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HHS and 15 other Federal Departments and Agencies Announce Revisions to the US Federal Policy for the Protection of Human Subjects (the Common Rule) – Statement from the HHS0

Posted by Admin in on January 19, 2017
 

The U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies have announced revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.

This change applies only to research that is reviewed by an IRB/research ethics committee that utilises the HHS framework. Nevertheless it might portend changes to the frameworks in other jurisdictions.

These revisions are an effort to modernize, simplify, and enhance the current system of oversight.
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The final rule is being put on public display on January 18, 2017, by the Office of the Federal Register and can be accessed at: https://www.federalregister.gov/documents…. It is expected that the final rule will be published in the Federal Register on January 19, 2017.
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HHS released a Press Release about the final rule that can be accessed at: https://www.hhs.gov/about/news/2017/01/18/final-rule-enhances-protections-research-participants-modernizes-oversight-system.html.

National and International Compliance Tools (Papers: Pamela Andanda, et al 2016)0

Posted by Admin in on January 10, 2017
 

Creating and enhancing TRUSTworthy, responsible and equitable partnerships in international research
A report for TRUST

Executive Summary

The main challenge in the governance of research at the global level is the existence of varying ethics review practices across countries. While differences in approaches per se do not necessarily create a problem, such varying practices can lead to “ethics dumping”; the purposeful exploitation of third country research participants/resources, as well as exploitation based on insufficient ethics awareness.

The TRUST project develops three tools to counter ethics dumping:

1. A Global Code of Conduct for North‐South Collaboration

2. A Fair Research Contracts Webtool, and

3. A Compliance and Ethics Follow‐up Tool.

This report provides the first step towards the Compliance and Ethics Follow‐up Tool. It was produced based on the following activities.

The resource developed which covers the first two activities can be found on pages 18‐32, structured according to the Horizon 2020 ethics review template.

An overview of self‐regulatory mechanisms operated by 13 pharmaceutical companies, as presented in their public sources, can be found on pages 33‐44. An overview of existing compliance tools can be found on pages 45‐54.

Andanda P, Wathuta J, Leisinger K and Schroeder D, a report for TRUST http://trust-project.eu/wp-content/uploads/2016/10/TRUST-664771-National-and-International-Compliance-Tools-Final.pdf

Revised CIOMS International Ethical Guidelines for Health-Related Research Involving Humans – The JAMA Network (JM Johannes et al | December 2016)0

Posted by Admin in on December 29, 2016
 

The Council for International Organizations of Medical Sciences (CIOMS) was established jointly by the World Health Organization (WHO) and the United Nations Educational, Scientific and Cultural Organization (UNESCO) in 1949 as an international, nongovernmental, nonprofit organization and now includes 45 international, national, and associate member organizations, representing many of the biomedical disciplines, national academies of sciences, and medical research councils. CIOMS recently released a new version of its International Ethical Guidelines for Health-Related Research Involving Humans.1 These guidelines were developed in collaboration with WHO and based on authoritative ethical guidance documents, such as the World Medical Association’s Declaration of Helsinki2 and UNESCO’s Universal Declaration on Bioethics and Human Rights.3 The aim of the guidelines is to provide internationally vetted ethical principles and detailed commentary on how these principles should be applied, with particular attention to conducting research in low- and middle-income countries (LMICs).

Reasons for Revisions

Several challenges and reasons prompted CIOMS to revise its ethical guidelines. A first challenge was to provide clearer guidance for ensuring that research addresses important questions for improving health using sound research methods. The ethical acceptability of research fundamentally depends on its social and scientific value,4 yet some of the research currently conducted is of questionable value.5

A second challenge was to further clarify what can be regarded as fair benefits of research in low-resource settings. Although the CIOMS guidelines have always addressed the interests of research participants and those in LMICs in particular, the previous version of the CIOMS guidelines (issued in 2002) was criticized for not providing sufficient guidance focused on this issue. That version required that externally sponsored research should be responsive to the health needs and priorities of the host country and that any proven products, such as drugs, should be made reasonably available to that population or community. However, the requirement was difficult to apply in practice, in particular because of its narrow focus on benefits that may, but not always will, result from a trial.

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Ethics in Indigenous Research: Past Experiences – Future Challenges (Books: Anna-Lill Drugge (ed.) | 2016)0

Posted by Admin in on December 27, 2016
 

dynamiccontent-propertiesAbstract
Ethics in research related to Indigenous peoples has, over recent decades, been increasingly discussed in a global context. Decolonizing theories and methods have gained legitimacy and prestige, and Indigenous scholarship has challenged mainstream research by adding novel perspectives and critical standpoints that encourage researchers of all origins to reflect upon their own positions within the colonial academic and social structures in which they work. This development has taken different directions and occurred at different speeds depending on local, regional and national settings. In a Swedish Sami research context, we are now in a time when it is clear that things are moving and discussions on research ethics are taking place on a more regular basis. This publication is one example of that. In Sweden, it is the first one in English that addresses ethics in Sami and indigenous research and this will, hopefully, facilitate collaborations, comparisons and discussions on an international scale.

The book is based on some of the contributions to the international workshop Ethics in Indigenous Research, Past Experiences – Future Challenges that was held in Umeå in March 2014. The workshop gathered together around fifty scholars from different parts of Sápmi and abroad, and aimed to move forward Indigenous research ethics in Sweden by highlighting and addressing research ethics related to the Sami and Indigenous research field. It is hoped that this book will serve as an inspiration, a critique, and an illustration of where discussions are heading in a Nordic, and more specifically, Swedish context. It is intended to function as a foundation for future ethical discussions at different levels, in national and international settings both within and outside academia.

Series
Samiska studier, ISSN 1651-5153 ; 7
Keyword [en] Ethics, Indigenous, Sami, Indigenous methodologies, Research ethics

Drugge, A-L (ed.) (2016) Ethics in Indigenous Research: Past Experiences – Future Challenges. Umeå: Vaartoe – Centre for Sami Research
Publisher (open access): http://umu.diva-portal.org/smash/record.jsf?pid=diva2%3A943266&dswid=1275

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