Australian Regulatory Authorities

Therapeutic Goods Administration
National Health and Medical Research Council
Medicines Australia

International Regulatory Authorities

International Conference on Harmonisation (ICH)
Medicines Control Agency
US Food and Drug Administration

NHMRC Australian Health Ethics Committee (AHEC) Information for Human Research Ethics Committees

National Statement on Ethical Conduct in Research Involving Humans (June 1999)
Human Ethical Issues
Ethical Aspects of Human Genetic Testing
Guidelines for Genetic Registers and Associated Genetic Material (1999)
Guidelines for Ethical Review of Research Proposals for Human Somatic Cell Gene Therapy and Related Therapies (1999)
When does quality assurance in health care require independent ethical review?

Other Human Ethics Resources

Joint NHMRC/AVCC Statement and Guidelines on Research Practice (1997)
Monash Bioethics Review
World Medical Association, Declaration of Helsinki (1996)
World Medical Association Revision of Declaration of Helsinki 2000
Medical Research Council of Canada et al, Code of Ethical Conduct for Research Involving Humans (1997)

DHS Human Research Ethics Committee

DHS Human Research Ethics Committee

Eastern Clinical Research Unit

ECRU