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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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

NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE (CPMP/ICH/135/95) – Annotated with TGA comments0

Posted by Admin in on May 28, 2015
 

“The Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) is an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials. These guidelines may be overridden by national legal requirements and the requirements of individual regulatory agencies as appropriate, to address matters relevant to local conditions or culture.

“In Australia, the National Health and Medical Research Council Act 1992 establishes the NHMRC as a statutory entity to pursue and foster issues relating to public health. The NHMRC is specifically required to issue guidelines for the conduct of medical research and ethical matters related to health. The National Statement on Ethical Conduct in Research Involving Humans (the National Statement) has been produced by the NHMRC as the Australian ethical standard against which all research involving humans, including clinical trials, are reviewed.

“The TGA has adopted CPMP/ICH/135/95 in principle, to replace the Guidelines for Good Clinical Research Practice (GCRP) in Australia, but at the same time has recognised that some elements are, by necessity, overridden by the National Statement (and therefore not adopted) and that others require explanation in terms of ‘local regulatory requirements’

Steven Lubet’s review of ON THE RUN: Fugitive Life in an American City (Fieldwork Encounters and Discoveries), by Alice Goffman0

Posted by Admin in on May 28, 2015
 

“Alice Goffman’s widely acclaimed On the Run: Fugitive Life in an American City has drawn more positive attention than almost any sociology book in recent years. The success of the book led to a lecture tour of at least twenty sociology departments and conferences. Her TED talk, which was often interrupted by applause, has had nearly 700,000 views. A careful reading of On the Run, however, leaves me with vexing questions about the author’s accuracy and reliability. There are just too many incidents that strike me as unlikely to have occurred as she describes them. One must try to keep an open mind about such things – especially regarding someone as obviously brilliant and dedicated as Goffman – so readers may disagree with me about the extent of her embellishments. In any event, there is a bigger problem. As I will explain below, Goffman appears to have participated in a serious felony in the course of her field work – a circumstance that seems to have escaped the notice of her teachers, her mentors, her publishers, her admirers, and even her critics.”

Review by Steven Lubet

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