How to use the National or Local Regulatory Frameworks


Each module is designed to provide a comprehensive overview of the national and local laws and regulations that govern research involving human beings. They can serve as educational tools to broaden users' knowledge of the regulatory landscape for research in a particular country or territory. Moreover, they offer an innovative opportunity for conducting comparative legal research, thus strengthening knowledge in the field on both a national and international scale.

Introduction to the national or local system

On the page of each national or local regulatory framework, there is a section entitled “Introduction to the national or local system”. This document aims to explain the national or local legal system (e.g. main sources of law) and to provide an overview of the regulation of research involving human beings (e.g. sources, authorities or the relation between international/regional standards and the national laws).


The structure of each module is organized around four main topics or chapters:

  • Chapter 1 : the 'Regulatory framework for research involving human beings and types of regulated research', which details the current legal and regulatory background applicable to various types of research;
  • Chapter 2: 'Research Ethics Committees', which focuses on the authorities evaluating and supervising research projects;
  • Chapter 3: 'Research Ethics Evaluation', which presents the detailed evaluation requirements for a research project ;
  • and Chapter 4: 'Health databases and Biobanks', which covers the regulatory framework applicable to these institutions and the associated requirements.

The chapters are presented on the left-hand side of the screen in the form of scrolling menus. Click on "+" to display the questions.


Each chapter develops in a Q&A format, featuring 'core questions' such as 'Is there a regulatory framework for biobanks? Is there a definition of a biobank in the regulatory framework?' Sub-questions then examine deeper these topics, for example, for the core question ‘Are there provisions on conflict of interest in research involving human beings ?’, some of the sub-questions include ‘If yes, who is concerned by these provisions?’ or ‘If yes, what are the interests considered?’.

The questions are the same for the regulatory framework of each country or territory.


Following the questions, a 'Comment' section provides some explanations of the elements mentioned in the questions. The comments are didactic sheets aiming to "translate" the law into common language. Their purpose is to enable a non-lawyer or non-specialist to make a link between all the sub-questions related to a main question by placing them in a wider context.


Following the comment, a ‘References’ section provides the legal basis ( = targeted article(s)) for each question and its answer. The references are organized by legal or regulatory source, with specific articles listed by question below. By clicking on the title of the source, the user can download the text of the law or regulation in PDF and access the full text in the official language of the country or territory.


Each national or local regulatory framework is written in the official national language of the country or territory. However, each framework can be translated into another language offered by TRREE, namely English, French, German, Portuguese, Lithuanian, Polish, Armenian or Spanish.

Legislation Comparison Tool

Our newest comparison tool allows users to compare regulations of all the TRREE countries and territories on a selected topic. As the questions are the same for every country and territory, the users can compare the answers, the comments and the references.

The comparison tool is represented by a small globe icon . Clicking on this tool redirects users to a comparative table that shows the answers, comments or references for the given question from each country or territory.

For instance, under the question 'What are the consent requirements for biobank contributions?', users can view and compare the applicable regulatory frameworks across all countries featured.

Although each regulatory framework is designed in the national language of the country or territory, the comparison table displays the data in the language chosen by the user. The automatic translation is made by Google Translate and identified by the icon . If this icon is missing, it means that the text appears in its original language. In some countries, such as Switzerland, an original English version is also available even if this is not a national language. This version in English has been written directly by experts in the field and not only by using Google translate.


The national or local regulatory frameworks for some countries (namely Nigeria, South Africa and Switzerland) include a quiz. The completion of the quiz leads to the issuance of a certificate. This TRREE certificate may be recognized by national authorities or institutions in the respective countries. TRREE does not have a list of authorities or institutions that recognise the TRREE trainings. We advise users to contact their authorities directly to find out about the recognition.

Last modified: Wednesday, 8 May 2024, 10:53 AM