Informed Consent: A Monthly Review

October 2020

This digest aggregates and distills key content adressing 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_October 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
BMJ Medical Ethics, 26 August 2020; 46(9) pp 565-568
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.

The ethics of deferred consent in times of pandemics

The ethics of deferred consent in times of pandemics
Rieke van der Graaf, Marie-Astrid Hoogerwerf, Martine C. de Vries
Nature Medicine, 10 July 2020; 26 pp 1328–1330
Open Access
In the current COVID-19 pandemic, many researchers are applying to research ethics committees for deferred-consent procedures for protocols that aim either to test treatments or to obtain tissue or samples from research participants. However, the deferred-consent procedure has not been developed for pandemics. In this Comment, we interpret existing guidance documents and argue when and under which conditions deferred consent can be considered ethically acceptable in a pandemic…

The Use of Electronic Consent for COVID‐19 Clinical Trials: Lessons for Emergency Care research During a Pandemic and Beyond

The Use of Electronic Consent for COVID‐19 Clinical Trials: Lessons for Emergency Care research During a Pandemic and Beyond
Eric Jaton, Jamie Stang, Michelle Biros, Abbey Staugaitis, Julie Scherber, Florian Merkle, Nicholas M. Mohr, Christopher Streib, Lauren Klein, Michael A. Puskarich
Academic Emergency Medicine, 24 September 2020
Open Access
The novel SARS‐CoV‐2 coronavirus poses many unique challenges to the implementation of clinical research, particularly as it relates to the processes of informed consent. Traditional methods of in‐person informed consent were no longer plausible, as face‐to‐face discussions may expose researchers and patients to increased risk of contracting and spreading the virus. In many circumstances the research personnel obtaining consent were considered non‐essential workers, and thus did not have priority for personal protective equipment in light of national shortages.

The Forgotten Element in the Resumption of Elective Bariatric Surgery During the COVID-19 Pandemic: the Patient Consent!

The Forgotten Element in the Resumption of Elective Bariatric Surgery During the COVID-19 Pandemic: the Patient Consent!
Brief Communication
Mohammed Said, Hosam Hamed
Obesity Surgery, 19 September 2020
Safety comes first, and the sympathy with the postponed bariatric patients should not come at the expense of the proper standard of care. This study presents a survey of 266 bariatric candidates who were rescheduled for bariatric surgery after postponement during the COVID-19 pandemic. The aim was to assess their knowledge and expectations regarding bariatric surgery and the risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. A total of 233 (87.6%) candidates believed that they were prone to a higher risk of severe SARS-CoV-2 infection, and 24.4% of them believed that bariatric surgery, during the pandemic, would improve their immunity. A total of 27.8% of candidates attributed the responsibility regarding potential perioperative SARS-CoV-2 infection to the medical personnel, and 10.7% of them believed it to be the surgeon’s responsibility.

COVID-19 consent and return to elective orthopaedic surgery allowing a true patient choice?

COVID-19 consent and return to elective orthopaedic surgery allowing a true patient choice?
Timothy M. Clough, Nikhil Shah, Hiren Divecha, Sumedh Talwalkar
Bone Joint Open 2020, 14 September 2020; 1(9) pp 556–561
The exact risk to patients undergoing surgery who develop COVID-19 is not yet fully known. This study aims to provide the current data to allow adequate consent regarding the risks of post-surgery COVID-19 infection and subsequent COVID-19-related mortality.
All orthopaedic trauma cases at the Wrightington Wigan and Leigh NHS Foundation Trust from ‘lockdown’ (23 March 2020) to date (15 June 2020) were collated and split into three groups. Adult ambulatory trauma surgeries (upper limb trauma, ankle fracture, tibial plateau fracture) and regional-specific referrals (periprosthetic hip fracture) were performed at a stand-alone elective site that accepted COVID-19-negative patients. Neck of femur fractures (NOFF) and all remaining non-NOFF (paediatric trauma, long bone injury) surgeries were performed at an acute site hospital (mixed green/blue site). Patients were swabbed for COVID-19 before surgery on both sites. Age, sex, nature of surgery, American Society of Anaesthesiologists (ASA) grade, associated comorbidity, length of stay, development of post-surgical COVID-19 infection, and post-surgical COVID-19-related deaths were collected.
At the elective site, 225 patients underwent orthopaedic trauma surgery; two became COVID-19-positive (0.9%) in the immediate perioperative period, neither of which was fatal. At the acute site, 93 patients underwent non-NOFF trauma surgery, of whom six became COVID-19-positive (6.5%) and three died. A further 84 patients underwent NOFF surgery, seven becoming COVID-19 positive (8.3%) and five died.
At the elective site, the rate of COVID-19 infection following orthopaedic trauma surgery was low, at 0.9%. At the acute mixed site (typical district general hospital), for non-NOFF surgery there was a 6.5% incidence of post-surgical COVID-19 infection (seven-fold higher risk) with 50% COVID-19 mortality; for NOFF surgery, there was an 8.3% incidence of post-surgical COVID-19 infection, with 71% COVID-19 mortality. This is likely to have significance when planning a resumption of elective orthopaedic surgery and for consent to the patient.

Allocation of Resources and Health Professionals’ Burden During the Covid-19 Pandemic: Reflection on Advanced Directives, Informed Consent, And Social Perception in Mexico

Allocation of Resources and Health Professionals’ Burden During the Covid-19 Pandemic: Reflection on Advanced Directives, Informed Consent, And Social Perception in Mexico
Karen Herrera-Ferrá, Leonardo Souza-García, Antonio Muñoz-Torres
Online Journal of Health Ethics, 11 August 2020; 16(2)
Open Access
One of the main problems in the COVID-19 pandemic is the insufficient availability of resources. This deficiency has resulted in emotional and moral burdens of health professionals. Decisions are having to be made as to who will live and who will die. Moreover, given the global impact of this pandemic, negative impacts are heightened in low and middle-income countries such as Mexico. Authors focus on two issues related to, but not exclusive, to the Mexican healthcare system in an attempt to partially address scarce resources and health professionals’ burden. First, is the empowerment of patients’ autonomy through the incorporation of advanced directives (i.e. nonresuscitate order, the use of intensive care unit and/or ventilator) within informed consent. And second, the socio-cultural perception of risk as relevant for public engagement on protective behavioral patterns. We argue that addressing these issues could possibly lessen the burden of healthcare professionals and bring about greater autonomy among the public.

An audit of questions asked by participants during the informed consent process for regulatory studies at a tertiary referral centre – An analysis of consent narratives

An audit of questions asked by participants during the informed consent process for regulatory studies at a tertiary referral centre – An analysis of consent narratives
Research Article
Unnati Saxena, Debdipta Bose, Mitesh Kumar Maurya, Nithya Jaideep Gogtay, Urmila Mukund Thatte
Clinical Ethics, 20 September 2020
To evaluate the questions asked during the informed consent process by adult and adolescent participants as well as their parents in five interventional regulatory studies conducted at our center from 2018 to 2019.
The study protocol was approved by Institutional Ethics Committee [EC/OA-116/2019]. Consent narratives in the source documents for the studies were evaluated. Questions asked were classified as per Indian Council of Medical Research’s (ICMR) guidelines (2017). We evaluated total number of questions, nature of questions and whether there was an association between education, gender, phase of trials, physician taking consent and number questions being asked.
A total of five studies that had N = 297 consent narratives were evaluated. Narratives of n = 284 adult participants/Guardians and of n = 13 children were analysed. A total of 374 questions were asked of which children asked only 10 questions. A total of 131/284 (40%) of the participants did not ask any question. Among the participants who asked questions, the majority132/171 (77%) participants asked about risks related to investigational products followed by questions related to study procedures 83/171 (49%). Participants/guardians with higher education (relative to those who were educated upto the secondary school and primary school) and those who consented for Phase III studies (relative to Phase I studies) asked significantly more questions (p < 0.0001).
A majority of the queries were related to the risks associated with the investigational products. Educational status and the Phase of the trial were found to be significantly associated with the number of questions being asked.

Characteristics Associated With Consent and Reasons for Declining in a Randomized Trial in Pregnancy

Characteristics Associated With Consent and Reasons for Declining in a Randomized Trial in Pregnancy
Original Research
Gail Mallett, Kim Hill, Jessica de Voest, Sabine Bousleiman, Donna Allard, Stacy Harris, Ashley Salazar, Kelly Clark, Felecia Ortiz, Anna Bartholomew, Wendy Dalton, Jennifer Craig, Melissa Bickus,
Obstetrics & Gynecology, 10 September 2020
To evaluate the maternal characteristics associated with consent to a randomized trial of labor induction in pregnancy.
This is a secondary analysis of low-risk nulliparous women randomized to induction of labor at 39 weeks or expectant management. During the trial, the Data and Safety Monitoring Committee requested additional fields on the screening log, which already included race and ethnicity: maternal age, type of insurance, and the reason for declining consent if declined.
From August 2016 (start of additional data collection) to August 2017, 1,965 (28%) of the 7,112 eligible women consented to the trial. Consent was more likely for Black women (41%, adjusted odds ratio [aOR] 1.47, 95% CI 1.24–1.74), and less likely for Asian women (15%, aOR 0.64, 95% CI 0.48–0.84), compared with White women (24%). Women without private insurance were more likely to consent (38%, aOR 1.55, 95% CI 1.34–1.79), compared with those with private insurance (22%). Younger women were also more likely to consent. Among eligible women who declined participation and provided a reason (68%), preference to be expectantly managed (85%) was most common, a response more common in Asian women (aOR 1.75, 95% CI 1.31–2.33) and less common in women without private insurance (aOR 0.60, 95% CI 0.51–0.70). Not wanting to participate in research was more common in Asian women (aOR 2.41, 95% CI 1.44–4.03). Declining consent because family or friends objected was more common in Asian women (aOR 2.51, 95% CI 1.27–4.95) and women without private insurance (aOR 1.68, 95% CI 1.10–2.59).
Frequency of consent and reasons for declining consent were associated with age, type of insurance, and race and ethnicity. These findings should be considered when developing recruitment strategies that promote diverse participant representation.

The Informed Consent Process in Health Research with Under-served Populations: A Realist Review Protocol

The Informed Consent Process in Health Research with Under-served Populations: A Realist Review Protocol
Eleanor Hoverd, Sophie Staniszewska, Jeremy Dale
Research Square, 9 September 2020
Open Access
The informed consent process aims to provide potential participants with information about health research that enables them to make an informed decision as to whether they choose to participate, or not. However, it remains unclear as to whether the process is effective for those whom are under-served in health research. It is a pivotal issue within health research that the diversity of people who participate is broadened. The National Institute for Health Research (NIHR) pledges to support equality, diversity and inclusion, actively creating opportunities for all citizens whom are eligible, to take part in health research.
In order to understand how the informed consent process for under-served populations in health research works, under what circumstances and in what respects, a realist review approach will be undertaken. Searches will be carried out using electronic databases (EMBASE, MEDLINE, Web of Science and PsychInfo), along with selected websites and grey literature. Development of initial rough programme theory(ies) will lead to a more refined programme theory that will provide an explanation of context, mechanism and outcomes. Stakeholder involvement by NIHR (Public) Research Champions, health professionals and clinical academics will provide expert opinion about concepts and programme theory.
Findings of this realist review will highlight how the informed consent process in health research affects the experience and decision-making process of potential participants from under-served populations. They will be written up in accordance with RAMESES guidelines and disseminated to patients and the public, health researchers, health professionals and policymakers through peer-reviewed publication, presentations and discussions. The review will contribute to our understanding of the mechanisms that trigger both positive and negative outcomes in the informed consent process for those whom are often under-represented in health research to inform policy, study design and delivery.