整合疟疾疫苗实施计划（MVIP）后的公共卫生项目和研究：下一步建议。

University Medical Center Utrecht, Julius Center for Health Sciences and Primary Care, PO Box 85500, 3508 GA Utrecht, Netherlands(1).

Distinguished University Professor Emerita, Albert Einstein College of Medicine, Bronx, NY, USA(2).

Vaccine. 2020 Oct 21;38(45):6975-6978. doi: 10.1016/j.vaccine.2020.08.077. Epub 2020 Sep 25.

BACKGROUND

In February 2020, international controversy arose about the ethical acceptability of the WHO Malaria Vaccine Implementation Program (MVIP). Whereas some have argued that this program must be seen as research that is not in line with international ethical standards, notably regarding informed consent and local ethical review, some WHO representatives consider the MVIP as a public health implementation program that need not adhere to these standards.

METHODS

We performed a case analysis in light of the 2016 CIOMS International Ethical Guidelines for Health-related Research involving Humans.

FINDINGS

We argue that the MVIP has a substantial research component, and that it is prudent to therefore apply ethical norms for research involving humans, such as the CIOMS guidelines. Accordingly, we agree that the ethical requirements of informed consent and independent ethical review have not been met. In addition, we are concerned that the study might not meet CIOMS's social value requirement.

RECOMMENDATIONS

We urge WHO to release more details about the process that led to the MVIP program and make the MVIP protocol publicly available. The full protocol should be assessed by the relevant ethics committees, new and already enrolled parents should be informed about the uncertainties under investigation and given a real opportunity to consent or refuse (continued) participation, communities should be engaged, and aspects of MVIP that require alteration in light of ethical review should be altered, if possible. Furthermore, in order to improve good ethical practices, it is necessary to engage in international debate regarding the integration of research and public health programs. Procedurally, vaccine implementation programs that combine both prevention and research should involve the wider international ethics community and ensure participation of the target populations in setting the proper conditions for launching such programs.

背景

2020 年 2 月，世界卫生组织疟疾疫苗实施规划（MVIP）的伦理可接受性引发了国际争议。一些人认为，该规划必须被视为不符合国际伦理标准的研究，特别是在知情同意和当地伦理审查方面，而一些世卫组织代表则认为 MVIP 是一个公共卫生实施规划，不必遵守这些标准。

方法

我们根据 2016 年 CIOMS 人类健康相关研究国际伦理准则，对该案例进行了分析。

发现

我们认为 MVIP 具有重要的研究组成部分，因此谨慎地应用涉及人类的研究伦理规范，如 CIOMS 准则。因此，我们认为知情同意和独立伦理审查的伦理要求没有得到满足。此外，我们还担心该研究可能不符合 CIOMS 的社会价值要求。

建议

我们敦促世卫组织公布更多关于导致 MVIP 规划的过程细节，并公开 MVIP 方案。应将完整方案提交给相关伦理委员会评估，新招募的和已招募的家长都应了解正在调查的不确定性，并给予他们真正的同意或拒绝（继续）参与的机会，社区应参与其中，如果可能的话，应根据伦理审查修改 MVIP 的需要修改的方面。此外，为了改善良好的伦理实践，有必要就研究和公共卫生规划的整合问题开展国际辩论。程序上，将预防和研究结合起来的疫苗实施规划应涉及更广泛的国际伦理界，并确保目标人群参与制定启动此类规划的适当条件。