While national and international legal rules closely govern experimentation on human subjects, the respect of those laws cannot in itself guarantee the acceptability of a research project. Ethical evaluation is necessary before conducting any research on humans. That is why any research project involving human subjects must go through a research ethics committee before going ahead.
Why the ethical evaluation of research projects? A brief history of the development of ethical standards
From the Nuremberg Code to the creation of Institutional Review Boards in the USA
In Nuremberg in December 1946 began the trials of the physicians accused of having participated in organizing or conducting experiments on humans under the Nazi regime. The verdict, delivered in 1947, contained a list of ten criteria, known as the Nuremberg Code, which was used by the court to ascertain the lawfulness of the experiments conducted on human beings. This was the first international document summarizing the fundamental rules to be respected when conducting research on human subjects. Article 1 of the Code concerns the necessity for subjects to give their free and informed consent to participate in research.
In 1964, the World Medical Association published the Declaration of Helsinki, the latest version of which is dates from 2013. The Declaration states that protocols for research to be conducted on human beings must first be the subject of research ethics committee opinion.
In 1974 in the USA, the discovery of manifestly unethical research being conducted on humans resulted in the National Research Act. This in particular led to the creation of the modern-day Institutional Review Boards (IRBs), placed under the control of the Office of Human Research Protections (OHRP).
At the end of the 1970s, the International Committee of Medical Journal Editors met in Vancouver to lay down recommendations for the submission of manuscripts for publication. These particularly emphasized the necessity for researchers to seek an opinion from a research ethics committee before beginning any research involving human beings, whether in the domain of medicine or human or social sciences. Since then, the number of journals adhering to ICMJE continues to increase.
Regulation of research on human subjects in France
In 1988, the Huriet-Sérusclat law was the first in France to govern the authorization of biomedical studies on human subjects. For this it created research ethics committees, called Comités Consultatifs de Protection des Personnes dans la Recherche Biomédicale (CCPPRB), which then went on to become known as Comités de Protection des Personnes (CPP) in 2004.
More recently, the legal and ethical texts concerning health research have been the subject of major upheaval. At the European level, Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use came into force, directly modifying the national rules. In parallel, Regulation (EU) 2016/679 of 27 April 2016 on the protection of natural persons with regard to the processing of personal data has impacted the French Data Protection Act (Loi CNIL) of 1978. At the national level, incorporation of the European provisions and the need to bring into force the Jardé law of 5 March 2012 have given rise to many legislative and regulatory texts (rulings, decrees and orders), considerably modifying the French normative landscape and, in particular, the procedures for authorizing research.
In this context, examination by the CPPs of research projects qualified as “research involving human subjects” (RIPH) (replacing the previously used concept of “biomedical research”) is a crucial stage in the authorization procedure. However, a certain number of projects are not qualified as “RIPH” but nevertheless require submission for the opinion of a body ideally registered as an Institutional Review Board.
The Inserm Institutional Review Board
The Inserm Institutional Review Board (IRB) is registered (IRB00003888) with the Office of Human Research Protection of the National Institutes of Health (NIH, USA). It issues opinions on the ethics of research projects conducted on human beings and is competent to examine research projects in the domains of health and human and social sciences.
The assistance it gives to investigators means that ethical considerations form an integral part of the scientific approach. The essential concern of the IRB is to ascertain the compliance of submitted projects with the internationally-accepted ethical principles for research on human subjects. It also ascertains compliance with national laws.