Consent in Canadian-Led Critical Care Research During the COVID-19 Pandemic: A Scoping Review
Karla Krewulak, Lisa Albrecht, Saoirse Cameron, Jessica Gibson, Dori-Ann Martin, Rebecca Porteous, Margaret Sampson, Katie O’Hearn
medRxiv, 3 February 2024
Abstract
Introduction
Despite the importance of critical care research during the SARS-CoV-2 pandemic, several pandemic-related factors made the process of obtaining prior written informed consent for research infeasible. To overcome these challenges, research studies utilized alternate informed consent models suggested by available guidance.
Objective
To describe the consent models used in Canadian intensive care unit (ICU) and pediatric ICU (PICU) studies during the COVID-19 pandemic.
Data Sources
We searched MEDLINE, EMBASE, CENTRAL, clinicaltrials.gov, and medRxiv from 01-Jan2020 to 28-Apr-2023 using Medical Subject Headings and keywords related to the setting (ICU, PICU), study design (e.g., RCT) and study region (i.e., Canada). We included Canadian-led studies that were enrolling during the SARS-CoV-2 and reported on consent. Two independent reviewers reviewed titles/abstracts and full text articles for inclusion.
Results
We included 13 studies from adult (n=12, 92.3%) and pediatric (n=1, 7.7%) populations. Some study authors reported that informed (n=3/13, 23.1%) or a priori (n=2/13, 15.4%) consent was obtained, without further details. Study authors also reported using written informed (n=4/13, 30.8%), deferred (n=3/13, 23.1%), verbal/waived/assent (each n=2/13, 15.4%), or that ethics approval was not necessary which means consent was not required (n=1/13, 7.7%). Five studies (n=5/13, 38.5%) used multiple consent models: a priori/deferred (n=2/5, 40%), written/verbal (n=2/5, 40%), or waived/assent (n=1/5, 20%).
Conclusion
This scoping review underscores the importance of transparent reporting of or modifications to trial procedures during crises, such as the COVID-19 pandemic. Improved reporting practices and exploration of alternate consent models, including electronic consent, are crucial for advancing critical care trials beyond the pandemic and preparing for future health emergencies.
Use of abbreviations in consent forms for orthopaedic patients: A quality improvement project
Use of abbreviations in consent forms for orthopaedic patients: A quality improvement project
Khan MN, Anjum S, Shafique H
Authorea Preprints, 30 January 2024
Abstract
Consent is a process of communication and the consent form is an important legal document of the evidence of discussion between doctor and patients. We observed frequent use of abbreviations in the consent forms in our department that can result in misunderstanding and miscommunication when consenting patients for orthopaedic procedures. We completed an audit cycle starting by reviewing a total of 350 consent forms retrospectively in level one trauma centres in October-November of 2019 for different orthopaedic trauma procedures. The standards for the project were guidelines published by the general medical council (GMC), The royal college of surgeons (RCS) Glasgow, and the British orthopaedic association (BOA). The results were presented at our mortality and morbidity meeting. Written Feedback was obtained from the attending members on how a change can be implemented to increase ccompliance in filling consent forms. A generic email was sent to all medical professionals to avoid the use of abbreviations on the document and encourage colleagues to point out errors if they spot them. The use of full medical terms and to avoid abbreviations in consent form was well advertised, The re-audit was performed for the period of January & February 2020 that included 400 consent forms. The results were analysed and compared with our original audit results. The use of abbreviations declined from 54% in first audit to 22% in the re-audit. DVT and PE were the most common abbreviations. This audit cycle has shown the importance of education and reminders to the health professionals in achieving better adherence to the guidelines and improves patient care.
Experiences Of Patients Undergoing Emergency Surgery And Next Of Kin On Decision Making During The Informed Consent Process In Two Tertiary Teaching Hospitals Of A Low-Income African Country: A Qualitative Study
Experiences Of Patients Undergoing Emergency Surgery And Next Of Kin On Decision Making During The Informed Consent Process In Two Tertiary Teaching Hospitals Of A Low-Income African Country: A Qualitative Study
Olivia Kituuka, Erisa Mwaka, Ian Munabi, Nelson Sewankambo, Moses Galukande
Advance, 29 January 2024
Abstract
Background
In emergency situations, patients and their next of kin must make complex medical and ethical decisions in a quick and timely way.
Methods
In-depth interviews were conducted among 22 patients and 17 next of kin of patients who had undergone emergency surgery within 24 -72hrs at two tertiary teaching hospitals. Responses about decision-making were coded into four themes; decision makers, people consulted, documentation of the consent, and factors influencing decision making.
Results
Most patients and next of kin made decisions on their own and personally documented the consent for themselves or their patient for the next of kin. Other family members and doctors were consulted during the decision-making process. Decision making was influenced by assurance of good outcomes of surgery and disclosure by the doctors.
Conclusion
Decisions were made collaboratively with the patient at the centre but with input from health personnel, the next of kin, and other family members.
Editor’s note: Advance is a preprint server in the Sage community.
Upcoming Calls For Public Consultation
INSERM – Public consultation of the Global Ethics Charter for the Protection of Healthy Volunteers in Clinical Trials
The draft Charter is open for public comments up to March 30, 2024.
Download the draft Charter (pdf, 201 Ko) [Attached with response template]
The « Global Ethics Charter for the Protection of Healthy Volunteers in Clinical Trials » is a key deliverable of the VolREthics initiative that was set up to promote ethical guidelines to protect healthy volunteers in biomedical research.
…The central ethical question raised by the involvement of healthy volunteers in biomedical research is that of respect for the person’s free will to decide to participate in the research, without any direct or indirect pressure. Another ethical imperative is to ensure the safety and well-being of the healthy volunteers both during and after the research. This is because all biomedical research involves a certain number of risks that, even if kept to a minimum by the researchers and authorities, can never be ruled out entirely. The two main risks to which healthy volunteers are exposed are:
:: That of being exploited in a context of vulnerability, for example economic, educational, cultural or related to age…
:: That of experiencing adverse events during or after the study in which they are taking part..
Key Information and Facilitating Understanding in Informed Consent; Draft Guidance for Sponsors, Investigators, and Institutional Review Boards
21 CFR Part 50 [Docket No. FDA-2022-D-2997] Comments due: May 1, 2024
SUMMARY:
The Office for Human Research Protections, Office of the Assistant Secretary for Health (OHRP), and the Food and Drug Administration (FDA) are announcing the availability of a draft guidance entitled “Key Information and Facilitating Understanding in Informed Consent.”
This draft guidance provides recommendations related to two provisions of the revised Federal Policy for the Protection of Human Subjects (the revised Common Rule) by the U.S. Department of Health and Human Services (HHS) and identical provisions in FDA’s proposed rule “Protection of Human Subjects and Institutional Review Boards.” FDA’s proposed rule, if finalized, would harmonize certain sections of FDA’s regulations on human subject protections and institutional review boards (IRBs), to the extent practicable and consistent with other statutory provisions, with the revised Common Rule, in accordance with the 21st Century Cures Act (Cures Act). The guidance addresses the provisions of the revised Common Rule that require informed consent to begin with key information about the research and to present information in a way that facilitates understanding and identical provisions in FDA’s proposed rule.
Informed Consent: A Monthly Review
_________________
February 2024 :: Issue 62
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:
Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: Center for Informed Consent Integrity – A Monthly Review_February 2024
Personalized and longitudinal electronic informed consent in clinical trials: How to move the needle?
Personalized and longitudinal electronic informed consent in clinical trials: How to move the needle?
Evelien De Sutter, Liese Barbier, Pascal Borry, David Geerts, John P.A. Ioannidis, Isabelle Huys
Digital Health, 23 January 2024
Abstract
Changes in the clinical trials landscape have been driven by advancements in digital technology. The use of electronic informed consent to inform research participants and to obtain their consent electronically has the potential to improve participant–researcher interactions over time, facilitate clinical trial participation, and increase efficiency in clinical trial conduct. A personalized electronic informed consent platform that enables long-term interactions with the research team could function as a tool to empower participant engagement in clinical trials. However, significant challenges persist impeding successful and widespread implementation. This Perspective provides insights into the opportunities and challenges for the implementation of electronic informed consent in clinical trials. It sets out key recommendations to promote the implementation of this innovative approach to the informed consent process, including the creation of uniform electronic informed consent platforms at regional and national level.
Participant comprehension and acceptability of enhanced versus text-only electronic informed consent: an innovative qualitative pilot study
Participant comprehension and acceptability of enhanced versus text-only electronic informed consent: an innovative qualitative pilot study
Research
Amy Corneli, Summer Starling, Yujung Choi, Jurgis Vosylius, Leanne Madre, Andrew Mackinnon & Pamela Tenaerts
Pilot and Feasibility Studies, 17 January 2024
Open Access
Abstract
Background
The use of electronic informed consent (eIC) in decentralized trials offers a pragmatic approach to enrolling participants across multiple geographic areas.
Methods
Using a randomized, cross-over study design, we conducted a qualitative descriptive evaluation of two eIC approaches—text-only eIC and enhanced eIC—in a mock hypertension Phase III clinical trial. We assessed participant comprehension and acceptability (usability, satisfaction, and eIC preference).
Results
A total of 24 individuals with hypertension participated in the study: 12 reviewed the text-only eIC first, followed by the enhanced eIC, and 12 reviewed the enhanced eIC first, followed by the text-only eIC. The study population was diverse in gender, age, race, and geographic location. We found no descriptive differences in participant comprehension and satisfaction between the two eIC approaches. However, more participants preferred the enhanced eIC, and participants indicated that the digital elements were personable and made them feel more informed, engaged, comfortable, and prepared to participate in clinical research.
Conclusions
Our findings suggest that enhancing the eIC process with digital elements may have beneficial outcomes among potential participants beyond comprehension and satisfaction.
Stakeholders’ perspectives on clinical trial acceptability and approach to consent within a limited timeframe: a mixed methods study
Stakeholders’ perspectives on clinical trial acceptability and approach to consent within a limited timeframe: a mixed methods study
Original Research
Elizabeth Deja, Chloe Donohue, Malcolm G Semple, Kerry Woolfall
BMJ Open, 2 January 2023
Abstract
Objectives
The Bronchiolitis Endotracheal Surfactant Study (BESS) is a randomised controlled trial to determine the efficacy of endo-tracheal surfactant therapy for critically ill infants with bronchiolitis. To explore acceptability of BESS, including approach to consent within a limited time frame, we explored parent and staff experiences of trial involvement in the first two bronchiolitis seasons to inform subsequent trial conduct
Design
A mixed-method embedded study involving a site staff survey, questionnaires and interviews with parents approached about BESS.
Setting
Fourteen UK paediatric intensive care units.
Participants
Of the 179 parents of children approached to take part in BESS, 75 parents (of 69 children) took part in the embedded study. Of these, 55/69 (78%) completed a questionnaire, and 15/69 (21%) were interviewed. Thirty-eight staff completed a questionnaire.
Results
Parents and staff found the trial acceptable. All constructs of the Adapted Theoretical Framework of Acceptability were met. Parents viewed surfactant as being low risk and hoped their child’s participation would help others in the future. Although parents supported research without prior consent in studies of time critical interventions, they believed there was sufficient time to consider this trial. Parents recommended that prospective informed consent should continue to be sought for BESS. Many felt that the time between the consent process and intervention being administered took too long and should be ‘streamlined’ to avoid delays in administration of trial interventions. Staff described how the training and trial processes worked well, yet patients were missed due to lack of staff to deliver the intervention, particularly at weekends.
Conclusion
Parents and staff supported BESS trial and highlighted aspects of the protocol, which should be refined, including a streamlined informed consent process. Findings will be useful to inform proportionate approaches to consent in future paediatric trials where there is a short timeframe for consent discussions.
Participants’ understanding of informed consent in clinical trials: A systematic review and updated meta-analysis
Participants’ understanding of informed consent in clinical trials: A systematic review and updated meta-analysis
Chengai Wu, Na Wang, Qianqian Wang, Chao Wang, Zhenjie Wei, Zhimin Wu, Shunan Yu, Xieyuan Jiang
PLOS One, 2 January 2024
Open Access
Abstract
Obtaining written informed consent from participants before enrolment in a study is essential. A previous study showed that only 50% of the participants in clinical trials understood the components of informed consent, and the methods of participants’ understanding of informed consent were controversial. This updated meta-analysis aimed to estimate the proportion of participants in clinical trials who understand the different informed consent components. PubMed, EMBASE, the Cochrane Library, and Scopus were searched till April 2023. Therapeutic misconception, ability to name one risk, knowing that treatments were being compared, and understanding the nature of the study, the purpose of the study, the risks and side-effects, the direct benefits, placebo, randomization, voluntariness, freedom to withdraw, the availability of alternative treatment if withdrawn from the trial, confidentiality, compensation, or comprehension were evaluated. This meta-analysis included 117 studies (155 datasets; 22,118 participants). The understanding of the risks and side-effects was investigated in the largest number of studies (n = 100), whereas comprehension was investigated in the smallest number (n = 11). The highest proportions were 97.5%(95% confidence interval (CI): 97.1–97.9) for confidentiality, 95.9% (95% confidence interval (CI): 95.4–96.4) for compensation, 91.4% (95% CI: 90.7–92.1) for the nature of study, 68.1% (95% CI: 51.6–84.6) for knowing that treatments were being compared, and 67.3% (95% CI: 56.6–78) for voluntary nature of participants. The smallest proportions were the concept of placebo (4.8%, 95%CI: 4.4–5.2) and randomization(39.4%, 95%CI: 38.3–40.4). Our findings suggested that most participants understood the fundamental components of informed consent (study confidentiality, nature, compensation, voluntariness, and freedom to withdraw). The understanding of other components, such as placebo and randomization was less satisfactory.
What do educational psychologists consider to be best practice when gaining consent across the 0 to 25 age range?
What do educational psychologists consider to be best practice when gaining consent across the 0 to 25 age range?
Althea Lyons, George Thomas
Educational Psychology In Practice, 8 November 2023
Abstract
Educational psychologists (EPs) have a legal and ethical obligation to gain informed consent prior to any psychological involvement. As EPs work across the 0 to 25 age range, the person giving consent may vary according to the needs of the individual service user and so it is necessary to be aware of relevant legislation and case law. This study explored what might be considered best practice for EPs in gaining consent across the 0 to 25 age range by conducting semi-structured interviews with six professionals as part of an expert reference group. The interviews were thematically analysed using a hybrid inductive-deductive approach. Six main themes were identified: ethical obligations; children’s rights; legal obligations; partnership; informed consent; and, barriers to best practice. There was considerable overlap between some of the main themes, reflecting the complexity of the issue. The findings are discussed in relation to literature in other areas of psychological practice. Implications for practice for individual EPs and EP services are considered, such as the possibility of developing a guidance document for use across the profession, as well as directions for further research.
Center for Informed Consent Integrity 