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

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

The risk of re-identification versus the need to identify individuals in rare disease research (Papers: Mats G Hansson, et al | 2016)0

Posted by Admin in on January 8, 2017

There is a growing concern in the ethics literature and among policy makers that de-identification or coding of personal data and biospecimens is not sufficient for protecting research subjects from privacy invasions and possible breaches of confidentiality due to the possibility of unauthorized re-identification. At the same time, there is a need in medical science to be able to identify individual patients. In particular for rare disease research there is a special and well-documented need for research collaboration so that data and biosamples from multiple independent studies can be shared across borders. In this article, we identify the needs and arguments related to de-identification and re-identification of patients and research subjects and suggest how the different needs may be balanced within a framework of using unique encrypted identifiers.

Hansson MG, Lochmüller H, Riess O, Schaefer F, Orth M, Rubinstein Y, Molster C, Dawkins H, Taruscio D, Posada M and Woods S (2016) The risk of re-identification versus the need to identify individuals in rare disease research. European Journal of Human Genetics 24, 1553–1558; doi:10.1038/ejhg.2016.52
Publisher (open access):

Friday afternoon funny – Taking compliance too far0

Posted by Admin in on December 30, 2016

Cartoon by Don Mayne

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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