ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)
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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Research Ethics (Journal) – Most Read Articles (Updated monthly)0

Posted by Admin in on May 29, 2015
 

“Research Ethics is aimed at all readers and authors interested in ethical issues in the conduct of research, the regulation of research, the procedures and process of ethical review as well as broader ethical issues related to research such as scientific integrity and the end uses of research. The journal aims to promote, provoke, host and engage in open and public debate about research ethics on an international scale but also to contribute to the education of researchers and reviewers of research. This journal is a member of the Committee on Publication Ethics (COPE).”

Declaration of Helsinki0

Posted by Admin in on May 29, 2015
 

Despite its limited utility outside of some health/science research (e.g. pharmacological clinical trials) the WMA Declaration of Helsinki remains the international reference point for the governance of ethical conduct in human research.

Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964
and amended by the:

29th WMA General Assembly, Tokyo, Japan, October 1975
35th WMA General Assembly, Venice, Italy, October 1983
41st WMA General Assembly, Hong Kong, September 1989
48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996
52nd WMA General Assembly, Edinburgh, Scotland, October 2000
53rd WMA General Assembly, Washington DC, USA, October 2002 (Note of Clarification added)
55th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added)
59th WMA General Assembly, Seoul, Republic of Korea, October 2008
64th WMA General Assembly, Fortaleza, Brazil, October 2013

TGA Clinical trial arrangements0

Posted by Admin in on May 29, 2015
 

This TGA web site provides information, forms and resources relating to the TGA’s CTN and CTX schemes as well key information about the appropriate design, ethical review and conduct of clinical trials. It is essential reading for trial sponsors, clinicians, research ethics/governance officers and the members of ethics committees that review clinical trials.

Also included below are links to other useful TGA material.

Clinical trial arrangements
Human Research Ethics Committees and the therapeutic goods legislation
Access to unapproved therapeutic goods – Clinical trials in Australia

TGA Clinical efficacy and safety guidelines0

Posted by Admin in on May 29, 2015
 

The web page covers the matters discussed below.

Clinical pharmacology and pharmacokinetics
Alimentary tract and metabolism
Blood and blood-forming organs
Blood products (including biotech alternatives)
Cardiovascular system
Dermatologicals
Genito-urinary system and sex hormones
Anti-infectives for systemic use
Antineoplastic and immunomodulating agents
Rheumatology / musculoskeletal system
Nervous system
Respiratory system
Biostatistics
General
Radiopharmaceuticals and Diagnostic Agents
Allergy/Immunology

It also includes downloads and notes relating to:

Clinical pharmacology and pharmacokinetics

Alimentary tract and metabolism

Blood and blood-forming organs

Blood products (including biotech alternatives)

Cardiovascular system

Dermatologicals

Genito-urinary system and sex hormones

Anti-infectives for systemic use

Antineoplastic and immunomodulating agents

Rheumatology / musculoskeletal system

Nervous system

Respiratory system

Biostatistics

General

Radiopharmaceuticals and Diagnostic Agents

Allergy/Immunology

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