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

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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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

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’

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.

Keeping research on track: a guide for Aboriginal and Torres Strait Islander peoples about health research ethics0

Posted by Admin in on May 28, 2015
 

The Keeping research on track document is resource produced for Aboriginal and Torres Strait Islander communities and peoples about human research. It is a useful document to make accessible to potential participants and for researchers to consider when initially designing a research project. Like the Values and Ethics Guidelines (see here) it has been drafted for health research and while (for the most part) the ideas are transferable to other areas of human research it is unlikely to be helpful for humanities or creative/fine arts research.

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