Informed Consent: A Monthly Review

May 2021

This digest aggregates and distills key content addressing 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_May 2021

Editor’s Note:
Posting of Informed Consent Content on Clinical Trials Registries was the latest webinar in the Center’s continuing series held on April 21st 2021. Foundation president David Curry opened the call with a short presentation followed by a panel discussion with Barbara Redman, Director of the Center for Informed Consent Integrity, and Jan Jaeger, Fellow of the GE2P2 Global Foundation. The discussion was focused on issues and opportunities around the posting of informed consent content [ICFs+] on clinical trial registries as a means to enhance transparency and strengthen consent in trials overall.


Nursing Home and Vaccination Consent: The Italian Perspective

Nursing Home and Vaccination Consent: The Italian Perspective
Nunzia Cannovo, Roberto Scendoni, Marzia Maria Fede, Federico Siotto, Piergiorgio Fedeli, Mariano Cingolani
Vaccines, 24 April 2021; 4(429)
Open Access
Since the beginning of the Covid-19 pandemic, many countries have begun vaccination campaigns, with different methods and timelines, with the goal of vaccinating over 75% of the population and thus achieving herd immunity. Initially it was necessary to identity the categories of citizens who should be the first to receive the vaccines, on the basis of scientific evidence. On the basis of this information, elderly residents in nursing homes and the staff who care for them should be the highest priority subjects for vaccination. In this context, obtaining informed consent to Covid-19 vaccination presents a considerable challenge, as the advanced age and frequent comorbidities of a significant number of the residents may mean that they are incapable of expressing consent themselves. The legislation of various Western nations substantially agrees on the general principle that those capable of judgement must be asked for their consent for healthcare services, and that even those with psychological weaknesses that limit their full ability to decide must be involved in these decision-making processes. The article can help systematize the processes to be implemented to protect the health of individuals as members of a close and fragile community.

Consent in covid: A researcher’s dilemma

Consent in covid: A researcher’s dilemma
Trends in Anaesthesia and Critical Care, 3 April 2021
Heena Garg, Puneet Khanna
An informed consent is a vital component of health care and forms an important component of any research study. Informed consent is the process where a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. A proper consent is imperative to ensure safety of the patients. However, obtaining a consent in the hospital settings has become a matter of concern in the times of this coronavirus-19 (COVID-19) pandemic. This brief review describes the additional complexities added to the consent for research and the various modifications needed in view of this pandemic. The current consent proformas need to be modified and individualised to the patient ensuring patient safety during research in the ongoing pandemic. We need to become more familiar with the technology and electronic tools as the acceptable alternative tools of communication in the current scenario. There is a need to incorporate a separate covid consent with due consideration to deferred consent, pre-emptive consent or waiver of a consent.

Global Ethical Considerations Regarding Mandatory Vaccination in Children

Global Ethical Considerations Regarding Mandatory Vaccination in Children
Julian Savulescu, Alberto Giubilini, Margie Danchin
The Journal of Pediatrics, 20 January 2021
Open Access
Whether children should be vaccinated against coronavirus disease-2019 (COVID-19) (or other infectious diseases such as influenza) and whether some degree of coercion should be exercised by the state to ensure high uptake depends, among other things, on the safety and efficacy of the vaccine. For COVID-19, these factors are currently unknown for children, with unanswered questions also on children’s role in the transmission of the virus, the extent to which the vaccine will decrease transmission, and the expected benefit (if any) to the child. Ultimately, deciding whether to recommend that children receive a novel vaccine for a disease that is not a major threat to them, or to mandate the vaccine, requires precise information on the risks, including disease severity and vaccine safety and effectiveness, a comparative evaluation of the alternatives, and the levels of coercion associated with each. However, the decision also requires balancing self-interest with duty to others, and liberty with usefulness. Separate to ensuring vaccine supply and access, we outline 3 requirements for mandatory vaccination from an ethical perspective: (1) whether the disease is a grave threat to the health of children and to public health, (2) positive comparative expected usefulness of mandatory vaccination, and (3) proportionate coercion. We also suggest that the case for mandatory vaccine in children may be strong in the case of influenza vaccination during the COVID-19 pandemic.

Rethinking consent processes for research in emergency departments

Rethinking consent processes for research in emergency departments
Joseph Miller, Stephen Guy Costa,  David Alan Taylor, Paul Buntine
Emergency Medicine Australasia, 17 April 2021
Emergency medicine researchers face the challenge of prioritising patients’ immediate interests and maintaining hospital flow while attempting to collect clinical data. Even in low‐risk scenarios, excessive consent processes can make it difficult to recruit patients while observing guidelines on efficient triage. We discuss a recent situation in which a six‐page consent form appeared to deter clinicians from recruiting patients to a low‐risk intervention. We then argue that there need be no conflict between the imperatives of patient wellbeing and clinical research. Apparent conflicts between treatment and research could be reduced through creative recruitment techniques: the adoption of an ‘opt‐out’ approach; securing the budget for a dedicated research assistant; early consultation with the institution’s human research ethics committee; and the use of a short, simple participant information and consent form with a QR code linking to a more detailed outline of the study.

Transparency of informed consent in pilot and feasibility studies is inadequate: a single-center quality assurance study

Transparency of informed consent in pilot and feasibility studies is inadequate: a single-center quality assurance study
Mohammed I.U. Khan, Lawrence Mbuagbaw, Matthew Holek, Faris Bdair, Zoha H. Durrani, Katie Mellor, Saskia Eddy, Sandra M. Eldridge, Claire L. Chan, Michael J. Campbell, Christine M. Bond, Sally Hopewell, Gillian A. Lancaster, Lehana Thabane
Pilot and Feasibility Studies, 16 April 2021; 7(96)
Open Access
Pilot and feasibility studies (PAFS) often have complex objectives aimed at assessing feasibility of conducting a larger study. These may not be clear to participants in pilot studies.
Here, we aimed to assess the transparency of informed consent in PAFS by investigating whether researchers communicate, through patient information leaflets and consent forms, key features of the studies. We collected this data from original versions of these documents submitted for ethics approval and the final approved documents for PAFS submitted to the Hamilton Integrated Research Ethics Board, Canada.
One hundred eighty-four PAFS, submitted for ethics approval from 2004 to 2020, were included, and we found that of the approved consent documents which were provided to participants, 83.2% (153) stated the terms “pilot” or “feasibility” in their title, 12% (22) stated the definition of a pilot/feasibility study, 42.4% (78) of the studies stated their intent to assess feasibility, 19.6% (36) stated the specific feasibility objectives, 1.6% (3) stated the criteria for success of the pilot study, and 0.5% (1) stated all five of these criteria. After ethics review, a small increase in transparency occurred, ranging from 1.6 to 2.8% depending on the criteria. By extracting data from the protocols of the PAFS, we found that 73.9% (136) stated intent to assess feasibility, 71.2% (131) stated specific feasibility objectives, and 33.7% (62) stated criteria for success of the study to lead to a larger study.
The transparency of informed consent in PAFS is inadequate and needs to be specifically addressed by research ethics guidelines. Research ethics boards and researchers ought to be made aware and mindful of best practices of informed consent in the context of PAFS.

Under consent: participation of people with HIV in an Ebola vaccine trial in Canada

Under consent: participation of people with HIV in an Ebola vaccine trial in Canada
Research Article
Pierre-Marie David, Benjamin Mathiot, Oumy Thiongane & Janice E. Graham
BMC Medical Ethics, 9 April 2021; 22(42)
Open Access
Little is known about volunteers from Northern research settings who participate in vaccine trials of highly infectious diseases with no approved treatments. This article explores the motivations of HIV immunocompromised study participants in Canada who volunteered in a Phase II clinical trial that evaluated the safety and immunogenicity of an Ebola vaccine candidate.
Observation at the clinical study site and semi-structured interviews employing situational and discursive analysis were conducted with clinical trial participants and staff over one year. Interviews were recorded, transcribed and analysed using critical qualitative interpretivist thematic analytical techniques. Patterns were identified, clustered and sorted to generate distinct and comprehensive themes. We then reassembled events and contexts from the study participants’ stories to develop two ideal portraits based on “composite characters” based on study participants features. These provide ethnographically rich details of participants’ meaningful social worlds while protecting individual identities.
Ten of the 14 clinical trial participants, and 3 study staff were interviewed. Participant demographics and socio-economic profiles expressed limited contextual diversity. Half were men who have sex with men, half were former injection drug users experiencing homelessness, one was female, none were racialized minorities and there were no people from HIV endemic countries. Fully 90% had previous involvement in other clinical studies. Their stories point to particular socio-economic situations that motivated their participation as clinical labor through trial participation.
Our findings support Fisher’s argument of “structural coercion” in clinical trial recruitment of vulnerable individuals experiencing precarious living conditions. Clinical trials should provide more detail of the structural socio-economic conditions and healthcare needs which lie “under consent” of study participants. Going well beyond an overly convenient narrative of altruism, ethical deliberation frameworks need to sufficiently address the structural conditions of clinical trials. We offer concrete possibilities for this and acknowledge that further research and clinical data should be made available underlying study participant contexts with regards to recruitment and participation in resource poor settings, in both the South and the North.

Assessment of the Appropriateness of the i-CONSENT Guideline Recommendations for Improving Understanding of the Informed Consent Process in Clinical Studies

Assessment of the Appropriateness of the i-CONSENT Guideline Recommendations for Improving Understanding of the Informed Consent Process in Clinical Studies
Fons-Martínez J, Ferrer-Albero C, Diez-Domingo J
Research Square, 5 April 2021
The H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders.
An adaptation of the RAND/UCLA Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, investigators, ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting.
Fifty-three recommendations were evaluated. After the first round, 34 recommendations were judged appropriate; 19 were judged uncertain; and none was judged inappropriate. After the second round, 9 uncertain changed to appropriate. All recommendations rated medians of 6.5-9 on a 1-9 scale (1 = extremely inappropriate, 5 = uncertain, 9 = extremely appropriate). The sections “General recommendations” and “Gender perspective during the consent process for clinical studies” showed the highest uncertainty rating. The four keys to improving the understanding of the ICP in clinical studies are to: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators’ communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant’s possible lack of health literacy and a glossary of terms.
The RAND/UCLA method has demonstrated validity for assessing the appropriateness of recommendations in ethical guidelines. The recommendations of the i-CONSENT guidelines were mostly judged appropriate by all stakeholders involved in the informed consent process.

Framing a Consent Form to Improve Consent Understanding and Determine How This Affects Willingness to Participate in HIV Cure Research: An Experimental Survey Study

Framing a Consent Form to Improve Consent Understanding and Determine How This Affects Willingness to Participate in HIV Cure Research: An Experimental Survey Study
Research Article
John A. Sauceda, Karine Dubé, Brandon Brown, Ashley E. Pérez, Catherine E. Rivas, David Evans, Celia B. Fisher
Journal of Empirical Research on Human Research Ethics, 14 December 2020
HIV cure research carries serious risks and negligible benefits. We investigated how participants understand these risks and what influences their willingness to participate. Through internet-based and in-person convenience sampling, 86 HIV+ participants completed an experimental survey. Participants were randomized to read a standard consent form describing a hypothetical HIV cure study or one adapted using Fuzzy Trace Theory—a decision-making model to facilitate complex information processing. We measured consent understanding and cognitive (e.g., safe/harmful) and affective (e.g., concerning, satisfying) evaluations of HIV cure research. Participants who read the adapted consent form had improved consent understanding, but only positive affective evaluations were associated with a willingness to participate. Consent processes can use decision-making theories to facilitate comprehension of study information.

Is the Language of Informed Consent Templates for Dental Treatment Patient Friendly?

Is the Language of Informed Consent Templates for Dental Treatment Patient Friendly?
Viktoriia Kostenko, Olena Bieliaieva, Iryna Solohor
Eurasian Conference on Language & Social Sciences, 2-3 February 2021; Gjakova, Kosovo pp 324-328
The patient’s voluntary informed consent for medical intervention has been known as an integral part of the modern system of moral, ethical and legal regulation of healthcare provision. Grammar complexity of formal language and terminology differences between healthcare providers and patients may cause communication problems and adversely affect patient access to health information, leading to poor satisfaction for both parties. There have been few reports clarifying the selection of the language means in order to facilitate patients’ complete and unhindered understanding of
the information in informed consent template for dental treatment and to influence them in making the right decision. The aim of the study is to investigate grammar characteristics (sentence structure, voice, the tense and aspect of finite verb phrases) and to analyze the findings from functional perspective and communicative purposes. This empirical research of qualitative descriptive type was based on the corpus of 50 informed consent templates for dental treatment used by the USA healthcare settings authorized to provide oral and dental services Critical discourse analysis is a main analytic technique employed in the study. The main idea behind the informed consent is that individuals having obtained a sufficient amount of special information and clearly understood it should be able to make their own knowledgeable and voluntary decisions concerning the exposure to potentially dangerous dental procedures. Text structuring, headings, metatextual devices in the templates demonstrate doctor’s responsibility for understanding text by the patients, i.e. the respectful and careful attitude to the clients. The average length of the texts and the average length of the sentences are also taken into account, whereas the documents are designed within the patient-centred approach and in patient-friendly manner. Though the texts of informed consent templates are relatively short, they abound in composite sentences: the complex sentences make up 69.3 %, the complex-compound sentences make up to 7.14%. Simple sentences, 21.5%, rank the second position. Composite sentences as well as numerous simple sentences with extended homogenous parts are exploited in the informed consent templates in order to minimize misunderstanding in the interpretation medical information, but, on the other hand, they can to interfere with quick and complete comprehension of the dependency relations among the ideas expressed in the sentences. Sentences in the active voice exceed those in passive voice that makes the text more readable and understandable.