New Zealand Blood Service, Epsom, Auckland, New Zealand.
Vox Sang. 2020 Jan;115(1):3-10. doi: 10.1111/vox.12866. Epub 2019 Nov 13.
It is recognized that blood transfusion services have an ethical duty to obtain informed consent from their voluntary, non-remunerated donors. This right was most recently affirmed by the 2017 revision of the International Society of Blood Transfusion (ISBT) Code of Ethics. However, the constituent elements necessary to adequately inform such consent have not been definitively established.
This review evaluates the historical background to informed consent in medicine and as it has been applied to blood donation. The question of what information should be disclosed is then considered with regard to existing statutory requirements in both the United States and EU as well guidance from relevant international organizations. The emerging ethical issues around repurposing of donated blood for sale as recovered plasma and use in research are included in this analysis.
A reasonable basis is found in the literature to advocate that valid informed consent of blood donors should encompass: the donation process itself and potential adverse effects, the need for pre-donation transfusion-transmissible infection (TTI) screening, potential non-transfusion uses of derived products, requirements to obtain and store personal information, the consequences that non-disclosure of such information may have for both the donor and the recipient and reassurance as to the confidentiality of this information.
Informed consent is a key component of the duty of care between a blood service and its donor. We identify essential elements that should be present for such consent to be considered valid.
人们认识到，输血服务机构有道德义务从其自愿、非付费的献血者那里获得知情同意。这一权利最近在 2017 年修订的国际输血协会（ISBT）道德准则中得到了肯定。然而，为了充分告知这种同意，必要的组成要素尚未得到明确确立。
本综述评估了医学中知情同意的历史背景及其在献血中的应用。然后，根据美国和欧盟的现有法定要求以及相关国际组织的指导，考虑了应该披露哪些信息的问题。本分析还包括了重新利用捐赠血液出售为回收血浆以及在研究中使用所引发的新兴伦理问题。
文献中发现了一个合理的基础，可以主张献血者的有效知情同意应包括：献血过程本身及其潜在的不良反应、进行献血前输血传播感染（TTI）筛查的必要性、衍生产品的潜在非输血用途、获取和存储个人信息的要求、不披露这些信息对供体和受体可能产生的后果以及对这些信息保密性的保证。
知情同意是血液服务机构与其献血者之间护理责任的关键组成部分。我们确定了这种同意被认为有效的必要组成要素。
