Wiesing Urban, Ehni Hans-Jörg
Director, Institut für Ethik und Geschichte der Medizin, Gartenstrasse, Tübingen, GERMANY.
Deputy Director, Institut für Ethik und Geschichte der Medizin, Gartenstrasse, Tübingen, GERMANY.
Indian J Med Ethics. 2021 Apr-Jun;VI(2):1-7. doi: 10.20529/IJME.2021.022.
Vaccines preventing Covid-19 have been approved in several countries. Is it still ethically acceptable to use placebo controls during the development of other vaccine options? If two of the most influential international guidelines of biomedical research are consulted, the Declaration of Helsinki and the CIOMS-guidelines, the answer is "no". We discuss the implications for ongoing vaccine research, and how placebo controls might be justified nevertheless. However, the ethical conflict remains highly problematic. We suggest that such ethical dilemmas should be avoided in the future by the introduction of a new system of global governance. Once vaccines are approved, a global regulation should oblige producers to provide the necessary amount of vaccine doses for the control groups of ongoing vaccine research.
预防新冠病毒的疫苗已在多个国家获得批准。在研发其他疫苗选项的过程中使用安慰剂对照在伦理上是否仍然可以接受？如果参考生物医学研究中两个最具影响力的国际准则，即《赫尔辛基宣言》和国际医学科学组织理事会（CIOMS）的准则，答案是“不可以”。我们讨论了对正在进行的疫苗研究的影响，以及安慰剂对照如何仍可能具有合理性。然而，伦理冲突仍然极具问题。我们建议，未来应通过引入新的全球治理体系来避免此类伦理困境。一旦疫苗获得批准，全球监管应要求生产商为正在进行的疫苗研究的对照组提供必要数量的疫苗剂量。
