Our findings evidence that several LA countries rapidly issued different instruments to adjust their research ethics governance frameworks in order to ensure that the conduct of COVID-19 research in their countries responded to the needs of the pandemic. These efforts should be recognized. However, the lack of emergency ethics preparedness in the region is still worrisome despite the various existing international guidance documents, and a 2018 mandate of PAHO’s Member States to strengthen ethics preparedness for research in emergencies in the region . Below we discuss the main issues that arise from our findings and provide recommendations to strengthen research ethics review during the COVID-19 pandemic and for future disease outbreaks.
Organization and coordination
It has been widely discussed the need to evaluate different organizational models to accelerate ethics review during health emergencies [16, 20, 24], yet 4 countries remained under the same ethics review structure. Even though it is not necessary for countries to implement a whole different organization of their ethics review processes, it is of relevance to establish mechanisms for the coordination and communication between research stakeholders, especially considering that these countries host several multicenter studies .
In addition, considering the similarities in the legal system and the ethics review processes, countries in the region not exploring organizational alternatives for joint ethics review of COVID-19 research could be losing opportunities to join efforts to define strategies to streamline ethics review beyond their borders during emergency contexts [15, 24, 25].
RECs “emergency mode” functioning
When general provisions that recommend accelerating ethics review are established in countries’ governance frameworks, they must include specific operational guidance [14, 15, 20]. Otherwise, they turn out to be too vague and leave to the discretion of RECs and their institutions the adjustments of their operating procedures to an “emergency mode”. During emergencies, clear operating procedures will prevent RECs’ difficulties in determining what would be ethically acceptable to streamline in a review process to save valuable time. This will also allow the harmonization of RECs functioning across a country.
Along with operational procedures, rigorous ethics reviews must be ensured so emergency research ethics training for RECs members should be promoted. However, only one country contemplated this topic in its regulations. In emergency contexts, there is a need for increased diligence in the review of research, and special scrutiny is of particular significance when novel, alternative, or complex research designs are proposed , in which RECs may not have experience. Alternative research designs, as well as a proliferation of studies - including some incapable of yielding valid results - and the false perception that urgency allows exceptions to high-quality research , pose extra challenges to RECs to objectively assess the social value, and scientific validity of research, as well as the risks and benefits for participants. Thus, RECs members need to be trained in order to be sensitive to these ethical challenges in emergency research, and to identify when to call for expert advice when required.
Finally, many countries have increased the oversight and monitoring of COVID-19 research considering the risk-benefit ratio, however specific operating procedures for ethics oversight in light of new scientific evidence were not considered . With controversial cases, such as hydroxychloroquine that came into the spotlight as potential coronavirus treatment, the global research community has witnessed how emerging evidence could impact the scientific validity and social value of ongoing research as well as on participants' safety [34, 35]. Therefore, in emergency settings it is recommended that RECs have procedures to facilitate follow-up and rapid communication between them, researchers, and participants when changes are needed to ensure the ethical acceptability of approved studies.
Key issues for ethics review
Regarding the informed consent process, the vulnerability, and the isolation of COVID-19 patients, precluding any contact with their families or others, have challenged the possibilities of obtaining informed consent in ordinary ways. As discussed in previous outbreaks [7, 8, 26, 27], it is important to highlight that most of the countries were able to rapidly adopt alternative informed consent processes for the pandemic to guarantee that it is obtained ethically. This is an important achievement in the region considering that many LA countries have strict laws and regulations regarding the formalities for documenting the process and the decision of research participants .
Future use of samples and rapid data sharing were two topics not considered from a comprehensive perspective in most countries. Lessons learned from previous outbreaks have shown the importance of having processes in place to ensure the ethical management of samples and data to allow future research in response to the pandemic, particularly when they are transferred abroad [8, 15, 29]. The use of broad consent processes, proper governance systems to safeguard the interests and wellbeing of donors, the confidentiality and the quality of the material and data collected, the use of material/data transfer agreements are considered ethical standards [12, 30] that should be subject to the review of a local REC. Moreover, as in any public health emergency, researchers have the moral obligation to share preliminary data from their research rapidly [11, 31]. Protocols should therefore include plans for sharing data with participants, communities, health authorities, and the scientific community, even before the publication of research results in scientific journals. This topic should also be considered by RECs.
Regarding mechanisms for community engagement in research, no provisions were found in any country as part of the ethics review of COVID-19 protocols even though international guidelines mention that community engagement strategies should be included as part of study protocols and should be assessed by RECs . Community engagement plans are essential to build and maintain trust and understanding in research activities and to show respect to the affected communities [32, 33], especially in emergency settings characterized by uncertainty and risks of misinformation. As long as these plans help the recruitment of participants, promote the social value of research, and increase the credibility of scientists and their activities to advance COVID-19 research, RECs should ask researchers to submit them to ensure ethical research.
Despite their relevance in emergency contexts, the absence of the abovementioned topics is a problem that existed in the region before the COVID-19 pandemic. In non-pandemic scenarios, biobanking, data sharing, and community engagement plans are not usually considered in research ethics governance frameworks, so it was foreseeable that countries would not include them among their COVID-19 regulations. In this context, LA countries should not lose this opportunity for a comprehensive ethics review of COVID-19 research and incorporate these key ethical issues into their regulations. Calling for action on these topics could also lead to further discussion on the necessity of including them into human research governance frameworks beyond the pandemic.
Finally, few countries considered provisions on post-trial access or research benefits in their COVID-19 governance frameworks even though fair access to benefits from research is an international ethical standard that is also adopted at the local level in most LA countries. During emergency contexts, rapid mechanisms and plans to make available to participants and communities any intervention that proves to be effective, such as agreements between sponsors and health authorities, should be in place and should be subject to RECs oversight.
Preparedness for ethics review in emergency settings
Our results may demonstrate that if not planned in advance, it is difficult for countries to design and implement an adequate research ethics response when a health emergency has already started. Partial and one-time efforts as those adopted by LA countries may not be sufficient to ensure timely and rigorous ethics review of research under challenging circumstances, especially because these circumstances may be evolving and RECs functioning will need adjustments over time. For these reasons, it is crucial to continue insisting LA governments and, in particular, their health authorities, that they need to prepare their countries and strengthen their research capacity to respond timely, efficiently, and ethically to future health emergencies. Planning measures and policies to catalyze ethical research in emergency settings in advance save valuable time and resources, reduce distress, and, ultimately, protect people’s health and lives.
The COVID-19 pandemic has demonstrated that a more comprehensive vision of research ethics during emergencies is needed. Past lessons and the ones we are learning must be the basis from which countries plan and develop their emergency research ethics governance frameworks for the future. To achieve this, further research to explore and analyze countries’ experiences in research in emergency settings, and to develop best practices to ensure ethical research during disease outbreaks in low- and middle-income countries, such as those of LA, should be promoted.
Tailor-made research responses to emergencies have also been part of international organizations that have issued ethics guidance to support countries on research in an emergency-specific context. While this does not mean that context-specific guidance or recommendations are not helpful, it calls for the development of standards and operational guidelines for ethics review and oversight that should be upheld during any public health emergency of international concern. International organizations need to work towards the identification of these standards and the most important ethical lessons learned from this and past emergencies around the globe in order to guide countries when planning and developing their emergency research ethics review and oversight policies and strategies.
This study is subject to several limitations. Although we searched legal databases and governmental official websites, we are aware that many documents may not be published online or may be published with delay, particularly because of the times of the pandemic. Some documents may have been also issued after we finished our data collection. Therefore, there might be governmental documents that were not included in this review. Moreover, our search was at a national level, so in federal countries, documents may be issued at a state or province level but not considered in the study.