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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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)).

The Clinical Ethics Resource0

Posted by Admin in on May 23, 2015
 

“The Clinical Ethics Resource provides an extensive range of resources addressing the ethical and legal issues experienced by those working in clinical environments. Health professionals face challenging issues on a daily basis. This website seeks to offer resources and best practice guidelines to assist with those decisions.

The website is part of a larger study into the practice of clinical ethics in New South Wales, Australia. The aim of the project is to identify what resources are necessary to develop clinical ethics capacity within the New South Wales health system, for example providing clinical ethics committees and/or making clinical ethics training more widely available. This web-based resource is aimed at providing initial support to people who are looking for further information and resources.

Search by topic to access guidelines, legislation, case law and position statements/policies of government authorities and professional bodies. We have also included references to some of the key articles and commentaries on particular topics.

While our focus is on the position in New South Wales our collection of resources comes from all around Australia and the world. If you have additional resources that should be included, please get in touch”.

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.”

 

The Ethics Police?: The Struggle to Make Human Research Safe (Podcast from Carnegie Council for Ethics in International Affairs, Public Affairs; Books: Robert Klitzman 2015)0

Posted by Admin in on May 22, 2015
 

PODCAST: Podcast from Carnegie Council for Ethics in International AffairsPublic Affairs | MAY 7, 2015

“Research on human beings saves countless lives, but has at times harmed the participants. Although in 1974, the U.S. government established Institutional Review Boards (IRBs) to oversee research on humans, ethics violations persist.

In this podcast from Carnegie Council, Robert Klitzman, director of the Masters of Bioethics Program at Columbia University, reflects on the ethical implications of using human beings for medical research. The transcript has been edited for clarity.”

Access the podcast

BOOKS: Klitzman, Robert. The Ethics Police?: The Struggle to Make Human Research Safe. 1 edition. Oxford ; New York: Oxford University Press, 2015.

“Investigates the hidden world of IRBs as they face increasing pressures, responsibilities and criticism from many sides. Examines issues, offers data, and provides insights that have never been presented in a book before concerning the inside world of IRBs: how they make decisions and view the controversies they now face. Explores how the potential future risks vs. benefits of studies actually get weighed, what complexities and ambiguities arise, and how these are dealt with. Discusses how the quality of science in studies is assessed and weighed in relation to ethics, how conflicts of interest play out in science and ethics, and how government agencies, researchers, and universities all affect the ethical reviews of studies”

More about the book

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