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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

What Keeps Patients Out of Clinical Trials? – Medscape (Lori M. Minasian & Joseph M. Unger | May 2020)0

Posted by Admin in on June 14, 2020

The conduct of clinical trials is key to identifying better ways to prevent and detect cancer in persons at risk and to treat patients diagnosed with cancer. Unfortunately, while patient participation in a clinical trial is entirely voluntary, few patients actually have the opportunity to consider trial participation. Instead, a combination of structural and clinical barriers intercedes to bar opportunities for trial participation for most patients. There are multiple fronts by which to improve the drivers underlying the system, and we offer three of them here.

“Clinical trials are key to advancing cancer research, yet patient participation remains low. What factors may account for this?” We expected this to explore participants’ views, but this is more from the perspective of clinical trial coordinators. Nevertheless, it is a useful discussion.

Much of the literature about accrual to clinical trials has focused on the patient’s willingness to participate. Seldom have researchers considered the entire trial decision-making pathway for patients. We previously conducted a systematic review of the literature and found 7,576 articles and abstracts matching the search terms “clinical trial accrual”, “clinical trial enrollment”, “enrollment in clinical trials”, “clinical trial enrollment barriers”, and “patient participation in clinical trials” in combination with the term “cancer.” Among these, only 13 studies explicitly examined the entire clinical trial decision-making pathway beginning at patient diagnosis.[1] We found that no trial was locally available for 56% of all patients with cancer, representing a structural barrier to clinical trial participation of considerable magnitude. Among remaining patients, 21% were not eligible for a trial. Thus, for more than three (77%) of four patients with cancer, the opportunity for the patient’s physician to offer a trial and for the patient to volunteer to participate is not even possible. Under these conditions, patient choice has limited influence on the overall pattern of trial participation.

The findings above highlight how structural barriers at the institutional level dominate trial decision making. Institutional participation in research requires a substantial investment in the conduct and oversight of clinical trials. Even if an institution chooses to build a trial program, its physicians and other health care providers must then choose to serve as investigators or research staff in clinical trials. The challenges of implementing such a program were examined in two recent studies. The National Cancer Institute (NCI) Community Oncology Research Program (NCORP; previously the NCI’s Community Clinical Oncology Program [CCOP]) is designed to expand access to clinical trials and promote cancer treatment innovations for community-based patients who often have limited opportunity to travel to major cancer centers to receive care.[2] On the basis of data from 41 administrative, physician, and nurse key informants from five sites, McAlearney et al[3] identified several major themes representing the administrative, financial, and organizational challenges of implementing a clinical trial program at a community site, including a lack of understanding and appreciation of the value and conduct of trial participation, the cost of supporting the program and meeting program requirements, managing clinic workflow changes as they pertained to patient recruitment and physician involvement, and sustaining hospital leadership support.

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‘It’s never okay to say no to teachers’: Children’s research consent and dissent in conforming schools contexts (Papers: Perpetua Kirby | May 2020)0

Posted by Admin in on June 11, 2020


With thanks to Dr Jo-Anne Kelder, University of Tasmania for suggesting this great paper.  This is a recommended read for researchers and research ethics reviewers.

This article examines the limits to children giving research consent in everyday school contexts that emphasises their conformity to comply with adult expectations, and highlights children’s competence and agency in navigating this conformity through different practices of dissent. It draws on research into children’s agency, using a multimodal ethnography of Year 1 classrooms in two English primary schools. The article includes a reflexive methodological focus, exploring the extent to which I counter the schools’ emphasis on conformity. This includes creating visuals for children to practice consent; positioning myself as the researcher in a non‐teacher role, as ‘least adult’ and the one who ‘least knows’; and designing interview spaces markedly different from classrooms. The article examines how children navigate conforming discourses by finding different ways to dissent in the research. Firstly, children demonstrate a sophisticated awareness of the cultural norms of indicating refusals beyond saying the word ‘No’. Secondly, children achieve unnoticeablity, by which they absent themselves from the ‘on‐task’ classroom culture, and by extension the research process. Thirdly, they engage in playful dissent, demonstrating their political knowingness of the classroom social order. The article discusses the implications for educational research when the values of consent are in conflict with a schooling focused on conformity. This includes emphasising the limits of consent procedures, paying closer attention to how researchers recognise and respond ethically to children’s multiple practices of dissent, and using research to disrupt problematic power structures in education settings that limit possibilities for children’s consent.

Kirby, P. (2020), ‘It’s never okay to say no to teachers’: Children’s research consent and dissent in conforming schools contexts. British Educational Research Journal. doi:10.1002/berj.3638
Publisher (Open Access):

The Lancet has made one of the biggest retractions in modern history. How could this happen? – The Guardian (James Heathers | June 2020)0

Posted by Admin in on June 8, 2020

The now retracted paper halted hydroxychloroquine trials. Studies like this determine how people live or die tomorrow

The Lancet is one of the oldest and most respected medical journals in the world. Recently, they published an article on Covid patients receiving hydroxychloroquine with a dire conclusion: the drug increases heartbeat irregularities and decreases hospital survival rates. This result was treated as authoritative, and major drug trials were immediately halted – because why treat anyone with an unsafe drug?

Now, that Lancet study has been retracted, withdrawn from the literature entirely, at the request of three of its authors who “can no longer vouch for the veracity of the primary data sources”. Given the seriousness of the topic and the consequences of the paper, this is one of the most consequential retractions in modern history.

It is natural to ask how this is possible. How did a paper of such consequence get discarded like a used tissue by some of its authors only days after publication? If the authors don’t trust it now, how did it get published in the first place?

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Should We Purposely Infect Healthy Volunteers With Covid-19? – WIRED (Victoria Turk | May 2020)0

Posted by Admin in on June 4, 2020

Such studies could speed up the development of a vaccine—but would mean deliberately giving people a disease that could kill them.

IN LATE MARCH, Josh Morrison was sitting in his apartment in Brooklyn, New York, feeling miserable. Work had slowed down at the nonprofit he runs, which advocates for living organ donors, and he was worried about his parents and whether they were following the guidelines to stay safe during the coronavirus pandemic. He’d been planning to visit them in early April for their 40th anniversary in Florida, but had to cancel. “That was hard, and that was really sad,” he says. “I really want to be able to see my parents as soon as I can, and be back to a situation where you can do that.”

Ethical reflections when they are theoretical can be entertaining and engaging, but the stakes and consequences here are frightening and real.  In a world desperate for a cure, a vaccine or just an efficacious treatment, how far should we go?  Should we allow people to expose themselves to a risk of death or potentially longterm disability?

Morrison, who is 34, felt powerless. He wanted to be able to do something constructive. It was in this context that he came across a paper in The Journal of Infectious Diseases which put forward the case for human challenge studies of Covid-19 vaccine candidates. Challenge studies purposely infect healthy volunteers with a pathogen in order to study a disease or test a treatment or vaccine. This paper suggested that using human challenge studies could speed up the development of a Covid-19 vaccine by months, potentially saving thousands of lives. “The idea of speeding that all up and getting this stuff done with is pretty appealing,” Morrison says. “And also, I thought that I personally could participate in one of these.”

After contacting some friends, Morrison set up 1 Day Sooner, a group that advocates on behalf of volunteers for Covid-19 human challenge studies. No such studies are yet being conducted, but at the time of writing, more than 24,000 people from 102 countries have signed up on the 1 Day Sooner website to express an interest in taking part in one. Globally, there have now been more than five million reported cases of Covid-19, and 300,000 deaths. Should we let people volunteer to be purposely exposed to a virus we know can sometimes be fatal?

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