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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Guidance and supplementary guidance: Safety monitoring and reporting in clinical trials involving therapeutic goods (Guidance: NHMRC | 2018)0

Posted by Admin in on May 3, 2018

The National Statement on Ethical Conduct in Human Research 2007 recognises that sponsors, investigators/researchers, institutions and HRECs all have relevant responsibilities. This Guidance, which replaces the Australian Health Ethics Committee’s 2009 Position Statement, is designed to clarify the responsibilities of all parties in relation to reports of adverse events (AE), including serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs), occurring in clinical trials for which institutions are responsible and for which the Human Research Ethics Committees (HRECs) have reviewed and approved.

This guidance specifically addresses the monitoring, collection and reporting of adverse events and adverse reactions that occur in clinical trials involving investigational medicinal products (IMPs) and investigational medical devices (IMDs) for trials conducted under the Clinical Trial Exemption (CTX) or Clinical Trial Notification (CTN) schemes. The Guidance is also broadly applicable to all clinical trials involving therapeutic goods.

NHMRC has developed the following documents to supplement the Guidance and to provide further advice for non-commercial and commercially-sponsored clinical trials involving therapeutic goods. This supplementary guidance covers the following topics…

Access the guidance material

Evolving friendships and shifting ethical dilemmas: Fieldworkers’ experiences in a short term community based study in Kenya (Papers: Dorcas M. Kamuya, et al | 2013)0

Posted by Admin in on April 29, 2018


This open access paper is a great read for researchers planning, or research ethics reviewers considering, projects that will involve local field workers.

Fieldworkers (FWs) are community members employed by research teams to support access to participants, address language barriers, and advise on culturally appropriate research conduct. The critical role that FWs play in studies, and the range of practical and ethical dilemmas associated with their involvement, is increasingly recognised. In this paper, we draw on qualitative observation and interview data collected alongside a six month basic science study which involved a team of FWs regularly visiting 47 participating households in their homes. The qualitative study documented how relationships between field workers and research participants were initiated, developed and evolved over the course of the study, the shifting dilemmas FWs faced and how they handled them. Even in this one case study, we see how the complex and evolving relationships between fieldworkers and study participants had important implications for consent processes, access to benefits and mutual understanding and trust. While the precise issues that FWs face are likely to depend on the type of research and the context in which that research is being conducted, we argue that appropriate support for field workers is a key requirement to strengthen ethical research practice and for the long term sustainability of research programmes.

Kamuya, D., Theobald, S.J., Munywoki, P.K., Koech, D., Geissler, W.P. and Molyneux, S.C. (2013) Evolving friendships and shifting ethical dilemmas: Fieldworkers’ experiences in a short term community based study in Kenya. Developing World Bioethics 13(1): 1-9.
Publisher (Open Access):

(US) Boston University rejects geologist David Marchant’s appeal of termination – Science (Meredith Wadman | February 2018)0

Posted by Admin in on April 28, 2018

Boston University (BU) has denied geologist David Marchant’s appeal of its decision to terminate him, the Massachusetts-based institution announced yesterday. Late last year, the university moved to fire Marchant after an investigation concluded that he sexually harassed a graduate student during fieldwork in Antarctica nearly 2 decades ago.

This is an update on a story we have previously included in the Resource Library

Marchant has not yet exhausted all options in attempting to save his job. Marchant “has the right to have a faculty committee determine whether termination is the appropriate sanction, and the timing of the initiation of that committee’s work is being determined,” BU spokesperson Colin Riley wrote in a 27 February email.

Riley said that Marchant remains on paid administrative leave. He declined to identify who at the university denied the appeal, or when and on what grounds the decision was made.

Read the rest of this news story

A real-life Lord of the Flies: the troubling legacy of the Robbers Cave experiment – The Guardian (David Shariatmadari | April 2017)0

Posted by Admin in on April 17, 2018

In the early 1950s, the psychologist Muzafer Sherif brought together a group of boys at a US summer camp – and tried to make them fight each other. Does his work teach us anything about our age of resurgent tribalism?
……Read an extract from The Lost Boys

July 1953: late one evening in the woods outside Middle Grove, New York state, three men are having a furious argument. One of them, drunk, draws back his fist, ready to smash it into his opponent’s face. Seeing what is about to happen, the third grabs a block of wood from a nearby pile. “Dr Sherif! If you do it, I’m gonna hit you,” he shouts.

A useful example of the degree to which such work not only fails modern ethical standards, its results were cherry-picked and stage managed. We note again our caution about using such cases to justify current human research ethics/research integrity arrangements. Also see James Kehoe recent post.

The man with the raised fist isn’t just anybody. He is one of the world’s foremost social psychologists, Muzafer Sherif. The two others are his research assistants. Sherif is angry because the experiment he has spent months preparing for has just fallen apart.
Born in the summer of 1905 and raised in İzmir province, Turkey, during the dying days of the Ottoman empire, Sherif won a place at Harvard to study psychology. But he found himself frustrated by the narrowness of the discipline, which mainly involved tedious observation of lab rats. He was drawn instead to the emerging field of social psychology, which looks at the way human behaviour is influenced by others. In particular, he became obsessed by group dynamics: how individuals band together to form cohesive units and how these units can find themselves at each other’s throats.

Read the rest of this discussion piece