Clinical investigation and informed consent form in times of COVID-19 pandemic. A vision from the comitee ethics of research

Dear Editor:

The exceptional situation created by the SARS-CoV-2 pandemic has raised a number of very serious health, social and economic problems.

Because of the lack of knowledge of SARS-CoV-2 and the absence of treatments for Covid-19, clinical research is paramount and will need to establish the efficacy, reliability and safety of new diagnostic, prophylactic and therapeutic approaches to this pressing health problem¹ in an agile, flexible and pragmatic manner.

Research during the outbreak is an ethical obligation and it is important that studies address local priorities, conform in design to local capacities and are acceptable to the affected population,² while joining forces in the international arena to share information and results. This exceptional clinical situation has generated a surge of interest among both established and emerging researchers and many clinicians with little or no research experience, resulting in a flood of research projects submitted to Research Ethics Committees (RECs).

RECs face an unfamiliar situation where, according to the Pan American Health Organization and the World Health Organization, alternatives to the ordinary ethics review processes need to be found to reduce the obstacles that arise during the conduct of research and to provide an efficient response to time and needs. Covid-19-related clinical research involves finding a balance between speeding up the ethical review processes of projects and ensuring their methodological rigor.

There is a need to develop flexible and alternative procedures for ethical review that allow for efficient communication, harmonisation of criteria, cooperation between committees and interrelation between committees and health authorities, and even foster international collaboration.

This health emergency situation has also generated a new healthcare framework in which it may be difficult to gain access to potential candidates to participate in a clinical trial or to their relatives, both because of their extremely serious clinical condition and because of the strict isolation measures and the lockdown of the population, circumstances that considerably hinder one of the basic pillars of research ethics, namely the appropriate procedure for requesting informed consent.

The European Medicines Agency has made a series of recommendations on how informed consent can be obtained for participation in clinical trials with medicinal products in this situation⁴ which attempts to facilitate and make this procedure more flexible, allowing oral consent to be confirmed in writing as soon as the situation allows it, mentioning this situation in the patient’s medical record.

With regard to informed consent for studies with clinical data or biological samples, the Spanish Bioethics Committee⁵ published a report on 28 April that clarifies that the Spanish legal system allows the secondary use of health data and biological samples without the requirement to obtain express consent from the source subjects and that these projects must be previously approved by the REC.

RECs now play a key role, as they are the entities responsible for assessing the methodological, ethical and legal quality of research projects and must ensure that informed consent is properly granted as a guarantee of respect for the fundamental rights of the subjects – also and especially – in a health emergency situation.

RECs should develop mechanisms to speed up ethics review processes, such as the creation of standing committees with full decision-making capacity on behalf of the REC, virtual e-mail meetings of pre-defined duration that allow all REC members to participate without the need for their simultaneous physical presence, and strategies to integrate the work of different RECs to avoid duplication of evaluations³ through a national electronic application and to ensure that the research that took place in this time of emergency, uncertainty and haste was of high quality and guaranteed the fundamental freedoms of the individuals who participated in it. Mutual recognition between ethics committees is now more necessary than ever.