The role of the individual and the community in the research, development, and use of biologicals with criteria for guidelines: a memorandum.
In view of the widely recognized need to use available vaccines and other biologicals and to develop new ones to control many diseases of world-wide importance, this Memorandum considers the increasingly complex problems that face investigators and public authorities that must review and approve pre-licensing studies and also large-scale regular use. It is stressed that the proper conduct of biologicals research in human beings must be considered from the scientific, sociological, ethical, and legal points of view. The Declaration of Helsinki is regarded of fundamental importance and its applicability to biologicals research is discussed. Recommendations are made for continued international collaboration in this field and "Criteria on the Role of the Individual and the Community in the Research, Development, and Use of Biologicals" are formulated. General criteria and specific criteria related to the design of field trials, human involvement in field trials, and surveillance of safety and effectiveness of biologicals in routine use are discussed.
D001688:Biological Products; D003140:Communicable Disease Control; D006805:Human Experimentation; D006801:Humans; D007114:Immunization; D011315:Preventive Medicine; D012106:Research
D001688:Biological Products