BackgroundResearch has been an essential part of the COVID-19 pandemic response, including in Latin American (LA) countries. However, implementing research in emergency settings poses the challenge of producing valuable knowledge rapidly while upholding research ethical standards. Research ethics committees (RECs) therefore must conduct timely and rigorous ethics reviews and oversight of COVID-19 research. In the LA region, there is limited knowledge on how countries have responded to this need. To address this gap, the objective of our project is to explore (...) if LA countries developed policies to streamline ethics review and oversight of research in response to the pandemic while ensuring its adherence to ethical standards, and to analyze to what extent these governance frameworks are in accordance with international guidance.MethodsWe conducted a descriptive and exploratory study assessing the COVID-19 research ethics governance frameworks of 19 LA countries, considering 4 dimensions based on international COVID-19 ethics guidance documents: (i) ethics review organizational model adopted, (ii) measures to coordinate between RECs and other research stakeholders, (iii) operational guidance for RECs, and (iv) key ethical issues for review and oversight of COVID-19 research.Results10 out of 19 LA countries have some policy to streamline ethics review of COVID-19 research. Of these countries only 6 issued comprehensive documents following international guidance that contemplate strategies with recommendations for concrete actions for a timely and rigorous review.ConclusionLA countries adopted partial strategies and operational guidance that may demonstrate a lack of a comprehensive view of research ethics for the review and oversight of COVID-19 research. Continuing efforts should be directed to strengthen LA countries' research capacity to respond timely and ethically to future health emergencies. Past lessons and the ones from this pandemic should be the basis to develop international standards and operational guidelines for ethics review and oversight of any research for public health emergencies. (shrink)

Over recent years, the research community has been increasingly using preprint servers to share manuscripts that are not yet peer-reviewed. Even if it enables quick dissemination of research findings, this practice raises several challenges in publication ethics and integrity. In particular, preprints have become an important source of information for stakeholders interested in COVID19 research developments, including traditional media, social media, and policy makers. Despite caveats about their nature, many users can still confuse pre-prints with peer-reviewed manuscripts. If unconfirmed but (...) already widely shared first-draft results later prove wrong or misinterpreted, it can be very difficult to “unlearn” what we thought was true. Complexity further increases if unconfirmed findings have been used to inform guidelines. To help achieve a balance between early access to research findings and its negative consequences, we formulated five recommendations: (a) consensus should be sought on a term clearer than ‘pre-print’, such as ‘Unrefereed manuscript’, “Manuscript awaiting peer review” or ‘’Non-reviewed manuscript”; (b) Caveats about unrefereed manuscripts should be prominent on their first page, and each page should include a red watermark stating ‘Caution—Not Peer Reviewed’; (c) pre-print authors should certify that their manuscript will be submitted to a peer-review journal, and should regularly update the manuscript status; (d) high level consultations should be convened, to formulate clear principles and policies for the publication and dissemination of non-peer reviewed research results; (e) in the longer term, an international initiative to certify servers that comply with good practices could be envisaged. (shrink)

In the context of a public health emergency it is imperative to conduct research studies that will produce evidence rapidly while upholding ethical standards. The Ebola and Zika outbreaks highlighted the importance of devising agile processes for ethics review in emergencies, and international research ethics guidelines stress the duty to depart from standard processes for ethics review in emergency circumstances. However, before the COVID-19 pandemic it was not entirely clear what emergency procedures should look like. An additional challenge is that (...) while the same substantive ethical standards apply in emergency and non-emergency settings, deciding what these standards entail in the specific circumstances of a pandemic may be difficult. During the COVID-19 pandemic, challenges included identifying thresholds of social and scientific value, along with duties towards research participants, given the absence of therapeutic options; assessing continually changing risk–benefit profiles of studies, given rapidly emerging new evidence; developing appropriate informed consent processes, given lockdown scenarios; and even addressing the ethics of offering unproven interventions outside research settings. Additional issues raised during epidemics include devising feasible and meaningful community engagement strategies, mechanisms to ensure fairness in the distribution of the benefits that may result from research, and equitable and effective data-sharing plans that will inform pandemic response. Learning from these procedural and substantive challenges encountered in the ethics review of COVID-19 research is important for enhancing ethics preparedness for future emergencies. It can also potentially contribute to improving the ethics review of research in non-emergency circumstances. The seven cases in this chapter highlight ethical issues associated with ethics approval of multi-centre studies in pandemics, the need for careful consideration of the social and scientific value of research and challenges encountered when interventions are being transitioned from research to rollout, and issues that can arise when existing regulations and policies may limit capacities to appropriately adapt research to pandemic contexts. (shrink)