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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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

Londoners give up eldest children in public Wi-Fi security horror show – The Guardian (2014)0

Posted by Admin in on May 28, 2015
 

“A handful of Londoners in some of the capital’s busiest districts unwittingly agreed to give up their eldest child, during an experiment exploring the dangers of public Wi-Fi use.

The experiment, which was backed by European law enforcement agency Europol, involved a group of security researchers setting up a Wi-Fi hotspot in June.”

Values and Ethics – Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research0

Posted by Admin in on May 28, 2015
 

The Values and Ethics Guidelines is an Australian national guideline for health research with Aboriginal and Torres Strait Islander peoples and issues. The document was intended to be a reference for researchers and ethics reviewers. The document was issued by the NHMRC. The Values and Ethics Guidelines introduces and discusses the following principles:

  • Reciprocity
  • Respect
  • Equality
  • Responsibility
  • Survival and protection
  • Spirit and integrity

Even though the document has not been enacted adherence to the Values and Ethics Guidelines is at least notionally a condition of NHMRC funding. The annual human research ethics compliance report sent to institutions by the NHMRC queries whether the Values and Ethics Guidelines were utilised. It is expected that the outcome of a review of the document will be released later in 2015.

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