Nursing Law and Ethics

Medicines *Exemption from Licences and Certificates) *Clinical Trials) Order 1995

*S I1995/2809). See further Mullon, K. *2000)Pharmacy Law and Practice,Blackstone

Press, London, Chapter 4.

32. GPs failing to report drug side-effects.Independent on Sunday15 April 2001.


33. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001.


34. McNeil, P. *1993)The Ethics and Politics of Human Experimentation,p.13. CUP,
    Cambridge.


35. Morehouse, R. *1994) Dilemmas of the clinical researcher: a view from the inside.
    Health Law in Canada,15, 52±3.


36. Kennedy, I. 1989) The law and ethics of informed consent and randomized con-
    trolled trials. InTreat Me RightI. Kennedy). OUP, Oxford.


37. See Fox, M. 1998) Research bodies: feminist perspectives on clinical research. In
    Feminist Perspectives in Health Care Law,eds S. Sheldon & M. Thomson). Cavendish,
    London.


38. Katz, J. 1993) Human experimentation and human rights.Saint Louis University Law
    Journal, 38 7) p. 35.


39. Morehouse, R. 1994) Dilemmas of the clinical researcher: a view from the inside.
    Health Law in Canada,15, 52. LREC guidelines state that the subject should be given
    an information sheet; Royal College of Physician guidelines suggest that she should be
    told the purpose, procedures, risk including distress), benefits including to others),
    informed that she may decline to participate or withdraw at any time and given a
    statement about compensation for injury. Guidelines on the Practice of Ethics
    Committees in Medical Research Involving Human Subjects1996) 3rd edn.


40. See for example Bowden, P. *1997)Caring: Gender-Sensitive Ethics,Chapter 4. Rou-
    tledge, London.


41. See footnote 5 above.


42. GMC,Medical Research: The Role and Responsibilities of Doctors,March 2001, available
    from http://www.gmc-uk.org/standards *last visited 17 April 2001).


43. MRC *1998)Guidelines for Good Practice in Clinical Trials,para. 5.4.6. Medical
    Research Council, London.


44. See para 22 of the Helsinki Declaration in the previous section of this chapter.


45. See McHale, J. *1993) Guidelines for medical research ± some ethical and legal pro-
    blems.Medical Law Review,160, 167.


46. See, for instance, MRC *1998)Guidelines for Good Practice in Clinical Trials,p.3.
    Medical Research Council, London.


47. Rawlings, G. 1992) Ethics and regulation in randomised controlled trials of therapy.
    InChallenges in Medical Careed. A. Grubb) pp. 41±2. Wiley, Chichester.


48. Oakley, A. 1990) Who's Afraid of the Randomized Controlled Trial. InWomen's
    Health Countsed. H. Roberts). Routledge, London.


49. Fletcher, N., Holt, J., Brazier, M. & Harris, J. *1995)Ethics, Law and Nursing,p.187.
    Manchester University Press, Manchester.


50. Tobias, J.S. 1997) BMJ's present policy sometimes approving research in which
    patients have not given fully informed consent) is wholly correct.BMJ,314, 1111.


51. Kennedy, I. 1989) The law and ethics of informed consent and randomized con-
    trolled trials. InTreat Me RightI. Kennedy). OUP, Oxford.


52. See footnote 5 above.


53. Para. 9.3.5.


54. See further the discussion of whistleblowing in Chapter 8A.


55. In recognition of the fact that this is contrary to many national regulations, which
    allow for more liberal use of placebos in trials, the World Medical Association has
    acknowledged the need for further discussion of this issue and committed itself to a

274 Nursing Law and Ethics