Trials, Regulation and tribulations

Author:

Petrini Carlo,Garattini Silvio

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine

Reference6 articles.

1. European Parliament, Council of the European Union (2014) Regulation (EU) 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Off J Eur Union L158:1–76

2. World Medical Association (1964-2013) Declaration of Helsinki. Ethical principles for medical research involving human subjects. www.wma.net/en/30publications/10policies/b3/. Accessed 11 November 2015

3. Council of Europe (1997) Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. http://conventions.coe.int/Treaty/en/Treaties/html/164.htm . Accessed 11 November 2015

4. Wendler D, Grady C (2000) What makes clinical research ethical? JAMA 283:2701–2711

5. Larcher V, Slowther AM, Watson AR, on behalf of the UK Clinical Ethics Network (2010) Core competencies for clinical ethics committees. Clin Med 10:30–33

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