Investigators, sponsors and institutional authorities share equal responsibility for producing high-quality data and following ethical recommendations for the conduct of biomedical research involving human subjects. The Declaration of Helsinki - first proposed in Finland in 1964 and later revised by the World Medical Assembly in Hong Kong in 1989 - is a universally accepted ethical code.

In 1987 the Medical Research Council of Canada (MRC) approved guidelines for research involving human subjects. The latest guidelines for good clinical research practices are stipulated in a document entitled "Conduct of Clinical Investigations"; they were officially adopted by the Health Protection Branch (HPB) of the Canadian government in 1989.

In the United States, federal regulations concerning the development of new drugs and their subsequent admissibility for clinical investigation were in place as early as 1938. Following the tragic events surrounding the use of thalidomide in the 1950s, important amendments were adopted: review of preclinical data, the informed consent of patients and the reporting of preclinical findings became mandatory in 1962. In an attempt to standardize compliance with regulatory requirements, good clinical practice (GCP) rules for sponsors (1977) and for investigators (1978) were developed by industry. The investigational new drug (IND) regulation was established in 1987.

The most recent and comprehensive set of guidelines for drug trials emerged in October 1990 as a result of a meeting where the tenets of good practice were compared by scientists from the European Community and North America. Uniform standards were subsequently defined.

Although some differences exist among countries in the government regulations governing clinical research in humans, these guidelines are becoming more uniform.