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
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
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.