General Introduction to National Supplements
Legal Framework for Research Involving Human Beings
A legal system is based on a pyramid of norms. At the highest level is the basic norm, the founding act of the State and its legal order. This is generally the constitution or a charter. This fundamental text is then completed at lower levels by laws, decrees, orders and regulations. Each text must find its justification, its legal basis, in a text of higher reach, except for the basic norm or the constitution, which finds its legitimacy in the founding values of the State.
However, the law cannot regulate in detail all the particular aspects of a domain. When the domain is very complex or entails specialized knowledge, the law, which is a system of general and abstract norms, should be complemented by professional or industrial standards, giving them a special status. These standards then acquire some legal force, either through their express recognition or by a delegation of jurisdiction. This is generally the case in biomedical research ethics.
Thus, within a particular domain, a hierarchy is established among general norms, specific particular norms and professional or industrial standards. In this latter case, the compulsory nature of the standards must be ensured. However, even when no a priori specific directive exists at these different levels, this does not give way to a legal vacuum. Law abhors a vacuum and in such circumstances, it must refer to general norms or general principles of law by interpreting them in the specific context of research involving human beings.
Research ethics is based on fundamental principles of universal scope. The consent of research subjects, the requirement of a favorable ratio between the expected benefits and foreseeable risks, and the need to obtain the agreement of a competent Research Ethics Committee are some of the ethical rules that have been developed to prevent abuses that could harm research participants. The purpose is to balance the protection of research subjects with scientific freedom, but also with public health and the legitimate interests of industry. Today, these ethical standards and principles are codified at the international level, for example, in the Declaration of Helsinki, the CIOMS Guidelines and the ICH-GCP.
Certainly, differences exist among the key international reference documents in research ethics, but these do not jeopardize the principles. The general nature of these rules and principles allows various interpretations according to circumstances. It creates space for intercultural as well as interdisciplinary dialogue because everyone can find his/her own particular values therein. The universality of research ethics does not necessarily lead to a denial of the local realities of research ethics committees, investigators and research subjects. The general rules and principles are often, by definition, too vague to give a clear answer to a specific question. The implementation of research ethics aiming at protecting research subjects thus requires consideration of the specific regulatory framework at the national and local levels of each research project.
Framework of Module
The need to better understand how the general principles of research ethics are reflected at national and local levels is clearly expressed by members of RECs. This module deals with the national regulation of research involving human beings. It aims at enabling the user to easily identify the legal standards applicable in his/her country on specific issues related to the elaboration or conduct of biomedical research.
There are several scenarios: either a single general law covers the entire domain (e.g., in France, Denmark, etc). Or there is no general law covering the regulation of all research but rather more specific standards dealing with specific issues such as the organisation of RECs or certain types of research. The law abhors a vacuum, and in the absence of a specific standard in a law directly applicable to the case at hand (e.g., a law on research involving human beings or a decree on Research Ethics Committees), reference is made to the general rule in ordinary law (e.g., the right of persons with respect to consent, the right to contract with respect to responsibility). Where appropriate, or in the absence of explicit rules, professional or institutional rules complete the rules of law.
Where possible in this module, each of the concepts in issues relating to ethics and the regulation of research has been attached to a rule of law, but this is not always possible. However, this does not mean that there is no law. We must always keep in mind the general principles developed in modules 1 and 2.1 and their implementation in the international instruments. In case of dispute, a judge might decide on the basis of these standards. In this sense, the ethical rules provide basic standards that apply when there is no specific law.
In general, the concepts in this module are not explained in detail, since they have already been covered in modules 1 and 2.1 and in the glossary. However, they may receive further explanations and precisions in the national context or at the legal level.
Each national module has an introduction offering an overview of the legal system with a short bibliography of the laws to which it refers. Some references are made to the law as a whole when, for example, they address a specific area. Sometimes the reference is limited to a part of the law or guidelines, when the issue covers different topics. Referral may also be made to a specific provision or a portion of the provision when it addresses the topic. In general, the references are multiple as many questions can often be treated in different ways and from different angles in a single document.