Ethical approval must be obtained before medical research can start. We describe the differences in EA for an pseudonymous, non-interventional, observational European study. Sixteen European national coordinators of the international study on very old intensive care patients answered an online questionnaire concerning their experience getting EA. N = 8/16 of the NCs could apply at one single national ethical committee, while the others had to apply to various regional ECs and/or individual hospital institutional research boards. The time between applying for (...) EA and the first decision varied between 7 days and 300 days. In 9/16 informed consent from the patient was not deemed necessary; in 7/16 informed consent was required from the patient or relatives. The upload of coded data to a central database required additional information in 14/16. In 4/16 the NCs had to ask separate approval to keep a subject identification code list to de-pseudonymize the patients if questions would occur. Only 2/16 of the NCs agreed that informed consent was necessary for this observational study. Overall, 6/16 of the NCs were satisfied with the entire process and 8/16 were unsatisfied. 11/16 would welcome a European central EC that would judge observational studies for all European countries. Variations in the process and prolonged time needed to get EA for observational studies hampers inclusion of patients in some European countries. This might have a negative influence on the external validity. Further harmonization of ethical approval process across Europe is welcomed for low-risk observational studies. Getting ethical approval for low-risk, non-interventional, observational studies varies enormously across European countries. (shrink)

In this analysis we discuss the change in criteria for triage of patients during three different phases of a pandemic like COVID-19, seen from the critical care point of view. Availability of critical care beds has become a hot topic, and in many countries, we have seen a huge increase in the provision of temporary intensive care bed capacity. However, there is a limit where the hospitals may run out of resources to provide critical care, which is heavily dependent on (...) trained staff, just-in-time supply chains for clinical consumables and drugs and advanced equipment. In the first phase, we can still do clinical prioritisation and decision-making as usual, based on the need for intensive care and prognostication: what are the odds for a good result with regard to survival and quality of life. In the next, the resources are mostly available, but the system is stressed by many patients arriving over a short time period and auxiliary beds in different places in the hospital being used. We may have to abandon admittance of patients with doubtful prognosis. In the last phase, usual medical triage and priority setting may not be sufficient to decrease inflow and there may not be enough intensive care unit beds available. In this phase different criteria must be applied using a utilitarian approach for triage. We argue that this is an important transition where society, and not physicians, must provide guidance to support triage that is no longer based on medical priorities alone. (shrink)

Background The first COVID-19 wave started in February 2020 in France. The influx of patients requiring emergency care and high-level technicity led healthcare professionals to fear saturation of available care. In that context, the multidisciplinary Ethics- Support Cell (EST) was created to help medical teams consider the decisions that could potentially be sources of ethical dilemmas. Objectives The primary objective was to prospectively collect information on requests for EST assistance from 23 March to 9 May 2020. The secondary aim was (...) to describe the Cell’s functions during that period. Research design This observational, real-time study of requests for Cell consultations concerned ethical dilemmas arising during a public health crisis. The EST created a grid to collect relevant information (clinical, patient’s/designated representative’s preferences and ethical principles strained by the situation), thereby assuring that each EST asked the same questions, in the same order. Participants and research context Only our university hospital’s clinicians could request EST intervention. Ethical considerations The hospital Research Ethics Committee approved this study (no. CER-2020-107). The patient, his/her family, or designated representative was informed of this ethics consultation and most met with EST members, which enabled them to express their preferences and/or opposition. Findings/results 33 requests (patients’ mean age: 80.8 years; 29 had COVID-19: 24 with dyspnea, 30 with comorbidities). 17 Emergency Department solicitations concerned ICU admission, without reference to resource constraints; others addressed therapeutic proportionality dilemmas. Discussion Intervention-request motives concerned limited resources and treatment intensity. Management revolved around three axes: the treatment option most appropriate for the patient, the feasibility of implementation, and dignified care for the patient. Conclusions COVID-19 crisis forced hospitals to envisage prioritization of ICU access. Established decision-making criteria and protocols do not enable healthcare professionals to escape ethical dilemmas. That acknowledgement highlights ethical risks, enhances the added-value of nursing and encourages all players to be vigilant to pursue collective deliberations to achieve clear and transparent decisions. (shrink)