Roles and Responsibilities according to ICH-GCP (Video)
This is a brief video by Astra Nova Training.
Developing Best Practice in Human Research Ethics Review
Guideline for HRECs in the conduct of ethical and scientific review of human research proposals. Prepared by Houston Thomson
Investigating Human Research Ethics in Practice: Project Report
Investigating Human Research Ethics in Practice aimed to investigate how health researchers and members of Human Research Ethics Committees (HRECs) understand research ethics, and how they make decisions about what constitutes ethical conduct in health research.
Researching Right Way –An Aboriginal and Torres Strait Islander Health Research Ethics: A Domestic and international Review
This review looked at inconsistencies between domestic ethics guidelines including the National Statement, Values and Ethics, Keeping Research on Track, GERAIS (AIATSIS), and the Aboriginal Health & Medical Research Council (NSW) guidelines. The review also looked at other documents that provided analysis of inconsistencies and advice for improvements. Throughout the review examples of good practice were identified. These may provide guidance to researchers coming into the Aboriginal and Torres Strait Islander Health research space or to provide examples of how researchers can and should addresses the principles and values within Values and Ethics and Keeping Research on Track.
Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind, placebo-controlled trial
Rotavirus is the most common cause of severe dehydrating gastroenteritis in developing countries. Safe, effective, and affordable rotavirus vaccines are needed in these countries. This research aimed to assess the efficacy and tolerability of a monovalent human-bovine rotavirus vaccine for severe rotavirus gastroenteritis in low-resource urban and rural settings in India.
The limitations of "vulnerability" as a protection for human research participants (Website)
Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges.
Ten principles relevant to health research among Indigenous Australian populations (Website)
Writing in the Journal about Indigenous health in 2011, Sir Michael Marmot suggested that the challenge was to conduct research, and to ultimately apply findings from that research, to enable Indigenous Australians to lead more flourishing lives that they would have reason to value. As committed Indigenous health researchers in Australia, we reflect Marmot’s ideal — to provide the answers to key questions relating to health that might enable Indigenous Australians to live the lives that they would choose to live.
Keeping Cultural Knowledge with Indigenous research protocols: a case study on the Kimberley land council’s intellectual property and traditional knowledge policy
This case study illustrates that Indigenous cultural protocols, use contracts and existing intellectual property laws to their advantage. Ultimately Australia should adopt laws and policies to recognise Indigenous Cultural and Intellectual Property as intellectual property.
What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research
This article talks about the fact that there has been substantial debate about the ethics of research in developing countries. It argues that the persistence of controversies reflects that existing ethical guidelines can be interpreted in multiple ways and are sometimes contradictory, or rely on unstated, yet controversial, ethical principles.
Ethical Principles for the Conduct of Human Subject Research: Population-Based Research and Ethics
This paper provides a halting first step in organizing a set of ethical guidelines for the conduct of populationbased research, surveillance and practice. These principles are not distinct from, but an expansion of, traditional ethics. Research ethics, which matured significantly from the Nuremberg Code through to the Helsinki IV and the CIOMS guidelines, nourished the individual human spirit. Ethical principles should have a similarly profound impact in the development of science and the protection of human populations in the 199os and beyond.