The ethics of clinical research and the conduct of clinical drug trials: International comparisons and codes of conduct

Medicine and Law

Volumn 19, Issue 3, 2000, Pages 501-521

  Beran, Roy G ^a  

^a NONE

Author keywords

Clinical trials; Codes; Conduct; Consideration; Ethics committees; International comparisons; Research

Indexed keywords

AUSTRALIA; BIOMEDICAL AND BEHAVIORAL RESEARCH; CANADA; CLINICAL TRIAL; COMPARATIVE STUDY; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; HUMAN; LEGAL ASPECT; MEDICAL ETHICS; PRACTICE GUIDELINE; PROFESSIONAL COMPETENCE; PROFESSIONAL STANDARD; QUALITY CONTROL; REVIEW; STANDARD; UNITED STATES;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

AUSTRALIA; BENCHMARKING; CANADA; CLINICAL TRIALS; ETHICS COMMITTEES; ETHICS, MEDICAL; EUROPEAN UNION; HUMANS; PRACTICE GUIDELINES; PROFESSIONAL COMPETENCE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0033641822     PISSN: 07231393     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (18)

1. Commission of the European Communities "Proposal for a European Parliament and Council Directive on the Approximation of Provisions laid down by Law. Regulation or Administrative Action relating to the Implementation of Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use" (COM (97) 369 final) Brussels, 03.09.1997.
2. Tri-Council Policy Statement Ethical Conduct for Research Involving Humans MRC, Ottawa, Canada August 1998.
3. Finnish Parliament Medical Research Act (SG/8541/99-EN), Helsinki 9th April 1999.
4. National Health & Medical Research Council National Statement on Ethical Conduct in Research Involving Humans Cth of Australia, June 1999.
5. Edwards I L, Jensen E K. & Frank G J. & Parke-Davis Pharmaceutical Research Good Clinical Practice for Investigators Conducting Clinical Trials for Parke-Davis Pharmaceutical Research 6th Edition Ann Arbor Michigan 1998.
6. IBAH (CRO) Code of Federal Regulations - Good Clinical Practice & ICH Harmonised Tripartite Guidelines for Good Clinical Practice. Blue Bell, PA, US A, August 1998.
7. Karpin I "Government Regulation, Health Policy and Ethics" - Course materials 1999 Part One 1-19 (Citing Contemporary Issues in Bioethics (4th Ed) Eds Beauchamp T L & Walters L at 11-28).
8. Breen K, Plueckhahn V, Cordner-S "Introduction to Ethical Principles in Medicine (extracts) in Ethics Law and Medical Practice 1-6 cited in Karpin I, Supra See 8 at 28-33.
9. The Belmont Report; Ethical Principles and Guidelines for the Protection of Human Subjects of Research, The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research, Department of Health, Education and Welfare Publication No (OS) 78-0012 US Govt. Printing Office, Washington, 1978.
10. TGA Guidelines for Good Clinical Research Practice (GCRP) in Australia Cth Dept of Health Housing and Community Services (DEB 3) Aust. Govt. Printers Canberra Dec 1991.
11. World Medical Association Declaration of Health, Helsinki (1989) Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects, Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964 and amended by 29th World Medical Assembly, Tokyo, Japan, Oct 1975; 35th World Medical Assembly, Venice, Italy, Oct 1983; 41st World Medical Assembly, Hong Kong, Sept 1989.
12. AMA Code of Ethics, Canberra 1996; Fluss S.S. International Guidelines on Bioethics - Informal listing of selected International Codes, Declarations, Guidelines etc EFGCP News, Sept. 1998.
13. Fluss, S.S. International Guidelines on Bioethics - Informal Listing of Selected International Codes, Declarations, Guidelines etc EFGCP News, Sept, 1998.
14. TGA "Clinical Trials of Drugs in Australia - Clinical Trial Notification (CTN) Scheme and the Clinical Trials Exemption (CTX) Scheme" Cth Dept of Community Services and Health DEB1 Aust. Govt. Printers, Canberra, May 1991.
15. Beran R.G., Tilley M.I. Clinical Drug Trials of Anti-epileptic Drugs Performed in Private Practice Setting". Epilepsia 35: 103-106, 1994.
16. Beran R.G. & Beran M E "Conducting Clinical Trials in Private Practice" Epilepsia 2000 (In Press).
17. Beran R.G. & Beran M E. - "Quality Assurance Should Not be a Special Programme but a Way of Life and a Way of Clinical Practice" (paper presented to) RACP ASM, 1998.
18. Beran R G. (Ed) "Epilepsy and Duty of Care" Yotzmot Heliger, Tel Aviv 2000.