1. Directive 2001/20/EC of the European Parliament and the Council of 4th April 2001, on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Available at http://ec.europa.eu/health/files/eudralex/vol1/dir_2001_20/dir_2001_20_en.pdf. Accessed December 21, 2015.
2. Mental Capacity Act 2005. 2015. Available at http://www.legislation.gov.uk/ukpga/2005/9/contents. Accessed December 21, 2015.
3. Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95), Volume 3C Efficacy, Rules Governing Medicinal Products in the European Union.
4. The Medicines for Human Use (Clinical Trials) Regulations. 2004. Available at http://www.legislation.gov.uk/uksi/2004/1031/contents/made. Accessed December 21, 2015.
5. The Nuremburg Code, 1947;BMJ,1996