ABSTRACT
The COVID-19 pandemic has exposed numerous unresolved research ethics challenges particularly for Data Monitoring Committees (DMCs). DMCs have worked to ensure the ongoing social value of research as rapid changes occur in health policy and epidemiology and there is substantial pressure to release early findings to the public. Unlike Institutional Review Boards, DMCs are charged with carefully monitoring ongoing research, but with limited ethical guidance and often without representation from all host countries. This article highlights ethical challenges for DMCs and lessons learned from the COVID-19 pandemic. DMCs have long faced high-stakes decisions in clinical trials including whether to continue, modify, or terminate a trial based on emerging trial data. Trial protocols, statistical analysis plans, and data monitoring charters establish principles for DMC decisionmaking;however, there has not been a great deal of systematic examination of the ethical issues faced by DMCs. For example, which ethical considerations should be addressed by DMCs as opposed to Institutional Review Boards or researchers is often unclear. Formal guidance rarely addresses whether DMCs should monitor the representativeness of trial participants as compared with the target population for the intervention. Furthermore, post-trial issues have received limited attention. Should DMCs ensure the accuracy of press releases and manuscripts detailing study findings? How should DMCs determine when to unblind participants after a study is over if it is relevant for their medical decision-making? In this presentation, we will report preliminary results of a qualitative study of DMC members (i.e. statisticians, clinicians, and ethicists). We will highlight persistent controversies, the range of roles DMCs are expected to play in monitoring clinical trials, and variation in formal guidance about the ethical obligations of DMCs. We will also examine the question of whether and when ethicists should serve on DMCs. We will conclude by identifying critical ethical issues facing DMCs that warrant further attention.
ABSTRACT
Introduction/ Background: During COVID-19, research and ethics review systems have been under pressure to ensure the timely review of research to inform health emergency response efforts. While previous health emergencies have provided lessons for research review systems, COVID-19 presents unprecedented challenges. The study explored Kenyan research review systems' responses to COVID-19 pandemic. Methods: An exploratory case study design was used. Data were collected through individual in-depth interviews (n=15), document reviews and secondary analysis of administrative records. Respondents included researchers and reviewers at the KEMRI Wellcome Trust Research Programme (KWTRP) and the KEMRI Scientific and Ethics Review Unit (SERU). Qualitative data were managed using NVivo 12. The Framework Approach was used for analysing interviews and documents while descriptive statistics were generated from the administrative records. Results: Between April 1st 2020 and March 31st 2021, 30 COVID-19-related protocols by KWTRP researchers were reviewed and approved by institutional and national-level ethics review committees. The committees made structural and procedural changes to expedite review of protocols, including fast roll out of online submission of protocols. There was a 1.4-fold and 2.4- fold delay in providing review feedback for new COVID-19 protocols and amendments respectively compared to internally set targets. Reviewers raised COVID-19 specific ethics issues, including virtual informed consent;COVID-19 screening and testing procedures and mitigation measures;and the challenges of study design and undertaking community engagement during the pandemic. Impact: Understanding how research and ethics review systems have responded to COVID-19 can generate valuable knowledge to inform future responses to pandemics and other public health emergencies. Strengthening research and ethics review systems is likely to build public confidence in research outputs. Conclusion: Despite best intentions, the review process became more complex and there were bureaucratic delays in final approval of research protocols. Our findings highlight the need for strengthening coordination and communication between researchers, institutional and national research ethics committees, including by improving information and technology infrastructure.
ABSTRACT
Background: The scale of the COVID-19 pandemic and novelty of SARS-CoV-2 presented unprecedented challenges in the review of COVID-19 protocols. We investigated how research at the Kenya Medical Research Institute - Wellcome Trust Research Programme (KWTRP) was reviewed, including by institutional and national level committees.