Ireland and medical research with minors: Some medico-legal aspects

European Journal of Health Law

Volumn 15, Issue 2, 2008, Pages 169-181

  Sheikh, Asim A ^a  

^a UNIVERSITY COLLEGE DUBLIN   (Ireland)

Author keywords

Child; Child welfare; Clinical trials; Consent; Constitution; Disclosure of risks; Genetics; International law; Ireland; Irish law; Medical research; Medico legal; Minors; Non therapeutic; Therapeutic

Indexed keywords

AUTHORITY; BLOOD SAMPLING; CLINICAL PRACTICE; HUMAN RIGHTS; IRELAND; LAW; LONGITUDINAL STUDY; MEDICAL RESEARCH; MEDICOLEGAL ASPECT; MINORITY GROUP; OBSERVATIONAL STUDY; ORGANIZATION AND MANAGEMENT; PRACTICE GUIDELINE; REVIEW;

ADOLESCENT; AGE FACTORS; BIOMEDICAL RESEARCH; CHILD; CHILD WELFARE; CLINICAL TRIALS AS TOPIC; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; HUMAN RIGHTS; HUMANS; INFORMED CONSENT; IRELAND; MINORS;

EID: 53549108867     PISSN: 09290273     EISSN: 15718093     Source Type: Journal    
DOI: 10.1163/157180908X322978     Document Type: Review

References (34)

1. The European Convention on Human Rights Act, 2003 transposed the Convention into Irish law.
2. Section 3, Age of Majority Act, 1985. This is also so defined in section 2 of the Child Care Act, 1991, in section 3 of the Children Act 2001 and section 2 of the Mental Health Act, 2001.
3. These regulations transposed into national law Directive 2001/20/EC 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.
4. [1995] 2 ILRM 401 at 454.
5. ibid., at 461. It should, of course, be noted that in this case the patient was an adult patient in a permanent vegetative state (PVS) and was a ward of court.
6. [1992] 4 All ER 627 at 647.
7. [1985] 3 All ER 402 at 421-422 per Lord Scarman.
8. [2001] 3 I.R. 622 at 723.
9. See also commentary by: Laurie G. "Better to hesitate at the threshold of compulsion: PKU testing and the concept of family autonomy in Eire."J Med Ethics 2002; 28:136-137.
10. ibid., at 764.
11. ibid., at 727.
12. An amendment to the Constitution has been proposed by the Government which will state, inter alia, that "The State acknowledges and affirms the natural and imprescriptible rights of all children." At: http://www.oireachtas.ie/documents/bills28/bills/2007/1407/b1407d.pdf. Accessed on 21/3/08.
13. [1985] IR 532 at 538.
14. At 687.
15. Unreported, 21st April 1980 at 73-74.
16. See fn 3 at 688.
17. [1980] IR 32 at 56.
18. Per Walsh J., G. v. An Bord Uchtála [1980] 1 IR 32 at 68.
19. ibid., at 69.
20. [1994] 3 IR 207 at 230.
21. A Medicinal Product is defined as "Any substance or combination of substances presented for treating or preventing disease in human beings."
22. At: http://www.dohc.ie/issues/clinical_trials_2004/ethics_committees.html accessed on 25th March, 2008.
23. The case of the death of Jesse Gelsinger in 1999 was the first death which resulted from gene therapy. The subsequent investigation by the US Food and Drug Administration found serious deficiencies in the research protocols. See further: Thompson L. "Human Gene Therapy: Harsh Lessons, High Hopes" at: http://www.fda.gov/Fdac/features/2000/500_gene.html - accessed on 25th March, 2008. It should be noted that the first gene therapy trials in Ireland have been ethically approved in adults: McDonagh M. "Gene trials for cancer patients" Irish Times (13/5/08).
24. HM Stationery Office. "Report of the Committee on the Ethics of Gene Therapy" Cm 1788 (HMSO, London, 1992) at paragraph 4.11.
25. The Medical Council, Sixth Edition, 2004 at paragraph 20.4.
26. Irish Council for Bioethics, 2004, at 6 see further at: www.bioethics.ie.
27. Sheikh A. A., (HRB, Dublin 2002) at 62.
28. See cases of: Fitzpatrick v Eye and Ear Hospital [2007] IESC 51 (Unrep. SC, Kearns J., Macken J., Finnegan J., 15/11/2007) and Geoghegan v Harris [2000] 3 IR 536.
29. 57 53 D.L.R. (2d) 436 (Sask. C. A. 1965) at 442-443.
30. Fn 27 above, at 61.
31. Council for International Organizations of Medical Sciences (CIOMS), 2002 at 66.
32. ICGP, Dublin, 2003.
33. Court of Appeals of Maryland, US, 16th August 2001.
34. ibid., at 7.