Asthma study yanked for serious ethical violations

by Cat Ferguson

A paper in SpringerPlus on treating asthma with antioxidants was retracted on September 25 for something of a trifecta of ethical problems.

The retraction notice indicates that the patients never consented, there was no ethical review, and the university supposedly overseeing the study had no knowledge of it:

Improved treatment of Asthma by using natural sources of antioxidants Nguyen Van Toan1,2* and Tran Thi Hanh3 1 School of Biotechnology, International University, Ho Chi Minh City, Vietnam 2 Faculty of Applied sciences, University of the West of England, Bristol, UK 3 Home Clinic, 345 D5 Street, Binh Thanh District, Ho Chi Minh City, Vietnam Retraction

The original version of this paper (Van Toan and Thi Hanh 2013) is retracted because of ethical concerns: the clinical trial was not approved by an ethical board and the authors did not provide evidence that patient consent was obtained. The scientific advisor for this clinical trial (ANZCTR 2012) at the University of the West of England UK (an affiliation of the corresponding author) indicated he was not aware of this study and that the university was not involved.

It is a requirement that experimental research reported in SpringerPlus was performed with the approval of an appropriate ethics committee, and that research carried out on humans must be in compliance with the guidelines of the World Medical Association. Dr. Max Haring, Executive Editor for SpringerPlus References Australian New Zealand Clinical Trials Registry (2012) Trial ACTRN12 612000766819: Improved treatment of Asthma by using natural sources of antioxidants.https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000766819. Accessed 03 Sep 2014 Van Toan N, Thi Hanh T (2013) Improved treatment of Asthma by using natural sources of antioxidants.

SpringerPlus editor Max Haring gave us the details:

We were alerted to this by a reader who found that the article differed from the published trial registration. The article indicates the study was randomized but the registration states: Allocation to intervention: Nonrandomized trial. The reader also noted a difference in patient numbers between the publication and the registration.

 

SpringerPlus requires any experimental research that is reported in a manuscript to have been performed with the approval of an appropriate ethics committee, and research carried out on humans must be in compliance with the Helsinki Declaration. Informed consent must also be documented and these documents must also be made available if requested by the editorial staff.

 

This manuscript was rejected by another Springer journal but the author chose to resubmit to SpringerPlus. Due to human error it was understood that the article had been recommended as a transfer with portable peer review to SpringerPlus, and that certain concerns had been addressed. We no longer use this method for transfers after peer review for rejected manuscripts, and now screen all submissions to SpringerPlus for ethical and other issues before peer review.

And about that 'scientific advisor' who didn't know anything about the study? That would be Steven Neill, a University of the West of England plant scientist who has never, as far as we can tell, done any human research. Paper author Nguyen Van Toan received his PhD from UWE in 2007, but otherwise his only connection to the school seems to be his listing himself as an affiliate on the retracted paper.

Haring again:

I contacted Professor Steven Neill at the University of the West of England and informed him about our intention to retract this paper: he indicated that he nor his university had any knowledge whatsoever of this research. It is entirely possible that the author overstated or incorrectly listed his affiliation with UWE.

We talked to a representative for the university, who confirmed they had no record of the study, though they have not answered whether either paper author works at the school. We'e also reached out to the authors, and will update with any new information.

[Note: Please see the following excellent efforts by Vera Sharav, founder of the Alliance for Human Research Protection (AHRP), to help people be aware of AHRP's effort to stop health care researchers, bioethicists and officials from doing away with the requirement of 'informed consent' by any human subject participating in research (either purely experimental or therapeutic research). In other words, these proponents of doing away with informed consent consider the public as just one big source of research data (for the "greater good", of course -- however you define that!) -- where we like it or not, or know it or not. As noted in the article below, failing to procure legally and ethically valid informed consent would violate several international codes of research ethics. Sharavâ's articles:  PART 1: Medical Research Stakeholders Seek to Overturn Informed Consent Protection--Babies in Cross Hairs, at: https://www.ahrp.org/cms/content/view/925/9/ The OHRP and SUPPORT ” Another View, at: N Engl J Med 2013; 369:e3July 11, 2013DOI: 10.1056/NEJMc1308015 https://www.nejm.org/doi/full/10.1056/NEJMc1308015  PART 2: Medical Research Stakeholders Seek to Overturn Informed Consent Protection--Babies in CrossHairs, at: https://www.ahrp.org/cms/content/view/927/9/  PART 3: Bioethicists Promote the Business of Medicine, Not the Ethics of Medicine, at: https://www.ahrp.org/cms/content/view/928/9/ Informed Consent: The Subject's Right to Know Here's what you should ask before you decide to give your informed consent to research https://www.ahrp.org/cms/content/view/189/153/ [Comparative Effectiveness Research (CER)] . The article first appeared here.-- DNI]