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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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

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.

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):

The grey zone: How questionable research practices are blurring the boundary between science and misconduct – Times Higher Education (Nick Butler: October 2016 )0

Posted by Admin in on December 26, 2016

Infamous cases of misconduct such as that of Paolo Macchiarini are just the extremes on a long spectrum of dubious research practices, say Nick Butler, Helen Delaney and Sverre Spoelstra

Earlier this year, Paolo Macchiarini – former star surgeon and professor at Stockholm’s Karolinska Institute – was dismissed from his post following a high-profile investigation prompted by a documentary broadcast on Swedish national television. Macchiarini was found guilty of failing to secure ethical approval for experimental transplant techniques and misrepresenting data in journal publications. The scandal continues to resonate throughout the scientific community and has so far led to the resignation of the vice-chancellor of Sweden’s most prestigious medical university and the secretary general of the Nobel Prize committee, among others.

Such egregious breaches of scientific protocol are serious, but mercifully rare. Far more prevalent – and therefore even more damaging – are research practices that fall into an ethical “grey zone” between overt misconduct and scholarly best practice. Academic misconduct refers to forms of fabrication, falsification and plagiarism (FFP) – in other words, the terrain of fraudsters, con artists and cheats. Questionable research practices (QRPs), however, are more difficult to pin down but typically involve misrepresentation, inaccuracy or bias. Recent research suggests that academics are becoming more adept at employing QRPs that skirt around the edges of misconduct, like athletes who optimise their performance with artificial enhancements without technically breaking the rules. To put it into perspective, one study found that only 2 per cent of scientists admit to FFP, while almost a third admit to engaging in QRPs.

One prominent example of a QRP is “HARKing”, standing for “hypothesising after the results are known”. Normally, researchers follow the standard scientific practice of developing a hypothesis and then testing it against the facts. But HARKing involves constructing or changing a hypothesis after the data have been collected and analysed. If this is concealed from journal editors, the integrity of the scientific process is compromised. Yet, strictly speaking, HARKing

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The high costs of getting ethical and site-specific approvals for multi-centre research (Papers: Adrian G. Barnett, et al | 2016)0

Posted by Admin in on December 22, 2016


Multi-centre studies generally cost more than single-centre studies because of larger sample sizes and the need for multiple ethical approvals. Multi-centre studies include clinical trials, clinical quality registries, observational studies and implementation studies. We examined the costs of two large Australian multi-centre studies in obtaining ethical and site-specific approvals.

We collected data on staff time spent on approvals and expressed the overall cost as a percent of the total budget.

The total costs of gaining approval were 38 % of the budget for a study of 50 centres (mean cost AUD $6960 per site) and 2 % for a study of 11 centres (mean cost AUD $2300 per site). Seventy-five and 90 % of time was spent on repeated tasks, respectively, and many time-consuming tasks, such as reformatting documents, did nothing to improve the study design or participant safety.

Improvements have been made to the ethical approval application system, but more gains could be made without increasing risks of harm to research participants. We propose that ethical review bodies and individual sites publish statistics on how long they take to process approvals which could then be nationally benchmarked.

Research ethics Ethical review Multi-centre study Australia

Barnett A, Campbell M, Shield C, Farrington A, Hall L, Page K, Gardner A, Mitchell B, Graves N (2016) The high costs of getting ethical and site-specific approvals for multi-centre research. Research Integrity and Peer Review. 1(16)
Publisher (Open Access):