Chalmers Donald, Nicol Dianne, Nicolás Pilar, Zeps Nikolajs
Centre for Law and Genetics, Law Faculty, University of Tasmania, Private Bag 89, Hobart, Tas, 7001, Australia.
J Bioeth Inq. 2014 Sep;11(3):301-6. doi: 10.1007/s11673-014-9552-1. Epub 2014 Jun 26.
International transfers of human biological material (biospecimens) and data are increasing, and commentators are starting to raise concerns about how donor wishes are protected in such circumstances. These exchanges are generally made under contractual material transfer agreements (MTAs). This paper asks what role, if any, should research ethics committees (RECs) play in ensuring legal and ethical conduct in such exchanges. It is recommended that RECs should play a more active role in the future development of best practice MTAs involving exchange of biospecimens and data and in monitoring compliance.
人类生物材料(生物样本)和数据的国际转移正在增加,评论者们开始对在这种情况下捐赠者的意愿如何得到保护表示担忧。这些交换通常是根据合同性材料转让协议(MTA)进行的。本文探讨了研究伦理委员会(REC)在确保此类交换中的合法和道德行为方面应发挥何种作用(如果有作用的话)。建议研究伦理委员会在涉及生物样本和数据交换的最佳实践MTA的未来发展以及监测合规情况方面发挥更积极的作用。