Institutional Review Boards and post-approval monitoring (PAM) of human research: content analysis of select university (academic health center) web pages across the USA.

Objective: To conduct a content analysis of IRB webpages of select universities (academic health centers) in the USA that describe post IRB- approval monitoring activities.

Method: This was a qualitative study. Thematic analysis was the method to review the webpage content of selected academic health centers (AHC) within the USA.

Research ethics committees and post-approval activities: a qualitative study on the perspectives of European research ethics committee representatives.

Objective: To explore the views of Research Ethics Committee (REC) representatives in the European Union (EU) on what the status quo is in terms of RECs' activities after the approval of trial protocols for clinical studies.

Method: This is a qualitative study. The participants in this study are members or representatives of a research ethics committee from the member countries of the European Network of Research Ethics Committees (EUREC) and the United Kingdom.

The role of research ethics committees after the approval of clinical trial protocols in the EU and the USA: a descriptive content analysis of international and regional normative documents.

Aim: To conduct a descriptive content analysis of normative documents on the role of research ethics committees (RECs) after the approval of clinical trial protocols. The question to be addressed is whether and to what extent normative documents support a monitoring role for RECs in the United States and the European Union.

Design: A qualitative content analysis of 19 normative documents on clinical research as outlined by the International Compilation of Human Research Standards 2020 edition and other related documents for the EU and USA.

Back to WHAT? The role of research ethics in pandemic times.

The Covid-19 pandemic creates an unprecedented threatening situation worldwide with an urgent need for critical reflection and new knowledge production, but also a need for imminent action despite prevailing knowledge gaps and multilevel uncertainty. With regard to the role of research ethics in these pandemic times some argue in favor of exceptionalism, others, including the authors of this paper, emphasize the urgent need to remain committed to core ethical principles and fundamental human rights obligations all reflected in research regulations and guidelines carefully crafted over time. In this paper we disentangle some of the arguments put forward in the ongoing debate about Covid-19 human challenge studies (CHIs) and the concomitant role of health-related research ethics in pandemic times.

To dispense or not to dispense: Lessons to be learnt from ethical challenges faced by pharmacists in the COVID-19 pandemic.

The year 2020 is facing one of the worst public health situations in decades. The world is experiencing a pandemic that has triggered significant challenges to healthcare systems in both high and low-middle income countries (LMICs). Government policymakers and healthcare personnel are experiencing real-life ethical dilemmas and are pressed to respond to these situations.