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

Resource Library

Research Ethics MonthlyAbout Us

ResourcesInternational

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Oxford University Research Integrity Seminar Series0

Posted by Admin in on May 29, 2015
 

Recorded in 2009–11, this is a free short series of audio recordings (and a few slides). Most of the presentations are around 45mins long. Even though the series has a definite biomedical focus, it includes useful commentary about matters such as authorship / acknowledgement, falsification/plagiarism of data, conflicts of interest, and research integrity in general. Of possible interest for researchers (early career and more experienced, HDR students and research managers.

Also available as downloadable media files.

Office of Research integrity (US)0

Posted by Admin in on May 29, 2015
 

“The Office of Research Integrity (ORI) oversees and directs Public Health Service (PHS) research integrity activities on behalf of the Secretary of Health and Human Services with the exception of the regulatory research integrity activities of the Food and Drug Administration.”

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

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’

0