Leiss William, Tyshenko Michael, Krewski Daniel
McLaughlin Centre for Population Health Risk Assessment, University of Ottawa, Ottawa, Ontario, Canada.
Transfus Med Rev. 2008 Jan;22(1):35-57. doi: 10.1016/j.tmrv.2007.09.002.
This article discusses issues associated with the lifetime deferral from donating blood of men having sex with men (MSM), in the context of well-established risk management principles, including ethical considerations associated with the risk-based approach to social policy matters. Specifically, it deals with the questions about the rationale for the existing policy in Canada of lifetime deferral for MSM, a rationale applied in practice by blood collection agencies and supported by the regulatory authority of Health Canada. We identify several alternative time frames for MSM deferral: sexual abstinence over either a 10-, 5-, or 1-year period or no deferral. Two options are selected for more complete discussion, namely, abstinence for a period of either 1 or 5 years before donation. The available evidence about estimated residual risk (RR)-that is, the risk remaining after various safeguards for blood are applied-strongly suggests that choosing a 1-year deferral period for MSM would almost certainly give rise to an incremental risk of transfusion-transmitted infection (TTI), over existing levels of risk, for blood recipients. The report argues that, under these circumstances, such a policy change would represent an unethical type of risk transfer, from one social group to another, and therefore would be unacceptable. The evidence is less clear when it comes to a change to either a 10- or 5-year deferral period. This is the case in part because the current level of RR is so low that there are, inevitably, substantial ranges of uncertainties associated with the risk estimation. There is no firm evidence that such a change in the deferral period for MSM would result in an incremental level of risk, although the possibility of a very small increase in risk cannot be entirely ruled out. Under these circumstances, other social policy issues, relevant to the idea of changing the deferral period for MSM, become worthy of additional consideration.
本文在既定的风险管理原则背景下，讨论了与男男性行为者（MSM）终身 deferral 献血相关的问题，包括与基于风险的社会政策事项处理方法相关的伦理考量。具体而言，它探讨了加拿大现行针对 MSM 的终身 deferral 政策的理论依据问题，这一理论依据在采血机构的实践中得到应用，并得到加拿大卫生部监管机构的支持。我们确定了 MSM deferral 的几个替代时间框架：10 年、5 年或 1 年的性禁欲期或不禁欲。为了进行更全面的讨论，选择了两个选项，即献血前 1 年或 5 年的禁欲期。关于估计残余风险（RR）——即应用各种血液安全保障措施后仍存在的风险——的现有证据有力地表明，为 MSM 选择 1 年的 deferral 期几乎肯定会给血液接受者带来高于现有风险水平的输血传播感染（TTI）增量风险。报告认为，在这种情况下，这样的政策变化将代表一种不道德的风险转移，从一个社会群体转移到另一个社会群体，因此是不可接受的。当涉及到改为 10 年或 5 年的 deferral 期时，证据就不那么明确了。部分原因是当前的 RR 水平非常低，以至于在风险估计方面不可避免地存在大量不确定性。没有确凿证据表明 MSM deferral 期的这种变化会导致风险水平增加，尽管不能完全排除风险有非常小的增加可能性。在这种情况下，与改变 MSM deferral 期这一想法相关的其他社会政策问题值得进一步考虑。
