[HTML][HTML] Registration and design alterations of clinical trials in critical care: a cross-sectional observational study

V Anand, DC Scales, CS Parshuram… - Intensive care …, 2014 - Springer
Abstract Purpose In 2005 the International Committee of Medical Journal Editors issued a
requirement that all randomized controlled trials (RCTs) be registered primarily to prevent …

Four reasons why too many informed consents to clinical research are invalid: a critical analysis of current practices

A Wisgalla, J Hasford - BMJ open, 2022 - bmjopen.bmj.com
Objective Informed consent (IC) is a central ethical and legal requirement for clinical
research that aims to protect the autonomy of participants. To enable an autonomous …

Can we trust observational studies using propensity scores in the critical care literature? A systematic comparison with randomized clinical trials

GD Kitsios, IJ Dahabreh, S Callahan… - Critical care …, 2015 - journals.lww.com
Objective: To assess the degree of agreement between propensity score studies and
randomized clinical trials in critical care research. Data Sources: Propensity score studies …

[HTML][HTML] Challenges and proposed solutions in making clinical research on COVID-19 ethical: a status quo analysis across German research ethics committees

A Faust, A Sierawska, K Krüger, A Wisgalla… - BMC medical …, 2021 - Springer
Background In the course of the COVID-19 pandemic, the biomedical research community's
attempt to focus the attention on fighting COVID-19, led to several challenges within the field …

Evaluation of research ethics committees: Criteria for the ethical quality of the review process

G Scherzinger, M Bobbert - Accountability in research, 2017 - Taylor & Francis
Repeatedly, adequacy, performance and quality of Ethics Committees that oversee medical
research trials are being discussed. Although they play a crucial role in reviewing medical …

[HTML][HTML] Action ethnography of community reintegration for veterans and military service members with traumatic brain injury: protocol for a mixed methods study

C Melillo, K Downs… - JMIR Research …, 2019 - researchprotocols.org
Background: Numerous studies of community reintegration (CR) in traumatic brain injury
(TBI) have been conducted in civilian populations, but research is limited in veteran and …

Exploring obstacles to critical care trials in the UK: a qualitative investigation

N Pattison, N Arulkumaran… - Journal of the …, 2017 - journals.sagepub.com
Background Clinical trials in critical care are often resource-intense, with many unique
challenges. Barriers to effective recruitment and implementation of study intervention have …

[HTML][HTML] A review of informed consent and how it has evolved to protect vulnerable participants in emergency care research

R Nandra, AF Brockie, F Hussain - EFORT Open Reviews, 2020 - eor.bioscientifica.com
A vulnerable participant in research lacks capacity to consent or may be exposed to
coercion to participate. Capacity may be temporarily impaired due to loss of consciousness …

[HTML][HTML] Participants' understanding of informed consent in clinical trials: A systematic review and updated meta-analysis

C Wu, N Wang, Q Wang, C Wang, Z Wei, Z Wu, S Yu… - Plos one, 2024 - journals.plos.org
Obtaining written informed consent from participants before enrolment in a study is essential.
A previous study showed that only 50% of the participants in clinical trials understood the …

Vulnerability, therapeutic misconception and informed consent: is there a need for special treatment of pregnant women in fetus-regarding clinical trials?

MK Sheppard - Journal of Medical Ethics, 2016 - jme.bmj.com
Historically, pregnant women have generally been excluded from clinical trials. One of the
reasons for this exclusion has been the belief that pregnant women are vulnerable as …