Informed Consent: A Monthly Review
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_November 2021
Editor’s Note: CICI Webinar Series
On October 20th 2021 the GE2P2 Global Foundation’s Center for Informed Consent Integrity continued a series of webinars focused on integrity in informed consent. Foundation President David Curry, who has led the Foundation’s Center for Vaccine Ethics and Policy since 2008, opened the session with a discussion on the intersection of limited supply of WHO/SRA [Stringent Regulatory Authority] reviewed vaccines, licensing and use of “questionable” vaccines outside WHO/SRA review, growing vaccine hesitancy/refusal as a global challenges, growing use of mandates of various types but specifically involving young persons and a return to FTF education, and limited options for young people who find themselves with few options to exercise. After the initial presentation participants on the call shared local perspectives.
Following a successful first year, we are pausing the CICI webinar series to evaluate future directions. Please watch for updates.
Parental consent for vaccination of minors against COVID-19
Nina Shevzov-Zebrun, Arthur Caplan
Vaccine, October 2021; 39(44) pp 6451–6453
As of May 2021, emergency use authorization (EUA) for Pfizer’s COVID-19 (COVID) vaccine applies to minors at least 12 years of age—some 25 million adolescents across the United States , . While this change marks a critical step towards herd immunity and return to normality in everyday life, it also raises a host of questions concerning parental consent for vaccination of minors in pandemic times, most notably: should parental consent be required for COVID vaccine administration?
Informed Consent for Neck of Femur Fracture Surgery During the Covid-19 Pandemic: An Evidence-Based Approach
R Cuthbert, D Ferguson, B Kayani, S Haque, A Ali, A Parkar, P Bates, K Vemulapalli
British Journal of Surgery, 12 October 2021; 108 (Supplement 6)
Surgical intervention for neck of femur fractures continues to be prioritised during the Covid-19 pandemic. However, there remains a lack of clarity for clinicians during the consent process. This study quantifies additional perioperative risks for Covid-19 positive patients undergoing neck of femur fracture surgery and establishes an evidence-based framework for facilitating informed consent during the Covid-19 pandemic.
259 patients undergoing neck of femur fracture surgery in four hospitals at the epicentre of the United Kingdom’s first wave of Covid-19 were recruited. 51 patients were positive for Covid-19. Predefined outcomes were recorded in a 30-day postoperative period.
Odds of intensive care admission were 4.64 times higher (95% CI 1.59-13.50, p = 0.005) and odds of 30-day mortality were 3 times higher (95% CI 1.22-7.40, p = 0.02) in Covid-19 positive patients. 74.5% of Covid-19 positive patients suffered post-operative complications. 35.3% of Covid-19 positive patients developed lower respiratory tract infection with 13.7% progressing to acute respiratory distress syndrome. 9.8% of Covid-19 positive patients experienced symptomatic thromboembolic events with a 3.9% incidence of pulmonary emboli.
The implications of Covid-19 on the informed consent process for neck of femur fracture surgery are profound. Covid-19 positive patients should be consented for increased risk of postoperative complications (including lower respiratory tract infection, acute respiratory distress syndrome and thromboembolic events), longer inpatient stay, increased frequency of intensive care admission and higher risk of mortality.
The Implication of Telephone Consultations During COVID-19 Pandemic on Informed Consent
N Ayoub, F Gareb, M Akhtar
British Journal of Surgery, 12 October 2021; 108 (Supplement 6)
Is to find whether telephone consultations have affected patient’s comprehension of the proposed surgical management and possible risks until the day of surgery and accordingly ability for informed consent.
This study included a sample of patients admitted to QEQM hospital for elective day case surgery during November 2020 and had only telephone consultation when referred for surgery. A feedback survey assessing quality of information given to patients before and on day of surgery was filled by the patients after the procedure.
The sample included 40 patients undergoing different procedures [cholecystectomy (25), inguinal hernia repair (25), rectal examination under anaesthesia (5), ventral hernia repair (2), incisional hernia (2), inguinal lymph node biopsy (1)]. It was found that 27.5% of patients didn’t have thorough explanation of possible risks and no explanation about postoperative care in 35%.20% were not provided a leaflet about procedure, 57.5% had concerns before surgery and 75% of patients wished for a leaflet with illustrative diagrams, explanation of risks with their management to be able to take the right decision and majority of these patients were from cholecystectomy subgroup.
The lack of face-face appointment affected greatly the informed consent process resulting in patient dissatisfaction which raised the need for new leaflets containing diagrammatic explanation of procedures and possible risks with their management to ensure fulfilment of autonomy principle.
The right to respect for family life, consent, minors and Gillick competence
British Journal of Nursing, 2 October 2021; 30(17)
Richard Griffith, Senior Lecturer in Health Law at Swansea University, discusses the statement made by the UK vaccines minister that healthy 12–15-year-olds could override their parents’ decision on coronavirus vaccination.
An audit on our procedural consent forms for complication of covid-19 during the pandemic
C. Chaudhary, A. N. Najdawi, K. N. Noureldin, M. D. Dworkin
Colorectal Disease, 2021; 23(supplement 1) pp 78-79
COVID-19 has had a global impact over the last 12 months Currently there have been over 2 millions deaths from close to 100 millions infected patients. With the changes from face to face consultations to remote virtual/phone/video consultations the consent process for common procedures both elective and emergency have been affected RCSE have produced a document published 30 June 2020 setting out the main principles of the consent process and providing advice on what additional information should be included in conversations with patients while COVID-19 is still prevalent in society
During 1st November to 28th November all patients in Southend University Hospital undergoing an operation were identified on a near daily basis. Wards reviewed Castlepoint -Orthopaedic Princess Anne -Elective Windsor -General Surgery/Urology Eastwood -Gynaecology Hockley -Acute surgical admissions
Discussion and Conclusion
Operation notes were reviewed and patients with COVID-19 complications mentioned were identified and recorded in an excel spreadsheet Only 72% of consent forms mentioned COVID-19 as a recognised complication 92% of consultants (n = 14) mentioned COVID-19 compared to 60% (n = 30) for registrars and 78% (n = 9) for SHOs There was no obvious difference between elective and emergency consenting process.
Leveraging Blockchain Technology for Informed Consent Process and Patient Engagement in a Clinical Trial Pilot
Baldwin C. Mak, Bryan T. Addeman, Jia Chen, Kim A. Papp, Melinda J. Gooderham, Lyn C. Guenther, Yi Liu, Uli C. Broedl, Marianne E. Logger
Blockchain in Healthcare Today, 14 October 2021; 4
Despite the implementation of quality assurance procedures, current clinical trial management processes are time-consuming, costly, and often susceptible to error. This can result in limited trust, transparency, and process inefficiencies, without true patient empowerment. The objective of this study was to determine whether blockchain technology could enforce trust, transparency, and patient empowerment in the clinical trial data management process, while reducing trial cost.
In this proof of concept pilot, we deployed a Hyperledger Fabric-based blockchain system in an active clinical trial setting to assess the impact of blockchain technology on mean monitoring visit time and cost, non-compliances, and user experience. Using a parallel study design, we compared differences between blockchain technology and standard methodology.
A total of 12 trial participants, seven study coordinators and three clinical research associates across five sites participated in the pilot. Blockchain technology significantly reduces total mean monitoring visit time and cost versus standard trial management (475 to 7 min; P = 0.001; €722 to €10; P = 0.001 per participant/visit, respectively), while enhancing patient trust, transparency, and empowerment in 91, 82 and 63% of the patients, respectively. No difference in non-compliances as a marker of trial quality was detected.
Blockchain technology holds promise to improve patient-centricity and to reduce trial cost compared to conventional clinical trial management. The ability of this technology to improve trial quality warrants further investigation.
Expectations, experiences and preferences of patients and physicians in the informed consent process for clinical trials in oncology
Laura Gangeri, Sara Alfieri, Margherita Greco, Marta Scrignaro, Elisabetta Bianchi, Paolo Casali, Davide Ferraris, Claudia Borreani
Supportive Care in Cancer, 7 October 2021
The aim of the present study was to explore (1) informed consent (IC) representations, level of understanding, needs, and factors that influence the willingness of cancer patients to participate in randomized controlled trials (RCTs) (phase I) and (2) representations, experiences, and critical issues of physicians involved in the same process (phase II).
Semi-structured interviews were conducted with 20 cancer patients who had been asked to enroll in a phase II/III RCT (phase I). Two focus groups were conducted with 13 physicians enrolled in the same process (phase II). The content produced was analyzed through a thematic analysis.
The themes that emerged in the first phase I were grouped into six categories: IC representation, randomization, experimentation, meeting with the physician, factors that influence the willingness to participate, and trial participants’ needs. The themes emerged in the phase II were grouped into four: IC representation, critical issues of the IC, relationship, and recruitment of trial participants. Each theme is articulated into sub-themes and deeply discussed.
This study highlights (1) the gap between what is ethically demanded in a RCT consultation and the reality of the situation and (2) the difference in perceptions between patients and physicians with reference to the meaning, objectives, and level of understanding of IC.
Deferred Consent in an Acute Stroke Trial from a Patient, Proxy, and Physician Perspective: A Cross-Sectional Survey
Inez Koopman, Dagmar Verbaan, W. Peter Vandertop, Rieke van der Graaf, Erwin J. O. Kompanje, René Post, Bert A. Coert, Martine C. Ploem, Wouter M. Sluis, Féline E. V. Scheijmans, Gabriel J. E. Rinkel, Mervyn D. I. Vergouwen
Neurocritical Care, 5 October 2021
In some acute care trials, immediate informed consent is not possible, but deferred consent is often considered problematic. We investigated the opinions of patients, proxies, and physicians about deferred consent in an acute stroke trial to gain insight into its acceptability and effects.
Paper-based surveys were sent to patients who were randomly assigned in the Ultra-early Tranexamic Acid After Subarachnoid Hemorrhage (ULTRA) trial between 2015 and 2018 in two tertiary referral centers and to physicians of centers who agreed or declined to participate. The primary outcome measure was the proportion of respondents who agreed with deferral of consent in the ULTRA trial. Secondary outcomes included respondents’ preferred consent procedure for the ULTRA trial, the effect of deferred consent on trust in physicians and scientific research, and the willingness to participate in future research.
Eighty-nine of 135 (66%) patients or proxies and 20 of 30 (67%) physicians completed the survey. Of these, 82 of 89 (92%) patients or proxies and 14 of 20 (70%) physicians agreed with deferral of consent in the ULTRA trial. When asked for their preferred consent procedure for the ULTRA trial, 31 of 89 (35%) patients or proxies indicated deferred consent, 15 of 89 (17%) preferred immediate informed consent, and 32 of 89 (36%) had no preference. None of the patients’ or proxies’ trust in physicians or scientific research had decreased because of the deferred consent procedure. Willingness to participate in future studies remained the same or increased in 84 of 89 (94%) patients or proxies.
A large majority of the surveyed patients and proxies and a somewhat smaller majority of the surveyed physicians agreed with deferred consent in the ULTRA trial. Deferred consent may enable acute care trials in an acceptable manner without decreasing trust in medicine. Future research should investigate factors facilitating the responsible use of deferred consent, such as in-depth interviews, to study the minority of participants who agreed with deferred consent but still preferred immediate informed consent.
Institutional Improvements in Readability of Written Informed Consent Forms Sustained Post-Revised Common Rule
Alison Caballero, Katherine J Leath, Jennifer M Gan
Journal of Clinical and Translational Science, October 2021
Obtaining informed consent is a fundamental and ethical practice within human subjects research. Informed consent forms (ICFs) include a large amount of information, much of which may be unfamiliar to research subjects, and the revised Common Rule resulted in several required additions to that language. As limited health literacy impacts many potential subjects, efforts should be made to optimize subjects’ ability to read and understand ICFs. In this brief report, we describe an assessment of ICFs at an academic medical center to evaluate longitudinal changes in readability with the introduction and update of a plain language ICF template.