Time to Bury Concerns about Monetary Undue Inducements in Research

Ethan Cowan, MD, MS, is an Associate Professor of Clinical Emergency Medicine and the Director of Research and Community Engagement in the Department of Emergency Medicine at Mount Sinai Beth Israel Hospital, Icahn Mount Sinai School of Medicine, New York, NY and our 2018 Andrew Markus visiting scholar.

Recently, I was a co-investigator on a National Institutes of Health (NIH) funded project studying the initiation of buprenorphine/naloxone in the Emergency Department for patients with moderate to severe opioid use disorder. This medication assisted treatment is instrumental in the fight against the raging opioid epidemic in the United States. To help encourage patients to participate in the study we provided them with a monetary incentive for enrollment and follow-up.  This incentive was not particularly large but for the Institutional Review Board (IRB) it raised concerns about undue inducement. In this study, and others like it, the concern of IRBs seems to hinge on the belief that money somehow impairs the ability of a potential research subject to provide valid informed consent for study participation. But, is this problem real or imagined? Continue reading “Time to Bury Concerns about Monetary Undue Inducements in Research”

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Time to Bury Concerns about Monetary Undue Inducements in Research

What is ‘necessary training’ in health-related research ethics?

Kristine Bærøe, Associate Professor at the Department of Global Public Health and Primary Care, University of Bergen

A couple of months ago a new Research Ethics Act was implemented in Norway. The rationale for replacing the preceding regulation was to strengthen legal responsibilities of researchers and institutions for promoting acceptable research [1]. According to the new regulation, researchers are held legally responsible for ensuring that they ‘act with caution to ensure that all research is conducted according to recognised research ethical norms’ [2]. At the same time ‘institutions are responsible for: a) necessary training of candidates and employees in recognised research ethical norms and b) that everyone who conducts or participates in the research is familiar with recognised research ethical norms’ [2]. The lawmakers have explicitly left it to the researcher community to define what is covered by ‘recognised norms’ [1], but implicitly the community will also have to define what should go into ‘necessary training’.

Continue reading “What is ‘necessary training’ in health-related research ethics?”

What is ‘necessary training’ in health-related research ethics?

Winter School @Ethox: “A most exciting experience!”

Suzanne Metselaar, Dept. of Medical Humanities, VU University Medical Center, Amsterdam, and Gerben Meynen, Dept. of Philosophy, VU University, Amsterdam

Since 2013, a one-week Winter School at the Ethox Center is part of our master programme Philosophy, Bioethics, and Health (PBH). PBH is an interdisciplinary, two-year MA-programme of the Dept. of Philosophy of VU University in collaboration with the Dept. of Medical Humanities of VU University Medical Center in Amsterdam. Students describe the visit to Ethox as a great learning experience: it is seen as the highlight of our Master programme. And the beautiful scenery and history of Oxford are certainly a great bonus!

Continue reading “Winter School @Ethox: “A most exciting experience!””

Winter School @Ethox: “A most exciting experience!”

It’s an emergency: should we ‘rescue’ vulnerable emergency care patients from research?

 pulpfiction

Kate Sahan, The Ethox Centre, Nuffield Department of Population Health, University of Oxford

A current emergency medicine trial, Paramedic2, which randomizes patients to adrenaline versus saline in cardiac arrest has put emergency medicine research (EMR) back under the spotlight. There are concerns that a ‘totally useless placebo’ will be more harmful than the standard adrenaline shot given during the resuscitation protocol. However, the history of EMR has taught us that some emergency interventions rest on an insufficiently-explored and updated evidence base[1]. For example, up until the early 2000s, corticosteroids were given to tens of thousands of severe head trauma patients in the belief they were medically beneficial. But it took a systematic, placebo-controlled research study of their use called CRASH to make an unwholesome discovery: steroids had no benefit, and caused actual harm by killing or severely brain-damaging more patients than placebo.

Continue reading “It’s an emergency: should we ‘rescue’ vulnerable emergency care patients from research?”

It’s an emergency: should we ‘rescue’ vulnerable emergency care patients from research?