The primary goal of these training modules is to provide training and resources to those who ensure the protection of the rights and interests of individuals and communities serving as participants in health research. The training material is designed for all those involved in collaborative research involving humans including physician-investigators and other researchers, students, research ethics committees and regulatory agencies. The modules are based on well-established principles of research ethics, as expressed in documents such as the Declaration of Helsinki. Research ethics operates within the universal human rights framework as elaborated in the Universal Declaration of Human Rights (1948), the Convention on the Rights of the Child (1989), and other international human rights instruments.
Research on humans often involves risks as well as potential benefits. Research risks are mostly borne by the research participants. So it is important to ensure that their interests are respected and their well-being is protected. Many actors have a collaborative role to play in this.
Within this framework, researchers bear the primary responsibility for the safety and wellbeing of research participants. Researchers fulfill this responsibility during the writing of protocols, the conduct of research involving humans and by acting with integrity. The process of research ethics evaluation by Research Ethics Committees (RECs) is also directed at protecting research participants. Ensuring appropriate protection of research participants while not unduly limiting potentially promising research requires awareness of local and international guidelines and critical assessment and thinking.
The training modules accessible here address the ethics of health research in general and provide a particular focus on clinical research. They are designed to assist those responsible for ensuring the respect and protection of research participants:
- Module 1 is an introductory module that presents the basics of research ethics evaluation and the broader context of research ethics. It is designed for anyone intimately or remotely involved with research involving humans.
- Module 2 focuses on the training needs of members of Research Ethics Committees (RECs) and any support function. It is also relevant to other stakeholders in the field such as researchers and their teams, or students of faculties who train researchers, who develop research projects and/or who conduct research. Module 2 addresses elements that should be considered when assessing if research is ethically acceptable.
- Module 3 presents the relevant norms and regulations on a country by country basis. It provides specific references for concepts and principles discussed in modules 1 and 2.
