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

Resource Library

Research Ethics MonthlyAbout Us

ResourcesHuman research ethics

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Ethical Considerations in Quality Assurance and Evaluation Activities0

Posted by Admin in on May 24, 2015
 

This NHMRC resource has been produced to inform the developments of institutional policy/ethical review arrangement for evaluative practice, quality assurance and quality improvement work.

Clinical trial resources – Therapeutic Goods Administration0

Posted by Admin in on May 23, 2015
 

The TGA has brought together a number of essential resources for trial sponsors, institutions, administrators and review bodies. Institutions should decide whether to direct researchers to this site or to produce reference material (see as the GUREM see below) that references the material. Also on this page are TGA forms (such as the CTN/CTX forms and notes on Australia’s implementation of international standards (such as the Guidelines for Good Clinical Practice (CPMP/ICH/135/95)).

Clinical Trials Research Agreements0

Posted by Admin in on May 23, 2015
 

“The NSW, Qld, Vic and SA Health Departments (the SEBS States), together with Medicines Australia, have developed four Clinical Trial Research Agreements (CTRAs) in order to provide template agreements that are fair and reasonable for both sponsors and institutions and provide certainty of application in the commercial trial environment. Some of the individual clauses have been the subject of long negotiation through this process.”

The Censor’s Hand: The Misregulation of Human-Subject Research (Books: Carl Schneider 2015)0

Posted by Admin in on May 22, 2015
 

BOOKS: Schneider, Carl E. The Censor’s Hand: The Misregulation of Human-Subject Research. Cambridge, Massachusetts: The MIT Press, 2015.

“Medical and social progress depend on research with human subjects. When that research is done in institutions getting federal money, it is regulated (often minutely) by federally required and supervised bureaucracies called “institutional review boards” (IRBs). Do—can—these IRBs do more harm than good? In The Censor’s Hand, Schneider addresses this crucial but long-unasked question.

Schneider answers the question by consulting a critical but ignored experience—the law’s learning about regulation—and by amassing empirical evidence that is scattered around many literatures. He concludes that IRBs were fundamentally misconceived. Their usefulness to human subjects is doubtful, but they clearly delay, distort, and deter research that can save people’s lives, soothe their suffering, and enhance their welfare. IRBs demonstrably make decisions poorly. They cannot be expected to make decisions well, for they lack the expertise, ethical principles, legal rules, effective procedures, and accountability essential to good regulation. And IRBs are censors in the place censorship is most damaging— universities.

In sum, Schneider argues that IRBs are bad regulation that inescapably do more harm than good. They were an irreparable mistake that should be abandoned so that research can be conducted properly and regulated sensibly.”

 

0