Ethical Review of Research

How research is reviewed varies across Europe. The scope might be different, including for example social sciences besides the medical, or not. They might be organized as regional or national committees, as authorities or as professional boards, have more or less support in legal regulations, etcetera.

Common, by a EU Directive, is the demand that clinical trials are performed according to the Good Clinical Practice Guidelines. They demand that a clinical trial on a medicinal product for human use may not start until an appropriate Ethics Committee has issued a favourable opinion. Regarding clinical trials, there are European and international guidelines that specifies how the application and the review should be done (see list to the right).

Also the Helsinki Declaration states that in all medicinal research there must be a research protocol that is submitted for consideration and approval to a research ethics committee before the study begins. This committee must be truly independent and take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards. The committee must have the right to monitor ongoing studies and no change to the protocol may be made without consideration and approval by the committee, according to the declaration.

For most committees, there is some common ground in basic requirements on research. It is fundamental that research only be approved if it can be conducted with respect for human dignity and if human rights and fundamental freedoms are constantly heeded. A person's welfare should be prioritized over the needs of society and science. A subject is therefore allowed to, for instance, withdraw his/her consent to participate in a research project at any time, effective immediately.

Animal research is vetted according to its own system.

Last updated: 2010-01-01

Rules & guidelines

Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects (World Medical Association)
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
Good Clinical Practice (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use - ICH)
Universal Declaration on Bioethics and Human Rights (UNESCO)

See further

Operational Guidelines for Ethics Committees That Review Biomedical Research and Surveying and evaluating ethical review practices - A complementary guideline to the operational guidelines for ethics committees that review biomedical research (World Health Organization)
Guidelines and Recommendations for European Ethics Committees (European Forum for Good Clinical Practice)
Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use (EU Commission)
Establishing Bioethics Committees - Guide book from UNESCO
Bioethics committees at work: Procedures and policies - Guide book no 2 from UNESCO
Educating Bioethics Committees - Guide book no 3
The Procedure for the Ethical Review of Protocols for Clinical Research Projects in the European Union (European Forum for Good Clinical Practice)
About rules, regulations and declarations...