In the wake of the unprecedented SARS-CoV-2 virus pandemic, leading to the disease, Covid-19, and the exploration of a few repurposed drugs, e.g. hydroxychloroquine (anti-malarial), dexamethasone (anti-inflammatory), Remdesivir (anti-viral), or artemeria (plant with possible medicinal properties), as potential treatments, there has been a sudden explosion of clinical trials – some 2,500 reported to date. Any clinical trial (fr. essai clinique) involves both ethical principles applied to medical research as well as to the vulnerability of the patient.

 Informed or enlightened consent

It is amazing how an informed or enlightened consent existed as a medical norm since antiquity. However, it was only around 1900 in Prussia that the first legislation was enacted concerning the official consent from the individual. Then, in 1964 came the Helsinki Declaration from the World Medical Association, whereby a formal signed statement, the Consent Form, was introduced. Ethical principles to guide the protection of human participants as well as recommendations guiding doctors in clinical research were spelt out.

Consent, above all, is an informed and self-determined decision that enables the doctor to act on the patient ultimately for the latter’s benefit. However, if carried out without the will of the patient, it would amount to an abuse of power. The patient should understand that the research does not aim at therapy but at the collection of reliable data for acquiring knowledge that could be of benefit to others. The patient should be provided with all relevant information – those that could make him change his mind either way. The information should enable him answer how this would affect him and his environment if he says either yes or no.

The process

The decision should be based on the patient’s priorities and in the light of current scientific knowledge. The doctor, usually well-trained in the process,(e.g. In France and Switzerland doctors have to follow a continuous professional development programme in the subject, have to develop the appropriate communication skills and also take part in simulation exercises) should be loyal and clear in his explanations and devote enough time to what could be a difficult interview.

In practice, the signed consent form boils down to an attestation as required by law, and also as a traceable record of the information provided to the participant. A patient’s perception of what is really at stake in a clinical trial can be distorted. The patient has a tendency to believe that a clinical trial aims at a treatment or cure and not at collecting data which will benefit others. Therefore, the reassured patient should realise that first and foremost a clinical trial is a piece of research work with a view to generate new knowledge. Explaining this aspect is of vital importance.

Covid -19 clinical trials

Some promising results from rapid clinical trials of a few drugs (those mentioned above) tried against SARS Cov2 virus have unfortunately made some patients interpret them as confirmation of their efficacy and wanting to benefit from any of these. One cannot equate ‘promising’ with ‘efficacy’. The ‘natural fear’ of the disease could have increased their hope of a potential treatment but the doctor should be aware of this and inform the patient accordingly. There are three outcomes to the clinical trial of any drug: (a) shows real efficacy (b) a risk that it is not (3) has deleterious (harmful) effects. In this respect, hydroxychloroquine (or together with azithromycin) after being controversial, has not been found yet to be beneficial whilst in the UK dexamethasone (a steroid) has reaped success in specific cases whilst remdesivir (used for AIDS) being an antiviral showed some promise and artemesia used in Madagascar is still not generally acclaimed. Furthermore, timely generation of regionspecific data for and against steroid efficacy from welldesigned African randomised controlled trials are advocated before recommending the incorporation of dexamethasone treatment guidelines for Covid-19 in Africa.

The short time of clinical trials on a limited number of patients in the prevailing situation ,coupled with the rush to disseminate preprint scientific communications in journals without peer review, has been the subject of much criticism.

Proposals for vaccines ,on the other hand, which usually pass through several stages of clinical trials, will be carefully evaluated in terms of rigorous and reliable data by the regulatory agencies in the US and EU to ensure safety and efficacy before being manufactured on a large scale and be made available worldwide. Participation is far and wide and also on a voluntary basis from healthy persons. The degree and strength of immunity achieved (in terms of antibody response and activated T Cells to eliminate diseased cells) are crucial factors to consider apart from for how long that immunity would last and be protective. Most groups are cautiously optimistic that vaccines for Covid-19 will be a reality by early 2021, if not earlier. 

 Consent for Biobanks

Any patient or participant from whom biological samples (e.g blood) are obtained and stored must also give consent. There is an added responsibility on the part of the doctor involved in the research to share same with his other partners in research. There exists still the misunderstanding on the part of some participants in that they believe the analyses carried out on their samples would reveal all about their health status and that they will be informed of any health risk. As this is not the case, this misunderstanding must be dispelled forthwith.

Much of the information in the present article has been gleaned from an interesting discussion of Dr Samia HurstMajno, Médecin – Bioethicienne, in a recent issue of Le Monde.