The law and ethics of the use of experimental medication in patients incapable of expressing consent: Between a rock and a hard place

Medicine and Law

Volumn 19, Issue 2, 2000, Pages 189-195

  Cooper, Jo ^a  

^a UNIVERSITY OF NEWCASTLE   (Australia)

Author keywords

Consent; Drug trials; Ethics committees; Experimental; Guardianship; Incompetent; Person's responsible; Placebo

Indexed keywords

NEW DRUG;

ARTICLE; AUSTRALIA; BIOMEDICAL AND BEHAVIORAL RESEARCH; CEREBROVASCULAR ACCIDENT; CLINICAL TRIAL; DEMENTIA; DRUG CONTROL; DRUG UTILIZATION; HUMAN; INFORMED CONSENT; LEGAL APPROACH; LEGAL ASPECT; MEDICAL ETHICS; MENTAL CAPACITY; PATIENT ADVOCACY; PRACTICE GUIDELINE; PROFESSIONAL STANDARD;

BIOMEDICAL AND BEHAVIORAL RESEARCH; LEGAL APPROACH;

CEREBROVASCULAR ACCIDENT; CLINICAL TRIALS; DEMENTIA; DRUG AND NARCOTIC CONTROL; DRUG UTILIZATION; DRUGS, INVESTIGATIONAL; ETHICS COMMITTEES; ETHICS, MEDICAL; GUIDELINES; HUMANS; INFORMED CONSENT; MENTAL COMPETENCY; NEW SOUTH WALES; PATIENT ADVOCACY;

EID: 0033641943     PISSN: 07231393     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (8)

1. This paper was delivered at The 12th World Congress on Medical Law, Siofok, Hungary, August 1998.
2. Article 7.
3. Previously known as Institutional Ethics Committees (IECs)
4. Report of the Standing Committee on Social Issues of the Legislative Council of New South Wales, Clinical Trials of Guardianship: Maximising the Safeguards, September 1997.
5. Report of the Standing Committee on Social Issues of the Legislative Council of New South Wales, Clinical Trials of Guardianship: Maximising the Safeguards, September 1997.
6. Guardianship Act 1987 s 45AA.
7. The Guardianship Tribunal is required under s 76A (2A) of the Guardianship Act to give details of any clinical trial approved by the Tribunal during the period under report. During the 1997-98 financial year one such trial was approved. This was an international multi-centre trial using Filgastim, a drug designed to increase the number and quality of white blood cells, and thus capacity to fight infection. The purpose of the Phase 3 trial was to "confirm the evidence of the Phase I and Phase II trials that Filgastim, together with antibiotics, is more effective than antibiotics alone to overcome pneumonia in adults who have pneumonia and severe sepsis." (Guardianship Tribunal, Annual Report, 1997-1998, 12). The Tribunal ordered that for incompetent persons the participation decision should be exercised by the person responsible.
8. Report of the review of the role and functioning of Institutional Ethics Committees, Report to the Minister for Health and Family Services, March 1996, 47.