2024-07-31 15:29:20
During the Covid-19 pandemic, many men and women from countries including India, Brazil and the UK have volunteered to take part in controlled infection trials. In these experiments, these healthy people agreed to be intentionally exposed to the SARS-CoV-2 virus that causes Covid-19 to learn how the disease develops and is spread.
This particular situation raises many ethical issues that are not foreseen by the various international texts governing biomedical research. In an emergency, the World Health Organization (WHO) mobilized experts to make several recommendations on the ethical acceptability of controlled infection trials involving the Covid-19 virus in healthy volunteers.
In France, the ethics committee of the French National Institute of Health and Medical Research (Inserm) has also begun to pay attention to this issue. The first step is to analyze the reasons why healthy volunteers participate in sometimes risky research. An initiative called VolREthics (“Research and Ethics Volunteers”) was established.
Experts involved in the international consortium have drafted a charter to promote globally good practices for protecting healthy volunteers in biomedical research.
This document is important because, beyond the unique circumstances of a pandemic, tens of thousands of healthy volunteers are exposed to other types of risks every year associated with participation in various studies. Here’s what you need to know.
Insufficient supervision of health volunteers
Closely supervised trials involving healthy volunteers could collect information necessary for drug development before they are tested on patients, or for a vaccine before it can be given to people more broadly.
While this type of work is treated with extreme caution by most regulators, and problems remain very rare, the risk of a serious accident is not zero. In France, the most high-profile case involves a trial conducted by Bial in Brittany in January 2016 to test a molecule that could relieve pain and anxiety: One of six healthy volunteers died.
It is therefore necessary to provide relevant and detailed advice to all involved: not only the healthy volunteers themselves, but also clinical trial investigators and members of regulatory or ethical assessment structures.
There are many texts on ethical principles, such as the Declaration of Helsinki published by the World Medical Association, or the International Ethical Guidelines for Health Research Involving Humans (CIOMS) published by the International Council of Organizations of the Institutes of Medical Sciences, but all of them focus primarily on patients. Interested in research. They do not address the specifics of studies with healthy volunteers.
To fill this gap, in 2019 a working group of the Inserm Ethics Committee initiated a reflection on these very special actors in order to better understand their motivations and identify the risks they may face in various regions of the world.
Based on this work, in February 2022, an international group coordinated by the Inserm Ethics Committee launched the VolREthics initiative to promote good practice for the protection of healthy volunteers in biomedical research worldwide.
To achieve this goal, several regional meetings were organized with different partners from Asia, Africa, Europe, North and South America. These discussions help to better understand the different approaches chosen by countries conducting trials or the expectations of countries wanting to develop these approaches.
Who are health volunteers and why are they involved?
These exchanges led to the observation that the vast majority of healthy volunteers participate in these studies for financial compensation, but sometimes to gain access to better health care, or access to experimental vaccines, as is the case during the Covid-19 pandemic.
The most compelling testimonies of health volunteers collected by VolREthics come from the United States. They described people who were often young, poor and without stable jobs seeking the most lucrative studies, even if it meant traveling long distances. For them, participating in clinical trials is like other “gig jobs”, an easy way to make money, as long as they master the coding.
Some healthy volunteers, not only in the United States but also in India, have reported participating in many trials and becoming experts at handling screening tests. In both countries, as elsewhere around the world, powerful commercial companies (“contract research organizations”) have developed that can quickly recruit dozens or even hundreds of healthy volunteers to optimize the development time of new drugs and vaccines.
France leads the way in regulating health volunteers
One of the key lessons from this work is that few countries have specific policies aimed at regulating research on healthy volunteers. France is an exception: in 1988, Hurier-Seruskra law The framework of specific regulations is clarified. This led in particular to the creation of national archives in the 1990s.
this database, named VRB, maintained by the General Administration of Health. It can limit the risk of “over-participation” in healthy volunteers by running multiple trials in succession without considering safety deadlines. This practice not only endangers participants but also compromises the validity of the research in which they participate…
In France, registration of healthy volunteers participating in research is mandatory, and only the researcher responsible for the study has the right to register volunteers in this file. When an investigator decides to initiate a study with healthy volunteers, he must check the database to ensure that the healthy volunteers to be recruited have not yet been included in clinical studies and have not exceeded the annual compensation cap of €6,000. Therefore, any non-compliance with this procedure will be automatically tracked.
It should be noted that personal protection committee (CPP), the independent ethics body that evaluates clinical trials conducted in France, has expressed its opinion on the amount of compensation allocated to healthy volunteers by study sponsors. This makes it possible to avoid being too attractive (which would result in acceptance of participation in the study), or having too little compensation associated with the participation of healthy volunteers in the proposed study.
Only two countries, the UK and Malaysia, have also implemented this same type of national register. Across the Asian continent, a large number of health volunteer studies are underway, and Malaysia stands out as a pioneer country committed to ensuring the best scientific and ethical quality of research in a competitive market.
International Ethics Charter Agreement
Within the VolREthics initiative, there was consensus that the primary goal should be for healthy volunteers to be recognized as an independent group among global research participants. This is actually a potentially vulnerable group that should benefit from specific protections.
There are indeed fundamental differences between the patients participating in the study and the healthy volunteers. The latter in particular differs in two ways: healthy volunteers participating in studies do not directly benefit from the research, but otherwise their main motivation is the prospect of financial compensation and they may face being dismissed if this is discovered. Risk of exploitation.
It was therefore agreed that an international ethics charter should be developed with the fundamental aim of recommending more ethical practices to all those involved in such research. A public international consultation process was launched on the first version of the Ethics Charter, and Revised version discussed in April 2024.
This charter, intended to be a framework of non-fixed recommendations, was finalized after final validation by an international panel of health volunteers. Now it can be circulated so that each country can distribute and use it according to its own constraints, whether regulatory or socio-cultural.
Its adoption at the international level will make it possible to provide a similar degree of protection worldwide. Most importantly, it will raise awareness of the special nature of healthy volunteers who contribute to biomedical research, which is currently ignored by most countries on the planet. At the request of many partners, discussions will continue on adapting the Ethics Charter to the research context of each country.
A charter could encourage health volunteers to organize themselves into associations to make their voices heard, just as many categories of patients organize to influence decisions that concern them. In addition to healthy volunteers participating in drug or vaccine studies, this work can promote the implementation of good practices to better protect “non-diseased” people participating in various research programs around the world.
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