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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’

Montreal Statement on Research Integrity in Cross-Boundary Research Collaborations0

Posted by Admin in on May 28, 2015
 

“The Montreal Statement on Research Integrity in Cross-Boundary Research Collaborations was developed as part of the 3rd World Conference on Research Integrity, 5-8 May 2013, in Montréal, as a global guide to the responsible conduct of research. It is not a regulatory document and does not represent the official policies of the countries or organizations that funded or participated in the Conference.”

The University of Minnesota’s Medical Research Mess – New York Times (Carl Elliot 2015)0

Posted by Admin in on May 28, 2015
 

“MINNEAPOLIS — IF you want to see just how long an academic institution can tolerate a string of slow, festering research scandals, let me invite you to the University of Minnesota, where I teach medical ethics.

“Over the past 25 years, our department of psychiatry has been party to the following disgraces: a felony conviction and a Food and Drug Administration research disqualification for a psychiatrist guilty of fraud in a drug study; the F.D.A. disqualification of another psychiatrist, for enrolling illiterate Hmong refugees in a drug study without their consent; the suspended license of yet another psychiatrist, who was charged with “reckless, if not willful, disregard” for dozens of patients; and, in 2004, the discovery, in a halfway house bathroom, of the near-decapitated corpse of Dan Markingson, a seriously mentally ill young man under an involuntary commitment order who committed suicide after enrolling, over the objections of his mother, in an industry-funded antipsychotic study run by members of the department.”

Integrating Integrity – Inside Higher Ed (Kaustuv Basu 2012 )0

Posted by Admin in on May 28, 2015
 

“Graduate schools need to do a better job teaching their students about responsible and ethical research, according to a report being released today by the Council on Graduate Schools.

If they do, they will have more success preventing research misconduct, the report states.

The report, Research and Scholarly Integrity in Graduate Education: A Comprehensive Approach, suggests that university administrators should work with faculty members and graduate students across disciplines to boost research integrity. For example, a successful workshop offered in one discipline can be adapted for another discipline or a course in research ethics taught intermittently by one professor could be taught by other faculty members.”

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