Emergency research without prior consent in the United States, Canada, European Union and United Kingdom: How regulatory differences affect study design and implementation in cardiac arrest trials
Review
Catherine E. Ross, Melissa J. Parker, Spyros D. Mentzelopoulos, Barnaby R. Scholefield, Robert A. Berg
Resuscitation Plus, March 2024
Abstract
Aim
A major barrier to performing cardiac arrest trials is the requirement for prospective informed consent, which is often infeasible during individual medical emergencies. In an effort to improve outcomes, some governments have adopted legislation permitting research without prior consent (RWPC) in these circumstances. We aimed to outline key differences between legislation in four Western locations and explore the effects of these differences on trial design and implementation in cardiac arrest research.
Data sources
We performed a narrative review of RWPC legislation in the United States (US), Canada, the European Union (EU) and the United Kingdom (UK).
Results
The primary criteria required to perform RWPC was similar across locations: the study must involve an individual medical emergency during which neither the prospective subject nor their authorized representative can provide informed consent. The US regulations were unique in their requirements for performing Community Consultation and Public Disclosure in the communities in which the research takes place. Another major difference was the requirement for consent for ongoing participation in Canada, the EU and the UK, while only notification of enrollment and the opportunity to discontinue participation are required in the US. Additionally, only Canada and the EU explicitly state that the subject or their representative may request withdrawal of their data.
Conclusion
Regulations governing RWPC in the US, Canada, the EU and the UK have similar goals and protections for vulnerable populations during medical emergencies. Differences in the qualifying criteria and implementation procedures exist across locations and may affect study design.
Ethical challenges in organ transplants for refugees in a healthcare system
Ethical challenges in organ transplants for refugees in a healthcare system
Research Article
Deniz Birtan, Aslihan Akpinar
Nursing Ethics, 7 February 2024
Abstract
Background
Several ethical issues are associated with providing living organ transplantation services, and there is limited information on these issues faced by the teams providing service to refugees or asylum seekers.
Aim
To determine the challenges healthcare professionals face in organ transplant centers providing services to Syrians under temporary protection status and discern whether these difficulties align with ethical issues in living organ transplantation.
Research design
This study employed a qualitative design and conducted individual semi-structured, in-depth interviews with 18 transplant team members in Istanbul between September and November 2022. Data analysis was based on Braun and Clarke’s thematic analysis.
Participants and research context
The participants comprised 18 healthcare professionals, including 6 physicians and 12 nurses working in organ transplant teams in Istanbul.
Ethical considerations
The University’s Ethics Committee provided approval. Participants were informed regarding confidentiality and signed an informed consent form.
Results
Three themes emerged from the data on ethical issues faced by organ transplantation services to Syrians: (a) beneficence or double equipoise, (b) autonomy, and (c) justice. Transplant teams experience problems related to preserving double equipoise in the provision of living donor organ transplantation because of language barriers, poor socioeconomic conditions, and cultural factors, which increases transplant teams’ individual and indirect social burden. Although problems arise from the language barrier when obtaining informed consent in the autonomy theme, institutional and national policies in preventing donor abuse have a comforting effect. Health workers had the least problems with the justice theme, wherein national health policies are determined.
Conclusion
Fewer issues related to autonomy and justice were reported in providing organ transplantation services to Syrians, with the most intense reported issues being maintaining double equipoise. The results revealed the need to develop institutional, national, and international policies with individual solutions to prevent difficulties healthcare professionals face in this process.
Adherence to General Medical Council guidance regarding disclosure of alternative treatments during the consent process
Adherence to General Medical Council guidance regarding disclosure of alternative treatments during the consent process
Conference Presentation
George S Bethell, Robert A Wheeler, Nigel J Hall
69th British Association of Paediatric Surgeons Annual Congress, 21-23 June 2023; Bruges
Abstract
Introduction
General Medical Council (GMC) guidelines dictate that reasonable alternatives to treatment should be disclosed during the consent process. We aimed to determine if GMC guidelines on disclosure of alternatives during consent are being followed in a real world example which is disclosure of non-operative management as an alternative to appendicectomy in uncomplicated paediatric appendicitis.
Methods
Retrospective single centre observational study and national consultant specialist paediatric surgeon survey. Two groups of 50 consecutively treated children (< 16 years) with acute uncomplicated appendicitis were included in the observational study during two time periods. UK based consultant surgeons that treat appendicitis were included in the national survey. The main outcomes were disclosure and use of NOM as an alternative to appendicectomy.
Results
Overall, in the observational study, NOM was disclosed in 30(30%) children and 77%(23/30) opted for this treatment method when it was disclosed. There were 83 survey respondents representing all 25 eligible specialist pediatric surgery centres. Ten(12%) consultants reported routinely offering NOM, 39(47%) offer it in select circumstances, and 34(41%) never offer NOM. Only 25(30%) respondents always disclose NOM as an alternative to appendicectomy, whilst 22(27%) never do. Consultants who never disclose NOM are more likely to prefer appendicectomy over NOM compared to those always disclose it(p<0.001).
Conclusion
In this illustrative clinical scenario, observed and reported practice regarding disclosure of alternative treatments during the consent process do not meet GMC guidance. This risks depriving children and caregivers of a choice that they are entitled to.
Assessing the Readability of Clinical Trial Consent Forms for Surgical Specialties
Assessing the Readability of Clinical Trial Consent Forms for Surgical Specialties
Amir H. Karimi, Maura R. Guyler, Christian J. Hecht II, Robert J. Burkhart, Alexander J. Acuña, Atul F. Kamath
Journal of Surgical Research, April 2024; 296 pp 711-719
Abstract
Introduction
To evaluate the readability of surgical clinical trial consent forms and compare readability across surgical specialties.
Methods
We conducted a cross-sectional analysis of surgical clinical trial consent forms available on ClinicalTrials.gov to quantitatively evaluate readability, word count, and length variations among different specialties. The analysis was performed between November 2022 and January 2023. A total of 386 surgical clinical trial consent forms across 14 surgical specialties were included.
Results
The main outcomes were language complexity (measured using Flesch–Kincaid Grade Level), number of words (measured as word count), time to read (measured at reading speeds of 240 per min), and readability (measured by Flesch Reading Ease Score, Gunning Frog Index, Simple Measures of Gobbledygook Index, FORCAST, and Automated Readability Index). The surgical consent forms were a mean (standard deviation) of 2626 (1668) words long, with a mean of 12:53 min to read at 240 words per min. None of the surgical specialties had an average readability level of sixth grade or lower across all six indices, and only 16 out of 386 (4%) clinical trials met the recommended reading level. Furthermore, there was no significant difference in reading grade level between surgical specialties based on the Flesch–Kincaid Grade Level and Flesch Reading Ease indices.
Conclusions
Our findings suggest that current surgical clinical trial consent documents are too long and complex, exceeding the recommended sixth-grade reading level. Ensuring readable clinical trial consent forms is not only ethically responsible but also crucial for protecting patients’ rights and well-being by facilitating informed decision-making.
Evidence-based informed consent form for total knee arthroplasty
Evidence-based informed consent form for total knee arthroplasty
Methodology
Satvik N. Pai, Madhan Jeyaraman, Nicola Maffulli, Naveen Jeyaraman, Filippo Migliorini & Ashim Gupta
Journal of Orthopaedic Surgery and Research, 2 March 2023
Open Access
Abstract
Introduction
Informed consent documentation is often the first area of interest for lawyers and insurers when a medico-legal malpractice suit is concerned. However, there is a lack of uniformity and standard procedure about obtaining informed consent for total knee arthroplasty (TKA). We developed a solution for this need for a pre-designed, evidence-based informed consent form for patients undergoing TKA.
Materials and methods
We extensively reviewed the literature on the medico-legal aspects of TKA, medico-legal aspects of informed consent, and medico-legal aspects of informed consent in TKA. We then conducted semi-structured interviews with orthopaedic surgeons and patients who had undergone TKA in the previous year. Based on all of the above, we developed an evidence-based informed consent form. The form was then reviewed by a legal expert, and the final version was used for 1 year in actual TKA patients operated at our institution.
Results
Legally sound, evidence-based Informed Consent Form for Total Knee Arthroplasty.
Conclusion
The use of legally sound, evidence-based informed consent for total knee arthroplasty would be beneficial to orthopaedic surgeons and patients alike. It would uphold the rights of the patient, promote open discussion and transparency. In the event of a lawsuit, it would be a vital document in the defence of the surgeon and withstand the scrutiny of lawyers and the judiciary.
Informed Consent for Anterior Lumbar Access Surgery
Informed Consent for Anterior Lumbar Access Surgery
Book Chapter
Steven E. Raper
Lumbar Spine Access Surgery, 21 February 2024 [Springer]
Abstract
Informed consent is a keystone of the surgeon-patient relationship rooted in the ethical principles of autonomy and beneficence. Many stakeholders (e.g., healthcare institutions, legislators, the courts, state and federal regulators, and professional societies) contribute to an informed consent process in constant evolution. Informed consent also remains important for patients undergoing spine access and spine surgery. Many of the material risks have been identified. Patients need to be told if their surgery will overlap with that of another. Medical malpractice lawsuits often allege lack of consent against neurosurgeons and orthopedic surgeons who perform spine surgery. Novel approaches are ongoing in the effort to improve the process of informed consent. Elements of social justice should be considered in spine access and spinal operations to ensure all patients can give fully informed consent. This chapter will touch upon all these elements of the informed consent process.
Quantifying the Effect of Consent for High–Kidney Donor Profile Index Deceased Donor Transplants in the United States
Quantifying the Effect of Consent for High–Kidney Donor Profile Index Deceased Donor Transplants in the United States
Jesse D. Schold, Kendra D. Conzen, James Cooper, Susana Arrigain, Rocio Lopez, Sumit Mohan, S. Ali Husain, Anne M. Huml, Peter T. Kennealey, Bruce Kaplan, Elizabeth A. Pomfret
Journal of the American Society of Nephrology, 13 February 2024
Abstract
Background
Despite known benefits of kidney transplantation, including transplantation from donors with increased risk factors, many waitlisted candidates die prior to transplantation. Consent to receive donor kidneys with lower expected survival (e.g. kidney donor profile index [KDPI]>85%) is typically obtained at waitlist placement. The presumed benefit of consent to receive high-KDPI donor kidneys is increased likelihood and timeliness of donor offers for transplantation. However, the specific impact of consent on access to transplantation is unclear. Our aims were to evaluate the characteristics of candidates consenting to high-KDPI donor kidneys and the likelihood of receiving a deceased donor transplant (DDTX) over time based on consent.
Methods
We used national Scientific Registry of Transplant Recipients data between 2015 and 2022(n=213,364). We evaluated the likelihood of consent using multivariable logistic models and time to DDTX with cumulative incidence plots accounting for competing risks and multivariable Cox models.
Results
Overall, high-KDPI consent was 41%, which was higher among candidates who were older, Black or Hispanic, had higher BMI, were diabetic, had vascular disease, and 12-48 months pre-listing dialysis time, with significant center-level variation. High-KDPI consent was associated with higher rates of DDTX(Adjusted Hazard Ratio=1.15,95% Confidence Interval=1.13,1.17) with no difference in likelihood of DDTX from donors with KDPI<85%. The effect of high-KDPI consent on higher rates of DDTx was higher among candidates ages >60 years and diabetic candidates and variable based on center characteristics.
Conclusions
There is significant variation of consent for high-KDPI donor kidneys and higher likelihood of transplantation associated with consent.
The Understanding of Informed Consent as a Practical Bioethical Problem: A Case Study of Hospital Pedagogy on Cancer Patients in Cuenca (Ecuador)
The Understanding of Informed Consent as a Practical Bioethical Problem: A Case Study of Hospital Pedagogy on Cancer Patients in Cuenca (Ecuador)
Alejandro Recio Sastre, Mónica Bustamante Salamanca, Nadia Micela Álvarez Pelaez, Edgar Mateo Guamán Barros
European Journal of Bioethics, 14 February 2024
Abstract
The relationship between the informed consent sheet and education is crucial. Our objective is to highlight how patients’ educational backgrounds impact the ethical rights within medical processes. Some patients face significant challenges in comprehending the significance and contents of the informed consent sheet. It’s likely that they may not fully grasp the potential symptoms resulting from their treatment or even be aware of their inherent rights. This issue isn’t merely psychological but rather a matter of education, requiring a comprehensive approach to educational development. Consequently, it becomes a social issue wherein both education and health play vital roles. This research delves into assessing the patients’ literacy indicators, thereby evaluating their educational backgrounds. We address this within the framework of an ethical problem in hospital pedagogy, integrating educational and philosophical concepts. Employing qualitative analysis, we aim to understand patients’ reading skills by conducting interviews, particularly focusing on circumstances of vulnerability due to illiteracy. These circumstances are categorized based on identified reading capabilities. By intertwining two knowledge domains, we aim to highlight human vulnerabilities that may not always be considered within the technical processes of healthcare workers and are rarely emphasized by educators or philosophers.
Information bias of vaccine effectiveness estimation due to informed consent for national registration of COVID-19 vaccination
Information bias of vaccine effectiveness estimation due to informed consent for national registration of COVID-19 vaccination
C.H. (Henri) van Werkhoven, Brechje de Gier, Scott McDonald, Hester E. de Melker, Susan J.M. Hahné, Susan van den Hof, Mirjam J. Knol
medRxiv, 20 February 2024
Abstract
Background
Registration in the Dutch national COVID-19 vaccination register requires consent from the vaccinee. This causes misclassification of non-consenting vaccinated persons as being unvaccinated. We quantified and corrected the resulting information bias in the estimation of vaccine effectiveness (VE).
Methods
National data were used for the period dominated by the SARS-CoV-2 Delta variant (11 July to 15 November 2021). VE ((1-relative risk)*100 %) against COVID-19 hospitalization and ICU admission was estimated for individuals 12-49, 50-69, and ≥70 years of age using negative binomial regression. Anonymous data on vaccinations administered by the Municipal Health Services were used to determine informed consent percentages and estimate corrected VEs by iteratively imputing corrected vaccination status. Absolute bias was calculated as the absolute change in VE; relative bias as uncorrected / corrected relative risk.
Results
A total of 8,804 COVID-19 hospitalizations and 1,692 COVID-19 ICU admissions were observed. The bias was largest in the 70+ age group where the non-consent proportion was 7.0% and observed vaccination coverage was 87%: VE of primary vaccination against hospitalization changed from 75.5% (95% CI 73.5-77.4) before to 85.9% (95% CI 84.7-87.1) after correction (absolute bias -10.4 percentage point, relative bias 1.74). VE against ICU admission in this group was 88.7% (95% CI 86.2-90.8) before and 93.7% (95% CI 92.2-94.9) after correction (absolute bias -5.0 percentage point, relative bias 1.79).
Conclusions
VE estimates can be substantially biased with modest non-consent percentages for registration of vaccination. Data on covariate specific non-consent percentages should be available to correct this bias.
Practices and attitudes of herbalists regarding informed consent in Uganda: A qualitative study
Practices and attitudes of herbalists regarding informed consent in Uganda: A qualitative study
Sumayiya Nalubega, Paul Kutyabami, Adeline Twimukye, David. K. Mafigiri, Nelson. K. Sewankambo
Research Square, 8 February 2024
Abstract
Background
Informed consent (IC) is a fundamental principle in medical ethics that upholds respect for patient autonomy. Although widely applied in healthcare, its feasibility and implementation in herbal medicine have been underexplored. This study therefore aimed to explore the practices and attitudes of herbalists regarding informed consent.
Methods
To achieve these objectives, a qualitative cross-sectional study was conducted from June to December 2020. Twenty-one in-depth interviews with herbalists and four key informant interviews with leaders of the different traditional medicine organizations were also conducted. The data were analyzed thematically using NVivo version 12 software.
Results
Sixteen of the twenty-one participants acquired oral herbal medicine knowledge from their relatives. Although a positive inclination toward obtaining IC was evident, the focus was on disclosing basic information. Discussions of alternative treatments and herbal specifics less frequent. Disease management decisions often involve shared responsibility within families or societies. Documented IC procedures are rare among herbalists, who deem consent forms unnecessary, although they recognize the potential benefits of IC in fostering trust and professionalism. Challenges hindering IC implementation included regulatory gaps, inadequate skills, and the absence of mechanisms to protect the intellectual property rights of herbal medicine.
Conclusion
This study illuminates how educational, cultural, familial, and regulatory factors influence herbalists’ practices and attitudes toward informed consent.
Center for Informed Consent Integrity 