Single research ethics committee review for multinational trials is a misconception

Author:

Dal-Ré Rafael1ORCID

Affiliation:

1. Epidemiology Unit, Health Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid, Madrid 28049, Spain

Publisher

SAGE Publications

Subject

General Medicine

Reference3 articles.

1. Improving research ethics review and governance can improve human health

2. Regulation (EU) No536/2014 of the European Parliament and of the Council of 16 of April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Official Journal of the European Union L 158/1-76. See https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf (2014, last checked 1 December 2021).

3. International trials in middle-income countries: different local scenarios require different ethical approaches

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