9. Publication of the Belmont Report
During the 1970s, a presidential commission was established in the US. Its aims were to identify ethical principles to guide research on humans and to develop guidelines for researchers and institutions. Its 1979 report, commonly called the Belmont Report, identified three basic principles of research involving humans:
- Respect for persons - this requires respecting people’s autonomy (capacity to make informed, independent decisions) and protecting people with diminished autonomy (people who are less able to make informed, independent decisions on their own).
- Beneficence - ‘doing good’, where the welfare of the research participant should be the goal of any clinical trial. In order to maintain this, harms should be minimised and benefits should be maximised.
- Justice - Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of ‘fairness in distribution’ or ‘what is deserved’. An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. These three principles form the fundamental requirements for ethically acceptable research.
In the past few decades, a number of countries have developed legislation that regulates research involving humans. In many countries, clinical trials with investigational medicines or other products are tightly regulated through specific legislation.
The increase in rules and guidelines internationally has resulted in varying requirements that researchers and sponsors must meet. The International Conference on Harmonisation (ICH) was initiated (April 1990) to develop a process to harmonise requirements, Within the clinical trial field the work aimed specifically for international multi-centre clinical trials (i.e. trials held at more than one centre or clinic). This resulted in the Good Clinical Practice (GCP) guideline. The GCP guideline aims to:
- Avoid the duplication of studies by making data generated in trials in one country admissible in other countries,
- Speed up the medicines development process.