Research ethics systems in Latin America and the Caribbean: a systemic assessment using indicators

Strengthening research ethics governance and regulatory oversight in Central America and the Dominican Republic in response to the COVID-19 pandemic: a qualitative study

“…As Mathur [ 26 ] stated, “An ethically conscious, well informed and updated governance framework which identifies the relevant stakeholders, defines their roles and responsibilities, lays down an implementation plan and a monitoring strategy, can safeguard the ethical values of the society, promote good science and deliver better outcomes.” Strict regulations are not always best; an appropriate balance is needed between regulating and promoting research both during and before/after a pandemic. Collaboration within and across regions is key to overcoming obstacles and working towards robust research ethics governance at national and regional levels [ 27 ].…”

“…Aguilera et al [ 27 ] found that “Most countries have adopted legal instruments to govern research with human participants and have implemented national bodies tasked with the oversight of RECs. However, performance regarding ethics training policies and clinical trial registration was less advanced, and efforts to adopt policies on responsible conduct of research and accelerated ethics review of emergency research did not meet the PAHO objectives in most countries.” Countries must do more to develop policies, procedures and standard operating procedures for fast-tracked and rigorous ethics review during emergencies [ 27 ].…”

Preparing ethical review systems for emergencies: next steps

“… Exploring the development of quality indicators to help cement trust between and within committees, researchers and other research stakeholders, and help identify, at the level of individual committees, where changes in practice would be beneficial. Such indicators could build on current work by WHO on benchmarking tools for ethics committees [ 19 ], and on a regional initiative by PAHO on indicators for core components of research ethics systems [ 20 ], to capture both substantive elements (the value added to the study as a result of ethical scrutiny) and valued performance elements such as flexibility and timeliness. Examples of initiatives in this area shared by meeting attendees included the development of performance indicators in Egypt; while in New Zealand, a new ‘decision analyses’ process will be used to identify what ethical issues most frequently lead to applications requiring revision, and then consider whether more training or guidance is required, or whether the standards themselves require review.…”

Safeguarding research staff “in the field”: a blind spot in ethics guidelines

“…Since there are no one-size-fits-all solutions, we urge individual organizations to develop more specific guidelines that address the persistent gap of safeguarding research staff conducting work in LMICs. This call for action is critical since ethics review processes often do not meet minimal standards (Aguilera et al, 2022; Sambiéni, 2018) or do not exist at all (Chin, 2013). This paper is structured as follows: after describing our methodology, an overview of the most important ethical challenges faced by research staff working in LMICs is provided and corresponding safeguards are presented.…”