provides lucrative opportunities to companies who use such data to market their products and services, often without our informed consent… The new standard, developed jointly by ISO and the IEC’s committee on information security, cybersecurity and privacy protection1), provides details on the implementation of privacy principles from ISO/IEC 29100. Specifically, it addresses consent and choice (Principle 1), and openness, transparency and notice… In addition to providing clearer information about what kind of PII is being collected and how it is being used, ISO/IEC 29184 will help people to better understand just what they’re signing up to when they use connected services and, importantly, how to withdraw their consent…

A qualitative study on aspects of consent for genomic research in communities with low literacy

A qualitative study on aspects of consent for genomic research in communities with low literacy
Research Article
Daima Bukini, Columba Mbekenga, Siana Nkya, Lisa Purvis, Sheryl McCurdy, Michael Parker, Julie Makani
BMC Medical Ethics, 12 June 2020; 21(48)
Open Access
Low literacy of study participants in Sub – Saharan Africa has been associated with poor comprehension during the consenting process in research participation. The concerns in comprehension are far greater when consenting to participate in genomic studies due to the complexity of the science involved. While efforts are made to explore possibilities of applying genomic technologies in diseases prevalent in Sub Saharan Africa, we ought to develop methods to improve participants’ comprehension for genomic studies. The purpose of this study was to understand different approaches that can be used to seek consent from individuals with low literacy in Sub-Saharan African countries in genomic research to improve comprehension.
Using qualitative study design, we conducted focus-group discussions, in-depth interviews and participant observations as data collection methods. This study was embedded in a hospital based genomic study on Sickle Cell Disease at Muhimbili National Hospital in Tanzania. Thematic content analysis was used to analyse the transcripts and field notes.
Findings from this study show that literacy level has little influence on understanding the research details. According to the participants of this study, the methods used to provide information, the language, and time spent with the study participants were the key factors influencing understanding. The availability of group sessions held before individual consent to allow for a detailed questions and answers format was agreed to be the best method to facilitate the comprehension.
The quality of the consenting process of participants will be influence by a number of factors. The type of research consented for, where the research will be implemented and who are the potential study participants are amongst the factors that need to be assessed during the consenting. Measures to improve participants’ comprehension need to be developed when consenting participants with low literacy level in genomic studies.

Research ethics and refugee health: a review of reported considerations and applications in published refugee health literature, 2015-2018

Research ethics and refugee health: a review of reported considerations and applications in published refugee health literature, 2015-2018
Emma E. Seagle, Amanda J. Dam, Priti P. Shah, Jessica L. Webster, Drue H. Barrett, Leonard W. Ortmann, Nicole J. Cohen,  Nina N. Marano
BMC Conflict and Health, 20 June 2020; 14(39)
Open Access
Public health investigations, including research, in refugee populations are necessary to inform evidence-based interventions and care. The unique challenges refugees face (displacement, limited political protections, economic hardship) can make them especially vulnerable to harm, burden, or undue influence. Acute survival needs, fear of stigma or persecution, and history of trauma may present challenges to ensuring meaningful informed consent and establishing trust. We examined the recently published literature to understand the application of ethics principles in investigations involving refugees.
We conducted a preliminary review of refugee health literature (research and non-research data collections) published from 2015 through 2018 available in PubMed. Article inclusion criteria were: participants were refugees, topic was health-related, and methods used primary data collection. Information regarding type of investigation, methods, and reported ethics considerations was abstracted.
We examined 288 articles. Results indicated 33% of investigations were conducted before resettlement, during the displacement period (68% of these were in refugee camps). Common topics included mental health (48%) and healthcare access (8%). The majority (87%) of investigations obtained consent. Incentives were provided less frequently (23%). Most authors discussed the ways in which community stakeholders were engaged (91%), yet few noted whether refugee representatives had an opportunity to review investigational protocols (8%). Cultural considerations were generally limited to gender and religious norms, and 13% mentioned providing some form of post-investigation support.
Our analysis is a preliminary assessment of the application of ethics principles reported within the recently published refugee health literature. From this analysis, we have proposed a list of best practices, which include stakeholder engagement, respect for cultural norms, and post-study support. Investigations conducted among refugees require additional diligence to ensure respect for and welfare of the participants. Development of a refugee-specific ethics framework with ethics and refugee health experts that addresses the need for stakeholder involvement, appropriate incentive use, protocol review, and considerations of cultural practices may help guide future investigations in this population.

Barriers to Obtaining Informed Consent on Shortterm Surgical Missions

Barriers to Obtaining Informed Consent on Shortterm Surgical Missions
Urška Čebron, Calum Honeyman, Meklit Berhane, Vinod Patel,  Dominique Martin, Mark McGurk
Plastic and Reconstructive Surgery – Global Open: May 2020; 8(5) e2823
Open Access
Short-term surgical missions (STSMs) enable visiting surgeons to help address inequalities in the provision of surgical care in resource-limited settings. One criticism of STSMs is a failure to obtain informed consent from patients before major surgical interventions. We aim to use collective evidence to establish the barriers to obtaining informed consent on STSMs and in resource-limited settings and suggest practical solutions to overcome them.
A systematic review was performed using PubMed and Web of Science databases and following Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines. In addition to the data synthesized from the systematic review, we also include pertinent data from a recent long-term follow-up study in Ethiopia.
Of the 72 records screened, 11 studies were included in our review. The most common barrier to obtaining informed consent was a paternalistic approach to medicine and patient education. Other common barriers were a lack of ethics education among surgeons in low-income and middle-income countries, cultural beliefs toward healthcare, and language barriers between the surgeons and patients. Our experience of a decade of reconstructive surgery missions in Ethiopia corroborates this. In a long-term follow-up study of our head-and-neck patients, informed consent was obtained for 85% (n = 68) of patients over a 14-year period.
This study highlights the main barriers to obtaining informed consent on STSMs and in the resource-limited setting. We propose a checklist that incorporates practical solutions to the most common barriers surgeons will experience, aimed to improve the process of informed consent on STSMs.