Carson P A, Holt J
Capenhurst Independent Research Ethics Committee, Rowanlea, 2 Greenfields Avenue, Bromborough, Wirral CH62 6DD, UK.
J Cosmet Sci. 2006 May-Jun;57(3):223-31.
The importance to the personal products industry of testing novel products in healthy human volunteers and the need to ensure the trials were both safe and ethical were addressed in Part I. The historical development of ethical standards for human testing was also summarized. The present paper highlights the ethical principles to be considered when testing novel non-medicinal products on human volunteers, and it describes how they can be implemented in a pragmatic manner to avoid delay to the sponsor's research program. The structure and function of ethics committees is discussed.
第一部分论述了在健康人类志愿者身上测试新产品对个人护理产品行业的重要性,以及确保试验安全且符合伦理道德的必要性。同时还总结了人体试验伦理标准的历史发展。本文重点介绍了在人类志愿者身上测试新型非药品时应考虑的伦理原则,并描述了如何以务实的方式实施这些原则,以避免延误申办者的研究计划。文中还讨论了伦理委员会的结构和职能。