Overview of Normative Frameworks Applicable to Health Research Involving Humans


2. International Instruments

1. World Medical Association (WMA), Declaration of Helsinki

The WMA was founded in 1947. It showed concern over the state of medical ethics in general and took up the responsibility for setting ethical guidelines for the world’s doctors. The WMA hoped that developing guidelines ‘would help to impress on newly qualified doctors the fundamental ethics of medicine and would assist in raising the general standards of professional conduct.’

One of the early guidelines developed by the WMA is the Declaration of Helsinki, which provides recommendations to guide doctors from all over the world in biomedical research involving human participants. The original 1964 text of the Declaration of Helsinki has been revised several times over the years. It has had ‘great impact on human experimentation and has served as a starter for establishing ethical committees in various countries to scrutinise research projects on human beings’.

It is referenced in many other international and national documents that address biomedical and other types of research. As such, the Declaration of Helsinki sets the core values that guide biomedical research.

The WHO is involved in many ways in supporting improved ethical standards and review processes for research with human participants. Guidance documents in this field have been developed directly by the WHO and cooperatively with other groups, particularly the Council for International Organisations of Medical Sciences (CIOMS).

Significant documents for researchers and RECs include:
  • Operational Guidelines For Ethics Committees That Review Biomedical Research (2000).

  • International Clinical Trials Registry Platform (ICTRP).
The WHO has also adopted Good Clinical Practice (GCP) guidelines that mirror the ICH-GCP discussed below.

The CIOMS is an international, non-governmental, non-profit organisation. It was established jointly by the WHO and the United Nations Educational, Scientific and Cultural Organisation (UNESCO) in 1949. It represents the biomedical scientific community, for example Medical Research Councils.

The CIOMS has issued international guidelines, particularly used in low-resource countries, for the application of ethical principles in various key areas, including:
  • International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002).

  • International Ethical Guidelines for Epidemiological Studies (2009).
The CIOMS guidelines cross-reference the Declaration of Helsinki and add more specific guidance.

4. International Conference on Harmonisation - Good Clinical Practice guidelines (ICH-GCP)

Clinical trials should be carried out according to the GCP guidelines developed by the ICH. Regulatory authorities in a number of countries require adherence to these guidelines. Thus, any country that adopts the ICH-GCP guideline technically follows the same standards when conducting clinical trials. The ICH-GCP is relevant for ethics since they refer to the principles of the Declaration of Helsinki and include guidance on various ethics-related processes and procedures. This includes ethics evaluation, investigator qualification, consent and confidentiality.

Other instruments

In addition to the texts described above, there are a number of other international instruments relevant to research involving humans that are broader in scope.

For example, UNESCO has adopted several declarations, including:
  • Universal Declaration on Bioethics and Human Rights.
  • Universal Declaration on the Human Genome and Human Rights.
Such declarations provide guidance by establishing fundamental principles in their respective fields.

In the EU, the key standards are set by commission directive 2001/20/EC (the so called ‘Clinical Trials Directive’) which has been replaced in June 2014 by the new Clinical Trials Regulation 536/2014, effective in 2016.

All of these documents should be considered within the broad framework of human rights protections in research.