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

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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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.”

 

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.”

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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”

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Research Ethics and Integrity for Social Scientists: Beyond Regulatory Compliance (Books: Mark Israel 2014)0

Posted by Admin in on May 22, 2015
 

BOOKS: Israel, Mark. Research Ethics and Integrity for Social Scientists: Beyond Regulatory Compliance. Second Edition edition. London; Thousand Oaks, Calif.: SAGE Publications Ltd, 2014.

“Ethics and integrity in research are increasingly important for social scientists around the world. We are tackling more complex problems in the face of expanding and not always sympathetic regulation. This book surveys the recent developments and debates around researching ethically and with integrity and complying with ethical requirements. The new edition pushes beyond the work of the first edition through updated and extended coverage of issues relating to international, indigenous, interdisciplinary and internet research.

Through case studies and examples drawn from all continents and from across the social science disciplines, the book:

  • demonstrates the practical value of thinking seriously and systematically about ethical conduct in social science research
  • identifies how and why current regulatory regimes have emerged
  • reveals those practices that have contributed to the adversarial relationships between researchers and regulators
  • encourages all parties to develop shared solutions to ethical and regulatory problems.”

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