Bio Pharms' adoption of the revised 2016 CIOMS document and challenges associated with its application in compensating research subjects in African countries--Compensation for research subjects in Africa

在非洲國家進行人體試驗賠償之試論

Peter F. Omonzejele

《台灣醫學人文學刊》 23卷1&2期 (2022/12) Pp. 26-44

摘要

This essay examines to what extent the adoption of the Council for International Organization of Medical Sciences (CIOMS) revised guidelines of 2016 by pharmaceutical companies, such as; Pfizer, for compensating research subjects is capable of preventing undue inducement when studies are designed to be undertaken in African countries. In particular, the reimbursement and appreciation compensation models in the research setting were discussed and found to be defective in the prevention of undue inducement in African countries due to the density of poverty in that region. An alternate model known as the compensation-in-community model was suggested for use in African countries as a way of preventing undue inducement. The model is a two-tier system of compensation where investigators or research companies negotiate the modality of compensation with host communities, while research subjects are compensated by their communities. The suggested model requires two modes of consent: community consent and individual voluntary first person consent.

關鍵字

Compensation ； Pfizer ； Risks ； Undue inducement ； Vulnerability