Participants’ informed consent in adaptive, platform drug trials in hospitalized COVID-19 patients: Not all approaches are ethically acceptable

Dal‐Ré, Rafael; Caplan, Arthur L.; Voo, Teck Chuan

doi:10.1016/j.ejim.2022.06.018

Cited by 6 publications

(2 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…However, even during a pandemic that threatens the health of many people such as the COVID-19 pandemic, the IC process must not be abandoned as it is one of the most important pillars of research ethics [ 20 ]. Alternative methods to obtain IC must be critically reviewed for their suitability, as they may prove to be ethically questionable [ 21 ]. It might be helpful to combine several methods of obtaining IC [ 5 , 20 , 22 ].…”

Section: Discussionmentioning

confidence: 99%

“…However, deciding on the degree of risk and, hence, whether a study qualifies for a waiver is extremely difficult during a pandemic. In this regard, the handling of IC in some studies conducted with COVID-19 patients was ethically unacceptable [ 21 , 28 ]. It should not go unmentioned that, in addition to ethical concerns, there are also clear legal requirements in Germany.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Informed Consent in COVID-19-Research: An Ethical Analysis of Clinical Studies Performed during the Pandemic

et al. 2023

View full text Add to dashboard Cite

Health crises such as the current COVID-19 pandemic pose challenges to the conduct of clinical studies. Aspects of research ethics, such as obtaining informed consent (IC), can be complicated. We are concerned with whether or not the proper IC procedures were followed in the context of clinical studies at Ulm University in the years 2020 to 2022. We identified all protocols of clinical studies dealing with COVID-19 that the Research Ethics Committee of Ulm University has reviewed and voted on in the years 2020 to 2022. We then performed a thematic analysis regarding the following aspects: study type, handling of IC, type of patient information, means of communication, applied security precautions, and the approach to participants from vulnerable groups. We identified n = 98 studies that dealt with COVID-19. In n = 25 (25.51%), IC was obtained traditionally in written form, in n = 26 (26.53%) IC was waived, in n = 11 (11.22%) IC was obtained delayed, and in n = 19 (19.39%) IC was obtained by proxy. No study protocol was accepted that waived IC in case IC would have been required in times outside of pandemics. It is possible to obtain IC even in times of severe health crises. In the future, it is necessary to address in greater detail and with legal certainty which alternative methods of obtaining IC are possible and under which circumstances IC can be waived.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Informed Consent in COVID-19-Research: An Ethical Analysis of Clinical Studies Performed during the Pandemic

et al. 2023

View full text Add to dashboard Cite

show abstract

Reevaluating the Ethical Issues in Porcine‐to‐Human Heart Xenotransplantation

Silverman¹,

Odonkor²

2022

Hastings Center Report

View full text Add to dashboard Cite

A major limiting factor with heart allotransplantation remains the availability of organs from deceased donors. Porcine heart xenotransplantation could serve as an alternative source of organs for patients with terminal heart failure. A first‐in‐human porcine xenotransplantation that occurred in January 2022 at the University of Maryland Medical Center provided an opportunity to examine several ethical issues to guide selection criteria for future xenotransplantation clinical trials. In this article, the authors, who are clinicians at UMMC, discuss the appropriate balancing of risks and benefits and the significance, if any, of clinical equipoise. The authors also review the alleged role of the psychosocial evaluation in identifying patients at an elevated risk of posttransplant noncompliance, and they consider how the evaluation's implementation might enhance inequities among diverse populations. The authors argue that, based on the principle of reciprocity, psychosocial criteria should be used, not to exclude patients, but instead to identify patients who need additional support. Finally, the authors discuss the requirements for and the proper assessment of informed and voluntary consent from patients being considered for xenotransplantation .

show abstract