Essential & Recommended Reading

Researchers should be familiar with the following documents:

• NHMRC National Statement on Ethical Conduct in Human Research 2007
• WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI 1996 - Ethical Principles for Medical Research Involving Human Subjects - http://www.wma.net/e/policy/b3.htm 
• Australian Code for the Responsible Conduct of Research 2007
• NHMRC Aspects of Privacy in Medical Research (1995)
• NHMRC Ethical Aspects of qualitative methods in health research (1995)
• NHMRC General guidelines for practitioners on providing information to patients (1993)
• NHMRC Ethical guidelines on the use of assisted reproductive technology in clinical practice and research 2007- http://nhmrc.gov.au/publications/synopses/e78syn.htm
• Values and Ethics - Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research 2003 - http://nhmrc.gov.au/publications/synopses/e52syn.htm
• NHMRC Report on Compensation, Insurance and Indemnity Arrangements for Institutional Ethics Committees (1994)
• Standards Australia, Personal privacy protection in health care information systems.(AS4400 - 1995)
• International Conference on Harmonization, Guidelines for Good Clinical Practice (1999)
  

Researchers may find it useful to refer to the following documents:

• TGA Access to unapproved therapeutic goods - Clinical trials in Australia 2004 - http://www.tga.gov.au/docs/html/clintrials.htm
• TGA Note for guidance on good clinical practice 2000 - http://www.tga.gov.au/docs/html/ich13595.htm 
• The Australian clinical trial handbook 2006 - http://www.tga.gov.au/ct/cthandbook.htm
• Review of Australian arrangements for clinical trials & access to unapproved therapeutic goods 2005 - http://www.tga.gov.au/docs/html/cltrialrev.htm
• Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO), International Ethical Guidelines for Biomedical Research Involving Human Subjects (1993)
• CIOMS, International Guidelines for Ethical Review of Epidemiological Studies (1991)
• Medical Research Council of Canada et al, Code of Ethical Conduct for Research Involving Humans (1997)
• Royal College of Physicians, Guidelines on the practice of ethics committees in medical research involving humans, Third edition, Royal College of Physicians of London, London (1996)
• Royal College of Physicians, Research Involving Patients, Royal College of Physicians of London, London (1990)