DOI:https://doi.org/10.20529/IJME.2020.062
The Covid-19 pandemic has created a situation demanding rapid ethics review of research on various aspects of the pandemic, while maintaining social distancing norms. Research during an outbreak is important for understanding the disease and its management and allows scientists to study the disease in situ.
In response to the 2013-16 Ebola virus outbreak, the World Health Organization (WHO) had issued a ‘Guidance for managing ethical issues in infectious disease outbreaks’ (1). The ethical guidelines for biomedical and health research, issued by the Indian Council of Medical Research (ICMR), mention that the ethics committee (EC) can undertake an expedited review or hold unscheduled meetings during humanitarian emergencies (2,3).
In 2018, a workshop organised by the WHO Global Health Ethics Team and the African coalition for epidemic research, emphasised “ethics preparedness” during outbreaks. It recommended that ECs should develop a formal standard operating procedure for emergency response ethical review (4).
Studies during infectious disease outbreaks can involve collection of data and/or clinical specimens which is useful in understanding the pathophysiology of disease and for diagnostics, management and surveillance. The drug/device interventions in outbreaks provide information about the effects of vaccines and therapeutics (5).
ECs have a vital role in the efficient review of Covid-19 studies during an outbreak. Research proposals involving more than minimal risk to human participants require critical review by the full board of the EC/Institutional Review Board (IRB). However, it is also vital to follow social distancing to reduce risks of cross-contamination caused by close contact. In the present situation, it is crucial and a challenge to give timely decisions on such research proposals. While telemedicine is an important means of delivering care, information of its use in the conduct of these meetings in emergencies has been limited. Zhang and colleagues reported the experience of ethical review of studies on Covid-19 by emergency video conference in China (6). We present our experience of conducting EC review meetings during the Covid-19 pandemic through telemedicine video conferencing using an online meeting platform.
The Institutional EC (IEC) at the Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India, has been constituted as per international and national guidelines. It is registered and FERCAP (Forum for Ethical Review Committees in Asia and the Western Pacific) accredited. Research proposals are submitted online on a dedicated submission portal developed by the Institute.
Research proposals on Covid-19 involving human participants, were screened by the Bioethics Cell office staff as per a checklist, to confirm all necessary documentation, namely, study protocol, informed consent forms (ICFs), undertaking, record forms etc. The Member Secretary performed a pre-review of proposals and forwarded them to the Chairperson, IEC. Where required, clarifications on the proposal were sought from the Principal Investigator via email. On receiving a response, a full Board video conference meeting of the IEC was scheduled through a licensed “Zoom cloud-meeting” platform.
Primary review (for scientific, ethical and ICF-related issues), of the research proposals was done by two members. Members downloaded the “Zoom Cloud Meetings” application and joined the virtual meeting through their devices. The Telemedicine department staff coordinated the meeting and recorded the proceedings.
The primary reviewers summarised and presented the proposal to the IEC, highlighting the ethical and other issues in the study, with comments on the informed consent forms provided for review. During discussion, the members raised their hands for additional questions and to present their viewpoints. There was a lively discussion, followed by a consensus decision. The process from online submission of research proposals to communication and dispatch of decision letters took three to eight working days. The committee welcomed the decision of the regulatory authorities to give priority approvals for clinical/investigator-initiated trials related to the pandemic.
The current Covid-19 pandemic has reminded us of the potential of telemedicine. Making timely decisions for Covid-19 research proposals is a challenge for ECs. Meetings by video conferencing are a feasible option for early decision making by the ECs, especially for research proposals related to the pandemic. In the absence of any formal strategy, it is important to prepare guidelines to assist with co-ordination and conduct of crucial EC meetings during an emergency.