Legal Framework for Research Involving Human Beings

At the basis of every legal system, there's a hierarchy of rules. The most fundamental of these is the constitution, charter, or a similar foundational document, which establishes the legal foundation of a State. This fundamental document is supported and completed by other types of laws, decrees, orders, regulations… Each of these is grounded in higher-level laws (its ‘legal basis’), except for the constitution itself, which is based on the State’s core principles and values.

However, not every specific detail can be covered by law, especially in complex and specialized areas like research ethics. This is where professional or industry standards come into play, supplementing the law with more detailed guidelines. Indeed, as the law is a system of general and abstract norms, the regulation of certain areas might necessitate more concrete rules. These professional standards often gain a sort of legal status, either because they are officially recognized or because they have been given specific authority (‘delegation of jurisdiction’). This is common in fields like biomedical research ethics.

Therefore, within any field, there is a structured order from general laws to specific norms and professional/industrial standards. Ensuring these standards are followed is essential. Even in cases where specific rules at different levels might not exist, the legal system does not allow for gaps; it relies on general norms and principles to guide decisions in research involving human beings.

Research ethics

Research ethics revolves around core principles that apply worldwide. These include ensuring research subjects' consent, balancing benefits against risks, and securing approval from a competent Research Ethics Committee. These ethical guidelines aim to protect participants from potential harm/abuse, balance scientific freedom with public health, and consider the legitimate interests of industry. Nowadays, such standards and principles, outlined in the Declaration of Helsinki, CIOMS Guidelines, and ICH-GCP, are recognized internationally.

While there are some differences among these major ethical documents, they do not undermine the core principles. The broad nature of these rules allows for different interpretations based on the situation, thus fostering dialogue and inclusivity across cultures and disciplines. This flexibility does not necessarily negate the specifics of local realities faced by ethics committees, researchers, and participants. Because these principles are often broad, they may not provide direct answers to specific questions. Therefore, applying research ethics – especially in protecting participants – necessitates adapting to the regulatory framework at both the national and local levels for each research project.

Overview of the ‘National or Local Regulatory Frameworks’

The need to better understand how the general principles of research ethics are reflected at national and local levels was clearly expressed by members of RECs in a survey conducted at the origin of the TRREE initiative (see Ateudjieu J. et al., ‘Training Needs Assessment in Research Ethics Evaluation Among Research Ethics Committees Members in Three African Countries: Cameroon, Mali And Tanzania’, Developing World Bioethics, vol. 10, no. 2, 2010, pp. 88-98). This module focuses on the laws and regulations regulating research involving human beings within different countries. It is aimed at helping users identify the legal standards applicable to specific issues related to the conduct of biomedical research in their own countries.

The regulatory landscape varies significantly: some countries may have a single law covering all research areas (like France or Denmark), while others might only have specific standards for particular issues, such as how RECs are organized or regulations for certain types of research. In situations where no specific law directly applies to a scenario, such as a law on human research or a decree on RECs, we turn to general legal principles, like the right to consent or legal responsibilities in research contracts. Additionally, professional, or institutional guidelines can fill any gaps left by the law.

This module aims to link ethical research issues to specific legal and regulatory rules wherever possible, though it is not always feasible. A lack of direct legal reference does not mean there is no applicable law; general principles from modules 1, 2 and 3 and their translation into international standards must always be kept in mind. Ethical rules serve as foundational guidelines in the absence of specific legislation.

Detailed explanations of concepts are generally not repeated in this ‘National or Local Regulatory Framework’ module, as they are already covered by Modules 1, 2 and 3 and the Glossary. However, national specifics or legal interpretations might be elaborated upon.

Each module begins with an overview of the country’s or territory’s legal and regulatory framework and includes a bibliography of relevant laws. References might broadly mention a law or be more focused, depending on the subject when the law covers different topics. They could also be as specific as citing particular legal provisions or parts of those provisions when they address the topic. Essentially, the module presents a diverse range of references to accommodate the varied ways legal questions can be approached within a single document.