Ethics Dumping by Doris Schroeder Julie Cook François Hirsch Solveig Fenet & Vasantha Muthuswamy

Author:Doris Schroeder, Julie Cook, François Hirsch, Solveig Fenet & Vasantha Muthuswamy
Language: eng
Format: epub
Publisher: Springer International Publishing, Cham

Analysis

The case study shows ethical inadequacy at several levels.

The suggestion that the study would be beneficial to participants is controversial. Vaccination against hepatitis B is included in the national immunization calendar of the Russian Federation . This is done with domestically and internationally produced vaccines that are registered and have been granted permission for use by approved order (Russian Federation 2014). Vaccination against hepatitis B is freely available to everybody, and obligatory for high-risk groups (newborns whose mothers are HbsAg carriers, or hepatitis B patients in the third trimester of pregnancy) . Therefore there were no benefits for participants taking part in the clinical trial .

The autonomy of the women who were indirectly involved in the study was not respected. There was no information or confirmation in any part of the protocol to the effect that these women (indirect participants) should be appropriately informed about the procedures, or that their informed consent should be obtained.

In addition, their indirect involvement in the clinical trial was not covered by insurance , even in the case of pregnancy with a serious adverse event (a congenital anomaly or birth defect), because they were not included in the framework of financial contracts and insurance coverage for study participants. No other guarantee (medical, financial etc.) for these women was described in the protocol or any other study documents. This violates Russia’s compulsory regulations on good clinical practice :In research which does not connect with treatment (without any benefits for potential participants from a medical point of view) only subjects who personally give, write and date the informed consent can be involved (Russian Federation 2005: item 4.8.13).

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