Bull World Health Organ. 1976;54(6):645-55.
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.
鉴于人们普遍认识到需要使用现有的疫苗和其他生物制品，并研发新的制品来控制许多具有全球重要性的疾病，本备忘录探讨了研究人员和公共当局面临的日益复杂的问题，这些当局必须审查和批准许可前研究以及大规模常规使用。强调必须从科学、社会学、伦理和法律角度考虑在人类身上进行生物制品研究的正确做法。《赫尔辛基宣言》被视为至关重要，并讨论了其对生物制品研究的适用性。提出了在该领域持续开展国际合作的建议，并制定了“关于个人和社区在生物制品研究、开发和使用中的作用的标准”。讨论了与现场试验设计、人类参与现场试验以及常规使用中生物制品的安全性和有效性监测相关的一般标准和具体标准。
