Resources

Ethical Considerations in Research

Is the concept of clinical equipoise still relevant to research?

Uploaded 11 Jan 2018

Spencer Hey, Alex John London, and Charles Weijer argue that there is no better framework for justifying patient participation in research. But Annette Rid and Franklin Miller say that it is a mistake to require clinical research ethics to align with the norms of clinical practice

Ethical Considerations in Research

Roles and Responsibilities according to ICH-GCP (Video)

Uploaded 09 Oct 2017

This is a brief video by Astra Nova Training.

Ethical Considerations in Research

Developing Best Practice in Human Research Ethics Review

Uploaded 09 Oct 2017

Guideline for HRECs in the conduct of ethical and scientific review of human research proposals. Prepared by Houston Thomson

Ethical Considerations in Research

Investigating Human Research Ethics in Practice: Project Report

Uploaded 09 Oct 2017

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.

Ethical Considerations in Research

Researching Right Way –An Aboriginal and Torres Strait Islander Health Research Ethics: A Domestic and international Review

Uploaded 09 Oct 2017

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.

Ethical Considerations in Research

Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind, placebo-controlled trial

Uploaded 09 Oct 2017

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.

Ethical Considerations in Research

The limitations of "vulnerability" as a protection for human research participants (Website)

Uploaded 09 Oct 2017

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.

Ethical Considerations in Research

Ten principles relevant to health research among Indigenous Australian populations (Website)

Uploaded 09 Oct 2017

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.

Ethical Considerations in Research

Keeping Cultural Knowledge with Indigenous research protocols: a case study on the Kimberley land council’s intellectual property and traditional knowledge policy

Uploaded 09 Oct 2017

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. 

Ethical Considerations in Research

What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research

Uploaded 09 Oct 2017

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.