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  • Gabriel Signorelli

Health & Medical Scientific Ethics


Prior to any research with humans and especially with patients, research methods should be taken to a committee that will judge whether the procedures meet the ethical requirements of protection for subjects who will be subjected to the intervention. This procedure is mandatory and the specialized journals in the area of medicine and health require that this information be in the text of the article submitted by the authors. But is this really verified?

Usually compliance with ethical procedures appears only as a citation in the part of methods in the papers, where the authors cite that the protocol was approved by an ethical committee and they refer to its protocol number in this ethical committee.

i.e. Signorelli GR et al. IJSM 2012.

This information is hardly checked with the aforementioned ethical committee, and a benevolence with the authors' austerity is the tool normally used to believe the ethical adequacy of the study. Still, not all studies clearly cite this information, which could generate mistrust as to how ethical aspects were considered in these surveys.

This information is hardly checked with the aforementioned ethical committee, and a benevolence with the authors' austerity is the tool normally used to believe the ethical adequacy of the study. Still, not all studies clearly cite this information, which could generate mistrust as to how ethical aspects were considered in these surveys.

The journal of medical ethics also published a study in 2006 with worrisome rates of studies where this information was not found in papers from five general medical journals [3].

"Ethical approval and consent were not mentioned in 31% and 47% of manuscripts, respectively.

88 (27%) papers failed to report both approval and consent."

Schroter S et al. J Med Ethics, 2006 [3].

More recently, specific studies of some health areas were published containing alarrant numbers of 36.5% articles did not report both in the Ayurvedic journal [4]. In otolaryngology journals the numbers of 49.9% studies lacked a statement of ethical approval and 42.9% lacked disclosure of informed consent [5].

Thereby, I believe that training and information for new researchers should be strengthened on the ethical theme, emphasizing the importance of this topic not only to publish but to ensure that subjects are having their rights preserved. Normally before participating in a trial, the patient receives a block of papers to be read and does not give due importance. it is up to the researcher to emphasize the main points and to encourage the patient to really understand what their role in research is.

I can make an analogy to the behavior we have when opening an account at the bank, where the extended contract is practically not considered and the contractor only trusts the bank manager's words. It should not be like that, we have to read the contract and understand the points clearly enough to take good care of our finances and avoid surprises in the future.

The health and integrity of subjects should be the most valuable item in research.

References:

[1] Yank V, Rennie D. Reporting of informed consent and ethics committee approval in clinical trials. JAMA. 2002 Jun 5;287(21):2835-8.

[2] Meschia JF, Merino JG. Reporting of informed consent and ethics committee approval in genetics studies of stroke. J Med Ethics. 2003 Dec;29(6):371-2.

[3] Schroter S, Plowman R, Hutchings A, Gonzalez A. Reporting ethics committee approval and patient consent by study design in five general medical journals. J Med Ethics. 2006 Dec;32(12):718-23.

[4] Bolshete PM. Reporting ethics committee approval and informed consent: Review of an Ayurvedic journal. Ayu. 2015 Jul-Sep;36(3):254-7. doi: 10.4103/0974-8520.182747.

[5] Murphy S, Nolan C, O'Rourke C, Fenton JE. The reporting of research ethics committee approval and informed consent in otolaryngology journals. Clin Otolaryngol. 2015 Feb;40(1):36-40. doi: 10.1111/coa.12320.

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© 2016 CATCH. This project has received funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie grant agreement 
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