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Chapter 8
REFERENCES
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3. Regulation (EU) No 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 OJ L158:1–76: 2014.
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11. Department of Health and Human Services F and Drug Administration. Protection of Human Subjects; Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency Research; Final Rules. Fed Regist 1996; Volume 61, Number 192: 51498–531.
12. U.S. Food and Drug Administration. Sec. 50.24 Exception from informed consent requirements for emergency research. Code Fed Regul Title 21, Vol I, Subchapter A, Part 50, Subpart B.
13. Kompanje EJO, Maas AIR, Menon DK, Kesecioglu J. Medical research in emergency research in the European Union member states: Tensions between theory and practice. Intens Care Med 2014;40:496-503. DOI: 10.1007/s00134-014-3243-6
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15. Directive 2001/20/EC of the European Parliament and of the Council of 4 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. OJ L121:34: 2001.
16. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data OJ L281:31–50: 1995.
17. Regulation (EU) No 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) OJ L119:1–88: 2016.
18. European Union GDPR. “Processing of special categories of personal data”. OJ L119:Ch. 2 Art. 9. 2016.
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